TAB E 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. ****DRAFT þ FOR DISCUSSION PURPOSES**** MEMORANDUM TO: Members of the Advisory Committee on Human Radiation Experiments FROM: Oral History Subcommittee DATE: August 29, 1994 RE: Status Report on Subcommittee Activities I. IRB Review of the Oral History Project Because the Ethics Oral History Project involves the collection of information from human subjects, and the Advisory Committee seeks to draw generalizable conclusions from this information, we believe the project is subject to review by an IRB. Susan Lederer, chair of the Oral History Subcommittee, has been named the principal investigator for the project. Consequently, the protocol for the oral history project will be submitted to the IRB of her affiliated academic institution, the Pennsylvania State University, for approval. A formal research protocol and consent form are being drafted for the application to the IRB of the University's College of Medicine, which is known as the Clinical Investigation Committee (CIC). II. Set of Core Questions A set of core questions is under development by the Subcommittee and staff. (See Attachment 1.) Questions are designed so that their language is not inappropriately leading or limiting. In addition, the questions are flexible and "personalizable" for each interview subject, according to the judgement of the historians conducting the interview. An important consideration for the design of the core questions is the intersection of the Ethics Oral History Project with the less formal journalistic interview project being conducted by the staff. Questions specific to each project have been merged to produce a throrough set of core questions better serving the ends of both projects. 1 The core questions will be submitted to the expert consultant panel of ethicists and historians that the Subcommittee has assembled for feedback. In addition, the core questions will be included in the application for IRB approval of the project. III. Recruiting Interviewees A list of ten to twenty-five senior research scientists active both radiation and non-radiation research from 1942 to the present, in both radiation and non-radiation research, is being finalized. These potential interviewees will be drawn from two age cohorts: one of clinical researchers who began their careers in the 1940s or 1950s and the other of those whose careers began in the early 1970s, when the federal government became extensively involved in the regulation of human experimentation. Once the project has been reviewed and approved by an IRB, formal contact with these individuals will be made. IV. Methodology The Subcommittee plans to follow a formal, rigorous oral history methodology. In preparation for each interview, experienced historians on the Advisory Committee and staff will read published and unpublished source material by and about the interviewee. The list of core questions discussed above will be tailored and expanded for each subject according to the reviewed source materials. Three people will be present in the room with the interview subject at the time of the interview: two trained historians to keep interview flowing and to monitor the coverage of specific questions and issues, and a third individual who will take notes on the interview and the spelling of names to facillitate the post-interview transcription process. Each interview will be tape-recorded, and professionally transcribed. The transcriptions will be distributed to the subjects for their review.