Tab L Staff Memo -- Methodological Case Study: "Cincinnati Experiments: 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. TO: MEMBERS OF THE ADVISORY COMMITTEE OF HUMAN RADIATION EXPERIMENTS FROM: ADVISORY COMMITTEE STAFF DATE: MAY 12, 1994 RE: DOCUMENTS ON "CINCINNATI EXPERIMENTS" What follows is a brief description of documentation related to the federally supported experiments conducted by Dr. Eugene Saenger and received by the Committee Staff from four separate sources: the Department of Defense, the Department of Health and Human Services, Representative John Bryant's office, and Mr. Gwendon Plair, an active member of patients' families group. Following that are suggestions for further documents which the staff feels may prove illuminating in completing a review of this particular federally contracted experimental work involving total body irradiation. Items marked by an asterisk*) are included in this packet. (If you would like to review copies of documents that are not attached, please contact Anna Mastroianni.) I. DOCUMENTS RECEIVED A. From the Department of Defense Approximately four linear feet of material were delivered to the Committee Staff from the Department of Defense concerning experiments designed and performed at Cincinnati General Hospital from 1959 through 1972 by a research team headed by Dr. Eugene Saenger. Much of the material was out of chronological order and scattered piecemeal throughout the files. All material was non-classified. A brief description of the documents follows: * 1) Dr. Saenger's original 1958 grant proposal to DASA (Defense Atomic Support Agency) for the proposed study and grant reviewers comments; * 2) A series often reports recording the progress of the contracted experiments. The reports were submitted periodically from 1960 through' 1972; (two samples are enclosed); 3) Portions of contracts stating the funding agreements between DASA and University of Cincinnati over the course of these experiments. The contracts were amended in response to applications for expansion by Dr. Saenger. 4) An expanded 1967 research proposal by Drs. Friedman and Saenger presented to a research review committee at University of Cincinnati, and comments by faculty reviewers on the merits of their proposal; 1 * 3) Statement for the Record," Dr. Donald A. Henderson, Deputy Assistant Secretary for Health--Science, UPS Public Health Service, provided to the subcommittee on Administrative Law and Governmental Relations of the Commission on the Judiciary, U.S. House of Representatives, April, 1994. C. Documents Received from Representative John Bryant's Office The testimony and exhibits prepared for the April 11, 1994 hearings before the Subcommittee on Administrative Law and Governmental Relations of the House Judiciary Committee were delivered to the Committee staff by Representative John Bryant's office. A brief description follows: 1) Testimony from family members of three patients; * 2) Testimony from Dr. Gordon Soper, Principal Deputy to the Assistant Secretary of Defense for Atomic Energy [includes a DOD chronology]; 3) Testimony of Dr. James Cox, Professor of Radiotherapy, M.D. Anderson Cancer Center; 4) Testimony of Dr. Joseph Steger, President, University of Cincinnati; 5) Testimony of Dr. David Egilman Department of Community Medicine, Brown University; 6) Testimony of Dr. Martha Stephens, Professor of English, University of Cincinnati, and principal author of the 1972 Junior Faculty Association report; * 7) Testimony of Dr. Eugene Saenger. (Attached documentation does not include appendices to testimony.) D. Documents Received from Mr. Gwendon Plair, Member of Concerned Relatives of Cancer Stud Patients (CROCSP) Partial medical records of three different patients in the Cincinnati study were delivered to the Committee Staff by Gwendon Plair, an active member of the patients' families group, and son of one of the patients. Mr. Plair testified at the first Committee meeting on April 21, 1994 during the public comment period. 2 II. STAFF SUGGESTIONS FOR ADDITIONAL DOCUMENTATION Review of this material by several members of the Committee Staff suggests that a more 7) Documentation of Dr. Saenger's role as a staff member and later as aconsultant to the Brooke Army Hospital, Lakeland Air Force Base Hospital, USPHS, and AEC Oak Ridge Program during the period 1953 to 1972. This was the period when the Cincinnati experiments were being planned, applications produced, contracts awarded, and contracted work carried out. This information may help to understand the purpose of these Cincinnati experiments. 8) Information on similar TBI human experiments contracted for at the Baylor College of Medicine and Sloan-Kettering Cancer Institute -- Drs. Vincent Collins at Baylor and James Nickson at Sloan-Kettering also had contracts from DASA during the 1950-70 decades to perform similar human radiation research. (DA 49007 MD 428 and DA 49 146 XZ 032 Baylor and at Sloan Kettering DA-49-007-MD-533, DA-49-007-MD-669, and DA-49-146-XZ-037) In recommending approval of the Cincinnati work, reviewers urged coordination with the New York and Texas research. Review of these contracts may add to the Committee's understanding of the background for all such experiments contracted for by Federal agencies. 9) All the documents received appear to have been unclassified -- In some cases, the investigator reports make express reference to a military purpose for the research. It would be interesting to know whether investigators had security clearances and access to classified documents? If so, is there documentation which might show how such clearances bear on informed consent issues? 3