ADVISORY COMMITTEE ON HUMAN RADIATION EXPERIMENTS


                                 + + + + +


                           Friday, June 23, 1995



          The Advisory Committee met in the Executive Chambers at
the Madison Hotel, 15th and M Streets, NW, Washington, DC, at
8:30 a.m., Ruth Faden, Chair, presiding.


     Advisory Committee Members:

          Ruth Faden, Ph.D., M.P.H., Chair
          Eli Glatstein, M.D.
          Jay Katz, M.D.
          Patricia A. King, J.D.
          Ruth Macklin, Ph.D.
          Lois Norris
          Nancy Oleinick, Ph.D.
          Henry Royal, M.D.
          Philip Russell, M.D.
          Mary Ann Stevenson, M.D., Ph.D.
          Duncan C. Thomas, Ph.D.
          Reed Tuckson, M.D.

     Staff Present:

          Dan Guttman
          Anna Mastroianni
          Steve Klaidman
          Jonathan Moreno
          Jeremy Sugarman
                Agenda Item                                            Page


Committee Discussion: Recommendations for the
     Protection of the Rights and Interests
     of Human Subjects [Part IV, Chapter 19]                              5


Committee Discussion: Findings--Contemporary
     Intentional Releases [Part IV,
     Chapter 18]                                                        128


Committee Discussion: Recommendations for
     Balancing National Security Interests
     and the Rights of the Public [Part IV,
     Chapter 19]                                                        129


Committee Discussion: Recommendations on
     Openness [Part IV, Chapter 19]                                     244


Committee Discussions: Outstanding Issues                                  






                           P-R-O-C-E-E-D-I-N-G-S

                                                                (8:44 a.m.)

          CHAIRPERSON FADEN:  It was a good morning until we read
the newspaper.   Actually it's usually a good morning until I
read the newspaper.

          DR. GLATSTEIN:  Oh, don't take it too seriously.

          CHAIRPERSON FADEN:  Thank you, Eli.  Yeah, but the
content isn't accurate either.  Okay, all right, we have a lot of
work to do.  Even if the Post can't get it right, we're going to
try to get it right.  Okay, we're going to pick up where we left
off.  I think the agenda will definitely change slightly, and
that is -- what we'll do, if you look at the afternoon schedule,
is that we've got lunch and openness and outstanding issues.

          What we're going to do is turn that around and put
notification issue that we didn't get in on -- what's today? 
Wednesday -- on Wednesday's agenda after lunch is when we'll do
notification.  Today's Friday.  So I'm saying on Wednesday we
didn't get to notification.  I'm not that -- I am distracted, but
not that badly.

          I still have the days of the week, right?  So instead
of doing openness after lunch, we will do notification and then
openness so that we had openness and -- because we can't risk
putting it off  yet again.  We also wanted to revisit -- I'm
flipping it over.  I want to make sure that notification gets --
I don't want to risk at all the possibility that we don't discuss
notification, because it's been put off too many times, and it's
still in many respects unresolved.

          We also need to find time in the agenda to revisit the
uranium miners' recommendation.  There's a draft -- no, two
drafts actually -- two alternative drafts for the committee to
consider.  They differ only in terms of -- one is the one that
says -- well, when you get to it, you'll see.  But there are two
versions of the  uranium miners' recommendation out reflected the
two approaches that the committee simply wanted -- we wanted to
consider on Wednesday.

          If we could march through the rest of the contemporary
recommendations for human subjects quicker than the agenda
requires, that would be nice.  What we need to do now is turn to
recommendations and continue as far as we can to get through the
recommendations for the protection of the rights of human
subjects.

          I would take us -- let us finish -- if we could get to
page 12 -- 23 of the recommendations chapter, chapter 19 -- this
is the set of recommendations on military personnel as research
subjects.  That's where we left off.  But we shouldn't think
we're that far ahead.  If you recall, we skipped recommendations
eight and nine, which we have to go back to -- the education
recommendations.

          And even though people tend to have an attitude --
well, education, that's not going to be problematic, we still
need to discuss it, and it is a real recommendation.  And we have
-- these are real recommendations, and we have to decide if we've
got them right.  But if it's all right with everybody, I'd like
to pick up where we left off -- do the rest of the contemporary
human research recommendations, and then go forward.

          Okay, if we could start with recommendation 12, which
is in how many parts here?  Four parts, 12A, 12B, 12C and 12D. 
Are there discussions, comments -- are people comfortable with
accepting these recommendations?  Does anybody want to take
objection to any of them?  Mary Ann?

          DR. STEVENSON:  One objection.  I want to probably
direct this at Phil.  How much of this do we know, if at all, is
in place?  Anything, nothing?  I mean, there's -- when you read
through the text, you get the feeling that some of it may have
been partially implemented in places.

          DR. RUSSELL:  Well, I think the system that's in place
in the military is probably --

          DR. STEVENSON:  Is what?

          DR. RUSSELL:  In the three armed services and the
Department of Defense, is very comprehensive and very detailed. 
I think the -- and where the research is military in nature or
related to military objectives rather than just clinical
investigation at a medical center, there are two levels of
review.

          So I think a substantial amount of it is in place. 
There's one recommendation about non-participation of leadership
that is partially in place.  It's a common practice, but not
always practiced.  I don't think there's a lot of -- a lot in
this recommendation that's going to make substantial change.  

          And I do want to have to comment about the -- that no 
unit officers or non-commissioned officers were present, because
in the first place, because of the high level of technology in
the services, there's a lot of non-commissioned officers.  And in
many potential studies, experiments, the participation of the
non-comms would be very critical.

          And especially if you need to do the study as units. 
And so, while it's -- I think important to minimize or eliminate
if possible command influence on volunteering, the -- in some
instances it's absolutely essential to allow at least the mid
level of the non-commissioned ranks to participate.  So, we have
to allow for that in here.

          CHAIRPERSON FADEN:  How would you want to amend it,
Phil?  Would you want to leave it that -- we're on page 26, line
five.  Would you want to -- would you agree with the
recommendation with respect to unit officers?  Let's start with
that.

          DR. RUSSELL:  Well, I would limit it to officers and
non-commissioned officers who would not be expected to
participate in the experiments.

          CHAIRPERSON FADEN:  Well, that's a -- so where they're
not being asked?

          DR. RUSSELL:  Where they're not being asked to
participate, then it's appropriate that the command not be
present at the briefings.  But I think if we put in a statement
about whether or not expected to be participants as volunteers.

          CHAIRPERSON FADEN:  Where they're not being asked to
volunteer themselves.

          DR. RUSSELL:  Where they're not being asked to
volunteer, yes.  That 12D, I'm not sure that the Navy and Air
Force don't have those registries already in place.  

          CHAIRPERSON FADEN:  Do they?

          DR. RUSSELL:  Yes, they probably do.

          CHAIRPERSON FADEN:  Dan, do we know that they don't?

          MR. GUTTMAN:  I don't know.

          CHAIRPERSON FADEN:  So we have to check.  So obviously
if they have the registries, we don't -- we're not going to ask
them to do it.  We can just tell them it's a good idea you have
it.  Okay, we'll change it from -- we applaud -- so 12D is
acceptable, provided it's not redundant.  Okay, 12C with a
modification that Phil has introduced.  Nancy?

          DR. OLEINICK:  Can I just follow up on the response
that you made, Phil?    I can understand the officers needing to
be there if they are part of the experiment, but the issue here
is whether the enlisted people or those under their command have
-- can voluntarily participate.  Now, is there some mechanism by
which the individual soldiers can be -- voluntarily participate
without undue coercion?

          DR. RUSSELL:  That's very common.

          DR. OLEINICK:  I mean, given the scenario that you've
given us now, if their officers are present.  I mean, that's the
issue.  Is there a mechanism by which they could be asked in the
absence of their officers?  I guess that's the issue here.

          CHAIRPERSON FADEN:  Well, the turning it around just
makes --

          DR. RUSSELL:  Oh, I see what you mean, certainly,  yes.

          CHAIRPERSON FADEN:  I mean, turning it around just to
make sure that what you're saying can't -- is a bar to the
recommendation in its current form,  Phil.  Assuming that either
unit officers or some NCO's are also being asked to participate
in the research, couldn't they be asked separately?

          DR. RUSSELL:  Yes, definitely.

          CHAIRPERSON FADEN:  So couldn't we leave the way -- I
mean, because there seems to me something to this recommendation. 
We know it's common practice voluntarily, so it can't be that
burdensome.  You could always ask them --

          DR. RUSSELL:  It depends on the study.  If you're just
looking for a group of volunteers to test a vaccine and it
doesn't matter whether you -- what the ranks are, it's very
common to exclude all the senior NCO's and officers from the
briefing.  And so, that the volunteerism has no -- on the other
hand, if for example you're doing a study that requires whole
tank crews, okay, then you can't exclude the tank crew
commanders.

          You have to have the whole crew participate or nobody. 
And so, you have those  kinds of -- what I'm trying to do is make
it -- put as much volunteerism and less command influence as
possible into without precluding doing some militarily essential
studies that may have to be done by a unit, or at least in small
groups.

          DR. STEVENSON:  Could you use that qualifier except
where militarily required?

          DR. RUSSELL:  Well, maybe we could do that.  Maybe we
could.

          CHAIRPERSON FADEN:  Ruth?

          DR. MACKLIN:  Let me try to understand here.  We're
talking about two things.  One is the recruitment process, and of
course closely related to that is the participation.  Now, what I
just heard you say, and I just want this for clarification, is
there are some experiments in which the whole crew -- I think as
you put it -- the whole unit, has to participate.

          In which case, there's no possibility of not
participating.

          DR. RUSSELL:  Yes.

          DR. MACKLIN:  If no one does?

          DR. RUSSELL:  But if they choose not to, they choose
not to.

          DR. MACKLIN:  As individuals?

          DR. RUSSELL:  As individuals.  But then you can't do
the experiment, okay?  So that has got in the way of doing a lot
of studies, and --

          DR. MACKLIN:  Well, that's what's important to know, I
think.  In other words, when you say it's gotten in the way of
doing a lot of studies, does that mean that sometimes there's not
-- the studies are not conducted because some people in fact
don't want to participate?

          DR. RUSSELL:  Oh, yeah.  We've had difficulties with
levels of participation.  We compromise the study.  What I want
to try to do is to keep it from coming administratively
impossible to do some essential studies such as -- oh, you can
think of a physiologic study of heat stress in a vehicle under
certain conditions where you have to instrument the crew and
drive it around in the desert.

          Well, you can't do that unless you've got the whole
crew participating.  And so, I would want to make it impossible -
- or, I mean I would want to make it possible to recruit those
folks.  And you can't exclude the NCO commander of the vehicle.

          DR. THOMAS:  It's an accepted principle that in this
situation a single person who declines basically makes it
impossible to do the study with that unit, is that right?

          DR. RUSSELL:  Well, it may be possible.  But you know,
that's a hypothetical experiment.  That one -- maybe you could do
it with only two, maybe a few of the people instrumented and not
all of them.  Maybe it's possible.  On the other hand, you have
various positions in the vehicle and so forth, so you -- I don't
want to be too specific about a hypothetical study.

          DR. THOMAS:  No, no.  Assuming that it were possible to
do the study with -- assuming it were not possible to do the
study without everybody in the unit being a participant, then it
follows that if a single individual in the unit declines to
participate, that means the unit doesn't participate?

          DR. RUSSELL:  That might be true.

          DR. THOMAS:  And then so the only remaining question --

          DR. RUSSELL:  If you had to do it on aircraft crews --
if the pilot refused to participate, you couldn't do it.

          DR. THOMAS:  Yeah.  But then I guess the only remaining
question is whether undue coercion might be placed upon that one
hold out.  But I don't see that we can do anything about it.

          DR. RUSSELL:  Well, I don't think we should put in
place -- make it absolutely impossible --

          CHAIRPERSON FADEN:  Why don't we do the following:  I
think what we can do is -- I take it that the ombudsman or
ombudsperson, whatever the -- is unobjectionable.  I want to
argue very strongly for that.  I think that it's --

          DR. RUSSELL:  No, I think that's fine.

          CHAIRPERSON FADEN:  Particularly in the circumstance
that you  just described.  There has to be some independent
person that is doing some sort of vouchsafing that the whole
thing isn't a farce, that it really is a sincere commitment to
the principle that this is not an order but a request or whatever
-- however we phrase it.

          With respect to the first one, we could put in with
some sort of a clause that says except under a narrow set of
circumstances determined by somebody or other.  And we'll figure
out maybe with Phil who the right person -- or let the services
decide the right procedure for determining when -- who should
decide when an exception is appropriate, but allow for an
exception.

          That the language we'll come up is the language --
clearly it's meant to be an exception, and the services have to
come up with some mechanism for indicating it's an exception and
it's certainly any that the ombudsmen could not be waived even in
the circumstance where the NCO and the unit officers were there. 
Yes?

          DR. KATZ:  Yes, the weakest kind of comment is that if
he had this exception, hopefully it can be that -- not in terms
of a person having the authority to get permission, but rather in
terms of the circumstance under which they can be considered --
if the words could be found, I would feel more comfortable.

          CHAIRPERSON FADEN:  Fine.  So you would --

          DR. KATZ:  It's quite an exception.  And of course, you
know in any other areas, people have no objection to the
ombudsmen, there is always the danger in some studies and have
documented this, that the ombudsmen then gets -- by the
institution --

          CHAIRPERSON FADEN:  Sure.

          DR. KATZ:  -- in which he lives.  So that's part of the
fact of life.

          CHAIRPERSON FADEN:  I think that's fine.

          DR. KATZ:  So -- but it could be done along those
lines, because it's an important exception to -- and a necessary
exception maybe to an individual choice.

          CHAIRPERSON FADEN:  Well, that would be fine.  I think
we could come up with some language.  So with that exception -- I
mean, with the revised -- the revisions that we've just
discussed, I take it 12C is okay.  12D will remain if it isn't
already in place.  So it will remain for only those branches of
the military where -- I mean, well, we already know the Army has
it.  

          So the issue is whether the Navy and the Air Force have
it.  I'm taking it -- because no one's commented, that let's just
for the record get it clear that 12A and 12B --

          DR. STEVENSON:  Are okay --

          CHAIRPERSON FADEN:  -- are okay?  Well, I don't know
that they're redundant.

          DR. STEVENSON:  Okay.

          CHAIRPERSON FADEN:  I mean, the point is -- at least in
my conversation with Phil and with the people from the military
with which we've been consulting, I really don't think either are
redundant.  And the services are in the process of reviewing
their own procedures as we speak, and I think particularly 12B is
a tough one.

          It's really no -- for those of us who have just
finished going through an accreditation process for their medical
institutions know -- although this was probably hospital, I would
assume, Reed, rather than the whole thing -- the whole deal --
that it's very hard to get curriculum space in a medical school
-- my understanding from talking to Phil and other people is it's
very difficult to get curriculum space in the training of
military officers.

          So to say that we think -- so the 12B, which says
basically officers have to be educated about the regulations
governing research involving military personnel as subjects is
not trivial.  And you know, may not be easy to implement because
there's only 100,000 things that obviously people in the services
want their officers in training to know.

          So it would be like a medical school curriculum, which
we'll go back to fighting over.  You know, an hour for subjects
regulations against an hour on God knows what -- but it might
seem a whole lot more important to the people who are designing
the officer training curriculum.

          So it's not -- you know, as -- as it sounds, I don't
think.  So I take it that 12A, 12B, 12C with the revision that
we've just discussed, and 12D are okay?  Ruth?

          DR. MACKLIN:  I just want a clarification on -- with an
example under number two, page 25, line six, number two, and that
is --  under 12A.  All right, clearly distinguish those
activities that are research and therefore discretionary on the
part of the member of the armed services from other activities
that are obligatory such as training maneuvers and medical
interventions intended to protect the troops.

          Now I mean, training maneuver sounds like it doesn't
have a medical research component.  But I'm just concerned that
there are some things that could be named research that
biomedical research -- or could be called training maneuvers. 
And my concern is whether some things that would otherwise be
research, except for the fact that they're taking place in the
military end up being in the training maneuvers or medical
interventions -- and maybe it's a second really -- medical
interventions intended to protect the troops because the context
is the military.

          So, I'm just wondering whether that clear distinction
is possible.  I mean, I don't have any examples, so I can't
clearly give the --

          CHAIRPERSON FADEN:  But the challenge is for the
military to figure out how to clearly distinguish.

          DR. RUSSELL:  I think that is --

          CHAIRPERSON FADEN:  That is what we're asking.

          DR. RUSSELL:  That goes right in to 12B.  There's a
whole set of regulations that define what is research that has to
be done under the human subjects regulation, what is equipment
testing that may involve people driving the vehicles or shooting
the weapons or whatever, and how that relates, and when -- what
the difference is between training and human experimentation.

          I think there's been a lot -- a tremendous amount of
work done on those regulations.  Some of my concern, based on
experience, is the capability of everybody concerned to
understand and interpret the regulations, which is why we've put
the 12B --

          DR. MACKLIN:  All right, well let me -- can I just ask
it a different way?

          CHAIRPERSON FADEN:  Sure.

          DR. MACKLIN:  Because I mean, I'm obviously thinking of
the only  thing I know about this, which is what this committee
has looked at.  The regulations that are now in place, Phil, that
you describe, are things -- I mean, the committee had a
difficulty understanding -- you probably didn't, but I did --
what the distinction in the studies that we looked at, what was
necessary for training maneuvers or for operations or for
occupational safety -- all these other words that we were using
to describe what went on.

          And it seemed to me we ended by saying sometimes you
can't distinguish the two from the nature of the activity because
it's exactly the same activity.  So we were left with a gray area
and with the understanding that for some purposes, what is a
training activity or occupational safety might otherwise be a
medical experiment.  

          Now, what I'm -- I mean, and that was what we looked at
and I think sort of came to the conclusion in those past -- in
the studies we looked at that took place in the military.  Now,
my question is about the regulations you've just described. 
Those, I take it, were put in place after the -- all those tests
that we looked at.

          CHAIRPERSON FADEN:  Way after.

          DR. MACKLIN:  And the question is whether they go
farther towards making this kind of distinction that is clearly
distinguishing what seems to be implied here and which I think
you said, that the regulations are there now.  Am I being clear?

          DR. RUSSELL:  Yeah, I think yes, they have been put in
place and rewritten -- or revised several times since the issues
we looked at here.  And I think the key issues that have to be
considered are whether you're really doing experiments on the
individuals or whether you're -- or conducting a military
training exercise.

          Now a military training exercise frequently is very
hazardous.

          CHAIRPERSON FADEN:  Yeah.

          DR. RUSSELL:  To train the troops and crews properly,
the have live fire exercises, very hazardous.  They -- and the
atomic weapons tests were -- the military took advantage of them
to basically do live fire maneuvers on the atomic battlefield. 
Those were novel maneuvers, but they were not -- and today would
not be human subject experiments.

          CHAIRPERSON FADEN:  They wouldn't.

          DR. RUSSELL:  On the other hand, if in the course of
these kinds of exercises somebody finds it necessary to do
studies of physiologic responses or psychologic stresses or
toxicologic studies or whatever, then the human subjects
regulations kick in and you have to do all that under the
volunteer regulations.

          But the fundamentally high hazardous occupational
problems of training military crews with live munitions and so
forth are not voluntary.  And they can --

          DR. MACKLIN:  Well, I don't think anyone would construe
those as biomedical experiments.  I mean, it would be foolish
opening the door to calling everything that ever exists a
biomedical experiment, and that's not right.  So all these things
that are hazardous that don't -- that could not reasonably be
called biomedical experiments except by expanding the concept
beyond reason, I don't have any problem with that.

          I'm going back to the gray area where in one context
something that would be a biomedical experiment to see what the
dose of radiation is that's absorbed when you rub your hand
against the fuselage or something might in another context be a
occupational training or hazard training study that's required
for the operation of the activity.

          That's the one -- I don't care about the weapons and
all that stuff, because that's not biomedical.  I'm thinking of
exactly the ones that could be classified in either setting,
depending on whether they take place in some laboratory in a
civilian environment, or whether they take place in the military.

          Now, I mean, that's really what I'm concerned about.

          DR. RUSSELL:  When you're doing the studies of
occupational hazards, I don't -- that one is a little bit gray. 
But I would -- I think it was a bit of a bizarre experiment, but
I think that probably would have fallen -- would today fall under
human volunteer.

          CHAIRPERSON FADEN:  The situation is clearly that there
will remain gray areas.  Now what we know is there's no
regulation in the world capable of addressing every context or
every situation.  As best as I was able to figure it out, the
military now has regulations up the wazoo for everything, okay?

          (Laughter.

          Now that doesn't mean --

          DR. MACKLIN:  I'm glad you said that.

          CHAIRPERSON FADEN:  Right -- it really was -- set down
their regulations for regulations for regulations, which sort of
doesn't surprise me.  But that's basically how it is.  And there
are very many regulations with respect to safety and risk
management for all of these hazardous training maneuvers that are
not considered research.

          So when we asked for regulations that govern protecting
exposing service personnel to risk, most of the regulations and
manuals and policies that we got were not for the human subjects
protections but for all this sort of training stuff and use of
new equipment.  And then they had this other evoking of the term
volunteer that's not in a human subject context, but they asked
for volunteers to check out -- in some of these hazardous new
things, they asked for volunteers to be the first to use the
whatever, but it's in the training.

          DR. RUSSELL:  There's a lot of volunteerism that has
nothing to do with the --

          CHAIRPERSON FADEN:  Right, exactly.  That's what I was
trying to -- so there's --

          DR. MACKLIN:  I'm interested in the intersection.

          CHAIRPERSON FADEN:  And the problem is that we won't be
able to regulate it away.  So the issue here is to tell the
military to try again -- look at it and see if you've got it as
clear as you can get it, okay?  And in any event, work on -- the
bigger problem seems to be not -- you know, refining the
definitions or coming up with yet more procedures and
protections.   

          But the concern that people who are in the position to
be telling other people under them what to do don't -- may not
know, even the distinctions that have been made.  And that's the
concern that -- the human volunteer stuff is apparently well
understood by the people -- or it's claimed anyway -- well
understood by the people who are the scientists in the military
or the physician scientists in the military.

          But they're not necessarily the people who we're most
concerned about in terms of the message that's given to the
soldiers or the sailors but their unit officers who may not
appreciate that hey, this is really an activity that's to be
considered discretionary.

          So, I don't know that there's a way  to resolve --

          DR. MACKLIN:  No, there's no way to resolve that.  I
mean, I would agree you can't regulate it away.  I would like to
see, however, some acknowledgement, some -- possibly a discussion
under 12B that captures some of these points --

          CHAIRPERSON FADEN:  That would be fine.

          DR. MACKLIN:  -- in the report.  So that it doesn't
then look as if this committee thinks that regulations can solve
everything.

          CHAIRPERSON FADEN:  That would be very helpful.

          DR. MACKLIN:  And that you can regulate it away.

          CHAIRPERSON FADEN:  Okay.

          DR. MACKLIN:  And I think it should include an
acknowledgement that there are many things in the military that
are not voluntary in the nature of what the military is.  I mean,
many things in these training maneuvers or whatever we're
discussing here that are not voluntary, and that sometimes
activities that would otherwise be or look like -- I don't know
what the right word is here -- or could otherwise be classified
as human experimentation, might be part of a training maneuver.

          That's what the gray area is.

          CHAIRPERSON FADEN:  I'm not sure that's right.

          DR. MACKLIN:  Well, --

          CHAIRPERSON FADEN:  We can try it.  I mean, we can go
back and see.  I'm not sure that characterization is right.  I
think what you're basic -- what you're going for is clearly
correct.  There are gray areas that are very significant.  But I
don't know that the training is the right place to pick it. 
We'll work on the language.

          DR. MACKLIN:  Well, maybe it's under -- sorry.  Then
maybe it's under medical interventions and to protect the troops.

          CHAIRPERSON FADEN:  Yeah, I think it may be.

          DR. MACKLIN:  If those are -- and maybe that's really
where we ought to look at it, because that's medical.

          CHAIRPERSON FADEN:  Right, right.

          DR. MACKLIN:  If medical interventions intended to
protect the troops are such that they are in the nature of the
case not established medical interventions, --

          CHAIRPERSON FADEN:  Correct.

          DR. MACKLIN:  -- but are the only thing that might
protect the troops, --

          CHAIRPERSON FADEN:  That's correct.

          DR. MACKLIN:  -- and they are authorized as mandatory
or obligatory or non-voluntary because of that, then I want to
see that as an acknowledgement.  I mean, otherwise it makes it
look like research in the military is just like research anywhere
else.  But I think it's not.

          CHAIRPERSON FADEN:  Can we work on language?

          DR. MACKLIN:  What?

          CHAIRPERSON FADEN:  You're talking --

          DR. MACKLIN:  Yes.  I'm just talking about putting in a
paragraph that acknowledges --

          CHAIRPERSON FADEN:  Acknowledges that the context is
complicated and raises different kinds of issues then.  And each
setting raises different issues.  We've already discussed
yesterday the complications in the context of the hospital
setting and the old person, and that raises one set of issues.

          Now you've got a different set of issues that are
raised in the context of the military with uniformed personnel,
which is a different set of issues.  And the different kinds of
pressures and different contexts and different kinds of attention
in different environments.

          So what you're suggesting is this report not look dumb
and pretend as it there aren't tensions that are inherent to the
military context, just are there are tensions inherent -- and
that's certainly appropriate.  And I think -- is that agreeable
to everyone?

          DR. RUSSELL:  You want to put that under the front end
of 12 before you get to the --

          CHAIRPERSON FADEN:  That would be nicer.

          DR. LEDERER:  Isn't that already on page 24 to some
extent?

          CHAIRPERSON FADEN:  To some extent, yes.  But we can
make it clearer.

          DR. LEDERER:  About the unique constraints of the
military?

          DR. MACKLIN:  No, because those -- what's under 24
describes the difficulty of ensuring voluntariness in those
activities that the regulations say are voluntary or that would
be voluntary under the regulations.

          DR. MACKLIN:  And you want another paragraph that deals
with determining whether activities require volunteer and human
use of rules. 

          DR. MACKLIN:  Well, --

          DR. RUSSELL:  That's the key issue.

          DR. MACKLIN:  The key issue is that there are some
things that would otherwise look, smell and --

          DR. RUSSELL:  Right.

          DR. MACKLIN:  -- quack like research.

          DR. RUSSELL:  Do they or do they not require a --

          CHAIRPERSON FADEN:  Right.  That may in the military
context --

          DR. MACKLIN:  Be obligatory.

          CHAIRPERSON FADEN:  Right, got it.  We can -- I wrote
down quack like research to remind me.  That will remind me what
to put in. Quack like research is very good.  I can do that. 
Okay, so with two major -- three major qualifiers, just to
summarize, the addition of the paragraph describing --
acknowledging this tension and the quack like research problem,
and that the military context has its own set of tensions and
problems around what's research and what's not -- akin to the
research and treatment situation we talked about for ill patients
yesterday.

          With the proviso that 12D may go away if it already has
been adopted by the other services, and with the proviso that
there be an exception to the recommendation that officers and
NCO's not be present when enlisted personnel are being recruited
-- the military one stands.  Is that agreeable?  And obviously
everyone will see the revised language, so that you're only
agreeing to the context and the words will be fought out.

          Now we're going to recommendation 13, which is in two
parts.  This is on compensation.  13A is  yet another call for
the federal government to figure out what to do about
compensation of former subjects for research related injuries. 
Here we are trying to think of a less vulgar phrase than the one
that's coming to mind, but we are joining a long line of other
committee, bodies, and groups that have called similarly in the
past for some kind of comprehensive federal policy.

          We don't hearsay what we think it should be, but we
simply point out out of the frustration of our own experience in
trying to figure out how to deal with the issue of compensation
retrospectively.  That it would be very nice if nobody 50 years
from now had to be sitting and struggling with -- figuring out
how to do this.

          So that's 13A, and then 13B is quite similar.  And I'd
like to hold off discussion about it for just a minute.  And it
has to do with a specific call about compensation for research --
for subjects who were used as research without their consent from
now on forward.  But can we do 13A?

          DR. STEVENSON:  Is A restricted to federally funded --

          CHAIRPERSON FADEN:  Well, this is compensation from the
federal government.

          DR. STEVENSON:  But for federally funded?

          CHAIRPERSON FADEN:  Yeah, yeah.  It should say so.  It
doesn't say what it should be or how it should be done.  It just
says please deal with it.  Yes, Eli?

          DR. GLATSTEIN:  Well, I'd like to see that -- I have no
problem with reviewing that area for compensation for research,
but I'd like to see -- explicitly request them to review the
issue of insurance companies declining to pay for patients who go
on clinical trial.  That is classified as research by third party
carriers, and they do not pay for it.

          And I think this is a serious issue that is
undercutting a lot of clinical research that could be done in the
country.  And I think that needs to be reviewed.  Specifically
clinical trials, not other forms of research, but patients for
whom there are no good treatments and they want to go on a
clinical trial and the insurance companies won't pay for that.

          CHAIRPERSON FADEN:  I understand the problem.  I'm
thinking about whether it's appropriate to bundle it with
compensation.  It strikes me as a separate kind of
recommendation.  It's about a different kind of an issue.

          DR. GLATSTEIN:  Well, if that general area is to be
reviewed, I think it comes under it.  But maybe others don't
agree.

          CHAIRPERSON FADEN:  Ruth, then Phil.

          DR. MACKLIN:  Well, first -- I mean, there is a
connection, because if in fact there were compensation for
injured subjects of research, then insurance companies might be
more willing to pay for the research maneuvers.  I mean, so
there's a connection, I think, if I understand that area.  

          But my other problem, which is a question, is what
authority does the federal government have over private insurance
companies in an area like this?  I mean, --

          DR. GLATSTEIN:  Excellent question.   There's virtually
no authority over the insurance industry period.  It's the most
unregulated industry in the United States.

          CHAIRPERSON FADEN:  States do.  The states do.  The
states have the authority.

          DR. GLATSTEIN:  The states do, but the federal --

          DR. MACKLIN:  So I mean, but my question -- in other
words, what could a recommendation --

          CHAIRPERSON FADEN:  To the federal government --

          DR. MACKLIN:  -- here to review -- we can ask the
federal government to review compensation for research injury
under federally sponsored research, but what could we recommend
that the federal government do about an area about which it has
no jurisdiction?

          MS. KING:  It goes in informed consent discussion. 
Because the other way you can get at it is to include in the
informed consent discussion that this is a major area that is
subject to --

          CHAIRPERSON FADEN:  You better be on the mic, Pat.  I'm
sorry.

          MS. KING:  That subjects need to be informed of the
economic and financial consequences of participation.

          CHAIRPERSON FADEN:  Right. 

          MS. KING:  Not that they can be informed by the
researcher, but it needs to be called to their attention that
they should be sure to find out for themselves these
consequences, because the researchers actually may not know.

          CHAIRPERSON FADEN:  I have Phil and Jay waiting on
this.  Did you want to comment?

          DR. RUSSELL:  I find it very  uncomfortable to get into
the issues of insurance coverage when we really haven't discussed
those issues and there's ramifications that are far beyond those
that I can comprehend at the present.

          CHAIRPERSON FADEN:  Jay?

          DR. KATZ:  Well, I don't know what we can do about it. 
It first came to -- the whole issue of -- as it affects informed
consent about who pays for research injuries came to my attention
when Eli talked about it briefly at the last meeting, and -- on
something that I had never considered.

          I was puzzled in the informed consent forms that I have
reviewed.  And I only touched on it without confidence because
it's really a can of worms that in some of the informed consent
forms, it's mentioned -- the incidents as a result of the
research was a 15% of collapse of the lung, and that was
acknowledged.

          And the 5% incidents where a chest tube and further
hospitalization would be required.  It was also stated that the
patient is responsible for payment.  I think -- and there was one
or two other experiments like that.  Any patient who would have
read this carefully would have said I'm not going to participate
in this unless, you know, the -- my insurance carrier assures me
that --

          DR. GLATSTEIN:  That's the dilemma.

          CHAIRPERSON FADEN:  Well, I think -- but I think we're
talking about two separate issues.  One is the issue of who pays
for the consequences when there are bad outcomes and someone
who's been in a federally funded research project.  And that's
what this recommendation is directed towards.

          The other is who pays for a clinical intervention which
is experimental and on protocol.  Who pays for that itself?  And
that was the issue that Eli raised, and that's where the
questions come up about whether we really have the territory. 
And even does the federal government have the reach to address
the question of whether insurance companies should have to pay
for bone marrow transplantation for breast cancer transplants.

          DR. GLATSTEIN:  Well, it's a little more complex than
that.  I mean, if you have a clinical trial that has a standard
treatment --

          CHAIRPERSON FADEN:  Right.  Oh, I agree.

          DR. GLATSTEIN:  And the third party carriers will not
cover that as a -- because that's research.  So the patient's off
study and the patient gets the standard treatment arm.  It's the
same treatment.  I mean, that's crazy.

          DR. KATZ:  If I can finish, it's like -- but it goes to
what Pat said, and it didn't come up.  So I apologize.  And let
me take another 60 seconds -- is I think now -- I speculate now
that one of the reasons why investigators -- the distinction
between research and treatment because they would like it to be
viewed as treatment, so that the insurance companies won't be
alerted to the fact that they may not be financially responsible.

          DR. GLATSTEIN:  That's absolutely correct.

          DR. KATZ:  Okay, and I never -- thanks to you, I
learned a new kind of complicated --

          DR. GLATSTEIN:  A new kind of --

          (Laughter.)

          CHAIRPERSON FADEN:  Yeah, and that certainly belongs in
the introduction to that last chapter.

          MS. KING:  I think that the economic issues for
subjects deserve -- not only in the last chapter -- and I'm not
suggesting we make this an area of recommendation.  I think that
this is going to be a bigger area in the future as the health
care system continues to change.  

          And I actually think that while we have focused on
medical risks, for many subjects economic risks are going to be
far more significant in the immediate aspect for them than
medical risks.  And so we should be sure to devote perhaps a
substantial pointing towards the future in the prior chapters.

          CHAIRPERSON FADEN:  Let me make a proposal.  Way back
on the recommendations that we discussed yesterday -- it doesn't
go to your point, Eli, directly.  It goes indirectly.  When we
talked about the kinds of -- the list of subrecommendations that
was federal government find some way to fix it, we certainly have
the base, based on our RPRP project where we found and people
commented on confusion in forms about --

          We had an item that said did they explain the financial
burdens, and we found that it wasn't always done well.  We can
certainly add another subrecommendation that says government,
find a way to fix it so that it's very clear that IRB's have an
obligation to make it very plain, to investigators that they have
to make it very plain to subjects -- potential subjects, what the
financial implications are of their being on this study or not.

          MS. KING:  The complication is they may not always
know.  But one of the things that -- what we're asking basically
are two things, I think.  One is, to the extent you know, we want
subjects to know.  But the other problem is that subjects,
because they are trying to get health care usually or some access
to something -- in many instances may need to be told to go find
out for themselves. 

          I mean, because I don't think that you can expect
researchers to know the -- so the big issue  a lot of times is
that this falls between the cracks.

          CHAIRPERSON FADEN:  I would agree.  I would think
sometimes the statement has to say you would need to check with
your insurance company --

          MS. KING:  Right.

          CHAIRPERSON FADEN:  -- to establish whether in this
case, being on --

          MS. KING:  It's so complicated that you may not want to
check.  This is an area where we need people to explore.  Because
if you check with your insurance companies -- so what we want
them to do is not so clear.  What we want to call for is some of
these issues have come to our attention -- we don't think that --
we didn't pursue them.

          CHAIRPERSON FADEN:  Okay, got it.

          MS. KING:  But that it needs to be investigated and
explored, and all these many complicating factors examined. 
Because it is not clear cut.

          DR. KATZ:  You need two consent forms.  One to be
submitted to insurance companies, and one for the patients.

          CHAIRPERSON FADEN:  Ruth, is that on this point?

          DR. MACKLIN:  Yeah, it is on this point.

          CHAIRPERSON FADEN:  Okay, if we could have that, and
then I'd like to close on that one and go on.

          DR. MACKLIN:  Yeah, it is on this point.  I mean, I
don't know why we want to be so wimpy here in recommending that
the government review --

          CHAIRPERSON FADEN:  Oh, excuse me, Ruth.  You're on
compensation?

          DR. MACKLIN:  Yes.

          CHAIRPERSON FADEN:  Before we do that, can we get
closure on the financial thing?  Is it all right with everyone
that we add to the informed consent recommendation another
subrecommendation to address the -- make sure that the system
starts working on this financial problem.  Is that agreeable with
everyone?  

          I mean, I take it then that that -- well, next time you
get the informed -- the list of government fix-it recommendations
that we went over yesterday, there will be that addition.  I'm
sorry, Ruth; I just wanted to get closure on that.  Now let's go
back to recommendation --

          DR. MACKLIN:  Yeah, I mean, there are two things in
here.  Compensation for research injury, and then the thing that
Jay pointed out particularly, and it says here particularly
reimbursement for medical costs incurred as a result of a
subject's participation in such research.

          Now, do we just want that to be reviewed?  I mean,
someone gets injured as a result of being in the research and
would not have been presumably injured had he or she not been in
that research.  I mean, we don't know presumably, but I think
that's the key here.

          Now, I just want to add to one point that Pat -- in
saying this, by way of background -- sure, calling up your
insurance carrier and finding out what they will pay for in
advance is going to alert them to the fact that you are going to
be a research subject.  In some cases, as I'm sure Pat well knows
and everyone else as well, people who otherwise might not have
access to medical care become research subjects.

          They agree to be research subjects in order to get this
top flight medical care at University Hospital X Research.  They
don't have an insurance carrier in many cases.  They don't have
an insurance carrier.  So the question what happens to them if
they get in one of these research -- I mean, they want to be in
the research so they can get the kind of care that they otherwise
wouldn't get because they don't have access to the system.

          Then they get injured and they have to pay, and where
are they going to get the money to pay?  I mean, so this is a
much more complicated thing.  And by saying the federal
government reviewed this makes it sound as if this committee is
neutral on these issues.  Well, I'm not neutral on these issues.

          CHAIRPERSON FADEN:  Yes, Pat?

          MS. KING:  I'm actually not neutral on the issue
because I have long agreed with the President's commission
conclusion.  But before that, the national commission discussed
it as well.  It's not a question of being neutral.  The question
is, did this committee --

          CHAIRPERSON FADEN:  That's correct.

          MS. KING:  -- sufficiently explore the issues so that
we can make an independent recommendation that compensation be
granted.  I think that's what the issue is, Ruth.

          DR. MACKLIN:  But why is this in here at all then?

          CHAIRPERSON FADEN:  It's in there because we did enough
to discover this is a big problem.  We did enough -- we struggled
enough on the retrospective issue of compensation to know that
it's tough.  We then look and see that -- and discover there are
no policies governing today.  

          So we can anticipate that 20 years from now, a
committee like ours could be sitting there hitting their heads
against the wall if there's a similar sort of thing.  So at least
we can say this has got to be fixed, okay; because we don't want
another committee 20 years from now to sit there with the similar
problem of trying to figure out remedies, and see that there's no
federal policy or guidance or any fair system for compensation.

          So that's why it's there.  The reason that it doesn't
stipulate the form it should take it Pat's point, that we haven't
collectively debated.  But I too have no problem --

          MS. KING:  But we could do something to strengthen it
along those lines.  I don't see what the problem would be once we
recommend the review indicating that substantial members of the
committee are in agreement --

          CHAIRPERSON FADEN:  That would be fine.

          MS. KING:  -- with the President's commissions
recommendation which would strengthen it.  But I still think that
there's a problem about not having explored or discussed some of
the implications.  And the President's commission conducted a
full exploration of the issues.  They did tons of work on the
issue.

          DR. RUSSELL:  What's the text of their recommendation?

          CHAIRPERSON FADEN:  It's on page 29.  I mean, I think
that's a great solution if that's agreeable to you, Ruth, would
be for those of us -- some of us -- and I also personally think
that the recommendation is right.  One, if we can have a sense
that some members of the committee or many members of the
committee, depending -- or all members of the committee agree
that the President's -- support the President's commission
recommendation, which is not the same as saying it's our
recommendation as a committee because we deliberated.

          But rather, it's the President's committee -- this
previous committee's recommendation.  They spent, you know, as
much time on that as we're spending on other issues.  And so we
say they made a good case and we agree with them.  Yes?

          DR. OLEINICK:  Is there any information that came out
of the subject interview study that would bear on this point?

          CHAIRPERSON FADEN:  Not to my knowledge.

          DR. OLEINICK:  Because we did ask questions about their
insurance.

          CHAIRPERSON FADEN:  I don't know.  I mean, --

          DR. OLEINICK:  Is this something that could add fuel to
the fire?

          CHAIRPERSON FADEN:  I don't know, Nancy.  And Jeremy is
occupied putting out the fire from the newspaper.

          DR. OLEINICK:  Oh, okay.

          CHAIRPERSON FADEN:  So I don't want to take him in and
ask him --

          DR. GLATSTEIN:  I don't think it went into any depth.

          DR. OLEINICK:  No depth.  But at least it did ask about
insurance --

          DR. KATZ:  Do you have any practical experience with
the problem or not? 

          DR. GLATSTEIN:  Plenty.

          DR. KATZ:  And that the patient ultimately had to cough
up the money or not?

          DR. GLATSTEIN:  Well, I think the vast majority of
cases where people go on this and wind up with the bill like that
-- generally written off.

          CHAIRPERSON FADEN:  By the institution?

          DR. KATZ:  By the institution.  They don't really
demand payment.

          CHAIRPERSON FADEN:  Can I do this?  I really -- it is -
- as compelling as it is, Pat is right to draw to our attention,
this is not something that we have as a committee taken on as an
issue -- forward looking.  I would like to support Pat's
suggestion that we include a sentence that indicates that some
members or all members -- and I'll just ask a vote -- support the
President's commission.

          What I would do though, since not everybody here is as
familiar with the President's commission's recommendation, let me
propose -- well, is anyone not prepared to vote yet?  Because I
would be happy to send -- we could easily send you -- we sent
once before, but we could send you a more detailed summary of the
President's commission's recommendation on compensation than just
this abstracted summary.

          So that when you indicate whether you want to be
included in the group, you can take a look at that.  So what I
will do is make sure that those of you who I -- who doesn't need
such?  Okay, so just to say -- in our reduced staff situation,
anything that we don't have to do.  Yeah, okay, so everybody
except the people who have raised their  hand, we will send you
more detailed information on the President's commission's
position, and then we'll circulate a little ballot that says
would you like to be included in the group.

          And if it turns out that it will be all, many, some, a
few -- okay, of the members have independently studied and
support the -- have independently considered and support the
President's commission.  Is that all right?  Okay. 

          Now let's go on to 13B.  13B is -- comes out of our
experience and basically says that from here on forward, if any
person is used in a research project without their informed
consent and it's federally supported, that there be compensation
awarded, even in the absence of research related injury.  

          So it's basically saying we want to send a very strong
message to the research community and to the federal government
that dignitary harm from now on forward warrants this level of
sanctions.  Well, the question is who else is going to give it? 
We can't -- you know, the federal government provides such
compensation.  The recommendation is the federal government do
it.

          So the problem is how would you then say the federal
government should be responsible if it's drug company supported,
for example.  That's the problem, Jay.  And if we could think of
a way -- there are lots of hands up, so let's get up there. 
Nancy, Pat, Lois, Henry -- okay, Duncan.  Nancy?

          DR. OLEINICK:  Well, one of my concerns about this is
what lawyers may be able to read into it. And maybe Pat can
comment on it.  But I can just see a case where a person is on a
protocol and the lawyer looks and says there's some little "i"
that wasn't dotted in the informed consent, and then -- so that
the consent was not fully informed, and it goes on from there.

          Now, I may be over reaching here, but I'm concerned
about --

          (Laughter.

          I'd like to hear a comment from the lawyers in the
audience as to whether that is a danger.

          CHAIRPERSON FADEN:  Pat happens to be next, and she's
our lawyer -- our only lawyer at the moment on the committee.

          MS. KING:  It would be one thing if we were saying
without consent that -- but that's not what the wording says.

          CHAIRPERSON FADEN:  All right, let's change it to
without consent if you're concerned is the informed consent part
makes it too --

          MS. KING:  This is a big shift, though.

          CHAIRPERSON FADEN:  I understand.

          MS. KING:  I don't want to change that -- the legal
tradition is that you can't do anything to a person without their
-- you can't touch a person -- would be a battery without
consent.  That one's always been pretty easy.  Informed consent
has always been troublesome because it raises questions about
what the informed means.

          So the litigation -- you're asking the lawyer's
question.  I answered that first.  The litigation about what is
informed, of course, has got standards that say material risk,
material benefits.  And so they're always subject to
interpretation, that kind of thing.  But my problem with this is
a different problem.

          I have that problem too, but this leaves a lot of room. 
But my problem is a different problem.  My problem is one that
says we have a preceding recommendation that says we think people
who are injured -- you know, who got -- who were injured and they
got costs and they got physical costs, they got medical costs,
etc. -- that for 40 years we have been trying to get something
through to protect those people.

          And now we come along and say we want to send a message
that you ought to protect people who did not give informed
consent.  My view is I am not interested in sending the messages
out into the air someplace.  I really want the problem dealt
with, and I want to start with what I consider the most serious. 
And I don't want to  undermine that by then making a statement
that can be used against me in trying to accomplish what I
consider the goal that I immediately need to accomplish.

          So my own sense of this is that in the discussion about
-- of the preceding --

          CHAIRPERSON FADEN:  13A.

          MS. KING:  -- 13A, that what I would have liked to have
seen would have been in the text following that recommendation
something about the commission's experience and a recommendation
that within this, we consider as a part of the discussion, our
experience which is that dignitary harms are the sorts of  harms
that also should be compensated for.

          I mean, that would be for me the way that it would be
acceptable.  I have a lot of problems.  I'm opposed to this
recommendation for those -- some of those reasons in addition.

          CHAIRPERSON FADEN:  Lois?

          MS. NORRIS:  Some of my major ones have already been
talked about, and I think there's going to be a -- I get a strong
sense that there are a lot of people who will not be comfortable
with this.  So I don't know how far I should go into this.

          CHAIRPERSON FADEN:  Go ahead.  I'm going to argue for
it in a minute.

          MS. NORRIS:  Okay, well that's fine then.  I think if
we are to adopt this in any form, I think we should specify that
we are looking at from today forward.

          CHAIRPERSON FADEN:  Oh, absolutely.

          MS. NORRIS:  Because it's not clear it's expressed in
the past tense.  That's an easy one to fix.  I also shared the
informed consent -- and I sent that in in writing -- question. 
Particularly in light of some of our current projects.  And it's
not clear to me what we're asking to be done. 

          It says in line 13 through 15 that we anticipate that
there won't be all that many because the subject will have to
legally prove.  Do you mean that this remedy or compensation
should be sought in a court of law?  I'm not quite sure --

          CHAIRPERSON FADEN:  No, that language isn't good.  But
the idea is the burden of proof would be on the subject in this
case.

          MS. NORRIS:  Proof to whom?

          CHAIRPERSON FADEN:  To whoever -- however this would be
administered, and that's the problem.

          MS. NORRIS:  Okay, so you're saying that these are open
questions?  Because it just simply wasn't clear to me.  And then
if you're talking about the courts of law, and I -- this is a
stupid, mid-western question type thing -- where does sovereign
immunity come in?

          MS. KING:  No, I think you can already -- I haven't
looked at my book, but it seems to me that the Mink case -- the
Chicago case where the women were involved in research of the
reproductive -- the drug -- where they recovered in battery, not
an informed consent case -- a consent case, that the law already
provides that if you are involved and you don't consent -- not
informed consent, you don't consent -- that's a battery.

          So the only thing that this could do is to add the
informed consent provision.

          CHAIRPERSON FADEN:  Also, this is where the
compensation comes from.  Okay, that came from the University of
Chicago. 

          MS. NORRIS:  I was wondering -- I guess whom did they
recover --

          CHAIRPERSON FADEN:  Well, Lois is --

          MS. KING:  The legal questions then go to the question
of being able to sue in the federal --

          CHAIRPERSON FADEN:  Well, this is why you can't --
you'd have to have a mechanism other than a suit.  There would
have to be some mechanism set up whereby the federal government
would be -- like it probably would be folded in with whatever
compensation --     

          MS. KING:  You want to say it should sue the
government?

          CHAIRPERSON FADEN:  I don't even want to have to sue
the government. I want a system whereby if a person can show that
they were used -- and we can get into the informed consent versus
consent -- in a federally funded research project, in addition to
suing the institution, if they want to sue the institution, and
they want to sue the investigator -- that there should be some
way in which the federal government makes amends, and I want it
to be in money.

          Because we couldn't do it backwards for all the reasons
that we could.  But going forwards, I think -- and I'm not saying
a large amount of money.  And we're not stipulating the amount. 
I'll put out my arguments in a minute.  I've got -- Lois has
still got the floor.

          MS. NORRIS:  I have one more point, and that is in the
text you say a clear signal needs to be sent to the research
community and the federal government.  It seems to me we run the
risk of sending the signal to the research community that the
federal government's going to stand behind their blunders. And in
fact, it might lessen.

          CHAIRPERSON FADEN:  Okay, well I think that could be
corrected by making it clear that this is not meant to be an
exclusive remedy.  That if you were involved as a research
subject without your consent and you recovered something from the
federal government, you could still sue the institution.  

          And in fact, presumably it would strengthen your case,
because if the government agreed that you had been used without
your consent, that would not hurt in your suit against the
institution.  But I don't know, I'm not a lawyer.  But that's
very helpful for a recommendation that probably isn't going to
make it -- we'll get it much better.

          We'll see how it goes.  Lois, do you have --  Henry?

          DR. ROYAL:  You made the statement that although we've
agreed that it's difficult to put something like this in place
retrospectively, that somehow it's going to be easier to put it
in place in the future.  And I guess I don't see how we're going
to avoid the very same problems that we had applying it
retrospectively with applying it prospectively.

          That is, at the time that someone puts a case forward
for the fact that informed consent was not obtained, they're
going to have to do some retrospective analysis at that point
about whether or not informed consent was obtained.  And to me,
and I assume to everyone on the committee, informed consent is
not the signing of the piece of paper.

          Informed consent is this process, this interaction
between the physician and the patient. And I just -- I don't
understand why it's going to be any easier in the future than it
was in the past.

          CHAIRPERSON FADEN:  The reference I made to that,
Henry, was not to the evidentiary problems.  Although I think
obviously 40 year remove is different than a six month or a year
remove.  But my concerns were more with the ambiguities around
the clarity that the duty was there in the first place and
fairness issues about how to set things up.

          So that the forward looking thing is if  you -- you
know, it's like saying well the rules of the game have to be
public, and everybody knows it.  And before you slam somebody for
it, it's got to be clear that the rules of the game are known. 
So that was my reference to the past.  The argument is you set it
up forward looking, you say look, from now on here are the rules
of the game.

          Okay, whatever those rules are so everybody knows them. 
But not to the evidentiary difficulties.  That doesn't mean there
aren't all these other problems people are raising.  Duncan and
Phil?

          DR. THOMAS:  Well, I can be brief, because Lois has
pretty much touched on my points.  I support this recommendation,
but as Lois pointed out, it doesn't explain that it's just
prospective.  And my concern is that -- assuming that the purpose
is purely prospective, no rationale for why it is only
prospective is offered, and that needs to be made clarified.

          CHAIRPERSON FADEN:  And the sort of rationale I just
provided would be the kind of thing you're looking for?

          DR. THOMAS:  That's right.  I mean, these issues -- the
same questions could be asked retrospectively as well.  And I
mean, I would have liked to have seen us make a stronger
recommendation retrospectively, but I understand the will of the
committee.  That rationale needs to be very clearly spelled out.

          CHAIRPERSON FADEN:  Phil?

          DR. RUSSELL:  My concerns were mostly retrospective, so
I guess they've been taken care of.  I think that if you --
looking back, we would open up a huge amount of problems without
attending to -- where I think we need to be concerned about are
the very, very large phase three trials of drugs and vaccines and
so forth.

          And the question of the adequacy -- you could wind up
with a huge number of people have been "involved" in a federally
sponsored research, most of whom -- or at least  half of whom may
have gotten either a placebo or a standard drug.  But they were
part of the -- and whether -- and if somebody decides that the
consent form or the process by which consent for 50,000 Swedish
children was somehow flawed, then you've got a nightmare, and a
lot of claims without any evidence of doing any good for anybody.

          DR. KATZ:  Could I just make a 30 second statement
about prospective and retrospective --

          CHAIRPERSON FADEN:  Sure.

          DR. KATZ:  Yeah, because it goes to just -- Pat or Dan
probably can talk about this very quickly, is there's a whole
legal literature of -- on prospective and retrospective.  And
when should it be retrospective and when should it be
prospective?  I think if you were to argue in favor of
prospective, we don't really have to explain too much why not
retrospectively, because it's almost -- about many things, you
just can't apply it retrospectively, because there were no rules
in effect to behave in this kind of fashion.  But anyway, --

          CHAIRPERSON FADEN:  I've got Ruth and Pat, and then I'd
like -- and then Lois, you can -- and  then I'm going to put
myself.  Ruth?

          DR. MACKLIN:  I'm surprised to hear myself say this,
but I'm actually ambivalent and leaning towards rejecting this. 
And the reason is as follows.  I mean, some have been given, but
-- it's often the case that when something's going to cost money,
the people who are in charge or responsible for these things fold
the money into the cost of doing business without changing their
practices.

          Now, what we really care about is for researchers to
get informed consent.  Granted, from the point of view of the
victim, as we're calling them, or the person who has not given
adequate consent -- and this is where my ambivalence lies --
there ought to be some kind of remedy if people have been
wronged.

          But that's all I can say about the remedy. And I'm not
sure why they should get money for it.  I mean, in our society,
money is the solution to everything.  But if in fact -- I mean,
Phil's example of the nightmare or the floodgates opening -- we
already know -- and I'm glad that this is not going to be
lawsuits, but as Ruth said, there may be suits against the
institution as well as whatever compensation scheme.

          We already know that there are a lot of frivolous or
unjustified lawsuits in the medical arena.  That is, where
doctors -- where some wrong happened, but doctors were not really
culpable.  The reverse is true too.  People don't sue for genuine
malpractice where there ought to be, and maybe that's a larger
category.

          But Nancy's concern I'm picking up on here that if
people see -- ah, here's yet another area in which we can win the
lottery, even though you're saying it's going to be a small
amount of money -- I mean, I think this will encourage people to
do that kind of thing.

          Now, what I really think we ought to do, and it doesn't
come under this heading, is talk about sanctions against
researchers.

          CHAIRPERSON FADEN:  That was my other alternative.

          DR. MACKLIN:  Now, sanctions against researchers, we
already know and it's just beginning to come in that people who
do things like falsify research -- also the scientific integrity
stuff -- are now beginning to be scrutinized, and in fact,
punished in ways that for researchers are much, much more
serious.  

          Namely, you take away their opportunity to get a grant
for five years or two years.  I mean, some of these things seem
like slaps on the wrist too.  But nevertheless, they are
sanctions against the people who did the wrong.  So Lois' point -
- oh, well, so, you complain to the federal government -- who
cares, they're going to take care of me.

          I mean, this seems to me the wrong approach to a
problem, giving some people money that may increase an incentive
for people to go mucking around with their consent forms and
making claims that may not be justified while not touching the
wrongdoers.  So, that's the basis for my ambivalence, or even
leaning against this.

          CHAIRPERSON FADEN:  Pat?

          MS. KING:  Two things, now one of them in response to
Ruth.  First of all, we should be clear that if this were done
where the money is coming from -- you know, we're all acting like
we're deep pockets plaintiffs.  The money is not going to -- the
Congress is -- if this were adopted, which it won't be, but -- I
predict that confidently.

          But if it were, the money is coming out of the research
budget.  Let's be clear about it.  We're talking about tradeoffs. 
This is not let us do nice things.  These are hard cost benefit
assessments.  And in case anybody has forgotten, NIH's
appropriation already with respect to research costs is -- on the
real research side, is in somewhat jeopardy.

          So for me, this is the real world.

          CHAIRPERSON FADEN:  Pat, can I interrupt you?  And the
reason I'm going to interrupt you is the interest of time.  It
seems to me very clear that the committee does not want to
endorse this recommendation.

          MS. KING:  Okay, then I'll go to my second point.

          CHAIRPERSON FADEN:  All right, so even though --

          MS. KING:  It's the sanctions.

          CHAIRPERSON FADEN:  All right, then let me just clarify
that and then go to sanctions for a minute.  I have a series of
arguments, and I'm not even going to try them.  Okay, we'll let
it go.  I am so concerned about getting through the rest of the
agenda.  My back up position was the sanctions one.  We didn't
get a chance to write it, so this is fine.        I think that
this could have been made workable, but it's not worth it given
everything -- if that's agreeable with the committee, we will get
rid of this recommendation.  I am so concerned about moving
forward, I don't want to have -- waste discussion on something
that looks like it's not going to go anywhere.

          So can we now -- we don't have a written text in front
of us, but we can now go to the issue if -- whether the committee
wants to consider a recommendation that makes a clear sanction
against the investigator?  And then after some discussion, we'll
try to come up with the text.

          MS. KING:  I don't have any -- in principle --
opposition to what Ruth said.  I have again a pragmatic one.  And
that is -- and the committee, in its own work, did not -- as we
acknowledged yesterday, explore the question of sanctions and
enforcement of what is currently a requirement.

          The requirement in the federal government is that you
obtain informed consent, and those requirements are to some
extent specified.  So what we are back in is to yesterday's
discussion about sanctions and enforcement.  It would be
acceptable -- we have something about that, if I recall, if you
want to fold this into it.

          But I would also be very hesitant to go too broad.  But
this again is one of those areas where we didn't discuss,
although we have experience about why there might be a need.

          CHAIRPERSON FADEN:  Let me do this.  I think we do have
some information, I just don't have it available right now, about
whether -- to what extent an investigator or institutions have
ever been sanctioned in any respect by the federal government for
failure to comply with the informed consent regulations of the
common rule.

          We will check into that and see if we have it.  If the
answer is no or if there are no sanctions -- formal sanctions in
place -- the first issue is are there specified sanctions for
violations of that part of the common rule.  We need to establish
whether that's the case and what they are, and if they've ever
been enforced, and under what conditions.

          We'll do a little homework and then come back with the
recommendation that responds to whatever the fact situation
actually is as to whether there is -- if there is a policy on
sanctions for violation of informed consent duties, maybe it
needs beefing up or needs teeth. 

          And if there isn't, then we can recommend that it be
introduced.  Is that agreeable?  Ruth?

          DR. MACKLIN:  Yeah, just a small proviso that we look
at this in this research context of human subjects.  That is, I
consider it a mild irony, to say the least, that all of the
attention has been paid to the research fraud and the --

          CHAIRPERSON FADEN:  No, I meant specifically sanctions
not only for the specific provision of the common rule that
requires informed consent, okay?  Because that's what we're
trying to replace this with.

          DR. MACKLIN:  Right.

          CHAIRPERSON FADEN:  What I'm struggling for is some way
to send a message and also to enforce this committee's
commitment, okay, to respect for autonomy and the duty to obtain
informed consent as rock bottom in research ethics.  We need some
forward looking signal to give that is strong.

          DR. MACKLIN:  This is at least as important as a
violation of the ethics of research as dropping data points on a
chart.

          MS. KING:  What it does do though, Ruth, is again to
ignore the other requirements like selection of subjects and
things that we also are concerned about.  And I have to say I'm
somewhat concerned that the recommendations really give a
prominence to consent and informed consent, which I think are
very important, as you know.

          In terms of disregard to what I think really protects
subjects in the real world in addition to their consent, which is
risk benefit and how they're selected.

          DR. MACKLIN:  I'll note that in an appropriate place. 

          CHAIRPERSON FADEN:  I'm not sure it has that effect,
and we can certainly look at the other provisions.  And I think
that one of the things that we have to acknowledge even in our
own work -- harms to subjects.  And as Jay pointed out, as well -
-  certainly the justice issues are a separate category in there. 
I would agree with you. 

          But if you do look at the history of research,
experiences as Jay has pointed out -- egregious harms have
occurred -- that they have occurred probably way less frequently
than violations of informed consent.  Dignitary harms are much
more common.

          MS. KING:  I agree that dignitary harms are much more
common.  But they also have, I think -- never mind.

          CHAIRPERSON FADEN:  Right, so I mean there are some
disagreements there.  Yes?

          DR. THOMAS:  I agree that the sanctions route sends a
clearer signal that what was originally proposed.  I just want to
point out that this approach does not address any remedies to the
individuals whose rights were harmed.

          CHAIRPERSON FADEN:  That's correct.

          DR. THOMAS:  And I want to be clear that it -- is it
the view of the committee then that the appropriate remedy is for
individual civil claims against investigators, or conceivably the
sponsors of the research?

          MS. NORRIS:  Pat, I thought you mentioned some way that
elements of recommendation 13B could be folded into 13A in such a
way as to express the committee's concern or something like that. 
Am I right on that?

          MS. KING:  You are, that one of my suggestions was that
our concern about dignitary harms and compensation before we got
to enforcement -- the possibility of compensation should be a
part of the preceding recommendation in the text.  That the
commission's -- its work on the past led the committee to raise
this as a consideration to -- for work in the compensation arena
that will be prospective.

          CHAIRPERSON FADEN:  That would be very helpful, and
because we can also indicate that this is our committee's
contribution to the work of the President's commission, which
focused on research related physical injury. And we could say
that we would -- those of us who want to -- that we endorse the
President's commission's recommendations.

          We also want, however, for this review to include
attention to how appropriate remedies for dignitary harms.

          MS. NORRIS:  Well, that would be a way of salvaging
some  of 13B.  And I really believe in 13B in principle.  But --

          CHAIRPERSON FADEN:  Is that agreeable with everyone,
that 13A would be amended to include that whatever scheme is
developed, also address violations of dignitary harm in some way?

          MS. KING:  But I recommended it for text.  And so,
people should -- not recommendations.  So people may want to
focus on that distinction.  I did not recommend changing the
recommendation.  I recommended in the discussion of the
recommendation.

          CHAIRPERSON FADEN:  All right, so the difference we
should get clear on, if you look on the text 13A, which is --
wherever it is -- on page 28.  It says -- recognize that the
federal government review the area of compensation for research
injuries. So the issue is, does the committee want to add a line
to the recommendation for -- maybe the word should not be
compensation but remedies for right now.

          That -- also look at appropriate -- consider
appropriate remedies for dignitary harms or whatever language we
want to put in here.  Not necessarily compensation, so that we
leave it open.  Would that be agreeable?  Is that agreeable to
you,  Pat, as we go around here?

          MS. KING:  I wasn't listening, I'm sorry.

          CHAIRPERSON FADEN:  What's coming out here is an
amendment to the text in 13A that doesn't specify compensation,
but says that this review also consider appropriate remedies for
subjects who have suffered dignitary harms, but in the absence of
physical injury.

          MS. KING:  That was what I --

          CHAIRPERSON FADEN:  In the text of the recommendation.

          MS. KING:  Oh, no; I would not agree to it in the text.

          CHAIRPERSON FADEN:  Even if the word says remedies?

          MS. KING:  No, because I have a fundamental
disagreement about where the committee is going with its
placement of dignitary harms for public policy recommendations. 
So that's why I took it upon myself to point out that my
suggestion applied to text, not recommendation.  If the committee
disagrees, the committee disagrees.

          DR. MACKLIN:  I don't think the committee's going
anywhere; it says the government review.

          CHAIRPERSON FADEN:  My point is where she wants to put
her emphasis in terms of her public policy recommendations.  And
she does not want to emphasize issues of consent and dignitary
harms.  She wants to emphasize research protections with respect
to risk and selection of subjects.  That's her priority.

          MS. KING:  That was the way I stated it.  So, if the
committee differs, the committee just differs.  I mean, I'm fine
with that.

          DR. LEDERER:  Ruth, can I ask you -- I don't understand
why you think the committee is only recommending reviewing,
because the second half of 13A is to create a mechanism to
resolve.  Isn't that strengthening -- isn't that more than
reviewing?  Isn't that movement?

          DR. MACKLIN:  Yeah, but to say a mechanism for
satisfactory resolution, if the government reviews it and says
the system ain't broke so don't fix it, they have created a
mechanism.  I mean, they haven't created it, but they have said
that the existing -- that there's no need to create a mechanism
because the existing system is fine.

          That is, the committee in being neutral and says review
this isn't really saying take a step beyond the status quo.

          CHAIRPERSON FADEN:  Okay.

          DR. MACKLIN:  They could fix it by saying there will
never, from this time forward, be any compensation for research
injuries.

          DR. LEDERER:  Given that, it should strengthen this
recommendation.

          CHAIRPERSON FADEN:  Let me just get -- let me get a
sense of whether we want -- whether other members of the
committee want it in the text or the recommendation or in the
text, so we know where we go.  This is also one in which we --
well, you can't if you put it in the recommendation.  

          How many people are wanting to see a reference to
remedies for dignitary harms in the text of the recommendation? 
Okay, and how many people would rather see it in the text?  All
right, so we have a divided committee on this point, and we'll
have to note it in the text.  

          We'll say that roughly half -- or we can say if half
the committee would recommend that this review -- the other half
-- but if it's in the text, what do we want to say about what the
other half of the committee wanted it only in the text but not in
the recommendation?

          DR. MACKLIN:  Look, I'll change my vote.  I mean, I
don't think it says anything, quite frankly.  I would rather see
unanimity in the committee because the -- since the
recommendation says so little, I want to know what we're giving
up by putting --

          (Laughter.)

          CHAIRPERSON FADEN:  Well, if it's in the text, I'm not
sure what difference it makes.  I really don't know what
difference it makes. 

          DR. MACKLIN:  I mean, to say the committee is divided
makes it sound like the committee is divided on some very
important issue. 

          CHAIRPERSON FADEN:  Fair enough.

          DR. MACKLIN:  And I think it's better for us to try to
stick together if we look at what are the implications and what
matters here --

          CHAIRPERSON FADEN:  Good point.

          DR. MACKLIN:  -- in the text or in the recommendation.

          CHAIRPERSON FADEN:  Good point.  We'll just put it in
the text.  I'm not sure what the difference makes.  And you
really don't understand the difference, but okay.  That's
helpful, Ruth.  Can we now go to recommendation eight?  We
skipped these yesterday because we went through the tough part.  

          So now we're going -- what seemed like the tough part. 
You never know with this committee.  

          (Laughter.)

          You never can tell where people are going to get hung
up.  So this is recommendation eight and nine.  They are directed
at education.  Eight is directed at the biomedical and behavioral
research community; and nine is directed at the public.  I'm
sorry, it's page 12, 13, 14 and 15.  And a lot of this comes out
of the discussion we had two meetings ago or last meeting.  I
can't remember when.  Ruth?

          DR. MACKLIN:  Well, this is not ambivalence as much as
cynicism.  I can see what has happened in the current
requirements for education for trainees, post NIH fellows, and
all of these in research ethics.  Namely, it has spawned a small
-- not really an industry for ethicists, because it's been a
burden for ethicists.

          Well, some say that.  But it's a burden for ethicists
and creative ways in a Mickey Mouse format of trying to meet
those kinds of federal requirements.  So I get invited to do
grand rounds in hematology, and although I really thought they
were interested in ethics in hematology, then I hear the head of
the division say well, you know, we now have a requirement -- 

          CHAIRPERSON FADEN:  There are no recommendations for
requirements.

          DR. MACKLIN:  Yeah, I understand that.

          CHAIRPERSON FADEN:  Okay.

          DR. MACKLIN:  But I'm saying the kind of thing that --

          CHAIRPERSON FADEN:  I just want to make that clear.

          DR. MACKLIN:  But then what do you think the deans and
the presidents and all these people are going to say?  We need to
have some more ethics teaching in here.

          CHAIRPERSON FADEN:  I don't know.  But this responds to
the point Reed made.  What this is saying is we've got to work at
the culture.  There are no recommendations here for requirements
of anything, okay?  This is hortatory.  It may not do anything. 
I am also somewhat cynical, but I do believe -- and I was very
moved by what Reed said -- you had done, Reed, at your
institution in response to your experience on this committee.

          And what I really am trying to communicate in 8A is
that if we had more people like Reed who were presidents of
universities and deans of schools of medicine and deans of
schools of public health who went back to their faculty and said
you know, this is really central to our mission as a training
institution, not because we're going to have federal dollars held
up and because there's a requirement, so let's go find somebody
to go hire.

          But rather, because we believe that this is what --
part of what we need to do to train people properly.  Now --

          DR. MACKLIN:  They have to be like Reed to begin with. 
Doing this isn't going to make them like Reed.

          (Laughter.)

          CHAIRPERSON FADEN:  And this is  not going to bind
anybody.  It's entirely hortatory.  So if we want to say no, we
say no.  But I  think that unless -- you know, if we send a
message out there, maybe the -- you know, maybe 5% but maybe 50%
of university presidents are people like Reed. 

          I mean, I would like to think that many of them are
people of integrity who, when it's brought to their attention,
might want to make this a priority.  Pat?

          DR. MACKLIN:  Let me say what -- repeat something I
said earlier, which is I like your word, Ruth, hortatory --
because I don't like hortatory recommendations.  Because I think
-- I'm quite serious about this. You're only as good as your
weakest link in the area in which you make recommendations.  So
as a general principle, I don't like them.

          On the other hand, I think -- and I don't know if
there's time -- and so I would vote against it in this form.  On
the other hand, I do think that -- with respect, for example, to
research fraud -- that there has  been a change.  There's a
beginning of a change in the community.  But the change didn't go
this way.  The way you got to deans and presidents was to address
the recommendations and then to be more specific about what we
want and we can do that to the associations, to the accrediting
agencies.

          It was the AAMC, for example, and organizations like
that that started some of the work that was the detailed movement
work.  And that's what we need to do in a recommendation like
this one.  That what we are basically -- and we can't use the
word add to the agenda.  I really need to know a little bit more
what they did in research ethics.

          But with respect to fraud stuff -- but that is where
the thing started to move.  It was the associations and
organizations in conjunction with presidents and deans, plus what
was going on in the federal government that started getting
universities to issue different kinds of codes internally.

          I mean, that's what we are aiming for here, I think.

          CHAIRPERSON FADEN:  That's correct.

          MS. KING:   And so, my view is either we spend some
time trying to identify how -- a little bit how it was done
before and craft a crisp recommendation about what they might
consider, or do away with this altogether.  I mean, I think
that's more useful.

          CHAIRPERSON FADEN:  Lois and Phil?

          MS. NORRIS:  This is a question, but didn't education
come off or come to some extent out of your inquires of the IRB? 
I thought that that was probably strongly supported there, and
I've heard strong support of it generally amongst committee
members.       

          I don't know how it can be crafted to satisfy Pat's
concerns, but I think it's important that this be included in
some way.

          CHAIRPERSON FADEN:  Are we talking about 8A or the
whole package of eight now -- A, B and C?

          MS. KING:  I was talking about -- I was talking
specifically about 8A, because that was the one that was the most
-- what I call nebulous -- and sort of being broadly directing
university presidents and deans.

          And I want to emphasize it's not, Lois, that I don't
think the  issues are important.  I think though that you have to
do more than say they are important.  You have to sort of give
some point in some ways about where you want change -- who you
want to look at it and someplace that might want to respond if
you can name organizations or --

          I do not think that this is not an important area.

          CHAIRPERSON FADEN:  Yeah, the rationale for 8A hasn't
been developed.  There's a thing that says "insert name here" for
the organizations.  I agree with you about the role of
professional associations.  Especially those that can control
accredit and things of that sort.  Phil and the Sue?

          You've got the floor.

          DR. RUSSELL:  I'm going to pass.

          CHAIRPERSON FADEN:  Sue?

          DR. LEDERER:  I guess unlike some of our other
recommendations, I guess the federal government does not have a
role in this set of recommendations that's recommended to --

          CHAIRPERSON FADEN:  The way it's set up now is in
response to the committee's concerns last time around the sorts
of issues that Ruth started raising.  An earlier set of
recommendations had -- it took the strategy that the federal
government should require as a condition for research spending or
financial assistance for students, or any other numbers of hooks
that the federal government has into higher education and
professional training.

           So the earlier set of recommendations did have the --
was set up -- the earlier draft was set up with the federal
government hooks in there, and  making it a federal requirement. 
The committee's discussion then went the direction of Ruth's --
where Ruth was starting to take us about -- these become Mickey
Mouse requirements and people just -- remember we had that
discussion and Reed went back and forth about on the other hand,
you clean up the animal houses because you are afraid you're
going to lose your whatever.

          So it's the stick/carrot problem.  See, the last
committee discussion, the view was get away -- let's not have
stick; let's go with the carrot.  This set of recommendations is
the carrot.  So when you have the stick, it's considered to be
Mickey Mouse.  When you have the carrot, it's  considered to be
worthless.     

          So we have to sort of strike a balance here, folks.  Do
we want to say anything about education?  Do we think there's an
-- and education as a means towards changing a value structure or
enhancing the right values or whatever language you want.  Do you
want to not say anything about education? Do we want to take one
strategy or the other?

          Sue, does that -- that's a history of why the federal
government's absent. There's a little throw away line that says
if this doesn't work in the requisite number of years, then the
committee would like to see the government adopt the stick
approach.

          DR. LEDERER:  Are we not suggesting any education to be
aimed at research administrators --

          CHAIRPERSON FADEN:  In the government.  No, that's a
mistake.  That should be in there.  I'm sorry, so I misunderstood
where you were going with your question.  Yeah, that is a whole -
- Phil -- I'm sorry, Reed?

          DR. TUCKSON:  Just a brief -- I think that the text --
first of all, I think we have to do both.  And I think we need to
-- you've done I think a good job with the first sentence under
recommendation eight in the text.  I think you start to get at
it.  I think we can perhaps make a little even stronger statement
that says, you know, that we don't always want to have to use
sanctions.

          And we don't know the best way of doing this.  That it
ought to be that we're recommending that the research community
itself -- the presidents -- when we name the associations and so
forth, that you know, they ought to take the lead and do this. 
And I think that's an important recommendation. 

          We don't say we know the answer to how to solve their
internal world, but it's something that they are clearly -- we
have to put the burden on them to do.  And that's reasonable, and
it's easy, and it makes sense.  You do both.

          CHAIRPERSON FADEN:  And when you say you do both, Reed,
are you saying --

          DR. TUCKSON:  The sanctions -- I mean, one level we've
got the tough stuff, and then the other level we're saying you
come in and make these recommendations.

          CHAIRPERSON FADEN:  Well, where would the tough stuff
come in though?  What are you suggesting?

          DR. TUCKSON:  The rest of the report -- I mean, the
rest of the recommendations.

          CHAIRPERSON FADEN:  I see.  But in this area here, you
think it's --

          DR. TUCKSON:  In this area here, it's -- I think you're
on the right track here.  And I think it just needs to be even
more clearly stated that we are -- we don't have all the answers
here and it's not our job to have all the answers, to know how to
reform the entire research culture.  

          But you folks are the ones who are doing it every day
and you know, these major named organizations, and you ought to
take this as an assignment.  It ought to be the --

          CHAIRPERSON FADEN:  So you would be comfortable with
this provided there was more text?

          DR. TUCKSON:  Just a little tight -- perhaps it even
better explains what you articulated a moment ago.  I think it's
important.

          CHAIRPERSON FADEN:  Okay.  And Sue, I will make -- your
proposal, somewhere or other, administrators in the federal
government who have responsibility for human research need to be
folded in with the recommendation.  Okay, we're still on this
discussion.  Ruth?

          DR. MACKLIN:  Are we considering all of eight?

          CHAIRPERSON FADEN:  Yeah, 8A, B, and C.

          DR. MACKLIN:  Okay.

          CHAIRPERSON FADEN:  As a package.

          DR. MACKLIN:  C does say required education -- required
education for medical students.

          CHAIRPERSON FADEN:  But it doesn't say that the federal
government is --

          DR. MACKLIN:  No, I understand that.  But it says
schools of medicine and then it goes on.  I guess my view about
medical students is they're so far away from research or the
research enterprise.  Many view it or will view it as entirely
outside their purview or what they're ever going to do.

          Much of the medical school teaching today takes place
in the preclinical years, in which it's often raised.  I mean,
those of us who have a lot of experience in this in which it's
often raised, whether what students are taught in the first two
years is remembered or applied by the time they get to be interns
and residents, that this will most likely find its way -- I mean,
this kind of recommendation into the existing courses as it
describes here -- generally emphasize the ethical dimensions of
clinical care.

          So there will be a required unit on research ethics
long before students have ever had any contact with a patient,
and therefore have to confront the real difficulties of the
informed consent process, etc.  So I don't think this is
effective.  I mean, who can argue against good education?  

          But on the other hand, I don't think it's going to be
at all effective in what we're really trying to do.  On the other
hand, when you talk about what's required, if that works -- why
for medical students?  Why not for research fellows or --

          CHAIRPERSON FADEN:  Oh, it is.  Under 8B, that's where
the fellows go.  See, there --

          DR. MACKLIN:  Right.  8B is --

          CHAIRPERSON FADEN:  Everybody.

          DR. MACKLIN:  -- in a way replicating what now exists -
- well, not what now exists -- but in some ways what exists in
the research and scientific integrity format.   That's what's
there.  And I've already exhibited my cynicism about that.  This
is not so much cynicism as it's just the wrong place.

          I mean, we have some -- the wrong time.  I mean, we
have some very important concerns.  And I think that by -- this
is window dressing.

          CHAIRPERSON FADEN:  So ought we to -- I mean, the
particular issue here is the distinction between -- as muddy as
it is, clinical medical ethics and research ethics.  So is the --
and is it more appropriate then to address this to house staff
and turn it --

          DR. MACKLIN:  Well, yeah.

          CHAIRPERSON FADEN:  I mean, that would turn it around
and say that education and training of house staff should make
sure that the distinction is on the grounds -- medical -- I mean,
that's --

          DR. MACKLIN:  Yes, because where it's likely to take
place for medical students is so early in their career.  And
those who are likely to tune out -- what they really want to do
is get their hands on live bodies and start taking care of
patients.  And the idea that they're going to be doing research
that involves this is far removed, both from their experience and
from what they will later remember or take seriously.

          CHAIRPERSON FADEN:  I've got Jay, Henry and Reed.  And
obviously, another way to amend this is to say medical students
and house staff.  I mean, rather than drop the medical students. 
But you're -- Jay?

          DR. KATZ:  I have one general and one specific comment. 
I hate to make the general comment at this time, but I think the
whole of eight is really premature.  But you can't --

          CHAIRPERSON FADEN:  All of eight or 8A?

          DR. KATZ:  All of eight.  I'll get to 8A -- that's my
specific comment in a moment.  It's premature because a general
recommendation that education in all these areas has really been
neglected should be a finding leading to the recommendation at
this point.  That some kind of body or bodies really immediately
and without delay begin to make proposals about what kind of
training medical schools, prospective research scientists and
scientists should receive.

          And by whom -- and who should give this training?  As
Ruth suggested, there are complex issues that need to be
considered that haven't been addressed.  As a recent -- I think
report on some kind of ethical training or human training that I
receive in the mail as a wonderful document, and it leaves all
these issues out.  You haven't seen it?

          CHAIRPERSON FADEN:  No.

          DR. KATZ:  I do not know, but it is -- it's buried in -
- whether I have the copy available, but if I do --

          CHAIRPERSON FADEN:  That's an interesting alternative.

          DR. KATZ:  -- I'll give it.  And to really say this --
put this in the strongest kind of language that how come this
hasn't happened yet, and that it needs to be done.  And that's
the direction in which I would go.  I like always to be much more
specific, but we haven't laid the groundwork yet.  I'll just
finish, because -- with my specific comment on the 8A, the last
thing I think we need is to convene a meeting of presidents and
deans of major research institutions.

          Maybe whatever meetings should be convened should
include some of them, but we surely don't want to be a little bit
provocative.  We don't want to invite the foxes who got the
chicken house to a meeting to discuss the ethical issues of human
research.  In terms of their record, they  have failed us so far
because they haven't really done very much.

          So we have to bring them together as a body all by
themselves.  It's an exercise in futility.

          CHAIRPERSON FADEN:  Let me just see if I understand
your first recommendation, because that would be an interesting
alternative.  You're saying step back and say what needs to
happen is that some group of people need to work on how best to
educate this community?

          DR. KATZ:  All of them, including --

          CHAIRPERSON FADEN:  All of them, including --

          DR. KATZ:  And neglected --

          CHAIRPERSON FADEN:  We start by saying how -- that our
argument.  Okay, we start by showing how little attention in fact
has been paid to the question of how to educate the research
community on the question of research ethics.  And then the
recommendation would then go on to say some group or groups
should be convened for the purpose --

          DR. KATZ:  At the moment, Yale Medical School would
pass with flying colors, but they're really doing nothing.  So
that's the problem.

          CHAIRPERSON FADEN:  I've got Henry and Reed.

          DR. ROYAL:  One of the things that I'm confused about
with the education issue is to me it's one of the things that
we've talked about that should have a solution.  And maybe it's
because of the culture that I come from.  And I've mentioned this
before, but I think it's worth mentioning again.  In order to use
radioactive material in human subjects, you have to become what
is called an authorized user.

          And in order to become an authorized user, there's a
limited fund of knowledge that you have to prove that you have. 
And they way this is done practically is there's a written
document -- I think it's probably 20 or 30 pages long, and you
have to take a multiple choice test after having read that
written document to demonstrate that you have some level of
comprehension of what the 30 pages said.

          And I guess I don't understand why as a minimal sort of
practical solution to the education problem that there couldn't
be a 30 page document that was developed about the ethics of
human research, and why there couldn't be this multiple choice
question, and why, when an investigator applies to a human
studies committee they couldn't have to prove to the  human
studies committee that they have at least a minimal understanding
of what these research ethics are.

          It doesn't involve individuals going and holding
classes and teaching people.  It's just a requirement that they
have to meet.  So because that's a doable thing, and I think it's
a step in the right direction, and it's a concrete thing, I would
rather see that kind of a specific recommendation made.

          CHAIRPERSON FADEN:  And you think you learned something
from that when you went through it yourself?

          DR. ROYAL:  Well, I didn't, because --

          CHAIRPERSON FADEN:  You knew it already?

          DR. ROYAL:  Well, because my whole training was the use
of radioactive materials.  But there are people who don't have
any training in the use of radioactive material, and if the 20 or
30 page document is written appropriately, I think that they
would learn something.  And it's just an accepted fact.  

          I don't really have any good sense for whether or not
people regard it as having been a valuable experience, having had
to take it.  But I don't know that sitting in a classroom or
going to a meeting that they would necessary regard as a valuable
experience.

          CHAIRPERSON FADEN:  I've got Reed and Lois.  Nancy? 
Reed?

          DR. TUCKSON:  Just a very brief thing on this.  I think
that that's -- Henry, not the -- it's not -- these issues are
changing.  And if they take a test, the researcher, about the
specific sub-specialty field in which they are working and send -
- and then that test gets corrected by an IRB, the question is
how does the IRB get educated?

          How do the folks that are on that committee as -- how
do you again establish that culture of what is the right answer
to the exam as we move into these new areas of increasingly and
complex ethical issues in these fields.  

          And so I just would again just think -- and also, I
would just say in terms Ruth's earlier point about the medical
students, it's true that the majority of medical students might
not be, but there are always in each class a group of students
who are very involved in conducting activities, even at the first
and second year, particularly those that are coming in with the
goal of being M.D, Ph.D's.

          So I guess the bottom line on this is that I don't
think we probably cannot -- I don't think we need to kill
ourselves on this thing.  I think we just simply need to say what
our intent is.  It is very clear that at every level of the -- of
participation in the conduct of research, and students in
training, house staff, fellows, scientists, people on review
committees.

          At every level, there is this need to  make sure that
this is a paramount issue.  The permutations of possibilities of
how to do this are beyond the range of this committee to try to
prescribe.   And that the best that we can simply do is to say
that these issues cannot be solved with -- always with a stick,
although there are recommendations in this report that are very
stick oriented perhaps.

          But here are carrots that simply say to them this is
their responsibility to do it.  These are the things that are
minimal that ought to be done in terms of identifying the
populations of people that need to be educated.  Now you guys
have to come up with the best of your recommendations.  If they
don't do it, then that's for someone else to begin to later on --
we can't do everything in this report.

          CHAIRPERSON FADEN:  Lois, and then I'm going to try to
see if we can't get some closure so we can stay on schedule.  Is
that all right?

          DR. LEDERER:  I'll pass.

          CHAIRPERSON FADEN:  Is that okay, Nancy?  All right,
let me see if I can get a sense of where we are.  We still
haven't talked public education.  I hear three strategies.  It
may be more.  

          One strategy is Jay's proposal that eight be replaced
with a recommendation that calls for some group -- and we'd have
to then think about which group and to whom the recommendation is
directed -- to work hard on trying -- after pointing out that
this is a neglected area, work hard at thinking through the
problems of how to educate the entire research community about
research ethics -- how to do it, what it would mean, what the
implications might be for training, for education.

          Whether it should be a carrot, whether it should be a
stick -- all that sort of stuff.  Basically passing it on to
another group with a real focus on figuring out what the content
should be -- what the content should be and how it could be done. 
You could have just that recommendation.  Let's call it Jay's
recommendation for short hand, okay?

          Then we could have what's called as Reed's
recommendation for short hand.  In addition or separately, or
maybe it's the same thing, I'm not sure which -- a recommendation
that says biomedical research community, this is your problem. 
It's our problem with you.  And we're not going to prescribe how
to do it, but you've got to find a way to fix it.

          There probably is a way to construct it so that's one
recommendation, or it could be two separate recommendations.  

          And then there's Henry's recommendation, either again
in concert or separately that -- yes, Henry?

          DR. ROYAL:  It seems that you could combine all three
recommendations into one.  You have Jay's recommendation as being
the recommendation, and then in the text, for example, things
like this should be considered.

          CHAIRPERSON FADEN:  Fine.  Now the issue is if we go --
and that's very agreeable, I think, because it would work -- to
whom does Jay's recommendation go?  If we're saying -- is it to
the biomedical research community, to the federal government, to
whom is it going?  Okay, who are we saying do we want to pick up
the mantle about education and ethics for the biomedical research
community.

          DR. KATZ:  Could two groups in terms of -- are we
asking them for blueprint -- two institutions come to mind, but I
do not know whether they are the best, is the American
Association of Medical Schools, possibly.  But I don't know.  But
surely the Institute of Medicine -- I mean, really in a sense,
ask them to -- at this point to convene a committee to come up
with a -- there may be others.

          DR. MACKLIN:  Well, why not both?  I mean, it seems to
me in the spirit of today's world, calling for some cooperation
between the public and private sector, if you -- if it's directed
at the federal government, the focus will be on the regulations. 
They'll be on the regulations.  And they may not -- and it won't
be on ethics,  it will be on the regulations.

          On the other hand, people who are concerned about
education or who have responsibility -- the AAMC is one and the
Institute of Medicine brings in very important people from
various institutions to put on their committees.  I mean, it
sounds to me like a collaborative thing because you want it to go
on in private institutions, and to encompass more than -- private
as well as public institutions, but not only government.

          And you want it to encompass more than the regulations. 
So why can't a recommendation be addressed to educators and the
public and private sector and the federal government that is
responsible for the funding?

          DR. KATZ:  Henry, and is there -- and Eli, is there a
major research institution -- research group like the American
College of Internal Medicine?  Is there some research like that
that could also -- that say look, you also -- you too ought to
think about it?  Is there such a group or not?  Is that an
umbrella kind of group?

          CHAIRPERSON FADEN:  And they're different in the
specialties.

          DR. GLATSTEIN:  There are several.

          DR. KATZ:  But in the spirit of Ruth's suggestion --

          CHAIRPERSON FADEN:  We can throw them all in, but -- 

          DR. KATZ:  Not too many, not all.  But if we bring that
third arm in also, that might be --

          CHAIRPERSON FADEN:  Here's my concern, okay?  This is
going to come in -- this is going to be one of these
recommendations that has a very high probability of landing like
a thud.  Okay, now maybe what's written here would land with a
bigger thud.  But there are a couple of risks here. 

          You now, one is -- is this going to sound like -- and
when I think about what Ken said yesterday -- a commission
recommending a commission.  Okay, well you're talking about some
kind of group.  Whether you call it a committee or a commission
or a group or something --

          DR. KATZ:  But if you make a strong statement about the
neglect with which all of them have -- all of us have pleaded
this issue, and that's really a high priority, somebody like the
Washington Post may take notice.

          (Laughter.)

          CHAIRPERSON FADEN:  That's not the kind of thing that
makes for a gold mine.

          DR. GLATSTEIN:  I do know that the Radiation Research
Society is very interested in the actions of the committee as a
whole -- the work the committee is doing, and will probably
sponsor a panel after -- at their next year's meeting on this --
once the report is written.

          They want to hear about it in detail.

          CHAIRPERSON FADEN:  I'm just sort of at a loss here. 
This is getting more and more and more -- this was hortatory,
this is more, this is basically -- unless we get something
concrete here, it's really going to sound like hey, they'll be
wonderful rhetoric, but said it's been neglected, it's terrible
and awful.

          And then we say do something.  Now we can do that,
okay?  And that's fine, and have one recommendation that doesn't
take up a lot of space.  But I'm not sure what goes with that. 
I'm looking for some way to give it a political emphasis so that
it's got the challenge to somebody who has to either take it up -
- there's no  sort of accountability issue here.

          CHAIRPERSON FADEN:  I see Phil and Reed.  And Nancy,
I'm sorry.  Nancy, you were waiting from before.

          DR. OLEINICK:  I was just going to say there is an
analogy of sorts in terms of the training that graduate students
are now mandated to receive in scientific -- you know, ethics of
conducting scientific research.  But this isn't -- this is
graduate students, and it's not research with human subjects
explicitly, but ethical treatment of animals and -- you know,
scientific fraud and those sorts of things.

          And this is now regulated by NIH, at least.  I don't
know if it goes throughout the federal government, but all
graduate students -- in order for the institution to receive
training funds from the federal government, the graduate students
have to have this.  And even those who are not on these training
funds are still getting the course.

          So each institution arranges their own course,
something like what Ruth is saying.  And at our institution,
there is a week in the summer that all incoming students -- you
know, stop whatever lab work they're doing and they spend an
entire week of intensive work on this subject.

          It's taught by some individuals from the bioethics
community and others -- scientists who also participate in it so
that they are given -- you know, real life situations as to the
kinds of things that they're going to have to think about.  So I
mean, but it is directed -- the reason for bringing this up is
that we could make the direction -- the recommendation to the
federal government.

          Because I think it's going to have to start there even
if the actual implementation is done at the local level.

          CHAIRPERSON FADEN:  Phil and Reed.  Phil?

          DR. RUSSELL:  The one organization I think could pull
the suborganizations together is the Institute of Medicine.  And
if there was a recommendation that asked the federal government
to support an activity under the Institute of Medicine to bring
together the educational organizations and the professional
organizations that are -- 

          CHAIRPERSON FADEN:  Anna's just brought to my attention
we ought to acknowledge that several members of the committee are
members of the Institute of Medicine.  I don't know if there's
any issue about us sort of suggesting that the Institute of
Medicine either do a study or get a study, but we'll look into
it.  Their funding is -- no, but if we have an interest in the
Institute of Medicine continuing to have important role and get
funding and stuff like that, it's a little bit of an issue.

          So we  have to think about -- we have to think about
that.  It is  potentially unseemly for us to --

          DR. MACKLIN:  Refer it to an ethicist.

          (Laughter.)

          CHAIRPERSON FADEN:  So we just have to think about
that.  Anna is right to draw it to our attention that there is an
issue about --

          DR. KATZ:  We are not making a recommendation that
people necessarily welcome.  So that's --

          CHAIRPERSON FADEN:  I wouldn't --

          DR. KATZ:  Well, I would.

          CHAIRPERSON FADEN:  Reed?

          DR. TUCKSON:  I want to support -- I think Phil's on
the right track.  And I would only amend it by just being more
specific, saying that through the Secretary of Health and Human
Services, this ought to be -- this ought to occur.  Therefore,
giving it some focus with the governmental establishment.

          CHAIRPERSON FADEN:  Well, I think if we -- because of
our mandate, I think if we were going to address it, we have to
address it to all the agencies.  I mean, there's an interagency
working group of agencies involved in human subjects.  So we
could direct the recommendation to that interagency group that
has -- that's responsible for the common role and all of that
good stuff.

          But are we --

          DR. TUCKSON:  That's probably -- I don't mean to single
them out as being more or less important, just a matter that
since there needed to be some focus of activity for this, it just
seemed like a reasonable place. But it's not worth beating it to
death.

          CHAIRPERSON FADEN:  Now, are we saying -- so I get
clear.  I mean, I'll try to write something up or Anna will write
it up or whatever.  We'll try to pull something together.  But
right now, I have a very uneasy feeling that this is just some --
you know, recommendation go and do good.

          You know, I'm not sure how to make it more specific. 
Nancy has reraised the issue of the stick, and is there no
interest in the committee in suggesting that --

          DR. KATZ:  Could you elaborate on this?  Because it's
important because I really don't  understand it.

          CHAIRPERSON FADEN:  On which --

          DR. KATZ:  On the issue of -- that there's no -- could
become a meaningless kind of statement.

          CHAIRPERSON FADEN:  Well, I mean, --

          DR. KATZ:  Let me just finish.  Is that if we really
point out in that -- whatever we write, that this has been a
neglected area of concern, even though it should have been
addressed by somebody.  If we make specific recommendations as to
what needs to be put into with respect to -- and some of these
things, people have mentioned even here about education -- what
kind of -- and your general kind of way that they need to address
and who should teach, etc., and what.

          And do that, you know, in a few paragraphs.  And then
say now appoint a group that makes these recommendations, maybe
even that it ought to be addressed -- I do not know whether it's
a possibility, but couldn't we ask the interagency group to
approach -- and some other institutions and ask them to look into
these matters, because this happens frequently.

          And so, bring the two together, and then submit a
report with them, because these things -- to serve thought, but
also immediate attention.  Would that be that nebulous?  I mean,
that's what --

          CHAIRPERSON FADEN:  I depends on how far we can carry
it down.  If we're talking -- I'm sorry, Ruth, you were --

          DR. MACKLIN:  Well, I was just looking at what we have
here so we don't lose it.  I mean, I'm not sure that the -- that
anyone is making an argument against including such a
recommendation in here.  We're worried about carrots, sticks,
watering down, etc.  Recommend eight as it stands before you get
to the A, B, and C.

          I haven't heard anybody argue against having it as a
recommendation, and I certainly would not argue against having
it.  The advisory committee recommends a multi-pronged effort to
ensure the centrality of ethics and the conduct of scientists and
research involving student subjects.   Now, that may sound like
apple pie, but I mean, that's there.

          Then there are the specific ones afterwards.  We don't
want to omit it all together.  I think the discussion has been
both about the efficacy and the appropriateness of the A, B, and
C.  I argued against A; my colleague to my left, notwithstanding
as the leader of this group, but I argued against it on the
grounds that I think sufficiently discussed.

          And I argued against C, because I think it's the wrong
time, seeing as it's the education of the medical students.  But
A -- I mean recommendation eight as it stands can include
certainly the education for medical students.  And the way B is
written doesn't actually say that it's required, so it's Nancy's
recommendation, but it's there as a specific tool.

          And I think combined with what Jay is saying and with
some address to those who do continuing medical education and
those organizations of research scientists, we can have the
education in here without being so specific that it's going to
either be inappropriately specific and required and not in the
right place, but still point to the lack or the things that
haven't been there.

          So I think that the -- I'm going to suggest that we
keep recommendation eight as it stands.

          CHAIRPERSON FADEN:  Lines 11, 12 on page 12.

          DR. MACKLIN:  Yes.  And that we fold into the -- that
we eliminate the A, B, and C and that we fold into the text under
A what's now in recommendation 8B as one of the examples.

          CHAIRPERSON FADEN:  So we're basically -- the
recommendation is essentially this call for this.  And then we're
going to direct something to -- I mean, somehow Reed's suggestion
directing it both to the federal government and to the biomedical
research community and saying federal government, you have --
we're directing you to exert leadership in concert to make sure
that the things happen.

          And here are the following things we're suggesting,
including the commissioning of a panel or a study of how best to
approach the question of the education of research ethics. 
Whether we mention the IOM or not will depend on the issue I just
described.          DR. MACKLIN:  But that could be a such as if
we mention the --

          CHAIRPERSON FADEN:  Such as the Institute of Medicine
or whatever.  That we explore the usefulness of extending the
federal requirement that all people who receive traineeships get
this course work to other sorts of things -- explore whether --
so we put all that stuff in the conditional -- explore the
utility and the development of accrediting.

          Whatever the kind of thing Henry is describing.  I just
threw it in there.  Is that where we're going?

          DR. MACKLIN:  I think that's where we should go.

          CHAIRPERSON FADEN:  Okay, so we'll try writing it that
way and see what happens.  But basically, the accountability is
the federal government should do in a timely fashion -- should
move on this and hear the various things that ought to happen in
a timely fashion -- that the federal government has to do it in
concert with the biomedical research community and the education
community.

          Okay, for two seconds before we take a break --  I
don't know if it will be two seconds -- public education.  Lois,
no?

          DR. GLATSTEIN:  Apple pie.

          CHAIRPERSON FADEN:  Yeah, I worry about it for that
reason.  It's almost nothing, right?  The sentiment is important. 
It's more than a sentiment.  The notion that the public needs to
understand in order to protect -- in order for each of us to
protect our own interests, we need to understand something about
the research enterprise.  The how is not there, and I'm not sure
--

          DR. GLATSTEIN:  Maybe this is the place in the text
that we can bring out that issue yesterday about exportation from
research to the -- to practice.  And maybe this is the place
where that can come out.  I don't know.

          DR. KATZ:  I thought you recommend that journalists
should be educated.

          (Laughter.)

          CHAIRPERSON FADEN:  I don't think -- I mean, we could
roll it into eight, but I don't think it works.  I mean, the
eight is directed at the biomedical research community.  This is
basically -- do we want to just drop it because it is nebulous? 
Or do we want somehow to --

          DR. GLATSTEIN:  I think the sentiment needs to be
expressed there somewhere.  I mean, we've got to get the -- it's
more than just the government, more than just --

          CHAIRPERSON FADEN:  Oh, but the concern is when you 
make -- you mean you don't want to make recommendations that are
totally throw away.  You want to have only recommendations that
you think have a chance of -- you know, that really should
happen, okay?  That doesn't necessarily mean that they -- that
politically you think they will; but at least that you think they
really should and you explain how.

          And the problem is, this doesn't go --

          DR. RUSSELL:  Is there a finding related to this?

          CHAIRPERSON FADEN:  Well, our whole argument has been
that people don't -- you know, we look at all that stuff.

          DR. RUSSELL:  Is there a specific finding?

          CHAIRPERSON FADEN:  The SIS stuff, I guess.  Henry?

          DR. ROYAL:  What about combining it with eight, saying
that medical professionals in the public should be educated so
that we don't have a lot of recommendations that are hortatory.

          (Laughter.)

          CHAIRPERSON FADEN:  Just one big one.

          (Laughter.)

          DR. ROYAL:  It doesn't have to be a big one.

          DR. MACKLIN:  The problem though is that different
institutions and agencies will be responsible for educating the
public.  So if you fold it all together, the public's going to
get lost and the emphasis is going to go on the IOM, the
professional organizations and the medical schools.

          I mean, unless you want to say that medical schools or
those kinds of institutions should themselves take on the
responsibility for educating the public, but I don't think they
have the foggiest idea how to do it.

          CHAIRPERSON FADEN:  I mean, one thing I -- Anna and I
actually toyed about is whether -- and this is  always that
problem.  It's easier to get to patients than -- it's easier to
get to people once they're sick than when they're just well and
walking around or at least not in anybody's care.  And we all
know the failures of the patient's self determination act. 

          But there is in here embedded the notion that
institutions -- hospitals in which research is done have some
obligations to educate the community from which most of their
patients come about the fact that we are a research institution
and here are the differences between, you know, research and
treatment.  And here's how we look out for our interest, and just
know this about us.

          Which is -- you know, a recommendation that could be
targeted towards institutions that provide medical care.

          DR. GLATSTEIN:  Maybe you could institute a program
that would serve as an alternate for the Internet pornography.

          CHAIRPERSON FADEN:  And be just as lively, I'm sure. 
Reed?

          DR. TUCKSON:  But see, Eli's point is extremely
important.  I think first you cannot --

          (Laughter.)

          Well, it's extremely important in the sense that the
notion of how patients and consumers participate in the process
of health from this day forward is very different -- inevitably
different than it has been in the past.  The sense -- because of
the Internet, because of America OnLine and CompuServe and
Prodigy.

          Absolutely because of those things, patients are so
much more highly educated and are going to be more highly
educated, and they're going to be much more empowered as they
participate in their own care.  And we cannot fail to recognize
that the clock has changed.  And so this notion then of
recognizing -- we have to recognize that.

          And I think that it is a very different recommendation,
this one, than number eight for the reasons that Ruth mentioned. 
Now, I'm not answering your question about how do you do it.  But
I think you have to speak to it.  And I think the question merely
is that I think the only way that I think we can do anything
about this is to first acknowledge it and put it front and center
as saying this is a major issue.

          I think secondly it is that the way in which we
distribute this report we ought to speak, I think, to the way
that the only thing that we can really control over this -- at
least at our level, is to say that we are -- it is our desire
that the distribution of this report be wide enough so that the
American people have access to this kind of stuff.

          So at least that helps to prepare them to know that
there is a way of participating.  And then I'm going to have to
think more about -- be even more specific.  I can't be smart
enough at this second to figure out any other mechanism. 
Hopefully somebody else has it.

          But I think even if we can't give the specific
mechanism, we have to address the issue.

          DR. GLATSTEIN:  Maybe there should be some effort made
to attract the media themselves to form some of this educational
-- perform some of this educational service.  I'm not sure that
couldn't be done.

          CHAIRPERSON FADEN:  I don't know how to fashion this in
a way that has any oomph is the problem.  So there's this -- the
issue of whether a recommendation format is the right form for
drawing attention to an important national issue.  Maybe it is,
maybe it isn't.  Maybe we're not -- as Reed put it, smart enough
to figure out how exactly to flag the issue without having it
just fall away.

          MS. NORRIS:  Do we have any findings without
recommendations?

          CHAIRPERSON FADEN:  I don't know; I haven't done the
check.

          MS. NORRIS:  Well, we could make this a finding,
calling attention to the need absent a recommendation.

          DR. GLATSTEIN:  And maybe you have a Ken Burns special. 
I'm serious.

          MS. KING:  I think I need a break.

          CHAIRPERSON FADEN:  All right, but I don't want to
promise -- after the break, I don't want to go back to those set
of recommendations. 

          MS. KING:  Well, I only said that only partly
facetiously because we seem not to be able to come to grips with
your -- with the problem that you described very accurately.  And
we are at the level where we're throwing off what comes to the
top of our heads.

          CHAIRPERSON FADEN:  All right, why don't we take a
break.  I don't know what we'll do with this.  But we're not
going to come -- no, I don't think we should come back to this
for a few minutes.  I think we can go back to other things and
see what we're going to do with this.  I don't think it's going
to get any better.

          Or not even at the end.  Maybe not even in the meeting. 
Maybe people will try to work out something and give people some
concrete alternatives.        (Whereupon, the proceedings went
off the record from 10:54 a.m. until 11:18 a.m.)

          CHAIRPERSON FADEN:  We are behind schedule.  Maybe we
could make up time.  Maybe we can't.  I'd like to stay on the
agenda, at least until lunch, and then at lunch slip in
notification.  Then we'll just have to see how much we can get
done.

          Next on the agenda is the findings.  We're switching
from recommendations to findings for just a minute, going
backward.  Then we're going to flip forward to recommendations
again.

          The findings on intentional releases is in your
findings chapter, Chapter 18.  That can be found on Page 11. 
There is a finding.  And then I'm hoping the finding itself will
be reasonably noncontroversial and we can go on to the
recommendations.

          Did we discuss this already?  I don't think we did. 
Okay.  Then these are my notes to myself or maybe it was some
reaction to a conversation with someone that in Finding 12, that
the text beginning in the case of the Green Run be not folded.

          Didn't we discuss this?  We did discuss it.  Okay. 
Good.  We discussed it already.  All right.  So we discussed it. 
So put away findings.  We're going to go to forward-looking
recommendations on intentional releases.  We discussed it when we
weren't supposed to discuss it.  Good.  I looked at it, and I
said, "Gee, why do I have this?"  This is my unedited copy.

          So now we're back to recommendations.  And these are
now the recommendations balancing national security interests and
the rights of the public.  This goes obviously to the very core
of our charge as a committee in terms of what we were set up
initially to consider.  It is Page 31.

          There is a recommendation on classified research, which
is Recommendation 14, which has a lot of background behind it
which is not intended to stay there but was put in there so that
it would enlighten.  I hope you could tell the difference.  It
could enlighten committee discussion.

          And then Recommendation 15 is with respect to
intentional releases.  They're grouped together because they're
both directed at national security as that interest may conflict
with other interests the public may have.

          Lois?

          MS. NORRIS:  We are on classified research?

          CHAIRPERSON FADEN:  Yes.  We might as well do them in
order.

          MS. NORRIS:  Recommendation Number 14?

          CHAIRPERSON FADEN:  Yes.

          MS. NORRIS:  I have a couple of problems, only one of
which is really major.  14(b) referred to approval of an
independent nongovernment panel of technical experts.  "Technical
experts" to me is inappropriately vague in this particular case.

          If you're talking about chemical warfare, for instance,
a technical expert could be a chemist and a weapons design
person.  And I don't think these are the people we want to be --

          CHAIRPERSON FADEN:  We want a different kind of
expertise, array of expertise.

          MS. NORRIS:  Some more specificity, whatever.

          CHAIRPERSON FADEN:  We want to make sure that it's not
just technical, that it's not people with now a technical --
experts in other things, ethics, politics.

          MS. NORRIS:  Right.  Then we also mention -- I think
this is Lines I think 17 through 19 -- that the record should be
made public as soon as national security concern justifying
secrecy no longer applies.  I assume that you have no intention
of subject identifiers releasing natural consent forms.

          CHAIRPERSON FADEN:  Oh, no, no, no.

          MS. NORRIS:  Just the forms themselves.

          CHAIRPERSON FADEN:  Right.  We can stipulate that.

          MS. NORRIS:  The one that really does concern me is on
Page 33, Lines 8 through 11.  And this is where we are calling
for security clearances for research subjects of classified
research.  That one worries me.

          Two reasons:  First of all, it could create a backlash,
create a new coercible, vulnerable set of subjects; i.e.,
military and civilian employees who already have security
clearances.  Therefore, they're accessible.

          CHAIRPERSON FADEN:  I see what you're saying.  They
would be disproportionately approached.

          MS. NORRIS:  Oh, yes, very accessible subject pool. 
That bothers me.

          And then also if you require security clearances for
subjects and they do elect to recruit subjects who do not already
have them, in order to volunteer, for whatever reason, you have
to subject yourself to the personal scrutiny of a security
clearance and subject all your friends, neighbors, colleagues,
business history to a security clearance.  And I think that
places an undue burden on those potential subjects who don't
already have clearances.

          DR. THOMAS:  A commitment which may make it difficult
for them to withdraw at that point.

          DR. RUSSELL:  Why?

          DR. THOMAS:  Because they have so much invested in the
process already and --

          CHAIRPERSON FADEN:  Yes.  Phil?

          DR. RUSSELL:  I assume you mean a panel of
nongovernmental experts, not a nongovernmental panel, because it
is a government panel.

          CHAIRPERSON FADEN:  Quite correct.  The modifier is in
the wrong place.

          DR. RUSSELL:  And it's a government advisory panel of
scientific and technical experts.

          I would argue that the Charge 1 is totally
inappropriate.  The responsibility for classifying or not
classifying something is the responsibility of a federal
official, not of an advisory panel.  And I don't think that the
panel should deal with the justifications for classification. 
That's clearly a federal official responsibility and probably by
law it is.  So I think the Number 1 ought to be deleted.

          I think that what should be added is a review of the
quality of the scientific experiment, that that --

          CHAIRPERSON FADEN:  We replace it with the scientific
review.

          DR. RUSSELL:  Right.  I think that the advisory panel
should assure that it's very high-quality science, that the risks
are acceptable, and that the risk to potential harm, the
risk-benefit, risk-harm ratio is appropriate.  And then the third
one is appropriate.

          I see the problems in that informed consent and
requiring security clearance for potential subjects, but I think
it's an option that needs to be retained.  I can see experiments
where those aspects that are classified are irrelevant to the
consent process as long as the subject would understand that the
reasons, underlying reasons, are classified, that he can be
provided, he or she could be provided, enough information on the
medicine, the biology, the risk, and so forth, to make a good
judgment.

          On the other hand, there may be certain kinds of
experiments where the nature of the experiment would be so
obvious that it does reveal the classified nature.  And,
therefore, you couldn't do the experiment.  You couldn't do the
studies unless the volunteers had security clearances.

          So I don't think we should make a recommendation that's
too restricted here.  I think you could make this an additional
charge to the advisory group to determine whether it's
appropriate or inappropriate for the subjects to have security
clearance.

          CHAIRPERSON FADEN:  That would be an interesting way of
--

          MS. NORRIS:  Yes.  That satisfies me.

          CHAIRPERSON FADEN:  That would be Charge 4 to the
independent panel that would address whether a security clearance
was necessary for someone to give an adequately informed consent
and, if so, to ensure that there are sufficient safeguards that
this is no coercible, whatever the deal is.

          It may be appropriate to go to people who already have
security clearance but in a way that makes it clear that they
don't need to do this.  I mean, there are a large number of
people who have security clearances.

          MS. NORRIS:  That would satisfy me.  That would be
great.

          DR. THOMAS:  I guess I'm still a little uncomfortable
with the idea that this advisory panel should not be charged with
reviewing the justification for why this experiment needs to be
done in secret.

          I accept Phil's point that the process of classifying
information is a government responsibility which should not be
delegated to an outside operation, but the appropriate ethical
conduct of the study being done in secrecy seems to me to be
something which the -- and the reason why it needs to be done
that way is something that this panel needs to be apprised of and
should consider whether or not in their view the additional
burdens imposed on the subjects are justified in the interest of
national security and whether or not the experiment should be
done at all under their circumstances or whether or not a pitch
should be made to the government to reconsider whether or not the
experiment could be done in a non-classified setting.

          DR. RUSSELL:  I don't have any problem with asking a
suitably declared advisory committee to advise on that issue.  I
could think of potential scenarios where there would be reasons
that are not revealed to the committee that because of some level
of security that would make it essential that the committee might
not be provided with all of the information, background
information, that would require the security and conditions and,
therefore, might not be able to make a fully informed decision on
the security requirements.

          On the other hand, having them be advised to the extent
that they understand it is perfectly appropriate.

          DR. THOMAS:  I guess I have grave reservations about
the notion that this committee could be only partially informed
of the circumstances and based on that partial information could
remain unpersuaded that the justification for the experiment
under the conditions that are proposed is justified and the
government could then go ahead and preempt that responsibility
and say "Well, let's go ahead and do the study anyway."

          DR. RUSSELL:  If you took a hypothetical scenario in
which the human subject research was needed to develop a
countermeasure against some threat, the assessment of that threat
might be so highly classified that it couldn't be revealed to
protect the sources of the information, --

          DR. THOMAS:  I understand.

          DR. RUSSELL:  -- for all the reasons that --

          DR. THOMAS:  I understand.

          DR. RUSSELL:  -- classifications are done.  And so that
the level of urgency of developing the countermeasure and so
forth is a matter that only the government officials fully
informed could make good decisions on.

          But if you got to the point where it's urgent to do
this, then you could give an advisory group enough information to
give good advice on:  Is this being done appropriately?

          DR. THOMAS:  But in this situation it seems to me we
bump up against Recommendation 14(a) in this case.  If you can't
give your advisory committee enough information to make a
decision as to whether or not the experiment is warranted, how
are you ever going to require the --

          DR. RUSSELL:  No, no.  That's not the question.

          CHAIRPERSON FADEN:  I think it's not that it isn't
warranted, but that it be classified.  Okay?

          DR. RUSSELL:  You're arguing about whether it will be
classified or not.

          CHAIRPERSON FADEN:  You give the advisory committee all
the details the --

          DR. THOMAS:  No.  I've already accepted that.  I'm not
asking this advisory committee to act on whether the experiment
should be classified, but whether or not the experiment should be
done or should be done in this particular manner --

          CHAIRPERSON FADEN:  Oh, I think that's okay.

          DR. THOMAS:  -- and whether or not the experiment is
justified based on the need, part of which must remain
classified.

          DR. RUSSELL:  Think about how that would play out.  The
committee might say that they don't have sufficient justification
for doing this, you know, "The experiment's okay.  And you can
see why it's doing it.  Why are you classifying that?  We aren't
convinced that it should remain classified?"  That could be an
interactive process.  And they may --

          DR. THOMAS:  Well, I want to stimulate that dialogue. 
You see, that's why I think that first recommendation, although
it does need to be reworded so that it doesn't imply that we're
asking this panel to --

          DR. RUSSELL:  You can't empower nongovernmental
officials with the responsibility for classification or
declassification.

          DR. THOMAS:  And I'm not asking them to.  I'm not.

          CHAIRPERSON FADEN:  Could we make 1 advise and 2, 3,
and 4 determine, advise on?  I'm just trying to come with
particular language.

          Pat?

          MS. KING:  First of all, I agree with what Phil's first
statement was, that, I think, if I got it right, that 1 in 14(b)
was appropriate.  Maybe if he didn't say that, I will say it for
myself.

          And I get at it this way.  I ask:  What is it that we
are concerned about?  We are concerned about potentially human
subjects.

          CHAIRPERSON FADEN:  Right.

          MS. KING:  How do we best accomplish that?  We have
agreed to this addition.  You want scientific review.  You want
to know whether it can be done.  You want informed consent, which
is a change, which we're now saying you cannot not do it.  And we
want risks to subjects that are acceptable.  And we want
disclosure.

          Now, one can make an argument that you can't do that
because if you're really assessing risk, you need to know how
important, not how scientifically valid, but how important the
work is.

          And it seems to me that when you get -- you notice I'm
not using "classification" or "secrecy" or "national security." 
When you want to know how important the work is, I think that
you're into a different realm of decision-making.  It is not that
it does not relate to what you're doing.  I see it as being
primarily decision-making of a different sort with which
government officials are properly charged.

          It is the work of the Executive and the Congress to
determine and their officials to determine in our system what is
significant to carry out our national interests.

          It seems to me that other groups may want to make
recommendations about maybe the national interest should be
carried out better or different ways.  But that doesn't seem to
me to be our charge.

          Ours is that at some point you have to trust the
government.  I mean, this is becoming the "Do Not Trust
Government" commission.  At some point you've got to trust it or
we might as well forget about it.  And I am willing to place the
stress in this on a panel whose expertise does not go to making
those kinds of decisions.

          Its expertise will go to science.  Its expertise will
go to risk.  Its expertise will go to consent.  Its expertise
will not be in making judgments about what the government needs
in order to carry on its business.

          Therefore, I am agreeing with Phil what I thought he
understood, which is to eliminate 1 and to add science and to
keep the remaining ones.

          CHAIRPERSON FADEN:  You would add science and add the
panel's reviewing about the security clearances, subjects need to
have security clearances and, if so, to introduce safeguards for
potential subjects.  So the proposal is to remove 1 and add
science and Lois' concern about security clearances.

          I remind you that the recommendation here is important. 
This is a hole in national policy.  So when we talk about stuff
where this committee is going to make a contribution, if they
listen to us here, this is a big deal.  This is not a little
deal, even if they only do one study a year or they don't do any
for 5 years and then there's a national threat and they've got to
do 30 and we just don't know.

          DR. RUSSELL:  I think it's important:  one, that there
be a mechanism for carrying out the necessary studies; and, two,
that we do it in as credible a manner as possible with regard to
the science and the potential risk and so forth.  I think we'll
make both national requirements.

          CHAIRPERSON FADEN:  So if we hadn't discussed some
recommendations this morning that we worried about being
hortatory, this is not hortatory.  Of course, it will be if they
don't implement it, but it has a potential to be implemented
rapidly as policy.  And it's core to the history of this
committee's charge, as the next one is as well.

          Ruth, you look troubled.

          DR. MACKLIN:  I know nothing about any of this.  I want
to hear again what Phil said about what might still have to be
kept secret.  In other words, we're talking here about what can
be disclosed, even if subjects have security clearances or to
this advisory panel.

          And, yet, I heard Phil say that something still because
it comes from a higher level -- maybe an example would help, some
wild hypothetical example might be --

          CHAIRPERSON FADEN:  Henry, did you want to answer or --

          DR. ROYAL:  Well, yes.  I mean, the more people who
know about it, the more chance there is that something is going
to leak out.  And I can imagine circumstances where there are
people who have security clearance but just because they have
security clearance doesn't mean that everyone who has security
clearance should know about this particular item because the more
people you tell, the more likely it is that it's going to get
out.

          MS. KING:  That is indeed what happens with the
Congress.

          CHAIRPERSON FADEN:  Right.  Let's --

          MS. KING:  They are only exposed to a very small
number, not --

          CHAIRPERSON FADEN:  To a small number of the members. 
Let's imagine.  Okay.  We had these discussions with people when
we were developing this memo.  Let's imagine that the government
has learned that a terrorist group of a certain sort, domestic or
overseas, has developed a new nerve gas and they actually have
information, intelligence information, that they plan to use it
in such and such a city in six months.  And that's the urgency
behind developing whatever defensive anecdote kind of thing is --
the whole panel doesn't need to know.

          And, arguably, it would not be a good idea for the
whole panel to know the name of the terrorist organization that
they have the chemical, where it is.  It's enough for the panel
to know that there is a real serious concern about this nerve
gas, this new nerve gas, that is being developed and there is a
credible threat.

          That's the kind of scenario we were presented with. 
And maybe the members of the committee don't want to now that the
name of the organization, the city, and the way it's planned to
be done.  So it's at that level that there's a concern about
distinguishing.

          DR. RUSSELL:  One of the big concerns of the
intelligence community is revealing what they know in the context
that if it's revealed what they know, then it's going to be
revealed how they got it and that frequently would put the lives
at risk and stop the source of the information.  This is
especially important in the terrorist arena.

          So that protecting the fact that this information is in
the hands of the government is very, very essential, even though
you have to act on it.  Well, you can act on it by clearing
people for certain kinds of activities, but they don't have to
know all the background.

          And they may not be immediately convinced of the
urgency of doing it unless they had that background, but --

          CHAIRPERSON FADEN:  They have to --

          DR. RUSSELL:  -- because of the level of concern you
can't reveal it.  So that's the example.

          CHAIRPERSON FADEN:  Is that helpful?

          DR. MACKLIN:  Yes.

          CHAIRPERSON FADEN:  All right.  With the amendments,
then can Recommendation 14 stand?  And, just so you know, the
italicized stuff is not intended.  That was there so that you
didn't have to go back and look at Chapter 14 in order to know
what was going on.

          Now we're on to Recommendation 15, which is a parallel
kind of recommendation for intentional releases and secrecy and
national security.

          (Pause.)

          CHAIRPERSON FADEN:  I'm sorry.  We were just conferring
because it looked for a minute to me like it had changed from the
last time I saw it, but it hadn't, though.

          Lois?

          MS. NORRIS:  This is a question.  And it may be
inappropriate.  But on Line 19, would it be possible or
reasonable or appropriate to change that to "substances for
research and development"?  It seems to me that research is a
little more narrow than research and development and --

          MR. GUTTMAN:  The intent here I think was to
distinguish between ordinary everyday releases.  Then you're into
the world of the operation of everyday --

          MS. NORRIS:  Yes.

          MR. GUTTMAN:  That was the nature of the boundary.

          MS. NORRIS:  This may be personal and maybe I don't
know the appropriate definition, but it seems to me that if you
throw development in there, it's more than an ordinary release. 
It might catch something that would slip through a crack if we
limit it to research.

          CHAIRPERSON FADEN:  Is there discussion on that point
or are people comfortable with the amendment that "development"
be added, "research and development"?

          DR. MACKLIN:  I'm not sure what development means.  I'm
not sure what it means.

          MS. NORRIS:  For instance, release of materials into
the environment in the course of developing a new weaponry.  That
to me catches something that research does not.

          MR. GUTTMAN:  How about testing?  I think the example
historically --

          MS. NORRIS:  Research and testing?

          MR. GUTTMAN:  -- is the safety tests that we had with
the nuclear rockets and so forth, which is sort of the notion of
development in that sense.

          CHAIRPERSON FADEN:  Maybe the word should be "testing,"
rather than "development."

          MS. NORRIS:  That's possible.  I just wanted to catch
something more than what we classify as research.

          DR. OLEINICK:  Well, but, you know, I think what you're
thinking of is research in the sense of purely basic research.  I
mean, you would consider it development or testing under applied
research, I think.  And I think it all, at least in my mind it
all, is captured under that research.

          DR. RUSSELL:  The acronym that's almost universal
throughout the Defense Department --

          DR. OLEINICK:  Is R&D.

          MS. NORRIS:  R&D.

          DR. OLEINICK:  Research and development.

          DR. RUSSELL:  R&D because research has the implication
for basic and --

          DR. OLEINICK:  Well, okay.

          DR. RUSSELL:  -- development has the testing and the
nth stage.

          DR. OLEINICK:  It's not a big point.

          DR. RUSSELL:  It may overlap to a great extent, but the
majority use both.

          DR. OLEINICK:  That's fine.

          DR. RUSSELL:  And it will be comprehensive.

          CHAIRPERSON FADEN:  Would you be comfortable, Phil,
with "research and development," --

          DR. RUSSELL:  Yes.

          CHAIRPERSON FADEN:  -- which was the suggestion?

          MR. GUTTMAN:  It's not RDT&E, research, development,
testing, and evaluation?  So we'll shorten the acronym.

          CHAIRPERSON FADEN:  Unless anyone objects, the
amendment is accepted.  And Line 19 reads "substances for
research and development purposes."

          Nancy?

          DR. OLEINICK:  I'm just wondering if we're going to get
hung up on the word "hazardous."  What is the definition here? 
What level is hazardous?  We say later on that most of the
releases that we talked about where there really wasn't very much
risk -- so in that sense they weren't hazardous because the
levels were so low.

          MR. GUTTMAN:  Here's the conceptual if I can be in the
Pat King policy mode and bungle it if Pat will pick it up.  One
intent here was the key into the existing body of environmental
laws, which has about a billion different and conflicting
definitions of hazards and also have the environmental review
process.

          So one intent was if there is under this whole system
of current environmental laws this market research and provision
for keeping something secret, then we don't want that to go
unchecked.

          So one way to have written this was to say "If under
existing laws governing hazard and environmental review some or
all is secret, then this has got to be triggered."  The question,
of course, is:  What happens if that body of law is changed or it
doesn't exist?  Then you have, you know --

          DR. RUSSELL:  But isn't that what you want to do?

          MR. GUTTMAN:  What?

          DR. RUSSELL:  You want to tie whatever --

          MR. GUTTMAN:  Yes.

          DR. RUSSELL:  -- this process --

          MR. GUTTMAN:  Yes.

          DR. RUSSELL:  -- to whatever evolves in the future with
regard to environmental laws and --

          MR. GUTTMAN:  Except the question, though, of -- the
committee I'm sure is of the view that that even if there were no
Environmental Policy Act, we would still want a review of things
that were being done in secret, I assume.

          DR. RUSSELL:  The fact is there is.

          CHAIRPERSON FADEN:  Yes, but it might go away.

          MR. GUTTMAN:  But if it goes away because there are no
resources at EPA or whatever.  That's the question.

          DR. RUSSELL:  Then we've got bigger problems than this.

          CHAIRPERSON FADEN:  Pat?

          MS. KING:  It seems to me that what we ought to be
focused on is -- this goes back to research and development.  It
seems to me that our focus, our problem with intentional releases
is what it can do to the people who were exposed.  And am I wrong
about that?

          And what this focuses on is when you're conducting
research, development, we're trying to cover the whole avenue of
activities that the government might take on.  And that's why
we're tangling with this problem of research.

          I guess I would turn around and write a recommendation
that focused on when a substance is released that posed harm to
those exposed, that is when --

          CHAIRPERSON FADEN:  The problem, Pat, is that what's
circumvented by going in secret is the public debate about
whether something is hazardous or not.

          In the environmental area especially, but I guess
everywhere in life, you've got communities arguing with feds
about whether a particular agent being released at the level
posed to be released is acceptable or not and the Environmental
Protection Act's requirements about publishing all that stuff
that puts it out there, it's got to be out there, the public has
a chance to comment, you fight.

          And, yet, all of that stuff is obviated when it goes
underground.  So the advocates for the community, the
environmental activists, everybody who might want to comment and
fight on the release no longer have an opportunity to do so.

          So what's at issue is precisely whose values about what
counts is acceptable are now not open.

          MS. KING:  That's not what my point went to.

          CHAIRPERSON FADEN:  No.  The issue is about who decides
it constitutes a harm.

          MS. KING:  I'm not arguing about hazardous.  I went
back to research and development.

          CHAIRPERSON FADEN:  Well, then you raised issues about
only posed a risk of harm.

          MS. KING:  I said that the focus of the recommendation
at Line 19 when we were talking about "substances for research
purposes and development in cases where" dah dah dah seemed to
place the trigger on the definition of research and development.

          And what I said was that's not what I thought we were
intending to do that our focus is on anything that goes into the
atmosphere that's hazardous -- I didn't touch hazardous -- that
what we wanted to say was to turn this around, the recommendation
around, to our focus when people are placed at risk.

          And I assume that now is covered by the recommendations
according to what Dan and you both said about all of these
multiple definitions of hazardous.

          CHAIRPERSON FADEN:  Okay.

          MS. KING:  What you're looking for is a trigger.

          CHAIRPERSON FADEN:  Right.  I'm sorry.

          MR. GUTTMAN:  Yes, yes.

          CHAIRPERSON FADEN:  I don't understand where you're
going.

          MR. GUTTMAN:  I think I understand, Pat.  Go ahead,
Pat.

          MS. KING:  What you're looking for is a trigger that
would call into place this process that you were outlining here. 
And the way this reads, the trigger is "propose environmental
releases of hazardous substances for research purposes," is the
trigger that triggers this process.  That's not what I think that
--

          MR. GUTTMAN:  Let me point out here's the dilemma. 
This is not the dilemma.  This is the policy question for the
committee.  Take the Green Run, Hanford.  You had, as Henry has
pointed out, 669,000 curies that were released during the normal
course of operation not for research purposes.

          So the question is:  If you want to cover all of that,
then you are talking about a committee reviewing all of the
releases that somehow are implicated in secrecy without regard
for whether or not they're operational.  You could do that, but
it's a different --

          MS. KING:  I guess we still haven't gotten the rest of
it.  But you're explaining better than I am because what I'm
trying to get is the meaning of the not-hazardous.

          MR. GUTTMAN:  Yes.

          MS. KING:  It is certain types of proposed
environmental releases are covered here.  And those types of
environmental releases covered here are if they have research
purposes.  And now we've added research and development purposes.

          CHAIRPERSON FADEN:  Wait a minute, Pat.  And if that's
wrong --

          MS. KING:  And what I'm trying to ask --

          CHAIRPERSON FADEN:  Okay.

          MS. KING:  -- is:  Is that what we want to make the
trigger?

          CHAIRPERSON FADEN:  As opposed to?

          MS. KING:  As opposed to talking about releases that
pose risks to people without a focus on the characterization of
the releases.

          CHAIRPERSON FADEN:  And you want to say "for all
potentially hazardous releases"?

          MS. KING:  That's the question I'm asking.  I'm asking
what the committee wanted to --

          MR. GUTTMAN:  Let me articulate the writing.

          CHAIRPERSON FADEN:  I'm sorry.  I couldn't follow you
until just now, Pat.

          MR. GUTTMAN:  Let me articulate the drafting.  There's
a point that we tie it into current environmental laws.  Then you
could say that anything that is normally covered by these laws,
but, for whatever reason, is secret, we want to have this thing
reviewed by it, which includes everything.

          MS. KING:  Right.  That's one way of going.

          MR. GUTTMAN:  Right.  The reason it isn't written that
way is because of the question:  Well, what if we didn't have or
don't have the same kind of --

          CHAIRPERSON FADEN:  But you forget the laws.  Pat's
saying forget the laws, whatever.

          MS. KING:  I'm just asking because it seemed --

          CHAIRPERSON FADEN:  Forget the law.  The law isn't the
issue.

          MS. KING:  Our concern about -- I'm trying to get to
the:  What is our concern about potential releases?

          CHAIRPERSON FADEN:  Why the releases were released.

          MS. KING:  Yes.  Do we care more about the fact that
the releases exposed people to risk and they didn't know about it
and had no way of finding out about it?  I'm only trying to find
that out so I can figure out whether this does what we think
we're doing.

          Phil, does that make sense finally?

          CHAIRPERSON FADEN:  Yes.  It does to me anyway.

          MR. GUTTMAN:  But let me explain.

          CHAIRPERSON FADEN:  You retained me, and you lost Dan.

          MR. GUTTMAN:  Let me explain if I can add sort of a
friendly amendment to the explanation is the difficulty is the
current body of federal law has in it all kinds of trigger
mechanisms so you're not -- just because it's a microcurie coming
out of some plant, you don't have a federal environmental impact
statement.

          If we talk about all releases and assuming the law
changes, then you have this body, which is now all of a sudden an
obligation looking all over the defense complex and determining,
you know --

          CHAIRPERSON FADEN:  How many releases are secret?

          MR. GUTTMAN:  Oh, you are talking about the question. 
I mean, I can tell you.  For example, I used to represent
workers.  Uranium hexafluoride is released in some secret part of
the fluorinal plant accidentally.  It's leaking.

          Is that something that would be -- this happens all the
-- we don't know.  I mean, what I'm saying is a large part of the
weapons complex is still operating in secret.

          CHAIRPERSON FADEN:  You can't have a panel to review
accidents in advance.

          DR. MACKLIN:  The distinction between accidents and --

          CHAIRPERSON FADEN:  I know.  I know.  That's what I was
responding to them, that you were talking about routine releases. 
How often are routine releases classified such that Pat's
question:  Why not address all the releases that are classified?

          MS. KING:  I'm really asking what the committee
intended to gain from its --

          CHAIRPERSON FADEN:  Its modifier.

          MS. KING:  -- its modifier because that way it would
let me know what we want to have here.

          CHAIRPERSON FADEN:  I think that from my opinion the
modifier was there because we were working at that context, but
it may not be necessary.  In other words, our mandate was to look
at the releases for research purposes.

          MS. KING:  One of the things that struck me from Dan's
comment -- and this is -- I actually don't have my own views on
this, but what struck me from Dan's comment is that one of the
entangling problems in intentional releases is that the people
who were there in the community who were being exposed to some
form of radiation release were in a better situation as a result
of that as they were of this additional release.

          And if I approach this from a human subjects, this sort
of goes back to the old debate from the perspective of the person
for whom the radiation falls.  Do they care whether there's a
plant or some airplane flew over in secret?  And so that's why
you really helped me to get it --

          MR. GUTTMAN:  No.  Of course they don't.  I don't think
this is a drafting problem in terms of --

          CHAIRPERSON FADEN:  It's not a drafting problem.  It's
a substantive problem.  Pat's quite right.  Do we want to say
that this ought to be the case for any release that's hazardous,
whatever the law defines it?

          It could be secrecy is what we want to say.  The
trigger is when it's done in secret and there's no public federal
environmental impact statement and all that kind of stuff.

          But Phil has been waiting patiently.

          DR. RUSSELL:  It doesn't make any sense to have a
different process for research versus non-research if you're
talking about intentional release under secret conditions.  It
ought to be the same process.

          So if we're going to make the recommendation, we
probably ought to just take out for research purposes.

          CHAIRPERSON FADEN:  Right.

          DR. RUSSELL:  Now, that would make it a fairly global
kind of a recommendation.  We'd need to think fairly carefully
about it.

          CHAIRPERSON FADEN:  But the important --

          DR. RUSSELL:  But I think that it doesn't make sense
that if --

          CHAIRPERSON FADEN:  It would be as if this had been in
place, the Green Run would have had this panel.  And everything
else that had been going on at Hanford would not have had a
panel, which does seem nutty.  That's the force of Pat's concern.

          DR. RUSSELL:  Right.  That's why it makes no sense.

          DR. MACKLIN:  Phil just said "intentional."  Now, I
mean, intentional means deliberate in contrast to knowing.  But
set aside accidents.  I mean, the routine releases are not
intentional in the sense that someone deliberately did.  I'm just
trying to understand now what we're talking about.

          CHAIRPERSON FADEN:  They are deliberate.  They are the
intentional -- I mean, it didn't really go into an action theory
kind of thing, but they are planned.  Do you want to say
"planned"?  They are planned?  I mean, the plant has to release
every six weeks X amount of gunk into the air.  It's part of the
operation of the plant.

          I don't know whatever language you want, but it is
purposeful and planned and if we don't want to say "intentional." 
I don't know, Ruth.  Do you see what I'm saying that it's
something that some human beings decided should happen?  It
didn't just occur.

          DR. MACKLIN:  Well, but it's necessary for the
operation presumably.

          CHAIRPERSON FADEN:  Right.  So if you want to do a
double -- you know, we don't mean to do this.  What we mean to do
is have a good running plant.  It happens that stuff comes out. 
I mean, I don't know.

          DR. ROYAL:  But in terms of the affected population, at
Pat was saying, they don't care whether it's necessary for the
operation of the plant or whether it was --

          CHAIRPERSON FADEN:  It's a planned release, as opposed
to an accidental release.  We obviously can't have an advisory
panel advise in advance of an accident.  After an accident,
maybe, but before the accident -- is that okay?  We can work on
the word, but the word is --

          MS. KING:  Even I understand some problems with the
standard version, but it seems to me if we're going to discuss
about hortatory, that one of the places where we can do not
something that I put in the category of hortatory is this is a
way of calling attention to something that I do think is
important.  And that is that it didn't make any difference to the
people who were under the Green Run where they got the radiation
from.

          And if part of it is in secret and you've got a
trigger, a mechanism, then one of the things that I hope will be
the outcome of that because I believe there are responsible
federal official around is that people will start asking the same
kind of question that we're asking.  Well, we need this process.

          Will there be some trickle down to those releases that
involve exactly the same thing that we sort of haven't paid that
much attention to because it's sort of just coming out of the
factory?

          But where there were releases that were routine, I
would hazard a guess that what was going on in the plant was not
generally available to the public because of the nature of the
plant that was at issue.

          So it wasn't secret in the same way that Green Run was
secret, but if the overall goal is that the communities get to
fight their own battles and it's more openness, then in my way of
thinking, those operations were closed or not out in the open. 
So that was the guise of this question.

          Why lay all of this on research, in other words?

          CHAIRPERSON FADEN:  No.  I think that's right.  Let me
just, to move us on, unless I hear otherwise, 15(a) is amended. 
Line 19 just says "releases of hazardous substances."  We'll come
up with a word for planned, intended, other than accidents. 
"Other than accidents" may be the right thing, although that's
sort of self-evident, the reason I just gave.

          So is everybody accepting of that?  Then we're moving
on to 15.  I'm sorry.  Henry?  I'm sorry.

          DR. ROYAL:  Some of the checks on Page 37, Lines 5 and
6.

          CHAIRPERSON FADEN:  Thirty-seven, Lines 5 and 6.  Yes.

          DR. ROYAL:  It says "Actions will be taken to measure
the actual effect in the release of the environment in health and
safety."  I'm not sure what that means.

          A lot of times the protection levels that are exceeded
are small enough so that it's not possible to measure a
statistically significant increase in anything in the
environment.  And it's just I don't understand.

          I guess I wouldn't want this to be interpreted as
forcing agencies to undertake unnecessary expensive studies when
there's no reason to believe that you're going to find anything.

          MR. GUTTMAN:  The intent was to provide what we've seen
as the bookkeeping things, that we don't have the problem 10
years later of people said "Well, what happened?"

          CHAIRPERSON FADEN:  That's 2, "Records will kept in the
nature and the purpose of" -- you want --

          MR. GUTTMAN:  This is after the fact.  It could be in
the form of Henry's statement that the scientists have determined
that there's not anything that is worth a major effort at
measuring.

          CHAIRPERSON FADEN:  Would it be sufficient to say that
records should be kept about the level, the amount of the
release, how much is released without necessarily stating it's a
fact?  I mean, would it be reasonable to require that records be
kept about --

          MR. GUTTMAN:  Well, it's something that's sufficient to
be able to explain to 10 people 10 or 20 years later "We didn't
take a big set of measurements because it wasn't necessary based
on" --

          DR. THOMAS:  But there may well be other circumstances
of where the release is of such a magnitude that you would wish
to take measurements downstream that you would try to understand
about the --

          CHAIRPERSON FADEN:  Why don't we just put "whether" in
front of 4, "whether actions should be taken," "The panel will
advise about whether"?  All right.  We've got it.

          Thank you, Henry.  That's one of the charges to the
panel.  Is this a big enough deal that there should a follow-up
study?  And if not, we'll know it in the minutes of this advisory
panel that says "It's not a big enough deal for the following
reasons."

          Can we then move on?  Thank you.  15(b).

          DR. MACKLIN:  Just one thing.

          CHAIRPERSON FADEN:  Yes, Ruth?

          DR. MACKLIN:  Just one small point.  And that is the
text in light of the changing of the recommendation itself and
eliminating the word "research," the text under 15 --

          CHAIRPERSON FADEN:  Line 4 on Page 37?

          DR. MACKLIN:  Well, it's later on, too.

          CHAIRPERSON FADEN:  Okay.

          DR. MACKLIN:  The findings were not only that the
government sponsored numerous intentional environmental releases
for research purposes but also that there were all of these
releases.

          CHAIRPERSON FADEN:  Right.  We have to change the
rationale.

          DR. MACKLIN:  So the text has to be changed.

          CHAIRPERSON FADEN:  We now have to give a rationale why
we as a committee charged with looking at intentional releases
for research purposes are saying we should go to all secret
releases.

          And our Green Run example is, of course, what motivates
us to say why we think it doesn't matter whether it was for
research or not.  The fact that it's secret is what's of concern. 
Thank you.

          Reed, are we on 15(b)?  Okay.  Reed and then Henry.

          DR. TUCKSON:  Just a quick question on just the EPA
itself.  Is that one of the agencies slated to be --

          MR. GUTTMAN:  Not at present.

          DR. TUCKSON:  Thank you.

          MS. KING:  It kind of waxes and wanes.

          DR. TUCKSON:  So they're not being that specific about
EPA.

          MR. GUTTMAN:  It's an important message here.  I don't
want to take --

          CHAIRPERSON FADEN:  No.  Go ahead.

          MR. GUTTMAN:  It's extremely important here, and this
is the whole of Pat's comment that we're now in a "Don't trust
government" theme, that we've got to be very, very careful for
reasons that are self-evident to anybody who reads the papers
that we aren't construed as saying that you can't trust the
people in government.

          This is EPA's responsibility.  EPA when it gets the
resources should be able to do a good job.  We're adding another
level for other reasons.  But you want to reinforce the notion
that you're not trying to say "Let's get rid of government and
put another level of government."

          And so it's critical to be able to say that there are
people who can do jobs and should do the job and we want to make
sure that they've got the resources to do it already in the
government.

          That's the point I mentioned because we get constant
comments from a lot of people saying "Well, you're not really
saying 'Get rid of government,' are you?"  And the answer should
be clear that we're not.

          CHAIRPERSON FADEN:  Henry?

          DR. ROYAL:  I was wondering if the second sentence of
the recommendation on Lines 6 and 7 says anything useful because
I'm not sure that I know what "critical records in perpetuity"
means.

          MR. GUTTMAN:  What that means is when Mark queried EPA,
they said they couldn't tell us what prior secret releases had
been reviewed by them because nobody had any records of anybody
reviewing.  Is that correct, Mark?

          So the critical means enough to be able to tell an
advisory committee what it's been doing for a couple of years.

          DR. ROYAL:  Isn't that taken care of under 15(a)?

          CHAIRPERSON FADEN:  We're saying that that panel is
going to keep records.

          MR. GUTTMAN:  Right.  That's a separate --

          CHAIRPERSON FADEN:  So the issue is --

          MR. GUTTMAN:  That the oversight agency, which is
formally --

          DR. ROYAL:  And I guess I don't understand.  Has EPA
formally had oversight of classified programs in the past?

          MR. GUTTMAN:   Yes.  Mark?

          DR. GOODMAN:  Formally the requirements to provide
oversight are there.  But the mechanisms haven't always been in
place.  For reviewing environmental impact statements apparently
they have on at least some occasions, but that was a specific
question where we asked them "Well, how many times have you done
it?"  They couldn't say.  They didn't keep environmental impact
statements.

          For review of substantive compliance; that is, not just
what do you do, but does what you do comply with environmental
laws, they have only recently put in place, begun to put in
place, a procedure for review of classified programs.  And for
many years they had the mandate to do it but were not doing it
because they didn't have people with appropriate clearances.

          DR. ROYAL:  So I'm wondering whether or not critical
records needs to be --

          CHAIRPERSON FADEN:  Rewritten?

          DR. ROYAL:  -- defined in some way.  It sounds like
what we'd like them to keep are maybe the minutes of this
advisory committee.

          CHAIRPERSON FADEN:  That should be kept separately, I
think, or whoever holds it, maybe EPA, should hold it.

          DR. ROYAL:  Well, who is going to hold it?

          CHAIRPERSON FADEN:  I don't know.  We have to think
about that.

          DR. ROYAL:  I mean, it sounds to me that if we're
saying the EPA does the oversight, that the EPA should --

          CHAIRPERSON FADEN:  Hold the records?

          DR. ROYAL:  -- maintain those records.  And I don't
know what the legal meaning is of "in perpetuity."  Like if the
EPA were to go out of existence, does that mean that no one else
has the responsibility?

          MR. GUTTMAN:  The government.  The sense of it is that
we don't want another situation where someone tells us "We used
to have a record of this, but we destroyed it 10 years ago."

          CHAIRPERSON FADEN:  Right.  Yes.  I think we know what
the sense of it is.  Henry is asking for how specifically to
craft it.

          DR. GOODMAN:  I think there are two categories of
documents that clearly need to be in there.  One is environmental
impact statement.  The other is permitting documents that are
required under the substantive laws.

          And I don't know.  That's how they're referred to in
jargon.  Environmental impact statements is a clearly defined
thing.  I don't know how the permitting documents --

          CHAIRPERSON FADEN:  Permitting?

          DR. GOODMAN:  -- permits are referred to specifically
in the legislation, but I think those are the kinds of things --

          MR. GUTTMAN:  So we should probably -- the key legal
documents, basically.

          CHAIRPERSON FADEN:  Would you be comfortable with the
stipulation of a few documents if the names were stipulated of
what they are?

          DR. ROYAL:  I think if we maybe gave some for examples
or something, that that would be helpful.

          CHAIRPERSON FADEN:  Okay.

          DR. ROYAL:  And then I think we should explicitly,
given the current environment explicitly, talk about that someone
else needs to be given the responsibility for these records
should the EPA go out of business. 

          CHAIRPERSON FADEN:  Instead of EPA oversight, you could
call it government oversight, indicate here that an appropriate
government agency, such as EPA.  Okay?

          DR. GOODMAN:  I should point out that there haven't
been proposals to get rid of EPA, but there have been proposals
to fold it together with others in some larger entities.  So it
might not have the name EPA.

          CHAIRPERSON FADEN:  So why don't we just say
"government oversight" and then say "an appropriate government
agency, such as the EPA, be obligated to"?  And that would take
care of the problem, indicating that right now it's the EPA, but
whoever the EPA goes into would inherit the responsibility.

          Mark, I just want to while we have you here make sure
that the tense is correct.  The first sentence suggests -- it
just says "recommends that EPA establish a program."  Are we sure
it doesn't have a program?

          MR. GUTTMAN:  When this was originally drafted, Mark,
it might have been a prospective.  Is it now retrospective?

          CHAIRPERSON FADEN:  Because we could simply say
"recommend that the committee maintain a program," "that an
appropriate government agency, such as the EPA, maintain a
program."

          DR. GOODMAN:  Let me put it this way.  I think, yes,
that it should probably not be "establish" since some part of it
has been established.  But it shouldn't be simply endorsing
what's there because what's there clearly they haven't yet
determined the scope of what needs to be done.

          CHAIRPERSON FADEN:  What it would read is something
like "The advisory committee recommends that an appropriate
government agency, such as the EPA, maintain a program directed
at," and then we specify what the program is.

          Are there other questions or comments on this?

          (No response.)

          CHAIRPERSON FADEN:  Okay.  Then 15(d), again,
substantive suggestions, is the recommendation that -- we don't
have 15(c)?  Henry?

          DR. ROYAL:  I have some idea of what the intent of
15(c) is, but I'm not sure that I totally understand it.  Right
now my understanding of how the regulation is done is the
government makes very conservative assumptions about what the
maximum exposure might be to an individual and sets limits based
on that maximum possible exposure.

          As I read this recommendation, what I understand it to
mean is that not only should the maximum exposure to an
individual be considered, but the number of in the case of
radiation person rems to the surrounding population also be taken
into consideration.  So that if there would be conceivably an
instance in which the maximum individual dose was not exceeded
but that based on some person rem trigger, that that might be
regarded as too big of a release.

          Is that what the intent of this is?

          DR. THOMAS:  That's exactly the intent.  I mean, it
should be self-evident, it seems to me, that a risk of 3.5 per
10,000, for argument's sake, to pick up a number that's in the
text here, might be viewed as an acceptable individual risk.

          And if this plant were located in eastern Washington
State, where there's a total population potentially exposed to
that level of maybe 1,000 people, that would be deemed to be
quite acceptable.

          But you take that same release and you set it off in
the middle of Denver, where the population -- I don't know what
Denver's population is.  Let's say a couple million.  And
suddenly you find that that leads to an expected cancer incidence
of a couple of hundred cases.  So that's quite unacceptable, the
same release but in two different population settings.

          So that's why we decide to site things like Hanford in
remote areas.  But there is presently no formal mechanism. 
Although this advice has been of use and population exposures
have been suggested in various circumstances, it's our
understanding that it's not formally enacted at the moment in
legislation.

          CHAIRPERSON FADEN:  Duncan, let me introduce a problem
that I see with the recommendation.  For one thing, it doesn't
belong under the "national security" heading.  It's not in any
way specific to national security or anything.  So that was a
mistake.  I'm not sure how it got in there, but it shouldn't be
there.

          The other issue is I'm wondering if this isn't one of
those topics that really isn't a topic that as a committee we've
debated or discussed.  I know very little about this area.  And
what you've just said to me right now makes a lot of sense, but I
don't know how it's a recommendation of the committee.

          DR. THOMAS:  Actually, I think that has come up enough
in our discussion of the whole chapter on intentional releases. 
And there's a discussion of that in the chapter.

          CHAIRPERSON FADEN:  It's not my sense of it, but I am
sympathetic to what is written here.  So I'm sort of struggling
with it.

          Phil?

          DR. RUSSELL:  I have no way of assessing the impact of
this on the regulatory process.  I'd be very uncomfortable with
it simply because if ignorance.

          CHAIRPERSON FADEN:  Sue?

          DR. LEDERER:  Is there a finding related to this
recommendation?  I mean, that would help focus our --

          CHAIRPERSON FADEN:  No, I don't think we have a finding
with this.  Well, let's see.  That would certainly help.  It's a
good point.  Where is "Findings"?

          DR. ROYAL:  Duncan?

          DR. THOMAS:  Yes?

          DR. ROYAL:  We said one of the things that might happen
based on this recommendation is that a release which might have
been deemed acceptable based on the maximum individual criteria
might be deemed unacceptable based on the population exposure
criteria.  Would the reverse also be true?

          DR. THOMAS:  Oh, absolutely.

          DR. ROYAL:  That doesn't come across clearly to me in
this recommendation because it says -- as a matter of fact, in
the recommendation it says "but not replace current regulations
based on maximum individual exposure."

          So the committee members know, I do think that a
population-based risk estimate makes some sense, although it's a
complicated issue.  So I'm not necessarily opposed to the concept
or to this recommendation.

          DR. THOMAS:  Both the individual and the
population-based criteria would have their own thresholds for
action or permitting or whatever.  So it's quite possible that
any release might be acceptable under one criterion but not the
other.  And it could go both ways.

          The issue which society would have to debate -- and I
don't think it's the job of this committee to do it -- would be
whether or not a release which posed an acceptable population
risk but an unacceptable individual risk would still be
permitted.

          But the wording at the moment is taken to imply that we
would not relax existing standards based on maximum acceptable
individual risk if the population were deemed acceptable.

          What I could well imagine might well happen, though, is
the presently extremely conservative levels for maximum
individual risk might well be relaxed to a somewhat more generous
level if the secondary level of protection were added.

          CHAIRPERSON FADEN:  Pat, we're on 15(c).  I checked on
the findings.  We don't have a finding that bears on this.  Now,
our findings bear on the secrecy issue and then the risk of harm
from the intentional releases, but not on standards for
evaluating.

          DR. THOMAS:  Peripherally the risk of harm historically
bears on this one, though it doesn't do it explicitly.

          CHAIRPERSON FADEN:  Right.  Are there other comments,
reactions?  I don't have a sense of the committee here on this
recommendation.

          MS. KING:  I feel like a broken of record.

          CHAIRPERSON FADEN:  I think I said what you were going
to say.

          MS. KING:  Yes.  That is why I'm silent.

          CHAIRPERSON FADEN:  So I take it from that that you
would not support the recommendation?

          MS. KING:  No.  I have problems when we don't have a
record built up, but I would not be averse to trying to work this
discussion into an appropriate place in the report.

          CHAIRPERSON FADEN:  Into a chapter?

          MS. KING:  Into a chapter; right, where it is in part
discussed, rather than making it a recommendation.

          DR. THOMAS:  It is actually in the chapter.  And,
although I would still like to see this recommendation
personally, having it in the chapter helps satisfy me.

          DR. GLATSTEIN:  Phil mentioned that he was
uncomfortable with it because he thought this would impair. 
That's exactly why I'm in favor of it.  I like the idea that the
releases wouldn't be made impossible but would be made more
difficult, additional consideration, additional check.

          I don't think there's been much of a check on this in
the past.  And I like the idea for just that reason.

          CHAIRPERSON FADEN:  I have the same sentiment with you. 
My concern is simply that we don't have whatever in the
experience of this committee to speak to it.  I just don't think
we are the right forum for this one.  So that's my concern.

          I'll just hold it up, see where we are.  How many
members of the committee would like to see this recommendation
met, favor the recommendation?

          DR. MACKLIN:  In this place or in some place?

          CHAIRPERSON FADEN:  No.  As a recommendation, not under
"National Security," actually.  That would have to change.  But
as a recommendation?

          (Whereupon, there was a show of hands.)

          CHAIRPERSON FADEN:  And how many people would not like
to see it as a recommendation?

          (Whereupon, there was a show of hands.)

          CHAIRPERSON FADEN:  Okay.  So it doesn't go in as a
recommendation.  Now, we can look at the discussion in
intentional releases and see if it ought to be beefed up more and
maybe take some of this language if it's not there.  I don't know
if it would fit.  My recollection of that chapter now is not
clear enough.  But I gather in line with it's already in the
chapter whether it can be led to highlight it more or not.  I
don't know.

          We are essentially on schedule again, which is rather
remarkable.  We're going to break for lunch.  But before we go to
lunch, this is the other wording version of the uranium miners'
proposal.  And so what I would like to do is call for a brief
discussion of it right when we come back from lunch and then go
to notification after that.

          We are going to come back from lunch.  Please come back
no later than 1:30.  We're only five minutes off.  We should be
able to get back here.  I'm going to start the meeting at 1:30,
even if I'm talking to myself, in which case I'll get the uranium
miners' proposal that I want.  Okay?  So how's that?  We're going
to start at 1:30.  So those of you who care about uranium miners
had better be here.

          (Whereupon, a luncheon recess was taken at 12:22 p.m.)                      A-F-T-E-R-N-O-O-N   S-E-S-S-I-O-N

                                                                (1:39 p.m.)

          CHAIRMAN FADEN:  I'm trying to reconstruct the
discussion of -- Was this Wednesday?  This was Wednesday.  I'm
trying to reconstruct the discussion of Wednesday, and we don't
have, obviously, everybody here who was there on Wednesday.  So
this is a little bit of a problem.

          Here's what we're going to do.  We're going to very
quickly discuss the uranium miners -- revisit the uranium miners'
recommendation, and then go right on to notification.  So what
you should have in front of you now are two versions of
recommendation 6.  The only thing -- The second one, alternative
proposal, does not have the supportive text, but it's intended as
an alternative to the bolded recommendation statement.

          Let's wait until everybody gets the two documents, and
the issue is whether there is sufficient Committee support for
either version of this recommendation.  It would replace the
recommendation currently in the draft report.

          MS. KING:  What was the recommendation in the draft?

          CHAIRMAN FADEN:  Six.  I believe it was 6 in the draft,
but let's go back and check.  I didn't verify that.  I believe it
was 6, Pat.  It's one of the ones that's on that separate
mailing.  Okay?  It's one of the ones that came on that June
19th.  It is number 6.  I'm sorry, it was 7 in the mailing.  I
don't know why it's six on this, but it's recommendation 7 on the
mailing that went on June 19.

          So it would replace the bolded text here.  The debate
on Wednesday was this is too weak.  Some members of the Committee
wanted to strengthen the recommendation.  The most directive
recommendation is the one -- The new version that is two pages
long is the most directive, and the one that's just got the bold
thing on the top is --

          MS. KING:  You mean, we're supposed to have three
pieces of paper.

          CHAIRMAN FADEN:  No, we're forgetting -- unless you
want to see the old one.  The old one is not at issue.

          MS. KING:  Forget that?

          CHAIRMAN FADEN:  Right.  Unless you want to see the old
one, there are two pieces of paper, one that looks like this. 
I'll give you another one.  Don't even look for it.  Here, that's
it.

          MS. KING:  I have that one.

          CHAIRMAN FADEN:  That's it.  You just need that one,
and the other one is the one -- Okay.  You need one of these?

          MS. KING:  Is this dated 6/17?

          CHAIRMAN FADEN:  No, 6/22. Give Pat this one.

          MS. KING:  I got it.  I got it.

          CHAIRMAN FADEN:  You can give it back to me, please. 
Thank you.  All right.

          DR. KATZ:  There's just one word that's different,
isn't it?

          CHAIRMAN FADEN:  Well, the difference is that the two-
page one is a straight recommendation to the Congress.  It's
directive.  It says, Congress, we recommend that you do this. 
The alternative one recommends that Congress review the Act to
consider the specific change, and then argues why the Committee
thinks it probably would be a good idea to make this change, but
it's one step removed from saying, Congress, do it.  It's,
Congress, review the Act to consider whether this change is
appropriate, and then the rationale would be why the Committee
thinks it's a good thing to do, but it's one step short of
saying, Congress, do it.

          Henry and Phil?

          DR. ROYAL:  I'm thinking that we should delete the
phrase "after some minimum duration of underground employment
such as one year" and just leave "without required."  My
rationale for doing that is I would think that, if you're a
uranium miner, that there is only a very small fraction of people
who might be uranium miners for less than one year, and I would
think that that would be their profession.

          As I understand it, they would basically have to prove
that they were a uranium miner, and I would think that that proof
would be sufficient to meet the criteria for having a plausible
cause for their lung cancer.

          CHAIRMAN FADEN:  So if I understand it, regardless of
which form it is -- obviously, those words are the same -- you
want the sentence to start, "Miners who develop lung cancer,"
period.

          DR. ROYAL:  You could say "without requiring a specific
level of exposure."

          CHAIRMAN FADEN:  Yes.  Yes, comma.  All right.

          DR. ROYAL:  Because exposure actually is dependent on
the level in the mine and how long they were there.

          CHAIRMAN FADEN:  I presume this is timed then to before
19-so-and-so?  We need to make sure that's in there.  Either way,
we have to put it in.

          DR. ROYAL:  It needs to have a date.  It's probably in
the mid-Fifties or something.

          DR. THOMAS:  All the regulations came in about 1966-67,
I believe.

          CHAIRMAN FADEN:  So uranium miners before.

          DR. THOMAS:  So that that would be a convenient cut-off
point.

          CHAIRMAN FADEN:  Before 1967 or whatever.

          DR. THOMAS:  Levels were gradually declining over that
period, but I think the point about which we have ethical
concerns continues up through the enactment of Federal
regulations.

          CHAIRMAN FADEN:  Okay.  So we put in the regulation
date.

          DR. GLATSTEIN:  But the cancer may have come up
afterwards.

          CHAIRMAN FADEN:  Exposure prior.  I've got Phil and Eli
and Nancy.  Phil?

          DR. RUSSELL:  To borrow a phrase from Ruth, the one
recommendation is very direct, and if we really believe this, I
think we should use that one rather than use the wimpy one.  It
has all the same context except it doesn't say it very strongly.

          CHAIRMAN FADEN:  Well, it says it less strongly, but --

          DR. RUSSELL:  It recommends that they review it, not
that they do it.

          CHAIRMAN FADEN:  That's right.  That's the difference.  

          DR. ROYAL:  Yes.  I actually would prefer also that we
recommend that they do it.  Again, the uranium miners are really
exceptional in the experiments that we've looked at.  They
clearly are at higher risk for lung cancer.

          CHAIRMAN FADEN:  Eli?

          DR. GLATSTEIN:  Yes, I'd like the second one.  Henry
just said that this group really is exceptional.  I cannot help
but feel a great deal of analogy between this group and the
events of Tuskegee, with which many people around the table are
far more knowledgeable than I, but as I understand it, the folks
at Tuskegee under study for a particular disease which they had
contracted were denied access to a cure for that that came out
during the period of the study.

          Here, we have people who are under study who are denied
information about their own risk from their employment that
basically let them go on to a very high risk, an extraordinary
risk, for lung cancer.  I see a lot of analogy here, and I
believe that this group has suffered a real invasion of their
civil rights, a real deprivation of civil rights.

          I think this group -- I think that point, I think,
needs to be brought to the Congressional attention, because I
don't think it has.  We've exchanged notes through the E-Mail on
our estimate about, you know, what's the epidemiologist supposed
to do.  I think we need a very strong signal on this one, because
that shouldn't be an area of controversy, in my opinion.

          CHAIRMAN FADEN:  I've got Nancy and Pat.

          DR. OLEINICK:  I certainly want to underscore what has
been said before.  I think that, if we are going to come out with
a very strong statement recommending compensation for any group,
this is the group, because it's so outstanding in terms of the
exposure and the government role.

          I would just like to make one very small change in the
wording.  This is on the fourth line or something.  I certainly
would say the word amend rather than review, but under developed
or will develop, because some of them will still be developing
lung cancer.

          CHAIRMAN FADEN:  Who develop or will develop.

          DR. OLEINICK:  Yes.  It's a minor point, but I think
that ought to be in there.

          CHAIRMAN FADEN:  Yes.  

          DR. ROYAL:  Just going to say to compensate them?  You
can't compensate them because they will develop it.

          CHAIRMAN FADEN:  No, no, no.  That's right.  "Who
develop."  Then a period.  Get rid of the e-d and to say "who
develop."  Okay, Pat?

          MS. KING:  I'm going to pass.

          CHAIRMAN FADEN:  Do you want to argue for the other
recommendation or not?

          MS. KING:  I'm just going to pass.

          CHAIRMAN FADEN:  We don't have Ken here, who was also
strongly arguing against the approach that's adopted here.  We
don't have him here to hear his argument.  All right, is there
anybody else who wants to speak to this. Ruth?

          DR. MACKLIN:  Are you open for just affirmations?  I
have no further thing to say.

          CHAIRMAN FADEN:  Are we ready to vote?  Does anybody
want to argue or otherwise go for it?  I have confessed to not
having read carefully the text that is underneath.  I haven't had
a chance to do it.  So I would just point out, if there are minor
things that need to be changed in there, I just don't know.  I
don't know if everybody else has had the chance.  I got into a
bunch of stuff, so I didn't get a chance to do that, but we're
voting primarily on the recommendation.

          DR. THOMAS:  I'm the only person that probably has read
it carefully.

          DR. GLATSTEIN:  I'd just like to see that  civil rights
point emphasized in the text.

          CHAIRMAN FADEN:  I'll try to come up with something.

          DR. GLATSTEIN:  I think it belongs.

          CHAIRMAN FADEN:  All right.  Are we ready to call?  I
will just call the two-page -- the current operative draft of
recommendation, which is really recommendation 7 for purposes of
the way in which this goes in.  Just replace recommendation 7. 
How many people are in support of recommendation 7 as it stands
right now, the two-page one.  Let's take -- Put your hands up for
a minute so everybody is -- No, down for a second.  I think
people are still looking for it.

          It's the one that was circulated yesterday.  There are
two versions out.  The first one, the stronger one -- Shall we
just try it one more time here? -- recommendation 7.  Change it
to 7 everywhere.  The two-pager says the Advisory Committee
recommends that the Act be amended.

          MS. KING:  Can I say something again?  I would ask
people to think about what is more important, feeling good or
conveying to Congress the strength of your beliefs in language
that members of Congress cannot tear apart.  If the goal is to
try to get the Congress to do something, is the issue the
strength of which we feel it or is it the appeal that we make to
them, and is the appeal in the recommendation or is the appeal in
the justification?

          It seems to me that what Ken and I were saying the
other day didn't have anything to do with the merits of what we
were talking about.  It is the how.  So I see this issue as what
I call a "feel good" issue.  We feel better saying, Congress, do
it, in our recommendation rather than putting it in language that
might be more amenable in trying to explain the strength of the
conviction that we have that this should be done.

          So I don't see it as a substantive question about which
we are about to vote.  I see it as a strategy question about
which we are to vote, and reasonable people can have different
views about strategy.  I am well aware of that, but I see it that
way.

          Some of the comments that I heard -- I heard it as a
substantive issue, and I don't think that that was the debate.

          CHAIRMAN FADEN:  I think you're right to point it out,
and let me say that when I changed the language, I changed it as
little as possible for that purpose, to try to make it not a
substantive change in terms of the position of the Committee
about what the right thing is to do, but to send the message to
Congress in a slightly softer tone strategically.

          Now I am not a wise political hand.  I really don't
know  -- What I want to say is I agree with Pat, that what is at
issue between these two recommendations is largely a matter of
political strategy.  I agree completely.

          My dilemma is I am not a wise political hand, and I do
not know how much difference it will make which way we do it.  I
have to say that Pat and Ken are more experienced and are wiser
than I am in that arena, but I think Pat is right to point it
out.  I personally just don't know.  I mean, I wish I did, but I
don't.

          DR. RUSSELL:  My instincts tell me that the stronger
language will get more of a reaction, but I may be wrong.

          CHAIRMAN FADEN:  I've got Ruth, Jay, and Duncan.  We
should just know what we're doing here.

          DR. MACKLIN:  I don't think the weaker one, as we're
calling it, conveys the Committee's view about the
recommendation.  The weaker one says, Congress, review the
provisions to consider whether compensation should be provided to
miners, et cetera.  So it's not only weaker because it says
review rather than the Committee recommends, but it doesn't even
say that the Committee thinks that ought to be done.

          CHAIRMAN FADEN:  Let me just point out, the rationale
would stay identically the same.  The text that follows is the
same, and the arguments are put out.

          DR. MACKLIN:  I mean, to recommend that Congress review
in the recommendation itself leaves it entirely up to Congress to
determine whether, without expressing the Committee's view about
that.

          CHAIRMAN FADEN:  What we could do -- Let me just pose
this as an alternative -- is after the sentence in the bolded
version that says "without requiring a specific level of
exposure," we could have a sentence that says, "The Committee
believes there is good grounds for such an amendment."

          You could put that in, and that would convey -- I'm
just putting that -- I'm just responding to Ruth's comment to see
if we could address it.  Yes, Jay, you have the floor now.

          DR. KATZ:  I disagree with Pat that this is done for
making ourselves feel good.  That, I think, in this instance puts
it badly.  I have read most of the Congressional Record on the
prior review by Congress.

          Congress had the same information, by and large, that
we are having here in the transcript of the hearings that I
reviewed; maybe not everything, but they had an awful lot, and
they came to the conclusion that they did.

          We cannot -- It's not a matter of predicting what will
sit better with Congress, because as one scientist once said, the
problem with prediction is that we cannot predict, and nobody can
predict what Congress might do in whatever language we put it,
one way or the other.

          At least speaking now for myself in this instance, and
what happened to the uranium miners in a variety of different
ways is so outrageous that we should be entitled as a group who
have deliberated about this that this is not a matter for review. 
This is a matter -- Congress, in its infinite wisdom, may
disagree with us, and that is their prerogative, but in terms of
our review that we are asking for an amendment.

          CHAIRMAN FADEN:  Do you want to respond quickly?

          MS. KING:  The discussion the other day and a point
that Duncan made -- My memory is getting all muddled, but the
point that Duncan made the other day is that there is scientific
information available now that was not, in fact, available to the
Congress when they passed this original Act.

          The problem with both of the recommendations is -- I do
think this -- The issue here is how to persuade Congress to do
something that you think should be done.  That is the bottom
line.  What's the best way to persuade?

          The best way to try to persuade, to put your best foot
forward, is to make your argument.  So if you're going to have a
recommendation that says, Congress, you must -- which, you know,
fine; they'll do what they want to anyway -- is the
recommendation should say changed scientific data --

          CHAIRMAN FADEN:  That's what the rationale does.

          MS. KING:  Not the rationale.  The problem is the
recommendation -- The persuasiveness is our rationale.  That's
the first thing I get to.  We have a problem.  You all don't like
to realize it is outside of our mandate, but it is outside, to a
large extent, our mandate.  That, in itself, is a substantive
problem.

          You have to be careful when you make these kind of
recommendations outside your mandate.  We have a strong case.  I
don't believe in blowing it, and you all think I'm talking about
little quibbles.  I'm talking about being persuasive, and either
your recommendation has to go with why you're -- It has to be in
the recommendation that why you're willing to do this or you've
got to at least say you have to have some -- I mean some sense of
where we fit in the political structure when we're trying to do
this.

          If the bottom line is to put our best foot forward to
say, Congress, this is serious, we really believe this -- You
don't accomplish that by the word you use necessarily.  You
accomplish that by the reasons you put forth and what your bottom
line is.

          So my suggestion is:  The Committee wants to use a
stronger language.  Then put something in it about in view of
changed circumstances or something like that.

          CHAIRMAN FADEN:  Whichever way it goes, it should say
the Advisory Committee recommends that, in light of scientific
information now available -- okay? -- or the other one, the
Advisory Committee recommends the Congress review, in light of
scientific information now available, so they can see that there
is a reason that -- This was the point Ken was raising, too --
this is not an old Act.  This is 1990.  Congress has lots of
things to worry about.  Why should they look at something that
they addressed only in 1990.

          So we have to lead with -- I think Pat is quite correct
-- lead with the reason why they should revisit the issue.  Now
there may be other -- Maybe we think they made the wrong decision
in 1990 as well, but that's a separate consideration.  Duncan?  

          Is that all right, by the way, that in either
formulation we add "in light of scientific information now
available"?  No one objects to that.  So whichever way it goes,
that contribution -- that change will happen.  Duncan, you have
the floor.

          DR. THOMAS:  Well, I think maybe Pat has now explained
herself to my satisfaction.  I was delighted to hear her earlier
say that this is an issue of strategy, not of the substance of
the message we're trying to communicate.

          MS. KING:  But that was all that Ken and I were trying
to say the other day.

          DR. THOMAS:   No, I appreciate that, and I have
infinite respect for Pat's and Ken's political savvy in this
area, but I still remain puzzled, I guess, as to accepting this
changed wording that we've just added, why it should be
politically savvy, politically more effective, to word it as we
recommend that Congress consider than simply to say we recommend
that Congress do it.

          MS. KING:  I can actually turn that around and ask you
why it matters, too, because in terms of where we're going, it
doesn't say anything.  It does not say that -- My concern -- Ken
will have to speak for himself.  My concern is mandate and how
much time the Committee deliberated on this issue, on the science
issue and the science findings to make this recommendation.

          My concern all along has been tying together what the
Committee did, what it reviewed, what it deliberated as a
committee with its recommendations, because it is one thing to
have one an extensive job on that and make a recommendation.  It
is another thing not to have done an extensive job, but to feel
strongly about something, and to be able to feel strongly that
you are right to do it.

          Part of what I was trying to say the other day was
strategy.  Part of what I've been saying all along is to keep in
mind that the credibility of what you recommend is also a
function of the process that you have gone through. 

          In your mind, Duncan, it may be different, but I'm the
lawyer, and you are the scientist, and that may explain the
difference.  My attendance at the Committee meetings do not lead
me to believe that as a committee member -- and I've tried to be
faithful -- as a committee member that we deliberated those kinds
of issues well enough to make a stronger statement; but on the
substantive issue, because you do have substance expertise and so
do others on the committee, it certainly seems to me well within
what the committee -- where we are now doing, to say we've got
enough to say that this needs to be reviewed again.

          That's sort of where I come out as my bottom line.  

          CHAIRMAN FADEN:  Ruth.

          DR. MACKLIN:  Unlike the other examples that Pat keeps
bringing to our attention on which the Committee did not
adequately deliberate, and I agree with her on most of those
others that we discussed, this received extensive deliberation in
a flurry of E-Mails -- and those who are not on the E-Mail get
all the E-Mail correspondence, if I'm not mistaken.  They get it
in some form, in a FAX form -- and in FAXes and in revisions of
the chapter and queries to the Committee members.

          So although we may not have sat in this room and
deliberate, as we have on some other topics, the information
about the chapter, about the changes, about the suggested changes
and all the things that went on about trying to find out what the
various  departments and divisions were doing about those miners
and what was kept secret and what could be kept secret -- All of
that, it seems to me, was amply communicated.

          Now if that doesn't count as deliberation, Pat, I guess
I can understand it.

          MS. KING:  For a committee under the Public Advisory
Committees Act, I would be very careful about those statements.

          CHAIRMAN FADEN:  Mary Ann?

          DR. STEVENSON:  I'm speaking for Pat here, but I think
what you're referring to is that the Committee did not debate or
examine at length the new piece of data that we are presenting as
rationale for asking for this review.

          CHAIRMAN FADEN:  I'm sorry.  Could you repeat that,
Mary Ann?  We just had a little sidebar conversation on the point
that Pat just raised.

          DR. STEVENSON:  I think -- I'm sorry.  I'm speaking for
Pat.  Pat can speak for herself, but I think the point is that we
as a Committee did not debate or look at the validity of this new
piece of data as a group at length with whatever scientific
expertise we think we do or don't need, because that's what we're
presenting.

          I mean, the Congress had all the data that we went back
and forth about as a committee in the chapter when they did their
own Act, but they didn't have that piece of scientific data --

          CHAIRMAN FADEN:  There were two pieces of information
that the Committee did not -- and we went through this on
Wednesday.  The other is the problems that people are getting.

          DR. STEVENSON:  Well, the other thing is the
complaints.

          CHAIRMAN FADEN:  So there are two things they could not
have known in 1990:  One, the new analysis that suggests that you
can attribute a much higher proportion of lung cancers to
exposure in the mines, and that's by a very credible context.  So
even if we haven't debated it, it's not so bad for the Committee,
on the basis of the recommendation of the Committee who are
expert in this area, to assume that the data are valid enough to
be considered seriously.

          The other, of course, is the testimony which we did
hear in Committee on the record from people who complained about
how difficult it was to recover under this Act.  Now that they
couldn't have known in 1990, too, for obvious reasons.

          So I would -- You know, that's where we are.  So there
are really two pieces of information that we need to signal,
although I think the scientific information is the kind that
ought to be signaled in the recommendation.  The other can be
signaled in the supporting text.

          I think we need to call for the question.  We have two
versions.  I want to read the alternative proposal.  Either way,
we are adding "in light of scientific information now available"
into the recommendation, which I think is a very good suggestion
that Pat highlighted, whichever way it goes, so that in the
recommendation we provide Congress for a reason why we think,
even that they just looked at it in 1990, they should look at it
again.

          Then in the one that is the one-pager, there was a
proposal to add "The Committee believes.." after the sentence
that says "Congress review the provisions" a sentence added that
says, "The Committee believes that there are good grounds for
making such an amendment."  In other words, pulling into the
recommendation a sense of the Committee's conclusion, but still
falling short of what is in this one.

          DR. GLATSTEIN:  Good, new scientific grounds.

          CHAIRMAN FADEN:  Right.  Yes, exactly.  

          DR. KATZ:  Ruth, I just have to express one brief
reservation, though not to change anything.  I don't mind to put
in "in light of the scientific information now available," but
the reservation I have about this -- Yes, we now know that the
incidence of lung cancer is greater than the Congressional
committee knew in 1990, but the Congressional committee knew in
1990 that there was a significantly higher incidence of lung
cancer, startling so, in uranium miners because of their exposure
to radiation, and at least to this person whether it's 40 percent
or 60 percent ultimately doesn't make any difference.  

          Forty percent is enough, but anyway I just wanted to
express it, and then leave it in there.  To that extent, I bow to
so called political pressures, but I wouldn't go any further than
that.

          CHAIRMAN FADEN:  Ruth?

          DR. MACKLIN:  Well, no, it's just a very small point. 
I don't think the statement "in light of scientific information
now available" is sufficient, because the other relevant thing is
the provisions of that Act that --

          CHAIRMAN FADEN:  My personal view is I would put that
in the supportive text underneath.  I think that's -- It's a
different kind of a problem.

          MS. KING:  Also, the Committee did not call for public
testimony --

          CHAIRMAN FADEN:  From the other side.

          MS. KING: -- on the record on the other side.

          CHAIRMAN FADEN:  Right.  See, we don't have established
that, in fact, that's an accurate or full picture of how well the
Act is working.  So it's a different kind of evidence, and for
that reason, I would write -- So if that's agreeable, there will
be reference to that in the text, but not in the recommendation
itself -- the testimony.

          All right, we're ready to call it.  Okay?  Let's just
do it.  I'm going to hold it up, the two-pager versus the one-
pager.  Everybody knows which is which, and everybody is clear on
the amendment to the one-pager which has the phrase "the
Committee believes that there are good grounds for making such an
amendment"?

          How many people want the two-pager?  

          DR. KATZ:  You mean the Duncan version?

          CHAIRMAN FADEN:  The Duncan version with the amendment
on the -- Okay.  I'm sorry, I've got to do this now.  So it's
going to have to be one of these.  One, two -- 

          DR. KATZ:  Eli?  How come?

          DR. GLATSTEIN:  I'm persuaded by Pat.  I want to get
something done.

          CHAIRMAN FADEN:  Four.  One, two, three, four, five. 
How many people want the other one?  Six.

          DR. ROYAL:  See how easy that was?

          CHAIRMAN FADEN:  I told you I stopped predicting.  I'm
not sure exactly how to handle this.

          MS. KING:  I'll make a personal statement.  Whatever we
do, we should not have a vote on the record.

          CHAIRMAN FADEN:  That was a show of hands.  It was not
a vote on the record.  I'm trying to get a sense of the
Committee.  Okay?  

          MS. KING:  It's on the record.

          CHAIRMAN FADEN:  All right.  All right, Pat.  I'm not
sure about that, though, but let's just go.  

          MS. KING:  The reason is a vote on the record won't --
will be interpreted many ways, because it is a vote, and a part
of the vote on the record is not worth having it interpreted in
any way.

          DR. RUSSELL:  I think everybody wants to accomplish
what we -- the maximum.  So I think we need to come to a
consensus, and I'll go with 6 rather than hold out, because I
don't think we ought to go on record as having a split on the
committee on this issue.

          CHAIRMAN FADEN:  It's not worth it.  The point is we
all have the same goal here.

          DR. RUSSELL:  It's not worth it.  It's a lose/lose
issue.

          CHAIRMAN FADEN:  Right.  It's so important that this be
done.  I think we're all in agreement that it's so important that
this be done.

          DR. RUSSELL:  Right.  We don't want to split on how.  

          DR. KATZ:  I was going to ask Pat a question.  It was
mentioned by a number of Committee members, and they were
persuaded -- seemed to be persuaded about this with respect to
you and Ken, but Ken isn't here.  

          Do you consider yourself an expert of predicting what
works better with Congress and what does not work better with
Congress in a political sense, because that --

          MS. KING:  No, I don't consider myself an expert, Jay,
but I do say this, and I don't think it requires political
expertise, just how people -- If you are trying to be persuasive,
the goal is to be persuasive, changing a word one way or another
that might do harm is simple, in my mind.  You can be equally
persuasive in another way and not give any adverse ammunition
which says that, in light of -- and I keep saying this -- in
light of mandate problems -- I'm going to try this one more time
-- in light of mandate problems, in light of evidentiary problems
which are the weaknesses, the strength is what we believe we are
doing is right; but in conveying what we think they should do, we
should not be unmindful of the fact that others might be able to
drive holes in our cases.

          Put it in the best foot.  That's really all I'm saying. 
I'm not trying to make this a big issue anymore.

          CHAIRMAN FADEN:  I think we've got to get past this
here.  I don't know which way to swing it.

          MS. KING:  I'm not going to object -- I'm not going to
write a dissent to this, no matter what you do to it.  

          DR. KATZ:  We'll keep that in mind, depending on which
way it goes.

          CHAIRMAN FADEN:  I don't think -- I mean, you can, Jay,
or you can't.  I don't think it's a big issue.  I really don't
think whether there's a dissent on this one -- The dissent is
going to be I would have preferred the word in, I would have
preferred the word out, but whatever it is, it's going to come to
that.  It's not going to be I disagree, the uranium miners
shouldn't get money.

          MS. KING:  I'll abide by the judgment of the Committee. 


          CHAIRMAN FADEN:  Okay.  It's not -- What I'm saying by
that, Jay, is that we're not anticipating dissent saying we
disagree with the inference that the uranium miners ought to have
their compensation.  So I don't think we should worry about
whether there are or are not dissents.  I think we're just trying
to figure this out.

          MS. NORRIS:  I do abide by the judgment of the
Committee, but I think that Pat has very strong instincts about
these things.  Therefore, it's based upon Pat's persuasiveness
and experience that I chose the other route.

          DR. MACKLIN:  Phil had a different instinct, but he
didn't talk as long as Pat did.

          DR. RUSSELL:  I bow to Pat's expertise at being
persuasive to Congress.  

          CHAIRMAN FADEN:  I suggest we do the following.  I'm
going to rewrite both of these and then we're going to -- I'm
going to deal with it.  

          MS. KING:  You're going to pluck one out of the hat.

          CHAIRMAN FADEN:  I'm going to pluck one out of a hat
and put it out there and run it by you, and you're all going to
say, fine, and then there will be a dissent or there won't be a
dissent, and that's it; but I think that we can't hammer this one
down.

          DR. GLATSTEIN:  I can live with it either way.  I'm not
unhappy with either choice.  

          CHAIRMAN FADEN:  I think we can all -- I'm sorry, sue.

          DR. LEDERER:  The only plea I would make is that the
explication for this be made clearer.  I think that it's somewhat
embedded in the text that is now provided, so that we provide the
best case that we can in order to accomplish our ends.

          CHAIRMAN FADEN:  I think that's, obviously, important. 
I mean, that's the whole weight of it.  All right.  So we had an
interesting discussion.  Okay.

          We're going to go on now to notification, which is yet
another piece of paper that we have to find or a couple of pieces
of paper that we should have.  Regrettably, we're not at the
point that it would be nice to be at.  

          We don't have the recommendations per se about whether
or not any particular groups of subjects should or should not be
followed in order to protect their health, but we do have a very
carefully thought through presentation for the explication by
Mary Ann and Jeff and then Duncan on how we ought to proceed. 
That has been, as we all can recall, a subcommittee that has been
working away on this issue.

          The hope is, if we can basically agree to the proposals
as they are outlined here, that the rest of the work can be done
quickly in the consultation context, and then the specific
recommendations sent out -- the particular findings of that then
brought out and turned into a recommendation.

          So the floor is open for discussion, while I go look
for my copy.  

          DR. THOMAS:  It might be helpful to think about what
brings -- for a moment about the type of recommendation that
might well emerge from these documents.  What occurs to me is
that it's almost certainly beyond the scope of our expertise to
make specific recommendations for particular studies, rather that
-- and it's my understanding that the -- Oh, well, wait a second. 
Yes.

          There is a proposal that we farm out to a panel of
consultants the decisions as to what specific studies might meet
the criteria, but the recommendation should basically lay out --
as a minimum, the criterion ought -- the recommendation ought to
lay out the criteria, either Mary Ann's wording or my wording or
some iteration thereupon, for the studies, if any, which would
meet these criteria.

          CHAIRMAN FADEN:  No, I think -- Let's go -- if we could
go to page 3 of the memo, and I would defer to you and Mary Ann
and Jeff; but my understanding that what is proposed here is,
first, a set of criteria, Mary Ann's and then your revision of
it, then the proposal that the Committee apply those criteria to
the two or three studies -- sets of studies indicated on the last
paragraph on page 18 where a lot of work has already been done,
and our whole rationale for looking at children in part lie on
the fact that we had this mandate to make recommendations about
medical follow-up.

          Then there is a further proposal which we can jettison
that the remaining studies be contracted out for a similar
analysis.  Now those we could -- That recommendation, we could
jettison.  Failing to comment on these studies puts us in a very
awkward position, not untenable but awkward.

          So I think that's what's at issue.  Is that correct? 
Okay.  Henry, I saw you wanting to speak.

          DR. ROYAL:  Yes.  I'm not on page 3.  I had -- I
thought this was quite good.  There were just a few comments on
the third paragraph on the first page, the fourth paragraph,
fourth line beginning with "Although the risk of leukemia..." --
I think if you deleted those two sentences that you wouldn't lose
anything.

          CHAIRMAN FADEN:  Where are you?  I'm sorry.

          DR. ROYAL:  On page 1, paragraph 4, line 4, beginning
with "although the risk of leukemia."

          CHAIRMAN FADEN:  Just get rid of that sentence.

          DR. ROYAL:  All the way through "fifty years after
exposure."  It just doesn't make any difference what the details
are of the latency period of cancers.

          CHAIRMAN FADEN:  Is anyone objecting to that?  No. 
Okay.

          DR. ROYAL:  Then on page 2 this whole one in 1,000 --
Let me tell you what the problem is with the one in 1,000.  First
of all, it includes incidence  of disease, and then it also
includes mortality in the detriment due to disease.  

          I mean, I might get -- I don't know -- some relatively
-- some disease that doesn't really cause me any big problem, and
I might have a one in 1,000 chance of having that disease. 
That's very different than having a one in 1,000 chance of dying
tomorrow.

          So it's not clear to me that, because the detriment due
to -- based on when you are going to die or based on your
morbidity is very different.  It doesn't seem to me that you
could have one number for both.  

          I would like to finesse this somehow as opposed to
somehow making this one in 1,000 be some magical number.

          CHAIRMAN FADEN:  Do you have a suggestion?  We're in
desperate need of -- 

          DR. THOMAS:  I have another problem with that one in
1,000 figure as well, which is my point number 3.  That's that
the only reason I can see for having that one in 1,000 in there
or any number like it is to indicate that any endpoints which
materialize have some reasonable probability, and I don't mean
like 50 percent.  I mean some nontrivial probability, having had
something to do with the radiation experiment which is our
mandate.

          If that's the purpose, then it should be expressed
relative to whatever the background rate is, and again it would
depend on the particular condition being studied.  It should be a
proportional -- some nontrivial proportional increase in risk.

          CHAIRMAN FADEN:  And this is where your ten percent
came?

          DR. THOMAS:  That's where that was suggested.

          CHAIRMAN FADEN:  This is on page 1 of Duncan's memo,
point 3, which is attached.  So this is a proposal to substitute
for the one in 1,000, whether it's morbidity or mortality.

          DR. THOMAS:  See, I think we're rolling two quite
separate calculations together in this one number, and that's the
problem.

          CHAIRMAN FADEN:  The one in 1,000.

          DR. THOMAS:  There is a rationale for one in 1000 as
well, the absolute risk, and that's that you don't want to waste
your time screening for diseases that you're almost certainly not
going to get.  So there has to be some reasonable probability
that the person is likely to get the disease or you're wasting
your time screening for it, in the first place.

          For that, a statement of absolute risk is sensible, and
it makes no difference from that perspective whether you're going
to get that disease as a result of a radiation experiment or as a
result of other factors, but it's not our business to be
concerned about general recommendations for population screening
in the absence of a particular experiment.

          For that reason, we have the second rationale, which is
that the radiation experiment increased your risk, to some
extent.  That's better done in relative risk terms.

          CHAIRMAN FADEN:  So what if the relative risk approach
says, yes, screen, but then it turns out that the condition
itself is so rare you're not going to find -- I mean, you don't
have the absolute risk.  Do you want both?

          DR. THOMAS:  You should have both, I think.

          CHAIRMAN FADEN:  You should have both.  So the proposal
is --

          DR. ROYAL:  One in 1,000 and ten percent.

          CHAIRMAN FADEN:  Increase over --

          DR. THOMAS:  Without committing ourselves to either of
those two numbers, but the principle is, yes, that both of those
factors are relevant.

          CHAIRMAN FADEN:  We'd better commit ourselves to the
numbers.  

          DR. THOMAS:  But, I mean, at this stage, not.

          CHAIRMAN FADEN:  All right.  So the notion would be you
would need a threshold of an increase -- a relative risk of 10
percent or greater, and then the condition itself has to have an
absolute risk of one in 1,000 or --

          DR. THOMAS:  Some number like that.  

          CHAIRMAN FADEN:  Then you would kick in.  Then is it
one in 1,000 -- Then we don't care whether it's death or --

          DR. THOMAS:  No, I think we do indeed.  Henry's point
is well taken.  A one in 1,000 increase in death might be very
severe -- you know, might be a very important one, but --

          DR. ROYAL: The ideal thing would be something like days
of life lost, but I don't know how to get there.  Sorry.

          CHAIRMAN FADEN:  Well, I know.  We can't get to a
decision theoretically.  

          DR. THOMAS:  It's quality of life loss.

          CHAIRMAN FADEN:  Yes.

          DR. ROYAL:  A simple lie is always easier to believe
than the complicated truth.

          CHAIRMAN FADEN:  But if we took -- If the issue is
thyroid cancer -- let's get concrete.  Right?  Is not the issue
thyroid cancer that we're talking about?  Okay.  So let's take
thyroid cancer.  That's one of them, and the risk of the
testicular, but let's just take thyroid cancer as concrete.  

          So we say that there has to be -- The relative risk has
to be 10 percent or greater, and not death from thyroid cancer
but thyroid cancer has to occur with an absolute risk of greater
than one in 1,000.  Would that be okay?  

          DR. ROYAL:  I don't know.  The reason I don't know is
it then depends on how you're going to calculate the risk of
thyroid cancer.  For example -- I mean, I know you want this to
be simple, but --

          CHAIRMAN FADEN:  I want it to be done, simple or
complicated.  I want it done.

          DR. ROYAL:  If you were to calculate it the way some of
the calculations have been done -- that is, based on the
maximally exposed person using the maximal risk coefficient, then
one in 1,000 would mean that you would have to go through a lot
of these experiments.

          If, on the other hand, you did it for the average risk,
and you used some more reasonable risk coefficient, then not many
experiments would reach the one in 1,000.  So stating the one in
1,000 without stating the methodology by how you get there could
make an enormous difference in terms of a number of experiments
that would need to be reviewed.

          DR. THOMAS:  Let me add another subtlety as well.  For
the purpose of deciding whether screening is meritorious, all we
care about is the future risk.

          CHAIRMAN FADEN:  That's correct.

          DR. THOMAS:  Not the risk up to this point, and that's
not the way we've done the calculation up until now.

          CHAIRMAN FADEN:  So ought it to be a 10 percent
relative risk of yet getting the condition?

          DR. THOMAS:  Yes, but I was actually thinking --
referring to the absolute risk figure, the one in 1,000.

          CHAIRMAN FADEN:  Oh, an absolute risk.  

          DR. THOMAS:  I suspect even those experiments which
attained a one in 100 risk, the future risk may well be below one
in 1,000.  

          DR. ROYAL:  That would be an interesting--

          CHAIRMAN FADEN:  No, it's okay.  I mean, that's all
right.  I just want to get it right and done, done and right.

          DR. ROYAL:  But to say one in 1,000 future risk is more
relevant.

          DR. THOMAS:  Absolutely.

          CHAIRMAN FADEN:  Right, because we're talking about --
But would that work?  

          DR. ROYAL:  That would be much more acceptable.

          CHAIRMAN FADEN:  Remember, we're only talking about
more or less 18 studies for what we will do.

          DR. ROYAL:  If you're talking about one in 1,000 future
risk, you're talking about one in 18, no matter how you do the
calculation.  That's theoretical.

          CHAIRMAN FADEN:  Right.  When you say -- No, I'm
putting aside the proposal whether we're going to farm this out
to be done for anybody else, but -- So what I'm hearing is that
the criteria that would be used is a 10 percent relative risk or
greater that would be attributable to the exposure that's
inherent in the experiment, and then a one in 1,000 future risk,
risk yet, of the condition occurring -- materializing -- for
everybody who is still awake.  Okay?  Is that agreeable?  

          DR. GLATSTEIN:  Yes.

          CHAIRMAN FADEN:  Okay.

          DR. ROYAL:  The concept of this one in 1,000 future
risk is not that complicated.  Basically, if you're going to be
at risk for 40 years and 30 of those 40 years have gone by, and
if the risks are evenly distributed --

          CHAIRMAN FADEN:  You would know how much is left.

          DR. THOMAS:  To be a little bit conservative here, the
assumptions -- We made a reasonable assumption for risk
calculation, that risk was a plateau of constant intensity from
five to 45 years after exposure, but that's certainly wrong.  We
don't know what it is.  So we should probably calculate assuming
some reasonable figure for lifetime risk, inasmuch as far as we
know, risk of thyroid cancer remains elevated at some level
lifetime.

          CHAIRMAN FADEN:  So we're just going to keep it flat?

          DR. THOMAS:  No, I wouldn't keep it flat, but I think
we should review what's in the BEIR V model.

          CHAIRMAN FADEN:  Okay. So that technical point, the
subcommittee could resolve, whether it's the BEIR V slope or
whoever else's.  Okay?  

          All right.  Now there's a slight difference between
Mary Ann's wording and Duncan's wording on the other conditions
that would have to be met.  That just gets you into the
discussion.  If you pass the 10 percent relative risk and the one
in 1,000 future risk, that just gets you into the discussion
about whether we're going to recommend follow-up.

          So it's like a screen for the studies.  Now let's
assume we have a study that passes that screen or more.  On page
2 of Mary Ann's memo there are five conditions, and on page 1 and
2 of Duncan's there's a slight reformulation of those conditions.

          DR. THOMAS:  Just to be clear, in defense of Mary Ann's
five, they are taken word for word out of the literature.  So
there is already a citation for this particular wording.  

          My quarrel was, therefore, not with Mary Ann.  It was
with the fact that the way it was expressed in the literature
didn't seem to be entirely logical.  It was an attempt to sharpen
it slightly, but I have no particular vested interest in this
particular wording.

          DR. ROYAL:  I like Duncan's wording  better.

          CHAIRMAN FADEN:  Can I get to how you would
operationalize these in Duncan's approach, which I liked.  These
screening methods must be acceptable to patients.  Do we need
these particular people, because if so, that means we have to
notify them and let them know.

          DR. THOMAS:  Well, they are, obviously, going to have
to be informed and consent to this procedure.

          CHAIRMAN FADEN:  What I'm suggesting is, if that gets
factored in, when does it get factored in?  Let's assume that D
and E don't apply.  Do we still do C?  Should that be the last
one is what I'm trying to say.  How many of these are made
objectively by us versus the last one, which is obvious, which is
that people have to decide they want it?

          DR. THOMAS:  A good point.  From that perspective, just
get rid of the first half of C.  They certainly have to have high
sensitivity and specificity.  That's a judgment for us to make.

          CHAIRMAN FADEN:  And what I'm saying is then, of
course, in the end, obviously, we're not going to make anybody do
this.  We then say there's an obligation to notify, and then the
person decides whether they want to avail themselves of the
screening or not.

          DR. THOMAS:  This wording about acceptability to
patients derives from sort of the standard screening literature. 
You know, there are plenty of very unpleasant procedures that
would not be considered acceptable.  So in the context of
population screening, that's a relative thing to put in here.

          CHAIRMAN FADEN:  So we pull that out and then say,
obviously -- I mean, it's sort of self-evident.  We don't kind of
need it.  We're not going to recommend that people be forced to
have follow-up.  We're only recommending whether or not anybody
should  be notified that it would be a good idea for them to be
followed-up.

          So the proposal is to take Duncan's rewording minus the
first part of C as the next level.  First screen is this formula
that we discussed, and then the next screen are these five
criteria, the edited version of Duncan's.  Is that agreeable to
everyone?  

          Then if we could turn to page 3 of Mary Ann's memo --
Mary Ann and Jeff's memo.  I wanted there to be ratification that
the studies to which we will apply this set of criteria are the
children's studies -- They're just listed here.  This is the
group about which we have -- where we have been pursuing these
issues.  Okay?

          DR. ROYAL:  So this is making the recommendation that
the Committee make the decision on these three instances whether
or not they should be notified or not.

          CHAIRMAN FADEN:  These three sets of studies.  Correct. 
That is correct.  Then I'm going to hold in abeyance what we want
to do with all the other studies.

          DR. STEVENSON:  Or considered for notification, because
we don't know --

          CHAIRMAN FADEN:  We're going to actually do the work. 
We're going to do the work based on the criteria that the
Committee has just agreed to and make a recommendation in these
studies, the ones that fall under categories 1, 2, and 3 -- Okay?
-- about whether anybody who was a subject in these studies 1, 2,
and 3 should be notified, and our rationale for why we picked
these studies we have rehearsed 100 times.  We don't need to go
through that again.

          Then I would like to leave it to the subcommittee with
staff to work out that -- to actually do that work, and then the
rest of us will receive their recommendations, which would then
become Committee recommendations if the rest of us buy it.  Is
that agreeable with everybody?  

          DR. THOMAS:  Number 3 has a question mark in front of
it, and I wrote in my piece that I would say the a priori
justification for including that one is as strong as the others. 
So I would remove the question mark.

          Then I went further and suggested that we should
include the submariners who are participants of a particular
medical experiment.  

          CHAIRMAN FADEN:  Okay.  So that's --

          DR. ROYAL:  Why don't we wait until we do the children? 
If the children don't meet the criteria, the adults won't.

          DR. THOMAS:  That's fine, but I don't want to exclude
them in advance.

          CHAIRMAN FADEN:  Excellent.  So if the children cut in,
then the adults would go forward.  Very good.

          DR. THOMAS:  Then we do the adults.  

          DR. ROYAL:  Then our justification about not having
done the adults will be there if the children don't meet the
criteria.

          CHAIRMAN FADEN:  So good.  So reasonable.  All right. 
Now the last proposal is the proposal whether the Committee ought
to commission consultants to go to work on a whole slew of other
studies that the Committee has partial information on.  

          My own -- Henry, do you want to speak to that?

          DR. ROYAL:  I don't think there's any reason to do
that.  Basically, we've picked out the studies which we think
would be most likely to qualify.  I mean, we could revisit this
question if it turns out that, after our analysis, there are a
number of studies that we do think need follow-up, but if looking
at these most likely candidates we were to decide that none of
them need follow-up, then it would be silly to --

          CHAIRMAN FADEN:  I would even go further, Henry.  I
would say that, if it turns out that, based on these, it looks
like it might be a good idea to look at some others, we make a
recommendation that somebody else look at these others.  I mean,
not even under our aegis.

          DR. ROYAL:  I see.  Not being an ACHRE recommendation.

          CHAIRMAN FADEN:  Right.  A recommendation from us to
whomever, because I really think, given the amount of work that
we have to do under the next couple of weeks, that we cannot
undertake anything.

          DR. STEVENSON:  So it's beyond the scope of this
committee, too.

          CHAIRMAN FADEN:  We picked out the experiments that we
thought were going to be the most likely for this concern to
materialize, and if in fact our examination of these studies
suggested there are people who need to be followed up, then we
could say now there's a reason to go look beyond the children to
other studies, and we would hope that the government will pick
that up, Public Health Service or somebody else, but we can't.

          DR. THOMAS:  Realistically, there would be no point in
having consultants start work until we had completed our work,
and then it's too late.  

          CHAIRMAN FADEN:  Then we're out of time.  Okay.  So as
a practical matter, it can't be done.  So we have done
notification except that the work is still left to be done, but
for those of you on the subcommittee, you can -- the endorsement
of the Committee to use these criteria to work with the
consultants to get the results, and then we will have a
recommendation for the July meeting that is specific about which
ones, if any, of these former subjects need to be contacted. 
Okay?

          DR. ROYAL:  Could I ask that someone from the staff
contact those of us who are on the  subcommittee to arrange a
conference call for early next week, so that we can see what is
left to be done?         For example, some of the things -- I'm
not sure if anything more needs to be done.  The testicular
radiation, for example -- I don't know if anymore needs to be
done.  We need to identify what the tasks are.  

          CHAIRMAN FADEN:  We will --

          DR. STEVENSON:  I actually do have a procedural
question.

          CHAIRMAN FADEN:  Sure.

          DR. STEVENSON:  In terms of getting outside experts'
opinion as to the validity, sensitivity of screening tests -- I
mean, can we -- I don't think we can do that as a committee.  I
don't think there is anybody on this committee that can say the
screening -- you know, that can actually give an opinion of that.

          CHAIRMAN FADEN:  I think at this point, it would be a
matter of calling up and asking for free advice.  Okay?  We
certainly can always do that and, hopefully, we have enough of a
network so that we can find --

          DR. STEVENSON:  So, hopefully, we'll find somebody that
will give us free advice.

          CHAIRMAN FADEN:  Yes.  For a complex of reasons, we are
restricted to that.

          DR. STEVENSON:  I've not gotten very far with School of
Public Health at Harvard.  

          CHAIRMAN FADEN:  I want to acknowledge all the hard
work the people on the subcommittee have been doing.  Everybody
has been working very hard.  I just never know when to stop or
when to start when I start acknowledging everything that's been,
being done, but for a complex of reasons we would have to rely on
free advice at this point.  But we certainly should avail
ourselves of free advice, especially if it's good.

          Okay.  We are then leaving notification.  The next
agenda item is recommendations with respect to openness.  So
we're back into recommendations.  Let's see where that is.  It
starts on page -- I've got the wrong draft always.  Forty-one, is
it?  Recommendations on openness, start on page 41.  I think you
have a later draft.  That's what I was struggling with. 
Recommendations on openness.

          The floor is open -- Let's see how many we've got to
deal with.  This is recommendation 16,  and it's 16(a), 16(b) --
It goes up to (i)?  Okay.

          MR. GUTTMAN:  A quick comment.  With the exception of
the first recommendation, each one of the recommendations is
discrete.  You can be for them or against them discretely.  

          The first one on the ombudsman, and Pat -- This is in
anticipation of what Pat is going to say -- is in the vein of, as
I understand the Committee's discussions, what was discussed
about what you do about the deficiencies in current
administration of the Common Rule.  Do you create a new public
board?  Do you have a new layer of bureaucracy?

      The sense of it is that what we have seen in the whole
process of getting the documents from the agencies, the Freedom
of Information Act is not adequate for historical records,
because people don't know where the record are, because records
are in different government agencies.  There is no central actor,
and because there is no proactive force helping people, in some
respects, the way the Committee is.

          So that the sense is that there's a vacuum.  In
crafting the recommendation, we were also keenly aware, as per
the discussion yesterday, that any solution will immediately meet
with the objection of, what, another this, another that, another
Federal this.  

          So that in the discussion -- I just want to make clear
-- The thrust of that is that there is a problem that needs to be
addressed.  We don't want to throw out that notion by focusing on
a particular mechanism and people will say, oh, you want to
create another bureaucracy or something like that, because people
have asked what do you mean by an ombudsman.

          CHAIRMAN FADEN:  We have -- we, meaning me.

          MR. GUTTMAN:  I had a nice conversation with a Canadian
ombudsman.  He's a wonderful guy.  You get him.  He talks to you,
but he isn't exactly what this is.

          CHAIRMAN FADEN:  We have A to I, and we have an hour. 
Okay?  We've really got to march through A to I.  Dan has started
us on the ombudsman.  Susan?

          DR. LEDERER: I just have a question of clarification. 
Does this recommendation -- Are we going to specify the records
collections that are in the National Archives or is this records
collections in general that are possessed by the Federal
government --

          MR. GUTTMAN:  Yes, Federal government.

          DR. LEDERER:  -- or those relating to the Cold War
period or --

          MR. GUTTMAN:  Well, the notion is Federal government in
general.  To me, from talking to people like Jim David, for
example, the experts, what is an extraordinary insight of this is
that, really, there is no practical, coherent governmentwide
sense of all the records.  People don't know, you know -- The
agencies didn't know -- Some of the agencies had a problem
knowing where even to look at the beginning.

          So if you as a citizen filed a FOIA request, the poor
person getting it would say, well, I looked around me, and I
don't know where to go.  So that there's a sense that on the
governmentwide level we've let this system develop and, while
there are plenty of wonderful actors in each crevice of the
system, there is no central person or individual that's looking
out and saying where can we --

          The other sense that is very important is that one of
the things I think the Committee has discovered is that there are
plenty of collections of records which don't have to be
inaccessible to the public, and you want to be able to say in
today's climate we can tap the energy of lots of all these
citizens out there and say, we'd love to look through these
records; why do we have to have a FOIA, and then sit back and
wait.  Why can't we go in and look?

          One of the things the Committee is saying is, yes,
there are a lot of indices that you could get that would make
this work easily -- more easily done -- or that there are
collections which you can't get into because there's one
classified document.  That's why you can't get into it.

          So the role of the ombudsman, in some respects, would
be to push and to implement on the kinds of issues that we've
identified, in some way analogous to the way, in the discussion
yesterday, as Ruth was saying, we've identified a couple of
issues, somebody has got to take those issues and push with it. 
There is no --

          CHAIRMAN FADEN:  What if the recommendation said that?  

          MR. GUTTMAN:  Fine.  

          CHAIRMAN FADEN:  Rather than recommend an ombudsman,
what if the recommendation said we've identified a series of
problems.  They need to be fixed.  Figure out how to fix it.

          MR. GUTTMAN:  That was the sense of the Committee.

          CHAIRMAN FADEN:  Rather than propose an ombudsman when
at least some of us aren't really persuaded that that's the right
way to go.  You can put in "such as an ombudsman" or something
like that.

          MR. GUTTMAN:  That would be fine, if that's the -- Yes. 


          CHAIRMAN FADEN:  Is that --

          DR. MACKLIN: But I thought Dan's comment just embraced
both A and B.  A is the ombudsman or equivalent mechanism.  B is
all that stuff about the finding aids, the inventories --

          MR. GUTTMAN:  Those are particulars you can either
throw in as examples.

          CHAIRMAN FADEN:  They're standing as a recommendation
in 16(b).  That's what we're confused about.  You got this whole
thing here.  

          DR. MACKLIN:  There are two separate things that just
fell under this comment.

          CHAIRMAN FADEN:  I think you can combine them.  Is that
your proposal, Ruth?  No?

          DR. MACKLIN:  Sounds like it's yours.  No.  I mean, the
problem is, if we have a difficulty with the ombudsman as a
particular mechanism, then I think we can combine them; because
the heart of it is to enable citizens to gain access.

          I mean, the point of 16(a) is to enable 16(b) to be
realized.  

          MR. GUTTMAN:  B, et cetera.

          DR. MACKLIN:  Well, yes, et cetera, but they go in
different directions.  

          CHAIRMAN FADEN:  Pat?

          MS. KING:  Do we have findings on this in this area?

          MR. GUTTMAN:  They were in the trust thing that we now
are --

          CHAIRMAN FADEN:  We're not going to pull it out, but
one set of the trust findings dealt with how hard -- the records
that were lost, the records you couldn't find, blah-blah-blah-
blah.

          MS. KING:  Okay.  I think this is an important area.  I
mean an important area based on the Committee's experience where
the Committee does, in fact, have something to say, because we
know from our experience not only the problems with classified
documents but with documents -- trying to access to documents.

          So we're doing it last.  So we're probably not giving
it the attention that we should, but this is actually, I think,
what should be one of our big things, because this matters in
terms of a whole range of activities.

          So I would agree that what we want to do, what our
primary goal is to build the case for something needing to be
done and being very careful and lengthy about the Committee's
experience on this, and then summing it up by saying that we
think some attention should be made.

          The point that Dan makes about indices, for example, is
really quite important, that people who want access could do lots
better jobs if they could even get access to indices, which they
often cannot do, not to mention nobody can find the documents.

          So it's one of those horribly dry and boring
recommendations, but I think it's a really critical
recommendation, and it is us.  This is one of those things that
we should be doing, pushing this kind of area and talking about
our experience.

          CHAIRMAN FADEN:  Phil?

          DR. RUSSELL:  It's a little unclear to me exactly what
action agency is targeted here.  

          MR. GUTTMAN:  All of them.  It's a separate question
about the CIA, because -- Well, all of them -- It's a general
finding, the same way that our experimental findings are not
radiation specific, I guess.  

          DR. RUSSELL:  The records are diffuse.  Is there a
central solution?  If so, who is going to carry it out?

          MR. GUTTMAN:  That's the question.    Presently, there
isn't.  

          DR. RUSSELL:  Who are you going to aim the -- Is the
Office of the President?

          MS. KING:  Yes, it should be.  One of the first points
made should be -- and I would make a second recommendation. 
Classified documents and general documents ought to be
distinguished.  They do present different problems, but there are
problems with access to both.

          It would be useful, so that those who classify could
focus on that, and we can talk about it.  The first point being
made ought to be the point about no central responsibility.  

          The closest we would have would be the National
Archivist, but that doesn't really satisfy some of the problems
that we ran into in doing this Commission's work.  So the first
point is that the responsibility is scattered, as far as we know.

          Now I haven't discovered anything else differently, Dan
-- that the responsibility is agency by agency, and given the
agencies' missions, it is the natural inclination of an agency to
put its mission ahead of its recordkeeping.  It makes a lot of
sense to me.

          So this is a way of calling out the attention that
there is an important overall public good to be served.

          CHAIRMAN FADEN:  This is very akin, by the way, to what
we did find with respect to human subject stuff in the sense that
we had -- all the agencies had problems.  It wasn't that one
agency had perfect records and the other agencies' records it was
variation, but all the agencies had difficulties, and they all
worked very hard, and it was a huge problem, and there wasn't one
source.

          So we can make that kind of argument and basically have
a recommendation that says that this is a governmentwide problem,
as best as the committee can find out, that needs high priority
for the following reasons.  Here are the sorts of things we would
suggest.

          It's kind of like the human subjects thing.  We can
make it very analogous to the human subjects one.

          MR. GUTTMAN:  Who is going to say we don't find any
gross human rights violations in the recordkeeping practices?

          CHAIRMAN FADEN:  Well, is that -- All right.  Rewriting
it in a way that combines 16(a) and (b) would then --

          MR. GUTTMAN:  There are a couple of them that fit in
there, yes.

          CHAIRMAN FADEN:  That would -- 16(c) does not.  16(d)
does not.  So transfer of records to the National Archives -- Can
we go to some of the ones that don't fit?  Let me just take a
simple one.  I assume that recommendation 16(i) is agreeable to
the Committee?  I'm taking it out of order.

          DR. STEVENSON:  My understanding was that, as a FACA
committee, all that would be done as a matter of course.  That's
--

          MR. GUTTMAN:  Not in resource -- Actually, it's
happening, but it's not a given.

          CHAIRMAN FADEN:  It's a good idea for us to say it. 
Lois?  Oh, no?  So 16(i) is agreeable to everyone?  Good.  We
think we are important.  All right?  Okay.

          DR. TUCKSON:  Even though it is straightforward, just
make sure.  People that need to have access to it -- is that a
convenient place to do that as opposed to where people now go?

          MR. GUTTMAN:  The answer is, no, but these things --
Oh, yes.  All those things we're trying to work out with the --

          DR. TUCKSON:  This doesn't mean to imply one place only
and not the accessibility --

          MR. GUTTMAN:  No.  These are resource questions, you
know.  

          DR. TUCKSON:  I agree.

          CHAIRMAN FADEN:  16(h) is cover stories.

          MR. GUTTMAN:  Yes. There was some E-Mail about this.

          CHAIRMAN FADEN:  There was considerable E-Mail,
actually, about this.  

          MR. GUTTMAN:  Right.  I wish Gary were here.  

          CHAIRMAN FADEN:  Does anybody want to speak to 16(a)? 
Do those of you who commented on E-Mail want to share your
comments?  Henry?

          DR. ROYAL:  I suspect -- Do you want on cover stories? 
I guess this apparently requires the Presidential waiver, and
whether or not that's too restrictive of a criteria -- I don't
know.  Phil was talking about, you know, a terrorist attack, and
I suppose under those circumstances the President would be
involved; but whether or not he always has to be involved is
unclear to me.

          DR. MACKLIN:  Well, this is not a question of the
President being involved in every declassification decision. 
This is false or deceptive information.  I mean, this is much
stronger than it would be to say that the President has to be
involved in every question of waiving Secrecy or classification. 
This is can you be lying all over the place to cover up something
without a Presidential involvement.

          DR. ROYAL:  Let me --

          DR. GLATSTEIN:  You only want the President to lie.

          DR. ROYAL:  Let me say it in another way.  I've never
found the government to be particularly honest.  I mean, what you
call a cover-up or a deceptive statement is very unclear to me. 
If one has a low threshold for calling something deceptive
statements, there might be a lot of deceptive statements out
there.

          I do think that's one of the fundamental problems with
people trusting the government.  I guess I'm really questioning
whether or not this is a realistic recommendation, that maybe
it's both in terms of the definition of what a deceptive
statement is and the fact that it would have to go up to the
President.

          CHAIRMAN FADEN:  I just don't know what this means.  I
mean, it has all the failings of apple pie.

          MS. KING:  I know, and I would have a different
question.  What do we have to tell us that we should make a
recommendation in this area?

          CHAIRMAN FADEN:  The only thing that -- The area where
this -- I mean, I asked the same question, and the rationale
comes from the --

          DR. ROYAL:  Project Sunshine.

          CHAIRMAN FADEN:  -- Project Sunshine, where there was a
cover story put out for the collection of body parts, the body
snatchers.

          MR. GUTTMAN:  Also in the Hanford data -- I mean,
there's plenty of instances of deception.

          CHAIRMAN FADEN:  Yes, but this is a little bit more
than -- 

          MR. GUTTMAN:  I mean cover stories.  I don't mean
things where people say let's have a cover story.

          CHAIRMAN FADEN:  We had several of those.  We've had
several of those in the historical record.  In some cases, we
don't know whether the cover story was ever used or not, but
we've got transcripts where there are discussions:  Can we tell
them this, you know, instead of telling them that.

          So we have come across in the historical record
instances in which either we have evidence that a cover story was
used or we have discussions of cover stories like, you know, can
we tell them we're from an insurance company when we want to do
an exam on them,  when in fact we want to do it because they are
living near a whatever-it-is.  

          We don't know if they actually did it or not.  It's
just a discussion in the transcript.  Somebody is saying this. 
So in that case, we don't know if they ever did it.  The one
where we know they did it was the Sunshine thing, and maybe one
or two instances.

          I, personally, am not comfortable with this
recommendation.  I am very uncomfortable with it.  I feel like we
don't know enough, and I don't know what this means, and for all
of those reasons I would encourage us not to.  Okay, does anybody
want to argue for it?  

          You know, the awkward thing is who could be against it? 
I mean, I'm sorry it's here, because in a way --

          DR. ROYAL:  But we shouldn't have that feeling that if
we don't -- if something is not a recommendation of our report,
that that means that we're against it.  It just means that we
can't address every problem in the world in this report.  

          CHAIRMAN FADEN:  Thank you for the -- You're right. 
It's what I have to keep remembering.

          DR. RUSSELL:  That's collateral damage.

          CHAIRMAN FADEN:  I'm working backwards to get to some
of the other ones.  16(g) is the CIA one.

          MR. GUTTMAN:  A brief explanation:  We actually had a
nice conversation with the CIA who is going to pick it up.  The
confusion about, first, why is the CIA being singled out -- there
are two respects.

          One is the MKULTRA records where it's being singled
out, because there was an admitted story whereas the CIA -- and
it's declassified -- document they gave us, the history, they end
up by saying we can see the public would still have questions
about whether we did human radiation experiments, because we
destroyed all these documents. 

          So there we're saying make whatever about MKULTRA.  You
still have --

          CHAIRMAN FADEN:  Gary has submitted, in response from
queries from several Committee members about why -- This gives
the impression that all the stuff about the CIA remains as
unsettled as it was when we started with respect to radiation
experiments, which is not the case.

          He has the following text, which we should have
Xeroxed, but okay.  "The Advisory Committee has found no evidence
to indicate that the CIA conducted or sponsored human radiation
experiments.  However, numerous documents, some of which remain
partially classified, make reference to possible CIA interest in
this area.  Although Advisory Committee staff has reviewed all of
the available classified information concerning human radiation
experiments and requested that it be declassified, the public
does not have the benefit of such access.  Accordingly, this
recommendation seeks to foster greater public access to and
accountability of CIA records."

          DR. THOMAS:  Can you just clarify the situation
regarding that thing in the February briefing book in which the
staff memo says, here is a project which is referred to or
there's maybe a couple of projects in that briefing book which
were never funded.  Then we have this other letter courtesy of
Ruth which says was indeed funded.  

          CHAIRMAN FADEN:  We're pursuing that.

          DR. THOMAS:  Do we know this?  We don't know whether it
was done, but according to the letter, it says it was funded.

          CHAIRMAN FADEN:  We're checking on that one.

          MR. GUTTMAN:  Our understanding -- Ruth doesn't say
that this is funded.

          DR. MACKLIN:  Not that it's funded, but that this is
the information about something that was sponsored -- No, it was
funded, but not carried out.  Funded but not carried out.  

          CHAIRMAN FADEN:  We are checking.

          DR. THOMAS:  It didn't say not carried out.  He said he
didn't know.

          DR. MACKLIN:  Not known.  Not known.

          CHAIRMAN FADEN:  And we are checking.  The answer is we
are checking.  Okay.  That was new information, and we are
checking.  This is a reference to an experiment that came to
Ruth's attention when she was traveling that may have -- that
appears to have been CIA supported, that may have -- that seems
to have involved radiation that we haven't ever heard about
before.

          So -- Oh, we have heard about it?  Oh, it's the same
one?  Okay.  I'm sorry.  I'm confused.  Anyway, we're checking. 
That's a scary thing, isn't it?  

          DR. ROYAL:  This thing that you're talking about, this
experiment, this was using radioactive material to identify
people.  Why is that an experiment?

          CHAIRMAN FADEN:  If it was an experiment.  If they were
trying to see if it worked.

          DR. ROYAL:  It didn't make any sense either, because
they were talking about they were going to use the half-life.

          MR. GUTTMAN:  That's why we need an independent
oversight board for these things.

          CHAIRMAN FADEN:  That's a side issue.  I want to go to
the recommendation.  Do we want to single out the CIA and, if so,
for what reason?  Pat?

          MS. KING:  That's my question.  I'm still listening for
the reasons.  

          MR. GUTTMAN:  Let me list the second one.  The first
point is that MKULTRA has got a special significance.  The second
point is that it's not a singling it out, the way at least the
staff used it.  It's a leveling of playing field.

          In the case of all the other agencies, including some
like the Defense Nuclear Agency which conduct terrific amounts of
Secret work, there is some accessibility to the public of the
structure of their records collections, that Jim David knows that
DNA records are record group blah-blah-blah or here, there and
that.

          Lots of them are classified, but he knows that.  In the
case of the CIA, by contrast, virtually none of their records are
in the -- a very small amount are in any kind of outside CIA-
National Archives accessible form, and there is no way when we go
around trying to even have a sense of what we get that we know
that they've looked in all the places.

          When we ran this through the CIA, I had an informal
discussion which is now going up.  I don't think that they --
Well, at the level that we were talking, what we're asking for is
some independent review of their records by appropriately cleared
people to make sure that the records are accessible to whoever
needs them for legitimate purposes, including the government.

          One of the things we cite here is this investigation
related to one of the bank scandals where a deputy of, I think,
Janet Reno said, well, they couldn't get the necessary records
for us, in response to our -- It took them a while to locate
their own records.

          That's part of the question that comes up here, because
of the work we've done with the Joint Panel in 1950 where we
found examples of their records in the public files, in
Department of Defense files, and they couldn't find them.  Now
maybe there's perfectly good reason.

          MS. KING:  With respect to your second point, that's
not what the recommendation -- I mean, it's not what this
recommendation recommends, that there be a level playing field. 
What it recommends is that we go into the CIA and make sure that
what's classified is classified -- is properly classified.

          What you just said is that the other agencies have
publicly accessible -- not indices; that's not the right word,
but you can tell what you're doing, because you can tell that
there are records there, whether the records are classified.

          What you said was that with the CIA you can't tell that
the records are there and classified. You can't tell that the
records are there.  That's the difference in the playing fields. 
Did I get that right?

          MR. GUTTMAN:  What we found, to go back to the first
point of the discussion, is that there is a mass of Federal
records out there which is in varying states of organization, and
the country doesn't have access in a practical sense to large
chunks, because they are not even sufficiently organized.

          So that DOE has now gone out and done a roadmap because
of this project, which is beginning to just identify the basic
collection, so that that is happening in the case of DOE.  You
can sort of get some sense in the case of the other agencies, but
the CIA --there is not even the level of organization.

          It's not got to do with the classification, but there's
not the level of organization and assurance that there's an
organizational structure by which these records are accessible to
whoever needs them, and that there is no independent -- We can't
say that.  Nobody else in the public can say that.  It's not
clear that any Congress or --

          MS. KING:  Sounds like what you're saying is that we
can't tell one way or the other whether there is within the CIA a
mechanism for getting to the records of somebody that the CIA
wants to --

          MR. GUTTMAN:  That's right.  When the government -- I
the B&L thing when the United States--

          MS. KING:  But we don't know either way.  Is that what
you're saying?

          MR. GUTTMAN:  Right.

          MS. KING:  What you're saying is that - - I'm just
trying to understand what you're saying.  

          MR. GUTTMAN:  Yes, that's right.

          MS. KING:  So in this respect, the CIA is different
from other agencies.

          DR. ROYAL:  I don't understand this.  I thought when
the CIA guy came here, he was talking about how they were in a
unique -- had a unique situation for finding documents, and a lot
of it was electronically accessible.  

          It doesn't make any sense to me that the CIA, which is
supposed to be a manager of information, can't retrieve anything. 


          MR. GUTTMAN:  Well, I don't want to give too many --
but -- That's the question.

          CHAIRMAN FADEN:  The issue here is whether we -- I
think that the recommendation has to be made more explicit than
in its current form, the first part of it.

          The second part of it, to declassify all of the
remaining MKULTRA stuff --

          MS. KING:  Now what is -- That was my second question. 
What's the basis of that recommendation?  Let's be clear about
why we are recommending declassification of all documents.

          MR. GUTTMAN:  MKULTRA.

          MS. KING:  MKULTRA.

          MR. GUTTMAN:  The reason being, obviously, if there are
documents that, for presently valid reasons, merit
classification, that's a separate issue.

          CHAIRMAN FADEN:  It doesn't say that.

          MS. KING:  It surely doesn't.  That's one of my
questions.

          MR. GUTTMAN:  We are not -- We haven't been -- There is
no -- I don't think the CIA has told us if there are any
documents.  They haven't pointed out any documents that they say
merit classification -- to my knowledge, and it's subject to
check.

          CHAIRMAN FADEN:  Have they refused to declassify
records, and we responding to that?  I mean, what is the issue
here?

          MS. KING:  Why is it here?  That's what I'm trying to
figure out.

          MR. GUTTMAN:  I'll have to focus it with Gary.  That's
a good question.

          CHAIRMAN FADEN:  We don't know why.

          MS. KING:  What it sounds like is -- and this is what
would concern me, because I think we have to be careful here.  It
sounded like a part of your  explanation was that we had access
to some documents because some of the people have clearances that
are not otherwise available to other people at this 

point --

          CHAIRMAN FADEN:  That's correct.

          MS. KING: -- and it is our belief that those documents
should be made available to everybody.  This is very sticky.  

          CHAIRMAN FADEN:  Yes, and I think what happens is that
the language from Gary, basically, says that.  I think I have an
idea of what he has in mind, and I'm not sure that it's
comfortable.

          MR. GUTTMAN:  Can I suggest something?

          MS. KING:  At least, it's sticky for a committee itself
that has not reviewed all of these documents.

          MR. GUTTMAN:  Pat, could I suggest something?  We
actually had a conversation with the CIA about this particular
recommendation, and the person we're working with has been away
for a week and is going to get back with us.  Can we try to work
this in the interim?

          CHAIRMAN FADEN:  I think we are not going to approve
16(g) in its current form.  Whether we approve another
recommendation that's specific to the CIA remains open, and
another possibility, of course, is to fold the CIA into that
first recommendation with maybe even a special mention, if their
record system is more opaque even to the public than other.

          So we will do that.  Let's keep rolling backwards here. 
We're on 16(f).

          MS. KING:  I don't mind being filmed; honestly, I don't
mind being filmed.  But it's disruptive when the person taking
the pictures is right down in front when we're trying to
interact.  So if the people who are doing the filming can somehow
get to the edges I'd appreciate it.  Thank you.

          DR. FADEN:  Thank you, Pat.  But I guess there are
certain issues, invasion of body space if not privacy, still hold
to have a claim too.

          Duncan.

          DR. THOMAS:  Can somebody educate me as to whether
present document destruction practices include any public
notification of the intent to destroy?

          MR. GUTTMAN:  No.  We're talking about a very very
routine.  Pat will tell you.  This is not like -- it happens
everyday.  This is routine.

          DR. THOMAS:  No, that's what I'm talking about; just
routine destruction.  But records which may seem routine to one
person may be important to somebody else.

          MR. GUTTMAN:  There has not been historically a great
ground swell for public notification of intent to destroy
documents.

          DR. THOMAS:  I wouldn't think so.  And we don't want to
create one more bureaucracy for that purpose.  On the other hand
you start off your first sentence here with reference to
important data collections, record collections somewhere here.

          Here it is, line 21.

          MS. KING:  There's a problem with this recommendation
though, and that is, the government generates so many tons of
papers not to be believed, and keeping a lot of these would be a
problem, and I would feel more comfortable if the committee made
recommendations about records in the areas that we're concerned
about.  So there should be some limiting, and we should be able
to justify why we need it.  If it's records pertaining to human
subject research why we can show that -- I know exactly what Dan
is trying to get to here, but it's one of those recommendations
that the cost benefit part of it is -- 

          MR. GUTTMAN:  That's fine.  The principle once
established will either fail or succeed.

          DR. FADEN:  We will keep going.  Again we're obviously
are going to have to see all of these, but we will see them in
the mail and then have our final sign off on them at the last
meeting.

          16e.  Transfer Records to the National Archives.

          DR. GLATSTEIN:  Who appraises these?

          MR. GUTTMAN:  The archives.

          DR. FADEN:  Is this a problem?

          MR. GUTTMAN:  Well, it's in some respects hortatory,
but useful because of the committee's expertise in this area.

          DR. ROYAL:  Which records are you referring to that
have been appraised as being permanently valuable?  Records that
we've discovered?

          MR. GUTTMAN:  No, no.  This is a general -- 

          DR. FADEN:  Whoever does these appraisings determines
that a record is valuable and should be retained it ought to be
transferred to the National Archives.

          MS. KING:  Well I have the same problem.  This one I
had with the one before.  I mean the committee's basic charge is
protecting human subjects or openness issues; and openness.  And
this is a nice thing to do but it's also got huge cost benefit
kind of assessment attached to it.  If there's already a federal
law maybe if we say anything it should be directed at why we
think the federal law's inadequate, or why it's not working in
the areas that we think are important rather than a general
recommendation then.

          DR. RUSSELL:  I can't tell from this whether we say
that they aren't obeying the law or whether the law's inadequate.

          MR. GUTTMAN:  No.  It's a case whereas I understand it,
it's resources and priorities and neglect, and all the things
that you would suspect.

          MS. KING:  It's by cost benefit analysis.

          DR. RUSSELL:  Are they not obeying a federal law
because they can't afford to?  Is that it?  So then they've got
two problems; both the law's inappropriate and we don't have
enough money to do it.

          MR. GUTTMAN:  Well, no.  The gist of, I think, for of a
lot of these recommendation everything is trade off in today's
world, but the point I think we're trying to make is that for
practical purposes they're inaccessible to the public and of no
use to the agencies in their present forms so that you've got an
asset that's of no value but just sitting in a warehouse without
being organized by the archives.  You're right; nobody expects a
large amount of money to be devoted to this overnight.

          DR. FADEN:  Ruth.

          DR. MACKLIN:  When we were talking about a and b I
think Ruth you made a comment; I think that e falls under this
too and maybe these could be combined in some way.  These are
different from the ones we just looked at, so 16a through e could
probably be condensed.

          DR. FADEN:  No, not c and d.  We've got to look at c
and d.  But you're quite right; let's go to c and d now.

          DR. MACKLIN:  So e would go with the a and b.

          DR. FADEN:  As all things that we are suggesting.

          DR. MACKLIN:  Because it's all the same problem.

          DR. FADEN:  Right.  It's all the fix it problem; make
the records better available, organized; all that kind of stuff
so that people don't have to go through what we have all gone
through.

          C and d are different.  They speak to different things. 
Shall we take -- I don't care which one we do first; we should
look at both.

          Recommendation 16d.

          MS. KING:  I don't know if I'd be in favor or not in
favor of that.  I am convinced that there's not enough
justification here why we should go to this enormous expense. 
Maybe there's some justification why we should ask them.  We
should ask the government to go to this enormous expense. 
Perhaps there's some justification that we can think about for
doing this and maybe it should be time dated; maybe it should be
lots of things.

          But I think the fact that you want to look at records
50 years later as sort of what we have been doing here is
sufficiently unusual that to ask for these permanent registries
for every type of research project has been much.  So either it
should be limited in some ways by dates, by types of research, by
something, and we should give a good reason about why these data
are needed for something other than the possible creation of
another committee.

          DR. FADEN:  Are we talking about d or c?

          MS. KING:  I'm talking about d.

          DR. FADEN:  Anna has something there.

          MS. MASTROIANNI:  It's my understanding the National
Library of Medicine is already evaluating the issues related to
creation of registry for clinical trials.  I don't know what the
status is at this very moment, but they are doing that.

          DR. FADEN:  And there are arguments for registries and
they usually are field specific or they are related to the
cryptic references here to justice questions and selection of
subjects, adverse outcomes and things like that, but it's a
massive undertaking.

          MS. KING:  It's a massive thing and if we want it it
should have limits.  I mean maybe we want it for a certain period
of time or something like that, or certain kinds of research.

          DR. FADEN:  Ruth.

          DR. MACKLIN:  Well it seems to me that this is related
to something we talked about this morning which was documentation
about consent processes and things like that.  That is we talked
about in a different context, not in the context of openness, but
in the context of -- it started out with ethics education, but of
course we were also talking about compensation and compensation
for dignitary harms and other harms in which it happens.

          There was a whole set of things that had to do with how
people might be able to find something out.  Now the federal
government wouldn't have control over what kinds of records are
in hospitals, doctors' offices, etc., but the federal government
is in a position to keep some kinds of central registries so that
if things come up in the areas where people are looking for
information about something like was there adequate informed
consent; we were looking at compensation and debating that but it
may go back to the question of investigators.  There may be other
purposes here that could be served that don't have to do with the
possibility that forty years later someone's going to raise some
problem.  But if we're urging in other sections of this report
the importance of things like ensuring that informed consent and
the ethics of research are carried out then this kind of record
would seem to me a way of being able to document and get at that.

          DR. ROYAL:  How is this going to document that adequate
informed consent was obtained?

          DR. FADEN:  I think it doesn't document; it just
provides you -- 

          DR. MACKLIN:  It doesn't document.  It has some
evidence that might not otherwise be available anywhere.  Henry,
it could protect the physician researcher.  If a patient says, I
never signed a consent form.  I mean, I don't know.  I'm just
saying we talked about things this morning that might require
records for being able to do it.

          DR. FADEN:  Here's a possibility.  If the NLM is
already looking at feasibility of a registry and a rationale for
clinical trials we could recommend that the National Library of
Medicine broaden its current inquiry to consider the merits and
disadvantages of creating a central registry for all research
involving human subjects.

          We're not going to be able to work it out here.  There
are arguments why it would be a good idea; there are arguments
why it wouldn't.  And it's in that category of we haven't had the
time to hash the whole thing out.  So if we sat there and said if
NLM is already in the business of figuring out the feasibility
and the clinical trial arena last ask them to take a look at the
other arena as well.  It seems to me they are an appropriate
agency to him to direct this recommendation under the openness
heading.

          DR. TUCKSON:  I would agree with that, and I think the
main thing is just to articulate what it is that we seek to
accomplish as opposed to trying to dictate the way of doing it.

          DR. FADEN:  I think that that's going to the problem
here.  If we're not clear about what it could accomplish then we
shouldn't even be asking NLM to take a look at it.

          DR. TUCKSON:  That's the critical language.

          DR. FADEN:  So that is part of it.  Obviously in
suggesting it I think that there are arguments that could be made
for registries in this area, but I don't know.

          DR. TUCKSON:  But given the realistic notions of
cutting back on government bureaucracy, and given the real
notions now of cutting back on the money available to conduct
research to put in a bureaucracy, I mean I just can't imagine
anybody would do this.

          DR. FADEN:  Let's do this.  I will take 16d; try to
think.  If we can't come up with a very persuasive argument, why
even NLM should take a look at it, it will not appear again.  But
it will either be in the form of we'll contact NLM and see what's
going on there.

          DR. ROYAL:  And remember the kind of information that
you need in the database to be useful to ethics is very different
than the kind of information that's likely to be in there.

          DR. FADEN:  The IRB stuff.  I'm sorry, I didn't mean to
interrupt.

          DR. ROYAL:  They're not going to have the IRB stuff,
what you just said, yes.

          DR. MACKLIN:  Why not?

          DR. FADEN:  If NLM right now is thinking about doing a
registry on clinical trials it's unlikely that their registry
will include the IRB documentation and the consent form.  This
recommendation includes that in order to increase the likelihood
that the registry would be useful for subsequent reviews or the
ethics of research along the lines of what we did in the RPRP.

          Basically what's suggested here is, there would be a
central registry that would contain all the information on funded
research projects that we had when we did our RPRP review.  So
that one argument is, if every five years somebody wants to do an
RPRP, instead of having to go to all the institutions they draw a
sample from the registry, look at the stuff, and it goes back.

          DR. ROYAL:  Maybe that recommendation then should be
part of the recommendation that they do the RPRP study every five
years.

          DR. GLATSTEIN:  We could build that in.

          DR. FADEN:  The issue is I'm not sure whether that's
the most efficient way to do it.  Maybe it is more efficient not
to have a registry and just request the materials every five
years.  Unless there are other reasons for the registry it
probably is more efficient to draw your sample from the list that
the agencies keep of their funding.

          That's the problem.  I'm just not sure, but that was
part of the thinking behind throwing these ones in.  Let us work
on this a little bit, because I think 16c is something that while
we still have the committee here there's some collective debate
in the next 10 or 15 minutes.

          16c is directed at recipients of federal funds;
grantees and contractors.

          MS. KING:  Well, I have the same problem with this one
as I did before.  I don't know whether I'm for it or against it. 
I was looking for a reason for it.  I mean I'm looking for what
we know, what we don't know.

          For example, there's a sentence that says, "The purpose
of the review is to determine the legal rights of citizens in the
records."

          I didn't quite understand what that meant.  It meant
that maybe it wanted OMB to say what it thinks; that the legal
rights are; but OMB's not going to do that.  Or whether citizens
have legal rights in their records in which case it says so. 
It's more a question of confusion.

          MR. GUTTMAN:  Yes, the gist of this is that basically
you've got a situation from the respect of the citizen, they
don't care.  This is like whether it's Green Run or the 699,000
other curators.  If there a human subject or if they're just a
member of the public who's interested in that subject.  If it's
done on taxpayer dollars, whether it's done by the AEC employee,
by Oak Ridge or by the University of California on Oak Ridge
money, it doesn't matter.

          A reporter from Spokane we talked to is calling up and
saying they've been trying to get information at Hanford. 
General Electric had some information about experimental stuff
that went on in the 60s and GE he doesn't want to turn it over
and the DOE says it's nothing we can do about it.  We asked the
DOE; maybe it is something.  But it's a notion that it's a
difference, depending upon the fortuity of whether that happens
to be something that is in the contractor's hands or the
government's hands.  And the general point here is that there
should be some -- especially with so much more work and the
government going out to these contractors and grantees -- some
clear statement that you don't immunize the public taxpayer
dollar from access by the luck of who's doing the work.

          Now Ruth's point; for contraries, you don't want to tie
up the university system and all kinds of -- that's true.  That's
why we're talking about parity.

          MS. KING:  My problem with this is, you can't discern
what we're doing here.  If what the idea is to do is of the same
rights of access that a citizen has to x kind of records.  The
federal government is what you want to give a citizen access to
with respect to contractors and grantees.  This doesn't do that.

          And so, one, I had trouble trying to figure our exactly
what the goal of it was, but I assume that that's the goal now
the way you just explained it.  So if that's the goal it seems to
me that's what we want to recommend OMB that they review.  And I
do think it should be a review because there are in fact -- from
a citizen's point of view I quite agree with you; it doesn't
matter who has the records.  However, from the holder of the
records point of view they are not in the same position.  The
universities are not in the same -- grantees are not in the same
position as the federal government.  So there is a way in
balancing questions here.

          So I would have a recommendation that would say that a
citizen -- We should review whether the citizen should be on the
equal footing with respect to access to the citizen's medical
records, because I assume that's what you're talking about.  And
maybe it's more than medical records.

          MR. GUTTMAN:  No, it's more than medical records.

          MS. KING:  Okay, then specify.

          MR. GUTTMAN:  Because medical records they technically
should have wherever they are I assume, right?

          DR. FADEN:  In any event you fill in the parentheses.

          MS. KING:  Fill in the parentheses, and then what you
want them to do is to review this, because what you want to see
is there any reason for maintaining this that makes any sense. 
And I would have the recommendation read that way.

          MR. GUTTMAN:  I wrote it all by myself, but I would
like to say it was written by a committee.

          DR. FADEN:  All right.  So that your revised one makes
explicit the agenda behind the recommendation, says, OMB or
whomever is the right agency, review whether a citizen's right to
access.  And it's intended as I understand it not only to be your
access to information about your own medical participation or
participation in research, but just if somebody wants to find out
about -- 

          MR. GUTTMAN:  Dr. X's research reports.

          DR. FADEN:  Right.  Something; anything like that;
allowing for privacy protections and things of that sort.

          MS. KING:  Is this then real equivalency?

          DR. FADEN:  The issue is first, I don't take the
committee should call for equivalency.  We should call for review
to see the extent to which there is not equivalence and then in
the examination of whether the absence -- where there are not
equivalences whether it is justified as a matter of public policy
to have those differences.  Because we have to acknowledge the
argument that we've been having for a while.  You expressed it
better that the holders of the records are not similarly situated
even though the people who have an interest in the records may be
similarly situated.  And we can't begin to resolve that.

          Okay.  We have a few more minutes, but I think we sort
of did it.

          Ruth.

          DR. MACKLIN:  I want to make sure we weren't promised
anything in the proceeding three days that we didn't yet get.  I
don't mean things we have to now.

          Now, what is that over there?

          DR. FADEN:  I'm scared to tell you.

          DR. MACKLIN:  I think one question we had was, which of
the chapters that we now have are considered final, meaning that
there is no ongoing revision.

          DR. FADEN:  The term I believe that staff -- is near
final or something like that because they were afraid to put
final on it.

          Anna, could you describe what's in the packet for
everyone?

          MS. MASTROIANNI:  You will have final reports status, a
yellow sheet that would stand out, and there's a box that says
near final and there will be a check mark there.  It also
identifies the dates in your notebook so when you're cleaning out
your notebook and looking to make -- for those of you who still
have your notebooks intact.  When you're cleaning out your
notebooks you'll be able to go back and look at the date to see
if it matches.  We would appreciate any comments you would have
on any of the versions that say last revised; or anything that's
not near final as well so that we can incorporate those in.

          The mailings will go out -- You will have a complete
start to finish, near final, best staff effort version of the
final report by July 10, and we're going to deliver those to you
on a staggered basis.

          MS. KING:  So I'm getting a new notebook with the first
set of the documents?

          MS. MASTROIANNI:  Pat, we will tailor it for you.

          DR. FADEN:  But the point is, it's going to come in
dribs and drabs and you'll have to keep -- 

          MS. MASTROIANNI:  You will have to keep updating, and
every time we send something out we'll just keep updating.

          DR. GLATSTEIN:  And that's the first drib?

          MS. MASTROIANNI:  And this is it.  So you're getting I
think four chapters that are in near final condition.

          And we're also be getting out a calendar explaining
when the publication dates and final comments are due; all those
sorts of things, early next week.

          DR. FADEN:  And a deadline for additional statements
and all that kind of stuff will be in there.  So we'll fold it in
and people can know what they're up against.

          Lois.

          MS. NORRIS:  Have you worked it out yet whether you
anticipate July will be a two or three day meeting?

          DR. FADEN:  No.  I think we should leave it as three.

          DR. GLATSTEIN:  Leave it as three; I can't imagine it
will take less.

          MS. KING:  Don't even worry about it; you don't have a
chance.

          DR. FADEN:  Can everybody come back for one second? 
The minutes were distributed two days ago.  Are there any
amendments, corrections, dissents on the minutes anyone cares to
make?

          Seconded for the approval.  All in favor?  The minutes
are approved.

          Thank you.  I forgot all about it.

          MR. GUTTMAN:  I hereby close the meeting.

          Whereupon, at 3:24 p.m., the proceedings went off the
record.)