Summary Report, Human Radiation Research

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DEPARTMENT OF THE ARMY BROOKE ARMY MEDICAL CENTER FORT SAM HOUSTON, TEXAS 78234-6200 MEMORANDUM THRU Commander, Brooke Army Medical CWCer, Fort Say& FOR Chief, Clinical Investigation Regulatory Office, AMEDD Center and School, Fort Sam Houston, TX 78234-6100 SUBJECT: Summary Report, Human Radiation Research Human Radiation Research (see Encl 13). subject: Human Radiation Research (see Encl 14). 2. This Summary Report describes the findings of an investigation conducted in accordance with Encl 2-1, Minimum Procedures for Identifying Human Experiments Involving Exposure to Ionizing Radiation, and additional instructions given in the memos cited above. The assigned Project Officer and key personnel within Brooke Army Medical Center attempted to collect and analyze information or records of human research involving ionizing radiation conducted at Brooke Army Medical Center (BAMC, Brooke General and Convalescent Hospital, Brooke Army Hospital, Brooke General Hospital), Fort Sam Houston, TX, during the period of 1944 to 1979 and for the same type of research during the period of 1980 to the present which was not considered by a human-use 3. As a summary of findings, 3 3 specific protocols utilizing ionizing radiation on human subjects between 1944 and 1979 were discovered within the available records. Twenty-one of the 33 involved radiopharmaceuticals (14 of 21 could designated as FDAlicensed safe and effective, SE), and 12 utilized external source radiation (3 of 12 could be designated as safe and effective radiotherapy, RT). Eight of the 33 were Oncology Group protocols. Specific protocol data was available through only 3 sources including DCI Annual Research Progress Reviews, the Human Use Committee/Institutional Review Board minutes (both maintained by BAMC DCI), and Radiation Control Committee Minutes (maintained by the Health Physics Officer). As a result, the oldest specific protocol found was dated 1964 as indicated on a Annual Research Progress Report submitted in 1972. Ionizing radiation studies Service/Department, but those-commentswere made in reference to *-- were mentioned in BAMC Annual Historical Reports by the Radiation

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departmental training and capabilities and not specific research 4. The actions taken by the Project Officer and the results or findings are listed in the order given in reference 1 above and were as follows: a. Actions: Review of Medical Treatment Facility (MTF) Annual Historical Reports. The BAMC Historian and the Public Affairs Officer (PAO) were contacted and tasked to conduct the required search of records available in their respective offices. The Project Officer conducted a search of BAMC Historical Reports available at the BAMC Medical Library. The Project Officer also contacted the AMEDDC&S Historian, Dr. Osterman, while investigating the whereabouts of the Annual Historical Reports not found within BAMC. (1) The BAMC Historian searched all available records and found no references to human research involving ionizing (2) The BAMC PA0 searched all available records and found only the attached Memorandum with guidance for subordinate PAOs from the Fort Sam Houston Public Affairs Office regarding the investigation on radiation testing (see (3) The Project Officer reviewed those BAMC Annual Historical Reports available at the BAMC Medical Library (1944-1968) and found several references to the use of radioisotopes in research in the Roentgenography/Radiography Service/Department reports. The Table of Contents and Radiology Report are provided from those issues (see Encls 3-1 thru 3-7). BAMC Annual Historical Reports from 19731977 are maintained at PTM&S and were part of the Historian's review (see Encl 2) and BAMC Annual Historical Reports from 1969-1972, 1978 and 1979 were not available (4) The Project Officer, in trying to locate the missing Reports, contacted the BAMC Historian, who in turn suggested that the AMEDD C & S Historian, Dr. Osterman, might know the disposition of years 1969-1972, 1978 and 1979. Dr. Osterman reported that he had no records from the period prior to his designation as Historian in 1990 and was told all such records were moved for storage to the AMEDD Medical Museum and were supposedly stored in an unorganized b. Actions: Task the Senior Radiologist (1), the Radiation Oncologist (2), the Nuclear Medicine Physician (3), the

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SUBJECT: Summary Report, Human Radiation Research Nuclear Pharmacist (4), and the Health Physics Officer (5) to review all records and report findings in the memorandum format given in reference 1 above. 1) The Senior Radiologist was unable to locate any records of this type of research prior to 1980 in the Dept of Radiology files and all human-use research on file since 1980 has been considered by a Human Use Committee (See Encl 2 ) The Radiation Oncologist was unable to locate any files of this type of research prior to 1980 and all humanuse research since 1980 has been considered by a Human Use 3 ) The Nuclear Pharmacist, organic to the Nuclear Medicine Service, searched the files for both Nuclear Medicine and Pharmacy and was unable to locate any records of this type from prior to 1980 and all human-use research since 1980 has been considered by a Human Use Committee (See c 4 ) The Health Physics Officer reviewed all available files since the Health Physics Office was established separate form the Dept. of Preventative Medicine in 1970 and located minutes from Radiation Control Committee (RCC) Meetings where specific protocols were reviewed (See Encl 7). He found consideration of 15 specific protocols and these are indicated as RCC among those in the combined list of protocols in Encl 8. c. Action: Announcement of the official inquiry and description of assistance needed at the BAMC Administrative Staff Conference, 16 February, 1994. Personnel with any information were requested to contact the Project Officer. Results: As of 1 March 1994, no calls or contacts. Action: Placement of an official announcement in the Brooke Army Medical Center Bulletin beginning 15 Feb 1994, describing the investigation, and requesting contact with the project officer (see Encl 9, item 11). Results: A s of 1 March 1994, no calls or contacts.

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SUBJECT: Summary Report, Human Radiation Research d. Action: Review of records maintained by the Department of Clinical Investigation (DCI), BAMC, which was established in 1972. All research conducted, reviewed, or facilitated by DCI which involved humans since 1980 has been Review Board. DCI records reviewed included: 1) Department of Clinical Investigation Annual Research Progress Reports (1972-1979). 2) Human Use Committee (HUC)/Institutional Review 1) The DCI Annual Research Progress Reports from 1972 to 1979 contained annual reviews of 24 protocols involving this type of research. See the combined list of all protocols found in Encl 8, where these particular protocols are indicated with DCI Annual Review after the title. 2) The HUC/IRB minutes contained comments indicating committee consideration of 17 protocols, all of which corresponded with a protocol review found in the DCI Annual Research Progress Reports. e. Action: The project officer compiled all such protocols into a typed list totalling 33 protocols (See Encl 8). The Project Officer also tasked the Radiation Oncologist and the Nuclear Pharmacist to review all appropriate protocols for Safety and Effectiveness, render a status, and provide a memorandum describing the appropriateness of their 1) The Radiation Oncologist reviewed the 12 externalsource protocols and found 3 to be presumably safe and effective radiotherapy and were designated RT. Insufficient data was available on the remaining 9 protocols to make the determination (see Encls 8 and 10). 2) The Nuclear Pharmacist reviewed the 21 radiopharmaceutical protocols and found 13 of the 21 to be FDA-licensed safe and effective and were designated SE (see f. Action: The Project Officer prepared separate data sheets on those protocols not designated as SE or RT. A

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SUBJECT: Summary Report, Human Radiation Research photocopy of either the DCI Annual Review or the Radiation Control Committee Minutes in which the protocol was found is attached to each data sheet. Result: See Enclosures 12-1 through 12-16. is MAJ Yeager, 210-916-9511. The Project Officer and the point of contact for this action Chief, Dept. of Clinical