DEPARTMENT OF VETERANS AFFAIRS Radiation Research in the Department of Veterans Affairs Issue: This briefing paper describes actions taken by the Department of Veterans Affairs (VA) in response to reports that government-sponsored research involving radioactive materials many years ago may have been conducted in an inappropriate manner. Discussion: Immediately following the publication of reports that questioned the conduct of radiation research involving human subjects sponsored by federal government agencies in the 40's and 50's, Secretary of Veterans Affairs Jesse Brown pledged a full review and disclosure of all such VA research. On January 6, 1994, he sent a message to all VA medical center directors to conduct an energetic and accurate review of all records relating to radiation research. As a part of the process, VA officials in the Central Office reviewed the Administrator's Annual Reports as well as the annual reports of Medical Research in the Veterans Administration for information on specific radiation research. The only information obtained from these sources related to radioisotope research which began with the Chief Medical Director's establishment in 1947 of a committee to advise him on matters of atomic medicine. That committee recommended that a radioisotope division be set up to support the broader atomic medicine program. The radioisotope program, later known as Nuclear Medicine, was very active both clinically and in research. During the early years, VA was recognized as a leader in nuclear medicine. One of the VA pioneers in Nuclear Medicine, Dr. Rosalyn Yalow, was awarded a Nobel Prize for her work at the Bronx VA Medicine Center. The first radioisotope laboratory was established in 1948 and at one time ten percent of all VA research was related to radioisotopes. The annual research reports from those years contain brief summaries of the activities at each of the involved medical centers. These summaries describe studies directed to thyroid function, diseases of the thyroid gland, metabolism, cardiac function, peripheral vascular disease, blood volume determinations, hemodynamics of the cardiovascular system, diagnosis and localization of brain tumors, and treatments for leukemia and cancer. Because the review of centrally held records revealed little specific information, a search for nuclear medicine research records at all facilities was ordered. This search recently has been extended to include radiotherapy research although there is little evidence of significant research activity in this area. Additionally medical centers have been asked to query their affiliated academic institutions for any information of research done by non-VA investigators but involving VA patients as subjects. The search of nuclear medicine research revealed that of the 137 VA facilities having nuclear medicine capability: 49 have located some protocols used during that period for radioisotope research, 24 have names of patients who participated in at least some research projects, and 54 have some publications available on specific research projects done during that period. No VAMCs found any evidence of research involving Plutonium and none had contracted out any research. A directive was issued to all VA facilities to preserve all existing records page 2. Radiation Research in the Department of Veterans Affairs of research involving human subjects. A review of records disposal requirements has also been done and revealed that a variety of retention rules apply to the files which might have relevance to radiation research and that these rules have changed over time. The majority now require a retention period of ten years so that many records relating to the 1940s, 50s, and even the 60s may have been destroyed already. Individuals' medical records files are maintained for a total of 75 years following the last episode of care. During most of that time the records will be held at the Federal Records Center. Research Projects Files which contain records of research projects including results, worksheets, questionnaires, progress reports, etc., are maintained for five years after completion of the project and preparation of the final report. A copy of the final report is then supposed to be maintained to document research activities. However, this policy was not instituted until 1960 and not incorporated into a manual until 1970. Therefore, it is possible that records from the 1940s and 50s were not retained. The process of inventorying the existing records is beginning in April using a prototype form developed by DOD in preparation for making them available to the Advisory Committee on Human Radiation Experiments. A rigorous "chain of custody" is being established. In addition to the searches going on, the Nuclear Medicine Services is investigating the licenses issued for radionuclides by the Atomic Energy Commission (ABC), now the Nuclear Regulatory Commission (NPC), for cross referencing with research information. The Office of Research and Development has reviewed protection of human subjects in VA research and reinforced the vigorous enforcement of policies and procedures in place to assure that all VA patients who participate in research are fully informed, consenting subjects. In the early days of VA research, nuclear medicine research studies were reviewed locally by the Radioisotope Committee which included individuals from outside VA. The committees also had access to radiation experts of international stature who served as consultants to the Central Advisory Committee on Radioisotopes. Research projects were not reviewed at the Central Office until the 1960s. A separate review by a human subjects subcommittee did not become a practice until about 1962. In order to be responsive to the public's need to know and the concerns of individual veterans, guidance has been issued to enable field facilities to respond to Freedom of Information requests in timely manner and procedures to respond to both the DOE Hotline, the VA Radiation Helpline, and similar inquiries are being developed. As of April 11, 1994, the Department of Energy had forwarded some 800 inquiries from their toll free hotline. Of these, approximately 650 related to exposure to ionizing radiation during military service and 150 related to possible research, diagnosis, or treatment involving ionizing radiation at a VA medical facility. Since mid-January 1994, VA Regional offices have taken 8,117 calls from individuals concerned about radiation exposure while on active duty or at a VA medical center. Approximately 800 callers were concerned about possible radiation exposures at a VA facility. VA is reviewing these cases and will contact each individual. Inquiries related to radiation exposure during military service will be referred to the Department of Defense and/or will behandled by VA. Veterans claiming exposure to ionizing radiation in the military from the detonation of a nuclear device in connection with nuclear tests or with the American occupation of Hiroshima and Nagasaki, Japan,between September 11, 1945 and July 1, 1946 are provided with free comprehensive health examinations, including base-line laboratory tests and other tests determined necessary by the examining physician to evaluate current health status. This is a part of the Ionizing Radiation Registry program. Priority health care services are also available at VA facilities to these veterans. Assistance in filing claims for service-connected disability compensation is available at VA Medical Centers and Regional Offices.