Advisory Committee on Human Radiation Experiments
Meeting of July 17-19, 1995
Monday, July 17, 1995
Attending: Ruth Faden, Eli Glatstein, Jay Katz, Patricia King,
Susan Lederer, Lois Norris, Nancy Oleinick, Henry Royal, Philip
Russell, Mary Ann Stevenson, Duncan Thomas.
Philip Caplan, Special Assistant to the President and Deputy
staff secretary, opened the meeting at the Executive Chambers,
Madison Hotel, 15th and M Streets NW, Washington, D.C. Dr. Faden
briefed members on the agenda.
Public Comment
Minister of Foreign Affairs Philip Muller, Senator Tony de
Brum, Ambassadors Larry Edwards and Wilfred Kendall, Republic of
the Marshall Islands. Foreign Minister Muller thanked the
Committee for its work in developing information important to the
Marshall Islands. Senator de Brum commented on the draft chapter
of the final report dealing with fallout exposures and subsequent
medical treatment and research in the Marshall Islands.
Bernard Aron, M.D., Cincinnati, Ohio. Dr. Aron, an
oncologist, described his work with total-body irradiation
patients at Cincinnati General Hospital. Members questioned Dr.
Aron about subject selection, general use of radiation therapies
at the hospital, and Department of Defense and Public Health
Service funding for the studies.
David Egilman, M.D., Braintree, Mass. Dr. Egilman commented
on the draft chapter on total-body irradiation.
Oscar Rosen, Boston, Mass. Dr. Rosen of the National
Association of Atomic Veterans commented on recommendations for
remedies for participants in atomic weapons tests.
Dennis Nelson, Bethesda, Md. Dr. Nelson briefed members on
additional materials regarding fallout exposures to citizens
living near the Nevada Test Site.
Mary Claire Mueller, Washington, D.C. Ms. Mueller described
her experience with radiation treatments and her difficulty in
obtaining relevant records.
Acie Byrd, Cincinnati, Ohio. Mr. Byrd presented a statement
on behalf of the Task Force on Radiation and Human Rights, citing
accomplishments of the Committee but urging additional steps to
respond to concerns of experiment subjects and their families.
Committee Discussion: Chapters in Part I and Part II
Dr. Faden asked members to identify chapters that needed
discussion by the full Committee.
Dr. Katz and Professor King expressed concern about the
substantial weight laid in Part I on the interpretation of
documents such as the Nuremberg Code and Defense Secretary
Wilson's 1953 directive adopting the code for DOD research.
Members suggested changes to the children's chapter relating
to risk assessment, consent, the rationale for medical follow-up,
and the suitability of today's regulations on risk.
Members discussed where to locate in the report a discussion
of the nasopharyngeal studies of children and military personnel.
Members agreed to include a discussion of the nasopharyngeal
studies as a box in the chapter.
Members discussed how to communicate radiation risks in both
the intentional release chapter and the rest of the report.
Dr. Thomas suggested that the context of risk assessment
could be added to a proposed box on risk being developed
elsewhere in the report.
Members suggested changes to the atomic weapons testing
chapter to define experimental activities precisely and identify
problems with military recordkeeping policies.
Members suggested changes to the chapter on plutonium
injections and related experiments. Members asked for clearer
descriptions of available evidence, particularly about consent
issues related to the experiments, and a more precise definition
of harms resulting from exposures. Members agreed that
information about Boston and Rochester uranium injections should
not be separated from the main text in a box.
Dr. Faden said staff was reviewing pathology reports from
uranium injection experiments to determine whether clinical harms
resulted from those studies.
Members suggested changes to the observational studies
chapter, including reconsideration of material on researchers'
obligations to warn uranium miners under study.
Committee Discussion: Findings, 1944-74
Members deferred discussion of Finding 11-C, assessing the
blameworthiness of experiments in which inadequate consent
appears tohave been obtained, until members could also address
Part I, Chapter 4, the analysis of ethics policies.
Finding 16 (regarding Marshall Islands exposures) was
deferred until Committee review of a revised chapter draft.
Tuesday, July18, 1995
Attending: Ruth Faden, Eli Glatstein, Jay Katz, Patricia King,
Susan Lederer, Lois Norris, Nancy Oleinick, Henry Royal, Philip
Russell, Mary Ann Stevenson, Duncan Thomas, Reed Tuckson.
Committee Discussion: Recommendations on Remedies for Former
Subjects.
Members discussed recommendations about remedies for former
subjects in the period 1944-74.
Members agreed to defer until Wednesday's discussion of the
total-body irradiation chapter a consideration of issues arising
from Recommendation 2, involving questionable therapeutic
rationales resulting in harm to subjects.
Professor King suggested that recommendations not include
headlines or titles, because cryptic headlines might be
misleading. Dr. Royal asked that staff look into ways to make
the texts of key documents available in the final report.
Members discussed the appropriateness of an apology to
subjects apparently unharmed by experimentation, but likely to
have been recruited through inadequate consent processes.
Members discussed the recommendations regarding apologies,
and asked that Dr. Faden express the tone of the Committee's
concerns in her letter of transmittal to the President.
Members discussed Recommendation 3, agreeing on the outrage
and regret felt about some cases in which people were used as
research subjects without any prospect of benefits, but noting
the grave evidentiary difficulties in many cases. Dr. Faden
agreed to consult with absent members but suggested that if the
consensus is to delete Recommendation 3 that additional language
in the preface or in chapters about specific cases may meet the
concerns of members who wished to include an apology
recommendation for specific cases.
Committee Discussion: Research Proposal Review Project. (RPRP)
Members discussed IRB review of the scientific merit of
research proposals, and instances in which basic ethical
principles were unaddressed in protocols.
Members suggested editing changes to integrate Dr. Katz'
independent review of protocols into the RPRP chapter.
Committee Discussion: Subject Interview Study (SIS)
Members discussed the subject interview chapter and
suggested editing changes, particularly focusing on making clear
the percentages in the surveys and avoiding misrepresentation of
the significance of the report.
Committee Discussion: Contemporary Projects -- An Ethical
Analysis
Dr. Kahn briefed members on the new draft chapter (Part III,
Chapter 17) to combine the ethical analysis of the RPRP and SIS
chapters.
Committee Discussion: Findings relating to the contemporary world
Members reviewed findings relevant to the contemporary world
and suggested changes. In Finding 21, members agreed to note that
the contemporary projects found no meaningful ethical differences
between radiation and nonradiation human subjects research.
Members agreed to note that radiation research is subject to more
regulation than nonradiation research.
Members agreed to add a finding designed to address public
confusion about the difference between research and application
of innovative therapies.
Committee Discussion: Recommendations for the Protection of the
Rights and Interests of Human Subjects
Members agreed to delete a proposed general recommendation
about public education, but at the suggestion of Drs. Tuckson and
Glatstein, references to public education about the risks and
benefits of research were to be added at appropriate places in
the text.
Members suggested that Recommendation 11 be separated into
four specific recommendations regarding changes to today's
federal regulatory scheme for the protection of human subjects.
Dr. Katz proposed adding a fifth recommendation, a general review
of the Common Rule governing human subject research in the
federal government.
Members discussed and suggested changes in the
recommendation dealing with the financial implications for
subjects of participation in research.
Dr. Royal suggested noting the bureaucratic burden to IRBs
of reviewing the growing percentage of protocols that, in an era
of declining research budgets, end up not being funded.
Committee Discussion: Recommendations for Balancing National
Security Interests and the Rights of the Public
Members discussed and suggested changes to recommendations
dealing with regulation of classified research and the regulation
of intentional releases conducted in classified programs by the
government. Issues included the "triggers" of review of
releases under existing environmental laws, and the need to
reassure the public about intentional releases, even where risk
is minimal
Members discussed recommendations relating to openness and
preservation of critical records about research. Dr. Lederer was
asked to redraft part of those recommendations for consideration
at Wednesday's meeting. Members discussed the bureaucratic
burdens of implementation of the recommendations and suggested
changes to the texts.
Members directed the staff to assess later whether a
recommendation is needed urging the National Archives to create a
specific repository Advisory Committee records. The
recommendation may be deleted from the final report if it has
already been substantially accomplished by the time of the
preparation of the final report.
Committee Discussion: Recommendations related to population
exposures
Members discussed Recommendations 6, 7, and 8, regarding
population exposures, and suggested changes. Key issues included
whether parts of the recommendations would overlap the ongoing
Institute of Medicine assesment of exposures to troops at weapons
tests.
Members discussed how best to represent to the government
the concerns of veterans and downwinders who have sharply
criticized existing government compensation schemes.
Wednesday, July 19, 1995
Attending: Ruth Faden, Eli Glatstein, Jay Katz, Patricia King,
Susan Lederer, Ruth Macklin (via telephone), Lois Norris, Nancy
Oleinick, Henry Royal, Philip Russell, Mary Ann Stevenson, Duncan
Thomas, Reed Tuckson.
Approval of Minutes
The minutes of the June 1995 meeting of the Committee were
approved without changes.
Committee Discussion: Strategy and Direction.
Dr. Faden briefed members on the agenda and noted that Dr.
Macklin would contribute to the meeting via speakerphone.
Dr. Faden asked members to share their views about
individual statements contemplated for submission into the final
report.
Professor King said that if she prepared a statement, it
would address the appropriateness of some of the retrospective
moral judgments in the final report, particularly in Chapter 4
(Ethics Standards in Retrospect), and some of the findings and
recommendations.
Dr. Katz said that if he contributed a statement, it would
focus on inadequacies in today's system of research oversight and
in the Committee's recommendations for protecting the rights and
interests of human subjects.
Dr. Royal said that if he made a statement, it would address
his discomfort with the evidentiary base from which many
judgments are adduced in the final report.
Dr. Faden said she might contribute a statement to
acknowledge the contributions of those who worked to produce the
report.
Committee Discussion: Total Body Irradiation
Members discussed the chapter on total-body irradiation and
suggested changes to the chapter. Members agreed how to
characterize the Defense Department's rationales for funding TBI
studies. Members also agreed to include material in the chapter
on subject selection and competence of some subjects to consent
to the Cincinnati TBI experiments.
Members discussed the conclusions of the TBI chapter and
suggested changes, particularly in bulleted material. Issues
included descriptions of the military's motives in sponsoring
different TBI studies; consent or lack thereof in the Cincinnati
case; ethical issues in multipurpose research projects; and the
palliative treatments afforded patient-subjects in the Cincinnati
study.
Committee Discussion: Ethics Standards in Retrospect
Members discussed the ethics framework outlined in Part I,
Chapter 4, and the related finding (11-C) regarding evaluation of
past experiments.
Members directed the staff to redraft the chapter to include
more detailed frameworks for moral analysis. Dr. Faden asked that
members make the draft a priority for returning their comments.
Committee Discussion: Medical Notification and Follow-up
Members discussed Recommendation 4, regarding medical
notification and followup (Part IV, Chapter 19) and suggested
changes.
Drs. Thomas and Royal pointed out the difficulties of
assessing risks and recommending appropriate follow-up. Dr.
Tuckson outlined the public-health issues involved in
notification.
Dr. Faden said language would be developed to explain trade-
offs between risks and benefits to portray for surviving subjects
the uncertainties of risk and responses.
Committee Discussion: Openness
Members discussed Recommendation 15 as redrafted by Dr.
Lederer, that conflated the previously considered Recommendations
15 and 16 on access to information about experimentation.
Members approved it with some changes.
Committee Discussion: Findings (Risks of Harm)
Members discussed a revision by Dr. Thomas of Finding 2,
regarding risks of harm. Members agreed to the new language, with
some changes to more precisely describe the risks from tracer
studies.
Committee Discussion: Recommendations (Epidemiological Study and
Atomic Veterans)
Members discussed a revised recommendation from Dr. Thomas
about epidemiological study of veterans involved in
experimentation in connection with atomic weapons tests. Members
agreed to the recommendation language with some changes, and
directed the staff to incorporate some of that language in the
relevant chapter of the report rather than the recommendations
chapter.
Committee Discussion: Recommendations (Monitoring, Oversight and
Sanctions)
Members discussed the draft Recommendation 11d, regarding
prospective monitoring and oversight of human subjects research,
and sanctions against ethical transgressions. Members recommended
changes in the recommendation in areas of oversight staffing and
in sanctions.
Committee Discussion: Observational Studies
Members discussed and made suggestions for the Marshall
Islands portion of the chapter on observational studies, and the
concomitant Finding 16 and Recommendation 9.
Professor King suggested that some of the concerns might be
communicated to appropriate federal officials by letter from the
Advisory Committee chair.
Members questioned Mr. Klaidman about evidence available
relative to the concerns raised by the Marshall Islands
delegation in the July 17 public comment period.
Dr. Thomas suggested that the references in Finding 16 to
deaths of uranium miners should be supplemented with mention of
the health effects of exposures in the Marshalls, including the
death of a Japanese fisherman on the Lucky Dragon exposed by the
1954 Bravo detonation. Members agreed that the finding should
reflect those issues.
Members agreed that parts of the Marshallese recommendation
and others that involve passing on of concerns drawn from public
testimony should be transmitted by the Committee to appropriate
federal authorities. Dr. Faden said she would try to make these
recommendations consistent, with pass-along issues either being
mentioned in the report, or expressed by letter to federal
agencies, or both.
Committee Discussion: Strategy and Direction
Dr. Oleinick requested that members see the findings and
recommendations in one document without explanatory text as soon
as possible, to provide members with an overview of all of the
recommendations.
Dr. Faden briefed members on the schedule of drafts to be
sent in July and August.
Mr. Caplan closed the meeting and expressed thanks to
members for the service on the Advisory Committee.