APPENDIX 33 Personal Statements from Committee Members UNIVERSITY OF CALIFORNIA, SAN FRANCISCO DENLEY. DAVIS. IRVINE. LOS ANGELES. RIVERSIDE. SAN DIEGO. SAN FRANCISCO. (LOGO) SANTA BARBARA. SANTA CRUZ DEPARTMENT OF RADIOLOGY SAN FRANCISCO, CALIFORNIA 94143 Dear Chancellor Martin: As Chairperson of the Ad Hoc Fact Finding Committee I wanted to add this personal note. The deliberations leading to the report you have just read were very difficult and time consuming. As you are aware, the issues surrounding the World War II era radiation experiments provoke strong emotional reactions. Every conclusion, every concept, every fact, and practically every word in our report generated extensive debate. I am extremely proud of the conduct of my fellow Committee members. Their deliberations of the issues struck me as completely honest and sincere. We made a concerted effort to state facts, conjectures, and conclusions without overtones. However, so many serious accusations have been made regarding this research, that any report demonstrating errors in those accusations will necessarily sound somewhat defensive. I want to assure you that the Committee did not take a defensive posture and that this report reflects our assessment of the plutonium experiments without regard for our understandable pride in the University of California, San Francisco. The most controversial issue in our deliberations concerned informed consent of the research subjects. Some of the most serious allegations leveled against the plutonium investigators included that patients were not informed about the experiments, did not consent to participate, and, indeed, were unaware of their participation in this experiment. So little hard evidence exists regarding what was told to the research subjects that it is impossible to make verifiable conclusions regarding the adequacy of informed consent. For that reason, the results of many hours of discussion, during which a number of important points were made by the Committee members regarding this issue, could not be placed in the body of our report. I wanted to relate to you an incident from one of our weekly Committee meetings that I believe was important in this regard. We were in the midst of heated debates on the issue of informed consent. Emotions were high and discussion ranged widely. I halted the discussions and asked each member present, in turn, to state whether or not they personally believed that the research subjects had been told that they were to be participants in a radiation experiment. Further, they were invited to say why they held that belief. All agreed that the subjects had been informed to some degree. Committee members expressed a number of salient reasons that led to their general belief that the subjects were aware of their participation. First, the subjects that drank the mixture of acidified water and plutonium (an experiment that immediately preceded the MED-sponsored project in which plutonium was parenterally injected) were known to be volunteers (Appendix 3, page 6). Also, the last CAL subject to be injected with plutonium, CAL-3, was a volunteer (Appendix 20, page 4). It seems unlikely that the intervening two subjects were not volunteers. 1 Second, we know that CAL-1 was reimbursed for saving and turning over his excreta to the UCSF researchers. If an individual is being paid for his bodily excretions then it is likely that the individual understood he was part of an experiment. If he believed he was saving his excreta to check on the progress of his disease then he would expect instead to be billed for the analysis. Third, many of the Committee members are experienced clinical researchers and understand that it is unnecessary to surreptitiously obtain research subjects. An investigator can virtually always find individuals who are willing to participate in an experiment even following disclosure of potential serious risks and other pertinent information necessary for the individual to make an informed and free choice. Patients with lethal disease processes are often willing to participate in experiments that have potential dangers if they believe the results may help themselves or other future unfortunate individuals with their disease. I would assume that during the height of World War II knowledge that the results of the plutonium experiment were important for the war effort would positively influence a potential research subject. When one notes the time delay over which only three subjects were entered into the plutonium studies, one can reason that there was ample time to find willing participants. Fourth, it is fundamentally impossible for members of a non- primary care department (like the Department of Radiology) to walk onto a clinical ward and surreptitiously perform an experiment on ward patients. The attending physician, residents, interns, medical students, nurses, and other ward personnel would promptly discover the activity and the researcher would be exposed and academically disgraced. We know instead that the attending physicians and house officers knew of the experiments from a variety of notations in the patients' records (Appendices 18-20). It would be impossible to gain the cooperation of such a diverse group if they believed that the research was unethical. Finally, I believe the lay public assumes that because the experiment was "secret", this fact necessarily implies that the investigators could not have disclosed adequate information to the research subjects to obtain consent. This is not the case. The researchers could have disclosed more than adequate information to obtain appropriate informed consent of the research subjects without needing to disclose those aspects about plutonium that made this element a war-time secret. Indeed, the patients could be adequately informed without ever mentioning the word plutonium. The lack of written documentation of consent was the practice of the era and does not indicate one way or the other what should be concluded regarding the information told to the research subjects. If the research subjects in the plutonium experiments were adequately informed, which may be the case, it was not because they were participants in "secret" government research. Research subjects in non-secret studies from the same era were historically no better informed. That the Federal Government and the university research community have enhanced and codified regulations regarding informed consent of research subjects is an implicit indictment that previous practices were inadequate. However, it does not follow that investigators who, in good conscience, adhered to those prior practices were unethical. It is likely that future generations of researchers will further modify informed consent 2 regulations. To harshly judge past generations for failing to meet current informed consent standards would be as unfair as judging our generation unethical because we may fail to meet future, yet unknown, standards. Sincerely, Roy A. Filly, MD 3