DISCLAIMER The following is a staff memorandum or other working document prepared for the members of the Advisory Committee on Human Radiation Experiments. It should not be construed as representing the final conclusions of fact or interpretation of the issues. All staff memoranda are subject to revision based on further information and analysis. For conclusions and recommendations of the Advisory Committee, readers are advised to consult the Final Report to be published in 1995. Advisory Committee on Human Radiation Experiments 1726 M Street, N.W. Suite 600 Washington, DC 20036 MEMORANDUM TO: Members of the Advisor Committee on Human Radiation Experiments FROM: Ethics Subcommittee DATE: June 9, 1994 RE: Proposal for Data Gathering Plan The Subcommittee is composed of Ruth Macklin (chair), Ruth Faden, Eli Glatstein, and Susan Lederer. Jonathan Moreno is the staff liaison to the Subcommittee, and is currently assisted by Jeff Kahn, Jeremy Sugarman, Jon Harkness, Kathy Taylor and Patrick Fitzgerald. The Subcommittee proposes the following plan, which instructs the staff as to the scope and depth of their data-gathering efforts in the ethics area. The Subcommittee approved the following as its data-gathering Charge: (1) to determine what policies, rules, guidelines, procedures and practices have existed concerning experiments involving human subjects from 1944 to the present; and (2) to ascertain whether there were or are any specific differences in policies, rules, guidelines, procedures or practices between human radiation research and other research involving human subjects, or between agencies sponsoring and/or carrying out research involving humans. For convenience, this Charge is divided into three areas of inquiry: (I) Policies, Rules, Guidelines and Procedures; (2) Professional Codes/Standards; and (3) Practices. PART 1: POLICIES. RULES. GUIDELINES AND PROCEDURES A. Government Departments and Agencies 1. Documents from the agencies and other archival material 2. Interviews with key individuals Information on policies, rules, guidelines and procedures will be sought from agency sources, as well as from any relevant agency advisory or oversight bodies, or consultants, who reviewed or consulted on agency research policies or practices. Liaison to coordinate with data-gathering efforts by federal departments and agencies has been established by designated Committee staff. Ethics staff will coordinate information requests through this mechanism. B. University and Federal Research Centers 1. Available survey data At least two surveys from the l96Os on university procedures regarding human subject research are available. 2. University/research center archives and policy statements The Subcommittee plans to select five or six universities that were engaged in biomedical research from 1944 to the present as "case examples" of research policies and practices (see Part 3 below). The Subcommittee will obtain research policy statements and procedures from each of these institutions. The Subcommittee will also gather information from VA hospitals affiliated with these institutions. In addition, several federal research centers conducting their own intramural research (e.g., DOD military hospitals and the NIH Clinical Center) will be included as case examples, for a total of no more than ten case studies. The universities will be selected according to the following criteria: major research center that did federally sponsored work with human subjects including, but not limited to, studies of ionizing radiation effects, affiliation with a VA hospital; availability of interviewers in local ethics centers and programs; quality of archival resources; and geographic location. 3. Interviews with key individuals Key individuals at the institutions selected for investigation will be interviewed. These will include past and present institutional review board (IRB) chairs, deans of research, investigators, etc. PART 2: PROFESSIONAL CODES/STANDARDS A. Professional Organizations Statements and policies on professional ethics in research issued by, and publications about, professional organizations will be collected. B. Other Sources Statements and policies will also be collected from other sources, including major private funding sources such as the National Foundation for Infantile Paralysis. C. Guidelines in contemporaneous medical ethics texts 2 D. Publicity in contemporaneous popular media regarding research ethics The purpose of examining the popular media will be to inform the Advisory Committee about the extent of knowledge of the Nuremberg Code and other stated research ethics principles and policies, among both investigators and the general public. PART 3: PRACTICES A. Universities and Federal Research Centers The following sources of information would be pursued at the up to ten institutions that constitute the "case studies" referenced in Part l.B. above. 1. Oral history and contemporaneous interviewing Oral histories and interviews conducted with identified individuals who were engaged in research involving human subjects (with ionizing radiation and in other areas) in the 40's, 50's and 60's, as well as interviews with those currently engaged in research with human subjects (with ionizing radiation and in other areas). Key topics to be covered in these interviews include: (I) oversight and approval process for human subjects research, if any; (2) consent practices; (3) considerations regarding the selection of subjects, and (4) considerations of harm/risk/benefit. The Subcommittee also plans to conduct interviews with persons who are currently subjects of research (involving ionizing radiation and other areas of research), to ascertain their perceptions of how their participation was solicited, the nature of their current involvement, questions of felt voluntariness and the differentiation of research from therapy. Several central bureaucratic and ethical issues have to be resolved before interviewing at institutions can go forward. A key design question is whether we should be focusing on "research involving ionizing radiation" versus "all other research", or whether we should have a more targeted comparison to radiation research such as (nonionizing) cancer research. This latter, more focused strategy would reduce the burden on universities and may result in more coherent, interpretable findings. The Subcommittee is considering the possibility of convening a special consultants' panel to critique and plan this portion of our efforts, particularly with respect to oral history, interviewing and any other original empirical research. The panel also 3 could advise as to the possibility of using contemporaneous surveys to measure the validity of oral histories. 2. Current policy review 3. Existing survey data 4. Archival sources Investigators' notes, diaries in collections of investigators' papers, etc. 5. Other secondary sources Empirical studies of consent practices and institutional review board functioning, histories of research in particular areas (e.g., vaccine research), history of clinical trials. 4