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. TAB I-5 DRAFT - FOR DISCUSSION PURPOSES ONLY TO: Members of the Advisory Committee on Human Radiation Experiment FROM: Advisory Committee Staff DATE: February 8, 1995 RE: Army Review of Original Contract Proposal Submitted by Dr. Saenger; National Institutes of Health Review of Cincinnati Total-Body Irradiation Study In response to questions raised at the January 1995 Committee meeting, the following is a guide to Dr. Eugene Saenger's contract proposal to the Army to conduct total-body irradiation research, from the initial application to the signed contract (the Army review documents are attached). Also attached is the Apr. 18, 1969 memo from the Chairman of the University of Cincinnati (UC) Faculty Review Committee (FCR) concerning the NIH's rejection of the TBI protocol. Document 1:Dr. Saenger submits an application for a research contract, dated September 28, 1958, to the Department of the Army, Office of Surgeon General, Research and Development Command; the application lists a total budget of $25, 085.00 for the first year, and requests $21,775.00 for the next two additional years. The grant application requested funds for 6 personnel -- 2 technicians, 1 physicist, 1 clinician, 1 statistician, and 1 secretary -- along with equipment and supplies. Document 2:On October 20, 1958, Arthur D. Sullivan, Lt. Col., MSC, Assistant Chief, Biophysics and Astronautics Research Branch, U.S. Army Medical Research and Development Command sends a memo to the Chief, Radiological Service, Walter Reed Army Medical Center (WRAH) requesting a review of the Saenger application. The application is reviewed by the following four persons: October 22, 1958 memo from John A. Isherwood, Col., M.C., Chief, Radiological Service, WRAH to Assistant Chief, Biophysics and Astronautics Research Branch, U.S. Army Medical Research and Development Command; October 24, 1958 memo from Clinton S. Maupin, Col., M.C., Special Assistant for Nuclear Energy, OTSG to Deputy 1 Commander, U.S. Army Medical Research and Development Command; November 3, 1958 memo from William W. Cox, Lt. Col., M.C., Chief Medical Research Branch to Col. Sullivan; November 7, 1958 memo from James B. Hartgering, Lt. Col., M.C., Director, Division of Nuclear Medicine and Chemistry to Lt. Col. Sullivan. Document 3:Based on the favorable recommendations of the above four persons, Col. Sullivan sent a memorandum, dated November 12, 1958 to Col. Hullinghorst, recommending that the AMS [Army Medical Service] support the contract at a cost of $21,775.00. Document 4:On October 29, 1959 [one year later], David Lambert, Captain, USN, Deputy Chief of Staff, Weapons Effects and Tests, Defense Atomic Support Agency (DASA), sent a memo, through the DASA Chief, DASA Chief of Staff, and DASA Comptroller, to the Director of Logistics, to the attention of the Chief, Contract Management Branch granting authority to allot funds in the amount of $25,085 to effectuate a contract with the University of Cincinnati. [We do not have documentation describing what occurred between November 1958 and October 1959, concerning how the contract went from the Army to DASA.] On March 2, 1960, a contract between the University of Cincinnati and the Department of Defense was signed. The contract was "issued by" DASA, but states that "payment will be made by" Finance and Accounts Office, U.S. Army; the contract also lists "Army" under the box indicating "Department." Document 5:Memo from Chairman of the University of Cincinnati Faculty Committee on Research to the Members of the Faculty Committee on Research (FCR), April. 18, 1969, describing NIH review of the FCR and rejection of grants on moral grounds. 2