Department of Health and Human Services Search for Records of Human Radiation Experiments Summary ORGANIZATION AND STRATEGY The Department of Health and Human Services (DHHS) is actively participating with the other Agencies of government in the search to. discover all instances in which human subjects have been experimentally exposed to ionizing radiation. The identification of all relevant documents and their public dissemination has been given high priority. On January 27, 1994, Secretary Shalala instructed all components of the Department of Health and Human Services to identify all records related to experimental human exposure to ionizing radiation conducted between 1944 and 1974. Because most experimental medical procedures are either conducted or funded by the Public Health Service (PHS), PHS established a working group to coordinate the DHHS records retrieval effort. This working group is co-chaired by Dr. D.A. Henderson, Deputy Assistant Secretary for Health Science, and Dr. Wendy Baldwin, Deputy Director for Extramural Research, National Institutes of Health (NIH). The group includes representatives from the NIH, the Centers for Disease Control and Prevention, the Indian Health Service, and the Food and Drug Administration. The working group is responsible for providing ongoing guidance and oversight for the search activities to assure the quality, comprehensiveness, and integrity of the records collection process. The working group is pursuing several strategies to identify relevant records, including: 1) All records of all PHS agencies are being carefully and systematically scrutinized for relevant information. 2) Past and present PHS employees are being interviewed for their recollections of this type of experimentation. 3) National Library of Medicine staff are searching the medical and scientific literature for articles involving the experimental use of ionizing radiation on humans. 4) PHS staff are contacting people who have either written the government or called the toll-free hotline with information related to possible PHS funded studies. RECORDS SEARCH When DHHS records are retired to the Federal Records Center or the National Archives, a subject index for each set of records is created. These indices are known as Records Transmittal and Receipt Forms (SF 135). Virtually all of these forms have now been examined for the appearance of certain key words which would suggest that the files have some information pertaining to ionizing radiation. This search generated a list representing more than 1,000 cubic feet of possibly relevant records. The list is now being screened to identify which boxes of records should be searched individually. In addition to the systematic review of SF 135 forms, each of the principal PHS agencies has established its own search strategy tailored to the types of research activities and records maintained by each agency. For those experiments conducted by PHS employees, the records that exist are likely to be found within agency files. One important center for experimental studies in medicine is the NIH clinical center. It has been ascertained that all the medical records of all experimental subjects ever seen at the NIH clinical center are on file. NIH is currently reviewing protocols of experiments conducted at the clinical center. When specific studies are identified, the medical files will be available. However, most of the research supported by the PHS is conducted by research institutions located throughout the United States. Thus, most records of special interest-- research protocols, documents related to informed consent, and identities of research subjects-- will be located at awardee institutions. On March 7, 1994, HHS sent a letter to 27,000 research institutions asking that they take special measures to ensure that all records related to human exposure to ionizing radiation are conserved. Several approaches are now being followed to identify specific instances in which PHS has funded relevant experimental human studies. The search for such studies is proving more difficult than had been expected. Available information about grants prior to the early 1960s consists solely of the study title, investigator's name and institution, and the amount of the award. For most grants, the very brief titles provide little information regarding the nature of the experimental work. Additional approaches are now being explored utilizing information from literature searches as well as special reviews of information pertaining to scientific groups identified with other studies. GUIDANCE NEEDED FROM THE ADVISORY COMMITTEE DHHS would value the guidance of the Advisory Committee on a number of points including the priorities for search and the nature and extent of materials desired. For example, might the search efforts be selectively directed to identify experiments having particular characteristics of greatest interest or concern to the committee. The committee could likewise provide useful on- going guidance with respect to the definition of experiments which are intended to by captured in the review. There are a variety of experimental and quasi-experimental projects which have proven difficult to know how to define, i.e. whether they represent forms of routing diagnostic or therapeutic modalities or whether they should be classified as experiments.