Advisory Committee on Human Radiation Experiments Public Meeting, May 18-19, 1994, Briefing Book (Volume 2)

Page 4

MEETING, ADVISORY COMMITTEE ON HUMAN RADIATION EXPERIMENTS, The Advisory Committee on Human Radiation Experiments conducted its second set of meetings on 18-19 May 1994 at the Ramada Plaza Hotel, 10 Thomas Circle, Washington, 2.0 SUMMARY OF MEETING, 18-19 MAY 1994. The first day’s session included opening remarks by Dr. Ruth Faden, Committee Chair, briefings by three Committee members on their areas of expertise, staff reports on their case studies of three experiments (Cincinnati, plutonium injections, and Green Run), and a public comment period. The second day’s sessions included staff briefings on visits to the Departments of Energy and Health and Human Services, a briefing from the White House Counsel’s Office on conflicts of interest (not discussed in this paper), and a discussion of Committee operational and organizational matters. After Mr. Phil Caplan of the White House officially opened the meeting Dr. Faden made her opening remarks. She stated that the Committee had a packed and important agenda and then reviewed the agenda. Dr. Faden announced that Committee member Frank Press, Ph.D, resigned from the Committee for personal reasons. A short discussion then ensued about whether Dr. Press could and would be replaced. Dr. Faden was checking with the Administration on this point. The Chair also announced that Committee member Dr. Philip K. Russell, M.D., who is listed as the Committee’s military medicine specialist, was absent because of travel conflicts. Dr. Russell has missed both sets of scheduled meetings. Dr. Faden then stated her three main objectives for the meeting. 3.2.1 First Objective. The first objective was for the Committee to begin its self education process by hearing presentations from three Committee members on their areas of expertise. The three Committee members who would make presentations, and their topics, were Dr. Ruth Macklin on the ethical principles of human experimentation; Dr. Henry Royal on the

Page 5

health effects of radiation; and Dr. Susan Lederer on the history of human experimentation in the United States. 3.2.2 Second Objective. Dr. Faden's next objective was that after the two days of meetings she wanted the Committee to have provided the staff with detailed and specific guidance for their work during the period between this meeting and the next. Dr. Faden also stated that over the next two days the Committee would hear reports on the tasks assigned to the staff at the end of the first meeting. These tasks were to begin identifying and evaluating the ethical policies of Federal agencies; to prepare individual methodological case studies on three experiments (See paragraph 2.0 above); to start evaluating agency research and record search efforts; and, as a result of their agency evaluations, to provide the Committee recommendations on the guidance to be provided the agencies. Two Federal agencies were evaluated--the Departments of Energy and Health and Human Services. 3.2.3 Third Objective. The final objective was to receive comments from the public during the public comment period scheduled for the afternoon of 18 May 1994. Dr. Faden stated that the Committee was notified that four members of the public to speak during the public Dr. Faden concluded remarks by having old and new staff members introduce themselves.(See Tab B for staff information.) She then stated that, as the staff has expanded and evolved, it started to informally organize itself around two "stories" that Dr. Faden believes that the Committee is responsible for relating to the public. The first is the "Cold War Story." The theme of this story is how the Cold War caused the Government to use research, in general, and human subjects specifically, to attain scientific objectives other than those that would advance medicine and be of benefit to mankind. The second story involves "ethics in science." This will address the evolving standards, policies, and practices of human experimentation. For the near future these ''stories'' and associated themes will guide the staffs data collection effort and, by extension, agency information requirements. 4.0 COMMITTEE MEMBER BRIEFINGS. Three Committee members presented briefings during the morning session. Dr. Ruth Macklin discussed ethics and human experimentation. Dr. Henry Royal described the health effects of radiation. Dr. Royal was followed by Dr. Susan Lederer, who presented a paper on human experimentation in the United States.

Page 6

4.2 ETHICS AND HUMAN EXPERIMENTATION. The presentation referenced the Belmont Report which was issued by a national commission in 1979. The report was described as a succinct statement of principles and, as such, it leaves room for interpretation and nonstandard application. Three principles were identified and their philosophical underpinnings were discussed, as well as their practical application. The principles were respect for persons, the obligation to maximize possible benefits and to minimize possible harm, and the validity of the of retrospective application of ethical standards. When discussing the principle of respect for persons an interesting parallel was drawn. The Belmont Report identified the use of prisoners in research as wrong because prisoners are in coercive environment, which limits their freedom to choose whether or not to participate in research. A parallel between the coercive prison environment was drawn with the environment in the military. 4.3 EFFECTS OF RADIATION. This was a technical presentation which provided the Committee members with an overview of radiation and its health effects. Topics included types of radiation (ionizing and nonionizing), background radiation, units of radiation, doses, and deterministic and stochastic effects. Aside from the technical points, the presenter made two interesting observations. He stated that society’s culturally conditioned perception of radiation was essentially negative. Also, that radiation is carcinogenic but it is a relatively weak carcinogen. 4.4 HUMAN EXPERIMENTATION IN THE UNITED STATES. The focus of this presentation was on the first forty years of the 20th century. This period was selected because it was during these years that the scientists and doctors who conducted experiments in the late 1940’s, 1950’s, and 1960’s were trained. The general historical evolution of human experimentation was first traced, followed by an analysis of the 19th century roots of 20th century practices. The work of two Army doctors, William Beaumont’s study of the human digestive system and Walter Reed’s yellow fever research, were cited as early examples of studies that incorporated elements of informed consent. Another point presented was that early efforts to protect humans in research grew out of the response, the briefer asserted, influential segments of the American medical community monitored research involving human subjects as a means to protect researchers and research, thus providing some sort of oversight and self regulation. The presenter concluded that in the early part of the 20th century the moral problems involved with human experimentation were acknowledged and that there were generally understood, but uncodified, rules for human mechanisms to enforce compliance with these standards. However, there were no formally adopted and promulgated standards or

Page 7

After each presentation there was a short question and answer period. The points 4.5.1 Did the concept of distributive justice--as applied to the Cincinnati experiments-- preclude a physician or institution that serves a minority population from doing research using such a population or in such an environment? The general answer was that it did not, if the subjects of the research benefitted from the research. 4.5.2 Again, in reference to the Cincinnati experiments, in which one of the criticisms is that it exploited a vulnerable population, was an adequate defense presented by the fact that the question of justice involves the issue whether the patients at Cincinnati had access to other 4.5.3 A question was asked of the ethical implications of the concept of added disadvantage(i.e., not only was person poor, but the person was also sick, in an environment [a hospital] in which they had diminished autonomy). There was not a simple answer to this question the briefer stated. 4.5.4 A Committee member asked whether the test(s) to apply to evaluate whether or not an ethical principle was violated were objective, subjective, or a hybrid. The general answer was any test would combine both objective and subjective criteria. 4.5.5 After the radiation presentation, the question was asked how a received dose of radiation was reconstructed. The presenter said that there was no good way to do this and that it was a complex process. Another Committee member noted that this was an important question and that the subject (dose reconstruction) should be incorporated into the 5.0 ADVISORY COMMITTEE STAFF BRIEFINGS. Over the two days of meetings six sessions were devoted to briefings by the Committee’s staff who prepared written and oral presentations. The written and verbal reports were generally similar. The general format included a description of what the staff found, followed by an analysis of what was discovered, and concluded with recommendations from the staff for further guidance and/or research. The briefing subjects were(Tabs identified contain the text of the reports presented to the Committee.) 5.1.1 A review of agency documents related to ethical standards.(Tab C)

Page 8

5.1.3 Reports on staff visits to the Department of Energy (Tab G) and the Department of 5.2 Agency Ethical Standards. The Committee’s staff presented its review of documents provided by the Departments of Energy, Health and Human Services, Defense, and Veteran’s Affairs. DoD documents were forwarded to the Committee on 9 May 1994 attached to a letter from Dr. Soper to Dr. Faden.(See enclosure to Tab C.) The letter was written in response to a 26 April 1994 letter from Dr. Faden in which she asked for, on the Committee’s behalf, “any ethical standards and regulations that may have been relevant to the human experimentation conducted or sponsored by your agency and its predecessors since, at least, 1940.’’ Documents related to ethical standards included in the DoD’s packet were the 1953 Memorandum from Secretary of Defense Wilson, information papers from the Army and Air Force on the evolution of their regulations pertaining to informed consent, and a description of the Navy’s regulatory history. The focus of the Committee’s review was the 1953 Memorandum and the points presented from their written report (subsequently cited in other venues)were 5.2.1 The Memorandum was a classified, verbatim recapitulation of the Nuremberg Code. In the report’s text, the word classified was underlined. This, and subsequent discussions over the next day and a half indicate that classified documents (real and presumed) and projects are of extreme interest to the Committee and its staff. 5.2.2 Why was it classified and how could a classified document be of use since its distribution would be controlled and limited? 5.2.3 What led to the Memorandum’s development and adoption? Did any specific event or 5.2.4 Did the Memorandum apply to only internal DoD projects, or did it also apply to 5.2.5 Did DoD-sponsored researchers need and have security clearances? 5.2.6 Before concluding the review of DoD policy the staff briefer did note a 1975 DAIG report on LSD experiments which revealed, at least to the staff, that the tenets of the Nuremberg code did exist within the military in an unclassified form. 5.2.7 The DoD portion of the report concluded with a statement that this was all that was provided to the Committee, which left the question of policy origins and implementation unanswered. Not stated was that, in his letter, Dr. Soper had stated that the DoD has been

Page 9

implementing the January 1994 guidance promulgated by the Interagency Working Group. This guidance did not include policy-related documents. Dr. Soper also stated that the Department would incorporate the Committee's requests into its research protocol. Furthermore, there was no acknowledgement by the Committee's staff of the information provided with Dr. Soper's letter on DoD component regulations related to human use. This was possibly done because the information provided was not primary source material, i.e., not the regulations referenced in the information papers. 5.2.8 The staff report also noted that they discovered 1942 documents that discussed human experimentation. The documents were from the World War I1 Committee on Medical Research which was later incorporated into the National Institutes of Health. In the staffs view, this document, along with the 1953 Memorandum and a 1947 Atomic Energy Commission (AEC) document referenced in their report, call "into question usual assumptions 5.3 CASE STUDY, CINCINNATI EXPERIMENTS. The staff presented a briefing on the results of their review of material related to the research conducted by Dr. Saenger in Cincinnati, Ohio. The Committee report at Tab D provides the details of their analysis. However, during the extensive discussion after the presentation several points arose that are of potential interest to DoD. L-- 5.3.1 A Committee member asked if the documents provided the Committee included any DoD documents that summarized the work and its military application. The staff member responded that the initial application and Defense Atomic Support Agency (DASA) reports were provided. These documents described the work's military application and the reports summarized the research. 5.3.2 In line with the staffs recommendation to research the question of why psychological and psychiatric tests were added to the research protocol a Committee member asked what the nature of the expanded protocol was and what the type of tests conducted were. The staff member answered that this was a question worthy of study because psychological/psychiatric testing was not mentioned in Dr. Saenger's 1958 application, but some time between 1963 and 1964 they were added. What was not clear from the available documents was why the tests were added and who suggested the expansion--the DoD or Dr. Saenger? He also said that the size of the expansion deserved study. While this discussion was going on, another Committee member asked when the LSD and other behavior control experiments were being conducted with the implication possibly being that there may be a possible connection between the addition of psychological and psychiatric tests and a larger Government 5.3.3 A question was asked if a patient list was available. It was noted that each report contained patient case histories, but the staff researcher was not aware of any patient list.

Page 10

5.3.4 The issue was raised of what can be learned from this specific case that would have a general application to the Committee’s work. The reply highlighted the fact that this case study revealed the strength of reviewing documents, but the document search technique does not tell the full story. The Committee or staff had not conducted any interviews nor gone to any of the sites. Also the staff did not have a sense if anything associated with this research was classified. Another benefit this case study identified that may have general applicability was that a possible thread or theme for the Committee to follow was the military’s interest in this type of research. 5.3.5 The staff researcher made the point that the military-funded research was “piggybacked” on Saenger’s other radiation research and that the military aspect of the experiment needed to be evaluated separately from the other research. Another aspect of this issue, and similar to the theme identified above, is the question of the military’s motivation and need to fund these and similar experiments. 5.3.6 A general discussion was conducted of the research’s mortality rates and research design. It became apparent from the discussion that research design …