Tab H Staff Memo--Methodological Review of Agency Data Collection Efforts: Department of Health and Human Services 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. Preliminary Report to the Advisory Committee on Human Radiation Experiments The Department of Health and Human Services Dated for Distribution May 13, 1994 This preliminary report includes the following: (1) the sources of information on which this report is based; (2) a synopsis of the report; (3) a brief organizational history of the Department of Health and Human Services (HHS); (4) a description of the status of the HHS search; (5) a description of agency concerns; (6) staff analysis of the HHS search; and (7) staff recommendations for future action. I. Informational Sources HHS representatives briefed committee staff on the status of the HHS document search and retrieval in a meeting on April 29, 1994 1{1 Advisory Committee staff designate (Dan Guttman, Faith Bulger, Jim David, Ron Neumann, and Gil Whittemore) met with Dr. Wendy Baldwin, Dr. Gary Ellis, and Dr. Kathy Hudson of HHS on April 29, 1994.} and several subsequent telephone conversations. HHS provided informational documents on its search effort at the April 29 meeting and in subsequent contacts. This preliminary report is based on the documentation and descriptions by HHS representatives of HHS search efforts as of May 9,1994. The committee staff has not verified or audited whether the work reported by HHS was actually completed. II. Synopsis The information contained in this preliminary report is based on the staff's best understanding of the HHS search at this time and is subject to elaboration and revision. (A) Extent of Interagency Coordination and Co-funding of Human Radiation Experiments It is likely that many human radiation experiments or investigators identified by HHS had multiple federal agency sponsors. In 1979, PHS conducted an agency-wide document retrieval process for all of its documents related to its efforts to monitor the health effects of the nuclear weapons testing program. As a result of this search, high level documents were located that appear to demonstrate formal coordination between the AEC and the PHS. (See Attachment C). 1 HHS has not systematically coordinated its search with other agencies. For example, HHS could cross reference its records with the AEC records. Attachment A contains sample pages from AEC's radioisotope license information and the semi-annual and annual reports of the AEC. In addition, the Advisory Committee staff located archived boxes containing PHS documents from the 1950s in the Office of the Secretary of Defense files in the National Archives. Attachment B contains an example of a letter reviewing a PHS grant application that was found also in the Office of the Secretary of Defense files in the National Archives. (B) Classification HHS recently discovered that it has classified documents within its control and a declassification officer. We have requested a report on the status of HHS classified documents. HHS acknowledges that Division of Radiological Health employees conducted classified research for the AEC. (C) Constraints on HHS Search HHS believes that there may be additional information on experiments or researchers supported by the NIH extramural program at the grantee institutions. NIH believes that it possesses only a brief description of extramural awards for the 1946-1961 period and that the most fruitful sources of information for extramural awards are located either in (l) the proprietary records of grantee research institutions or (2) published medical or scientific literature. Record retrieval from grantee or contractor institutions raises logistical, economic and possibly legal issues. (D) Limitations of HHS Current Search The search efforts at NIH particularly, but HHS generally, to date have focused primarily on locating documents related to actual experiments, not headquarters or central office files. From our information, it appears that FDA attempted to reconstruct relevant predecessor offices and trace records for these offices. It is unclear, from our information, to what extent PHS files of key headquarter offices were searched for information related to human radiation experiments. For example, it is unclear whether HHS has checked the Surgeon General's office files. HHS' search did not include documents like the ongoing CDC study of the health effects of the Green Run test HHS takes the position, as it did in the initial Committee meeting, that "follow up" epidemiological studies are not human radiation experiments within the purview of the Committee charter. HHS explained that including these types of "follow up" studiews in the document 2 search will increase the volume of documents exponentially. NIH has devoted about 2,509 person hours to the search effort; when provided, the person hours expended on the other PHS agencies' searched are noted in the report. (E) Results to Date Thus far, FDA has identified 13 human radiation experiments from its search of the Bureau of Radiological Health files; NIH has identified 200 relevant intramural experiments to date from its internal review of the NIH Clinical Center Medical Board minutes and the Radiation Safety Committee minutes. NIH is currently in the process of compiling a composite list of intramural human radiation experiments. NIH has not yet been able to create a lisp of human radiation experiments sponsored or funded through its extramural awards, because of a lack of available information and lack of control over the records at grantee institutions. III. Brief Organization History The Department of Health and Human Services (HHS) is the principal federal agency charged with advancing the health of Americans and providing essential human services. The existence of a Department-level organization began with the creation of the Federal Security Agency (FSA) in 1939. Its successor, the Department of Health, Education, and Welfare (DHEW), was established in 1953. The contemporary structure of the Department dates to 1930. when HEW was reorganized and renamed the Department of Health and Human Services. The United States Public Health Service (PHS) is one of five components of HHS. PHS is the primary health agency of the federal government. It is administered by the Assistant Secretary for Health, who reports to the Secretary of the DHHS. The Surgeon General serves as an advisor to the Assistant Secretary and to the general public. The Surgeon General is delegated administrative responsibilities that include oversight of PHS's Commissioned Corps, a uniformed service of health professionals that comprises about 15% of PHS's workforce. In addition to an Office of the Assistant Secretary for Health (OASH), PHS consists of eight agencies: the Agency for Health Care Policy and Research (AHCPR), the Agency for Toxic Substance and Disease Registry (ATSDR), the Centers for Disease Control and Prevention (CDC & P), the Food and Drug Administration (FDA), the Health Resources and Services Administration (HRSA), the Indian Health Service (IHS), the National Institutes of Health (NIH); and the Substance Abuse and Mental Health Services Administration (SAMHSA). Attachment D is a recent organizational chart for PHS. In this report a general overview will be given for PHS as a whole, followed by brief sketches to describe PHS's hospital system, NIH, FDA, CDC and IHS. PHS began as the Marine Hospital Service, created by an Act of Congress in 1789, to provide care to merchant seamen. It was operated under the auspices of the Treasury Department. 3 The Service was reorganized in 1870, and the first Supervisory Surgeon (later called the Surgeon General) was appointed the following year. In 1912 the agency was given its current name, to reflect a growing number and variety of duties. Beyond the traditional role of service to federal beneficiaries, activities included research at the Hygienic Laboratory (the predecessor of NIH), field studies, quarantine, and the inspection of immigrants. At the time of PHS's transfer to the new Federal Security Administration in 1939, PHS consisted of 12 separate Divisions, each organized by type of activity; Division heads reported directly to the Surgeon General.2 {2 With the advent of World War II, the FSA also housed the Office of Health, Welfare, and Related Defense Activities from 1940-1941, the Office of Defense, Health and Welfare Services from 1941-1943, and the Office of Community War Services from 1943-1947.} Since World War II, there have been three major reorganizations of the PHS. The first occurred in 1943 and 1944, when the PHS's Divisions were gathered into four "Bureau" units: the Office of the Surgeon General (OSG), the National Institutes of Health (NIH), a new Bureau of Medical Services (BMS), and a new Bureau of State Services (BSS). The second change took place between 1966 and 1968. A series of reorganizations resulted in the transfer of the Surgeon General's line authority to HEW's Assistant Secretary for Health and Scientific Affairs (1968) and splitting of the agency briefly into five components (1966-67) and then into three (1968) including FDA, NIH, and the Health Services and Mental Health Administration (HSMHA). The third major reorganization occurred in 1973 and strengthened the Assistant Secretary's role, among other things. CDC was given agency status in 1973. IHS was elevated to agency status in 1988. PHS's first responsibility, one carried out until the early 1980s, was the delivery of health care to merchant seamen and other federal beneficiaries, through a network of hospitals and outpatient clinics. Until 1943, PHS's Division of Marine Hospitals and Relief administered the network of facilities. At that time, the new Bureau of Medical Services assumed the old Division's functions and retained them, save for a brief period (1966-67) in which duties were split between a new Federal Health Programs Service and a short-lived Bureau of Health Services. In 1981, the last of the PHS hospitals and clinics were closed. The National Institutes of Health began as the Laboratory of Hygiene in 1887 and was renamed the National Institute of Health in 1930. Within NIH, a number of Divisions continued and expanded the Hygienic Laboratory's program of in-house, or intramural, research. NIH activities encompassed a variety of disciplines such as industrial hygiene, physiology, and field studies of public health methods.3 {3 During the late 1930s and early 19405, NIH had a Division of Industrial Hygiene to develop research and training programs for industrial hygiene, but which during World War II began to provide direct occupational medical and industrial hygiene services to the Army and state programs. While it is not known whether this Division conducted or sponsored radiation research, it was involved with air and water pollution monitoring and uranium mining studies.} The National Cancer Institute was created in 1937 and was authorized to award research grants.4 {4 By 1946, the National Cancer Institute was conducting research for the Manhattan Engineering District.} Beginning in the 1940s, NIH greatly expanded 4 its progrsms of intramural research, opening several Institutes organized by type of disease and a Clinical Canter in 1953 for patient-oriented research. In addition, a program of research grants-in-aid to nongovernmental institutions -- the extramural program -- was established in 1946, with the assumption of a grants program from wartime federal authorities. The Food and Drug Administration (FDA) was established in 1927 as the Food, Drug, and Insecticide Administration within the Department of Agriculture to enforce the Federal Food and Drug Act of 1906. The FDA remained within Agriculture until its transfer to the new FSA in 1940 and to the new HEW in 1953. In 1968 FSA became a constituent agency within PHS. The Centers for Disease Control and Prevention (CDC) began as the Malaria Control in War Program in 1942. CDC is charged with protecting the public health from the spread of diseases and responding to public health emergencies, including radiation emergencies.5 {5 A few of the CDC,s operating components are the Epidemiology Program, the International Health Program, the Center for Prevention Services, the Center for Environmental Health and Injury Control, the National Institute for Occupational Safety and Health (NIOSH), and the National Cater for Health Statistics, among others.} The Agency for Toxic Substance and Disease Registry (ATSDR) was established in 1983 to assume the health related responsibilities of several federal environmental laws relating to the control of toxic or hazardous substances. The Indian Health Service (IHS) has its origins in health care programs that had been operated by the Department of the Interior since 1849. Through the loan of Commissioned Corps officers, PHS has been involved in the care of American Indians since the 1920's. In 1955 all Indian health programs and responsibilities were transferred to a new PHS Division of Indian Health, located within the Bureau of Medical Services. In 1988 IHS achieved full agency status. IV. Description of the Search (A) HHS-wide Search (1) Guidelines On January 27, 1994, Secretary Shalala instructed all components of the Department of Health and Human Services (HHS) to identify all records related to experimental human exposure to ionizing radiation conducted between 1944 and 1974. An executive committee for HHS was established in January which included the Deputy Assistant Secretary for Health-Science, General Counsel, Assistant Secretary for Legislation, Assistant Secretary for Public Affairs, and Chief of Staff. This committee served to coordinate HHS-wide activities. The Committee met weekly during the first six weeks and then every two to three weeks thereafter. 5 (2) Search Organization Because most experimental medical research is either conducted or funded by the Public Health Service (PHS), PHS established a working group to coordinate the HHS 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 Institute of Health (NIH). The group includes representatives from NIH, CDC, IHS, and FDA. The PHS 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. (3) Search Logic and HHS-wide Key Word Search When HHS 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). Each component of the Department was instructed to examine these forms for the appearance of certain key words which would suggest that the files have some information pertaining to ionizing radiation. Each agency within HHS was directed to work with the appropriate records management personnel to review every SF 135 generated by the agency between January 1, 1944 and May 30, 1974 to determine if it contains one or more of the following key words: radiation radiology radioisotopes radiological radionuclide radiotherapy radioactive x ray radiometry roentgen This search generated a list representing more than 1,000 cubic feet of possibly relevant records. Most of the records identified by this search belong to NIH, although FDA and CDC also identified SF 135s containing the key words. Boxes of records identified by this search are now being 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. 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 request that all records elated to human exposure to ionizing radiation are located and preserved. 6 (4) Document Retention or Destruction Policies and Practices On January 27, 1994, Secretary Shalala directed all of the HHS agencies not to destroy any records relating to human radiation experiments even under regular approved destruction schedules. Dr. Henderson, the Deputy Assistant Secretary for Health and Science, and Dr. Baldwin, the Deputy Director for Extramural Research, jointly requested HHS grantee institutions likewise to locate and retain any documents in their possession relating to human radiation experiments. Further investigation is necessary into the HHS current document retention and destruction policy and records management policies. Committee staff plans to meet with PHS records management personnel to develop a better understanding of the records management practices at HHS and the HHS search process. It may not be possible to determine what the current or past practices are at the individual agencies within HHS and their predecessors, what the document retention and destruction policies are at the grantee institutions, or what level of compliance with the HHS directive can be expected from grantee institutions. (B) Individual Agency Search Logic: NIH NIH formed the NIH Human Radiation Studies Task Force. The Task Force is comprised of 25 people representing various divisions at NIH and spearheads the NIH document search effort. The Task Force has met weekly since January 27, 1994. Its present search strategies include: 1. identification of the records of NIH extramural awards; 2. identification of the records of intramural research conducted at the NIH; 3. oral interviews of selected senior NIH staff; 4. pilot program review of literature related to extramural awards; 5. review of stored NIH records by searching for 11 key words on the agency's record disposition form; 6. evaluation of calls referred to NIH from the Department of Energy 1-800 helpline; and 7. response to media and congressional interests in "flagship incidents." Since January 1994, NIH has devoted approximately 4-5 persons per day to these strategies, approximately 2,500 person hours. A brief elaboration on each strategy follows: (1) Identification of the records of NIH extramural awards The NIH Division of Research Grants (DRG) is responsible for managing records related to the extramural program. DRG has nominal records for the period from 1946-1961. DRG files are available only in paper copy for the years 1946 to 1961. Attachment E is a sample page from DRG's grant records for the 1946-1961 period. The information for 1946-1961 available from 7 DRG records includes: (a) a list of projects funded after review by the study section and the members of the section; 6{6 However, this information is not available for most years in the 1946-1961 period.} (b) the name of the principal investigator; (c) the name of the investigator's institution; (d) the title of the proposal; and (e) the years funded. From 1962 to the present, DRG information has been computerized. At some point, the DRG records contain more information about the research. Since grant titles in these records can be general, reviewing titles alone is unlikely to be helpful in identifying human subjects and relevant experiments. NIH staff currently are considering several ways of using this limited information in this search. Presently, the NIH titles are being hand searched for the period from 1946-1961 and searched by computer from 1962 1974 for matches with "rad" or any of 39 terms, as follows: calcium isotopes radioactivity calcium-45 radiology calcium-t7 radium carbon isotopes radiotherapy chromium-51 strontium cobalt-60 thorium krypton-85 thorotrast iodine isotopes radiopharmacology iodine-125 radiological implant iodine-131 radiological health iodine-132 barium irradiate fluorine leukemia induced radiation tritium plutonium potassium radiation sodium radiation effects zinc radiation injury NIH believes that limiting the records search by using an institution name, investigator name, or a focused literature search may be more helpful and a reasonable use of time and resources. NIH notes that reliable documentation in the award information on 8 whether human subjects were involved may not exist in many cases for the period 1946-1971. 7 {7 ln some situations, where the grant record information does not show whether human subjects are involved, even a subsequent literature search may also not provide this information.} NIH representatives and Committee staff discussed the logic of a search directed at records maintained by organizational components. Identification of the relevant institutional offices and procedures at NIH and its predecessors, if any, is the first step. When an application for a grant comes to NIH, it is assigned to a study section, which is the peer review group that makes the initial evaluation. Since the 1940s, NIH has had a Radiation (Radiobiology) Study Section. A computer search found 400 awards that had been reviewed by this Section in 1962, the first year of computer data. A hand search uncovered 15 awards reviewed by the Radiation Study Section in 1946. Thus, it appears that from 1946 to 1961, the Radiation Study Section reviewed between 15 and 400 grants that were awarded per year. However, NIH is not aware of any records of the criteria used to determine which proposals were sent to which study sections. Thus it is possible that other study sections (e.g., Physiology) may also have reviewed human radiation experiment grant proposals. In fact, documentation exists demonstrating that requests for funding involving human radiation experiments did go through the NIH/FSA Physiology Review Section in 1950. (See Attachment B) Study Section sessions are conducted as closed meetings. Today, there are no minutes of Study Section meetings, but summary statements of peer review recommendations are recorded for each grant. Any past records are believed to have been destroyed, according to NIH. However, Committee staff have found documents related to NIH/FSA grant application review in the archived records of other agencies. Attachment B includes a negative evaluation by a reviewer returned to the Physiology Section on a 1950 proposal to use Iodine 131 tracers on children. After review by a study section, a grant proposal would have been reviewed by one of the Advisory Councils for the different Institutes at NIH. The Advisory Councils are comprised of scientists, laypersons, and other federal officials (serving in an ex officio capacity). According to NIH, Advisory Councils generally meet three times a year in open session; the minutes are archived. However, this may not have always been the case. They also meet in closed sessions when discussing individual grant applications. The documentation of any review of a grant proposal by an Advisory Council is believed by NIH to have probably been destroyed or lost. According to NIH, the Advisory Council minutes have not yet been located. The time period in question is beyond the normal record destruction period. Other documentation of the NIH peer review process or other types of documents may be in the files of individuals who participated in the reviews.8 {8 NIH stated that interagency radiation health groups apparently have been established periodically. The HHS representative to the 1970 Interagency Radiation Health Group has files on these meetings.} As part of its search, the NIH Task Force mailed two sets of 9 letters to the directors of the 20 Institutes and Centers at NIH requesting them to search their files for protocols of intramural human radiation experiments. HHS states that the vast majority of the records of the NIH extramural grant program are most likely housed at grantee institutions. On March 7, 1994, HHS informed 27,000 grantee institutions by letter to locate and preserve relevant records. HHS has not yet directed any grantee institution except the University of Cincinnati to collect or retrieve records. HHS has some authority to audit these institutions under its grant management authority, which may possibly allow NIH to request and retrieve documents from institutions that received an NIH grant. (2) Identification of the records of intramural research conducted at NIH The NIH intramural research program conducts protocols (experiments) at the Clinical Center, which has been in existence from 1953 to the present, and several off-site hospitals including St. Elizabeth's Hospital in Washington and Francis Scott Key Medical Center in Baltimore. The Medical Record Department possesses records for the 245,000 patients admitted to the Clinical Center since it opened in 1953. Much of NIH's clinical work is experimental in nature, and much deals with radioactive substances. Inactive records are housed on microfiche off-site at the National Underground Storage (Boyers, PA). Inactive medical records from the NIH Clinical Center are estimated at between 500 million and 1 billion pages of material. NIH therefore believes that it cannot search feasibly for all relevant documents related to human radiation experiments without further refinement of the experiments most relevant to the Committee's work, either by experiment type, particular patients, or certain years or investigators. NIH staff reviewed the Medical Board minutes 9 {9 The Medical Board reviewed "controverted protocols."} and the Radiation Safety Committee minutes from the Clinical Center. NIH plans to review the Clinical Research Committee minutes. NIH staff is compiling a list of human radiation experiments at NIH intramural program and the protocols, titles, and investigators from these minutes. NIH staff currently have identified approximately 200 experiments conducted at the Clinical Center that either deviated from standard procedure or involved healthy volunteers. NIH believes that the medical records for these patients and healthy volunteers are in its possession. (3) Oral interviews of selected senior NIH staff Seven current NIH employees who were authorized radiation users and members of the Radiation Safety Committee from 19Th 1974 were interviewed. Five specific questions were asked: * Which investigators were conducting human radiation experiments prior to 1955? * Where were the experiments conducted? 10 * How did NIH handle its oversight responsibility for protocols involving ionizing radiation? * Where can we find the records of theme protocols? * What was the nature of the research? These interviews led to the discovery of one previously unidentified investigator at NIH that was added to the list that NIH is currently compiling relative to human radiation experiments. (4) Pilot program review of literature related to extramural grants NIH is not aware of any programs at NIH related to human radiation research that were not public or any research that NIH funded or sponsored through its extramural program that was not published in the scientific or medical literature if it qualified for publication. As a pilot program to determine the value, effectiveness, and cost of a published literature search, NIH employed two medical librarians to track the published literature related to the 16 grants that the Radiation Study Section reviewed in 1946. Each librarian was asked to pull all of the relevant published articles for 8 of the 16 investigators. After reviewing approximately 300- 400 articles each, 10 {10 It costs $3.00 to pull one article; there were 600-800 articles relating to the 16 grants.} less than 100 articles relating to human research remained.11 {11 In some cases, the literature did not even note whether human subjects were involved.} Even in early years, one award could spawn a large number of articles. The abstracting of the 100 remaining articles involved the greatest effort. 12{12 As discussed later, it may be possible to cross check against AEC records to reduce the number of articles that need to be abstracted.} (5) Review of stored NIH records by searching for 10 key words on the SF 135 The SF 135 key word search located 1,200 boxes of NIH records at the Federal records center in Suitland, Maryland. The NIH Task Force plans to search these boxes. However, as of May 3, the SF 135 search at NIH did not involve opening any stored boxes to determine the actual contents of any box. HHS plans to go only to the Federal records center in Suitland during this search. (6) Evaluation of calls referred to HHS by the Department of Energy 1-800 helpline HHS has had twenty calls referred to it by the DOE. NIH is coordinating the responses to these referrals. Sixteen callers provided what HHS considered "insufficient information to be linked to any identified DHHS activity." Four callers provided information that HHS believed could be pursued. In fact, three of these callers were patients at the NIH Clinical Center, and 11 therefore, their medical records are at NIH. NIH has been unable to contact the fourth caller because his phone is currently disconnected. For the other callers, HHS correspondence consisted of a form letter sent to each of the 16 callers stating that these callers cannot be linked to any identified HHS activity at this time. (7) Response to media and congressional interest in "flagship incidents" In response to intense media interest and Congressional hearings on Dr. Saenger's experiments at the University of Cincinnati and planned upcoming hearings on New Orleans Charity Hospital HHS has undertaken searches targeted at its activities related to these locales or experiments. HHS provided a statement related to the whole body irradiation experiments at the University of Cincinnati to the Subcommittee on Administrative Law and Governmental Relations of the House Judiciary Committee on April 14, 1994. NIH discovered that it had funded Dr. Saenger for various projects totalling a $1 million in support, instead of the $11,000 of which it previously had been aware. Dr. Saenger was receiving funding as a participant in training grants and a general clinical research center grant, as well as funding as a principal investigator. In addition, NIH funding is represented in more general support for research at Cincinnati. NIH funded eight hospital beds at the University of Cincinnati, one of which Dr. Saenger used for his research. HHS requested that the University of Cincinnati review its files for records reflecting any involvement or funding from HHS of Dr. Saenger's work. The University of Cincinnati has notified NIH that it did not uncover any documents related to particular NIH grants for the years in question. (C) Individual Agency Search Logic: FDA The FDA mapped out a strategy to determine whether the FDA or any of its predecessor agencies had any direct or indirect involvement with ionizing radiation tests on humans at any time from 1944 through May 1974. FDA interviewed past and present employees and conducted the SF 135 key word scan. The key word search was conducted on the records holdings at the National Archives and at the Federal records center in Suitland. FDA concluded (based on the word search, and the interviews) that the Center for Food Safety and Applied Nutrition did not give grants to support human radiation research and did not conduct any such research. The Office of Regulatory Affairs, which manages the FDA field offices, did not conduct any radiation research on humans during this period and never had a grant program. The Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research have both had some role in regulating radiopharmaceutical products but have not had "direct involvement in the human testing of (radiopharmaceutical) drugs and/or biological products" on humans. The word search revealed that the only FDA records reflecting the key words belonged to the Center for Devices and Radiological 12 Health (CDRH) and itspredecessors. FDA concluded that the CDRH, which is the successor organization to several radiological health organizations located within the PHS until their functions were transferred to the FDA in 1971, had documents reflecting an involvement in human radiation experiments. FDA identified and examined 20 separate access ions (shipments) from the CDRH to the Federal records center; an FDA scientist from the CDRH's Office of Health Physics and an agency historian reviewed these records at Suitland. The CDRH's Office of Health Physics conducted a search of the published literature, in house publications, and records of grants and contracts administered by the Bureau of Radiological Health. FDA notified HHS of 18 studies that clearly involved human radiation experiments from the Bureau of Radiological Health files. All of the FDA documentation will be available to the committee when requested. Ten of these 18 studies involved multiple agency sponsorship. In addition, FDA is aware of classified research being conducted under its predecessors auspices. Oral histories at the PHS Division of Radiological Health's Southwest Radiological Health Laboratory in Las Vegas revealed that about one-fifth of the lab's 1000 workers were involved in classified research for the Atomic Energy Commission. The AEC reimbursed the Division for this work. Division researchers were not privy to the results, and no Division records have been identified from this period. FDA has sent the March 7, 1994 HHS memorandum regarding preservation and retention of any experiment records to the 27 institutions involved in these 18 experiments. FDA is also working with archivists at the National Academy of Sciences (NAS) and the Center for the American History of Radiology to examine correspondence and other records donated by scientists or administrators who had worked for the federal government in the field of radiation.13 {13 The NAS Archives also contain record of the Biological Effects of Atomic Radiation (BEAR) Committee which met from 1955 to 1964. One subcommittee of the BEAR committee apparently had access to the AEC biomedical data to study the pathological effects of atomic radiation.} FDA is interested primarily in the records of scientists who worked for FDA and the Bureau of Radiological Health. No estimate of the number of person hours expended on this search strategy has been provided. (D) Individual Agency Search Logic: CDC CDC also has pursued several different strategies to locate human radiation records. These strategies are outlined below. (1) Using HHS' key word search, CDC reviewed SF 135s and SF 258s (which are apparently another records management form) maintained by CDC and the ATSDR for shipments of CDC and ATSDR records to the National Archives and to the Federal records centers. The SF 135/SF 258s represent CDC documents from 1953 to the present that were sent to the Federal records centers and those documents from 1960 to the present that were sent 13 to the National Archives. The word search identified 21 shipments from CDC to a Federal records center with references to radiation; nine of these inventoried shipments already have been destroyed under the Federal record center's approved destruction schedule. No ATSDR references to radiation were identified. Review effort: 40 person hours (2) CDC reviewed its files from 1943 to 1994 to determine if any radiation related activities were conducted by the CDC and its parent agencies. It also reviewed its organizational charts and mission statements. Until the National Center for Environmental Health (NCEH) was created in 1980, the organizational chats and mission statements did not contain any references to radiation. No estimate of the number of person hours expended on this search strategy has been provided. (3) ATSDR reviewed its files for radiation-related activities, including those of the former CDC Superfund Implementation Group. ATSDR reports that "No radiation related activities matching the White House definition were found while searching the Superfund Implementation Group files." No estimate of the number of person hours expended on this search strategy has been provided. (4) CDC and ATSDR working group has developed a plan to identify officials who should have knowledge of historic CDC activities. Staffing charts were reviewed back to 1951 to identify key officials of CDC components, such as, Directors and Deputy Directors of CDC. A roster has been created, including NIOSH officials, for the HHS to contact regarding their knowledge of radiation activities. These officials will be separated into two broad categories: those officials with knowledge of groups or individuals conducting radiation related work, and those with specific knowledge of that work. They will be questioned and their knowledge will be documented. This information will be used to focus CDC's search. Review effort: 32 person hours (5) CDC reviewed its AEC and Nuclear Regulatory Commission (NRC) licenses. The original license issued to CDC by AEC was dated 9/22/60. The license specifically prohibits CDC use of "byproduct material" "in or on human beings." The CDC Radiation Safety Officer (RSO) reviewed the radiation records in the Radiation Safety Office and did not find any exceptions permitting human radiation exposures. Review effort: 20 person hours (6) CDC searched its listing that begins in 1966 of all of the protocols submitted for review for the protection of human subjects. These protocols were reviewed by Ad Hoc Review committees until 1983, when Institutional Review Boards (IRBs) began these reviews. 14 CDC searched the entries through 1975; no protocols were identified including human radiation exposure. Review effort: 5 person hours (7) Because CDC did not have grant authority until 1980, the CDC used contracts as its funding mechanism. CDC maintained two handwritten logs for contracts in this time period. Each contract was entered in a single line entry with the date issued, RFP number, CDC program, award date, contract number, contractor, contract dollar amount, contract type, and a brief single sentence description. These logs were manually reviewed for radiation experimentation references. Six references were identified, and all were for either X ray film, X ray development equipment or X ray machines. The descriptions are "vague," but none specify "non-diagnostic use." CDC's approved Records Control Schedule results in the destruction of procurement records after seven years. According to CDC, no records exist before 1975 except the logs. Review effort: 2 person hours (8) Research projects by the CDC and the ATSDR CDC reports that it did not expose humans to radionuclides. However, CDC has conducted and is conducting several "follow up" studies for other government agencies and their contractors who did sponsor or conduct activities that exposed human beings to radiation. HHS takes the position that these CDC "follow up" studies and documentation from them do not fall within the definition of human radiation experiment as embodied in the Executive Order establishing the Committee. If these records are included in the documentation and search process, these "follow up" studies and their extensive supporting documentation will increase exponentially the number of CDC documents, according to HHS. CDC has documents from the following studies: (a) Hanford Environmental Dose Reconstruction Project These documents relate to "follow-up" on activities at Hanford that include the Green Run test, The contractor, Pacific Northwest Laboratories (PNL), estimates that there is one cubic feet of documents relating to Green Run that are either derivative reports or "sanitized versions of classified documents." PNL estimates that 3% of the Green Run documents remain classified. The original documents are the property of the Department of Defense. (b) Hanford Thyroid Disease Study CDC is studying the prevalence of thyroid disease in subjects exposed to Iodine 131 from the historic operations at Hanford. From 1989 to the present, over 750 people who were born in the Hanford area in the 1940s have agreed to participate in a pilot phase of the study. 15 (c) Idaho National Engineering Laboratory Dose Reconstruction CDC's contractor is conducting a dose reconstruction project at DOE's Idaho National Engineering Laboratory (INEL). CDC's contractor recently located documentation of intentional releases of environmental radiation at INEL and the intentional exposure of volunteer human test subjects that were not explicitly listed in the advisory committee charter. DOE has been formally notified of this discovery. The documents related to the releases are in DOE's or the National Oceanic and Atmospheric Administration's (NOAA) possession. (d) Mortality and Cancer Frequency Among Military Nuclear Test (SMOKY) Three thousand participants were exposed to radiation in a 1957 military nuclear test in Nevada. (e) Oregon prisoner follow-up CDC consulted with the State of Oregon's Department of Human Resources from 1989 to 1990 in the development of tracking and medical follow up protocol for the prisoner test subjects intentionally irradiated between 1963 and 1973 by a contractor for the AEC. HHS represents that the State of Oregon has the documents. (E) Individual Agency Search Logic: Indian Health Service The IHS has pursued several different but complementary strategies to locate records or information about radiation research involving American Indian and Alaskan Native (Al/AN) people. Many IHS strategies are similar to those by other PHS agencies and, indeed, were adapted from them. The IHS strategies, as reported by IHS, are discussed below: (1) Using the HHS-IHS keywords, IHS manually reviewed all IHS SF 135s for all environmental health records, and for any other category (not individual medical records) that might be related to radiation research. In its searches, IHS used the original HHS keywords plus "uranium" and "plutonium:" this augmented list is called the "HHS-IHS keywords." No records were found. IHS also asked its Record Officers and Medical Records Staff in all 12 administrative Areas for location of on-site stored records concerning research, environmental health, and any other categories possibly related to such work. No records were found. (2) Using the HHS-IHS keyword search, IHS manually reviewed every single file from the beginning of the Office of Research and Development (ORD) through December 1975. ORD was the IHS research unit that began near Tucson in 1969; it is now the Office for Health Program Research and Development (OHPRD). No files had been archived; all were available for review. There were no references to radiation experiments or 16 intentional releases of radiation. Six records contained one or more keywords. Three of the six records referred to epidemiological studies about exposure to low-level environmental radiation, not, exposure by experiment or by intentional release of radiation. The studies were: a radiation ecology study in northern Alaska from nuclear fallout; a study in Utah and neighboring states of long-term exposure to nuclear bomb test fallout; and a study of Navajo people exposed to radiation from uranium mine tailings.) The remaining 3 of the 6 records referred to diagnostic x-rays that were done for routine care and not as part of any experiment (The studies were: pulmonary disease among White Mountain Apache children; any losing spondylitis among the adults; and history compatibility antigens among Apache adults with diagnosed reactive arthritis.) (3) IHS located the logs of grants and contracts issued by IHS before June, 1974 irrespective of the apparent category. research or otherwise. Using the HHS-IHS keywords, IHS manually reviewed the titles and any description of each grant or contract in the logs. No title or description contained any keyword. (4) IHS asked the Medical Imaging Program Officer of each administrative Area to do a manual search of their records before June 1974. These records are primarily of the radiation exposures of staff doing x-rays; the concern was that there might be a reference to experiments involving medical imaging if any had been done in IHS facilities. The search is not complete; so far, no relevant records have been found. (5) IHS asked the administrative Area Officers of Environmental Health to do a manual search of their files, similar to that described in (4). The search is not complete, but so far, no relevant records have been found. (6) IHS asked the counterparts in Records Management in the Bureau of Indian Affairs (BIA), Department of Interior, to search its SF 135s and any relevant unarchived records, using the HHS-IHS keywords. The BIA was the predecessor to the IHS until 1955. The BIA search is not yet complete. (7) IHS asked the Native American Research Information System (NARIS), U. Oklahoma, to conduct a computer search of its records using the HHS-IHS keywords. NARIS has a computerized database of articles, reports of government grants and contracts, books, etc. concerning Al/AN. 14 {14 The NARIS database appears incomplete. It did not print out the famous article in the New England Journal of Medicine of a case-control study proving the high incidence of lung cancer among non-smoking Navajo uranium miners (Samet J. Key C, et al. Uranium mining and lung cancer in Navajo men. NEIM 198a; 310:1481-1484.)} Many of the entries are reports of the results of grants or contracts awarded by the federal or tribal governments and not available in other computer databases. Most of the almost 14,000 entries are not medical. The search could not be done in one pass using all keywords in a Boolean logic "key 1 or key 2 or key 3." 17 Because a separate search was done for each keyword, the results have duplicate entries. The title and abstracts of 104 total entries were printed out. No entries were directly relevant Most of the entries concerned environmental impact reports, diagnostic use of x-rays in articles about diseases, epidemiological monitoring studies of fallout or uranium mining, or policy assessments or proposals. (8) IRS interviewed people who would be likely to know about any such research in Indian country by IHS or anyone else. The initial list of people included the four living former Directors of the IRS (a fifth former Director had already died), and the four former directors of research in the IRS. No one remembered a single radiation experiment carried out by IRS or anyone else involving AI\AN people or intentional release of radiation on or near Indian reservations. (9) IRS asked the above mentioned interviewees to suggest names of others who might know if research had been done. The number of "secondary offspring" suggested by the people initially interviewed doubles the initial list. Most of the "secondary offspring" are "old hands" in environmental health. Those interviews are in progress, and so far no relevant information has been found. (10) IRS also asked the above mentioned interviewees to suggest other sources of information. One source suggested a report done by LaDonna Harris about 15 years ago documenting environmental health hazards, especially radiation. IHS is obtaining the report (11) In a research project in 1955 at the Arctic Aeromedical Laboratory, Ladd Air Force Base, Fairbanks Alaska, a U.S. Air Force researcher studying thyroid metabolism gave diagnostic doses of Iodine 131 to 102 healthy people, including 2 adolescents; Athapaskan Indians of interior Alaska (from the villages of Arctic Village and Ft. Yukoa); coastal Eskimos (Wainwright, Point Lay, and Point Hope), and inland Eskimos (Anaktuvuk Pass). This study made headlines in Alaska when revealed by Alaska Senator Frank Murkowski in April 1993. The dose used was up to 65 microcuries of I-131. (The current diagnostic test is 200 microcuries of I-123.) Although a higher number of microcuries is used for I-123, the amount of radiation effectively delivered by the 1955 Alaska diagnostic tests was ten times that used currently, due to the shorter half-life and weaker type of radiation of I 123. I-131 is the current iodine nucleotide to ablate the thyroid as a treatment of, for instance, thyroid cancer; the ablation dose is 30 millicuries, about .002 the dose used in the Alaska study. One of the IRS people pursuing the IRS strategies knew about this study from the previous news reports and obtained a copy of this research report The report lists the names, ages and home villages of each volunteer subject. There was no record or reference to informed consent. A copy of the report has been sent the PHS 18 Human Radiation Studies Working Group, and to the Chief Medical Officer of the IHS to determine possible follow up of the subjects of this experiment. In summary, IHS found no records or memory of any radiation experiments by IHS. IHS found one study by others; the Air Force gave diagnostic I-131 to healthy adults to study thyroid metabolism. Given the concerns of all of the former IHS Directors for the public health impact of radiation exposure on AI/AN communities, IHS does not believe that it is likely that other research has been done on Al/AN people. However, the Air Force study was not detected by the formal strategies pursued by IHS. Thus, IHS cannot say for sure that no other experiment had been done. IHS continues to pursue the remaining strategies mentioned above. No estimate of the number of person hours expended on these search strategies has been provided. (F) Individual Agency Search Logic: Public Health Service Hospitals Although the PHS hospitals have not been operating under the PHS since 1981, they have been identified by PHS as entities that once conducted or sponsored human radiation research. According to HHS, the PHS hospital records are located either in the Office of the Assistant Secretary for Health (if shipped off-site with the appropriate SF 135, they were subjected to the key word search) or in the regions in the Health Resources and Service Administration (also subjected to an SF 135 search if properly shipped). Patient records are kept at what used to be called the National Leprosarium and is today the Hansen's Disease Center in Carville, Louisiana. Records can only be retrieved by patient name according to HHS. Much more explanation is needed to develop the picture regarding records that may exist from these PHS hospitals, and any radiation research that they may have conducted or funded. No estimate of the number of person hours expended on this search strategy has been provided. (G) Individual Agency Search Logic: Other HHS Agencies HHS believes that its other agency components would not have been likely to conduct or sponsor human radiation experiments. For example, the Social Security Administration, the Health Care Financing Administration, the Family Support Administration, and the Office of Human Development Service were not likely to be involved in human radiation experiments. For these agencies, the HHS required an SF 135 search with the key word list. These agencies were to document the results of the key word search to the HHS. V. Agency Observations and Concerns HHS made a number of observations and expressed a number of concerns. The NIH raised three separate types of concerns: (1) agency record keeping (i.e., grant list) that cannot distinguish relevant experiments; (2) a potentially unmanageable number of documents related to 19 experiments known to have occurred intramurally (for example the medical records corresponding to the 200 experiments identified to date by NIH at the Clinical Center); and (3) the potentially large number of documents at grantee institutions. NIH believes that the bulk of existing documentation of human radiation experiments sponsored or funded by NIH is located at the grantee or awardee institutions for the extramural program. HHS requested further refinement of the definition of human radiation experiment in the Advisory Committee charter, or at least a prioritization or categorization scheme with which to better define, limit, or direct the search for potentially responsive records. HHS believes that the Executive mandate is extremely broad and requests that the Committee provide specific guidance or interpretation of the charge to HHS in order to clearly focus its search to assure that the Committee receives relevant and helpful documentation. HHS suggested some criteria that could be considered to set parameters on the search for relevant documents, for examples the level of exposure or dose, particular populations of subjects, types of experiments, certain investigators. or particular institutions. NIH's literature searches indicate that while exposure information may be available, informed consent information probably is not available from the published literature in the earlier periods. HHS raised the question of whether documentation of an experiment is of any practical use to the Committee if information about consent or whether subjects were humans or non-human animals is not available. HHS queried if experiments could be categorized or prioritized as high, medium, and low priority or whether a set of criteria could be developed to sort experiments into categories with different priority. NIH also has a concern that the definition of human radiation experiment excludes only "common and routine clinical practices" and "established diagnosis and treatment methods." All of the work done at the NIH Clinical Center is experimental in nature, and much of it involves radiation. The records for all of the 245,000 patients at the Clinical Center number between 500 million and one billion documents. NIH intramural program was able to identify 200 relevant human radiation experiments to date. While the medical records that correspond to this group of patients should be considerably less, NIH is not aware of any apparent way to link the protocol titles to medical records. NIH is willing to computerize the pre-1962 Radiation Study Section grants for cross referencing. NIH would enter these records into its existing database with the format that it uses for its other records. NIH was amenable to adopting a classification system similar to the DOD format, if useful to the Committee. NIH is also willing to focus on the grants that were reviewed by the Radiation Study Section in the pre-1962 period. NIH recognizes that no search strategy identified by NIH is expected to retrieve all items of potential interest. 20 VI. Committee Staff Analysis of the HHS Search (A) Limitations of Search Techniques HHS has set certain parameters for its search. No documents after 1974 were included in this search. HHS adopted its official federal policy for the protection of human subjects in research in 1974. However, post-1974 practices may be an issue for the Committee. The staff has not yet explored the types of information available or the strategies that might be pursued for retrieving relevant documents after 1974. Additionally, HHS excluded CDC records related to any epidemiological "follow up" studies because HHS believed that these studies were not within the purview of the Committee's Charter. The quality of the HHS search is constrained by record-keeping practices, due to the nature of the NIH extramural process, the different practices among various agencies and offices, and both major and minor reorganizations of PHS. HHS records management personnel believe that most of the relevant records would not be physically in the agency's possession but rather in storage or the archives. It is doubtful that HHS has adequate records, inventories, or finding aids for its own documents still in its possession, and large numbers of records could be in its possession. HHS acknowledges that the SF 135 search is a limited search tool with obvious flaws. SF 135 forms are only filled out when records are sent to storage, and SF 135 descriptions are too often cursory. Depending on the circumstances, the detail and quality of the description on the SF 135 can vary considerably. The key words used by HHS focused on scientific terms, not relevant agency offices. Any records that are currently in agency's files would not be located with an SF 135 search. An SF 135 search is insufficient for locating records in the National Archives. The SF 135 search is useful as a starting point to locate radiation experiments, but the search is not reliable for identifying the bulk of relevant records. (B) Better Quality Assurance HHS needs a strategy that will provide a higher level of assurance that the relevant files not yet archived have been identified, searched, and documented. The level of effort expended on the review of files could be increased and should be directed towards searching the central files of relevant offices. Some, but not all of HHS' search appears to have been well-documented. Some but not all of HHS' search was formal and structured and designed to produce confidence in the results. FDA's process for reviewing the Bureau of Radiological Health files appears to be a good example of a well designed and documented search. CDC's interview process also is a good example of a more comprehensive interview procedure. (C) Response to the Public HHS has responded to the public in two direct ways. First, HHS has responded by letter 21 to the twenty or so telephone queries that were referred to the, HHS from the DOE helpline. HHS, however, could supplement its follow up letter to the callers with a second letter requesting any written documentation that the callers have related to their exposure to radiation, and a written narrative explaining their knowledge of their exposure. This approach was helpful to the Department of Energy when it initiated the Helpline. Second, in response to public controversies, HHS has initiated one intensive search for records related to the University of Cincinnati experiments and is planning to search for documents related to the New Orleans Charity Hospital experiments. These searches are resource intensive, but have proven to be informative. For example, HHS learned that it had actually provided more funding than it realized, and in different ways. (D) Revised Approach to the Interview Strategy The scope of the interview process of the former and present employees who may have had experience or involvement with human radiation experiments could be expanded. Within NIH, for example, the scope of the current interview process, as of May 6, 1994, was limited to seven individuals who were each asked only five questions. An overall interview strategy could be designed that is integrated with the other strategies of the search. Points of particular interest should be identified for discussion, including co-funding relationships, classified projects, people who may have been involved in reviewing human radiation experiments, and the criteria for assigning grant applications to the Radiation Study Section as opposed to other study sections. Attachment B documents an application that was assigned to the Physiology Study Section. VII. Committee Staff Recommendations At this time, the tasks of quality assurance and historical research are not easily separable. Assuring the quality of HHS' search overlaps with refining its search efforts in ways most likely to be useful to the Committee. Once search strategies have been refined, the quality assurance task may become more distinct from the historical research itself. Options for historical research are not mutually exclusive (as may be the case later for options concerning ethical standards or compensation schemes), but may need to be prioritized due to limited time and resources. The options presented to the Committee options are organized by activities that would be carried out by (A) HHS as recommended by the Committee, (B) the Committee itself, or (C) the Committee staff as directed by the Committee. HHS supports Options Two, Three, and Four as valid approaches to focusing its search for relevant records. Option One, in the staff's opinion, is the most significant recommendation that the Committee can make regarding HHS in particular, and perhaps the Interagency Working Group in general. Option Five can be exercised to facilitate Option One. Option Six is also important for public outreach. Options Seven through Eleven also are recommended. 22 (A) Committee-requested Action by the Department of Health and Human Services (1) Option One: Revise search strategy to locate higher-level policies and evidence of the policies and practices of interagency coordination or co-funding HHS' search has indicated that many of the experimenters it funded were co-funded by other federal agencies. HHS' search reinforces the concept the multi-agency sponsorship research or researchers in fairly common. For example, during HHS' intensive search for records related to the University of Cincinnati, HHS found greater evidence of its own funding of Dr. Saenger than HHS previously realized. This result suggests that co-funding was not an anomaly for many of the relevant PHS agencies. The current HHS search process will not locate documents that explain the relationship between agencies that co-funded researcher or co-sponsored human radiation experiments. The Committee could request HHS to revise its search strategy to include a search for higher-level documents reflecting the policies and practices of interagency co-funding. The likelihood of the existence of relevant documents is suggested by several factors. For example, some documents that HHS has been unable to locate reflecting the PHS review process for grant funding were discovered in the DOD files in the National Archives by Committee staff. The presence of these documents in DOD files suggest closer coordination between HHS and other agencies than HHS may have realized. Also, PHS has previously located Memoranda of Understanding between AEC and PHS regarding studies of the health effects of offsite exposure to the fallout from the nuclear testing program (Attachment C) in a 1979 document search. Thus,PHS has conducted an agency-wide document search and uncovered evidence of important high level coordination between AEC and PHS. A similar search strategy might be reproduced for our present purposes. Additionally, HHS has found that its predecessor's own employees conducted classified research for the AEC. The policies and procedures that would have applied to these experiments probably cannot be obtained by the present search. Moreover, the HHS SF 135 search did not focus on high level policy or co-funding relationships. This option requires that HHS devise a search strategy for records of higher level policies for reviewing human experiments and co-funding or coordination between more than one federal agency. For example, one search strategy can focus on relevant HHS policy offices and offices engaged in interagency liaison. Similarly, interviews can be structured to elicit information on the interrelationships of co-funding agencies. HHS can draw on other agencies' records as well. Staff proposes that the Committee advise HHS develop a search strategy, in conjunction with the Committee and staff as appropriate, calculated to efficiently locate higher level policy documents evidencing coordination or multi-agency sponsorship. This option could produce documents about the formation and implementation (by expression or implication) of HHS policies applicable to the sponsorship or finding of human radiation 23 experiments or investigators; documents indicating whether these policies and practices were any different from those governing other types of human experimentation; documents demonstrating experiments which require special scrutiny; and documents leading to the discovery of relevant documents possessed by other agencies: (2) Option Two: Coordinate with DOE to create a search strategy for identifying extramural awards related to human experiments with radioisotopes HHS agrees that it could focus its search on the Radiation Study Section grants awarded before 1961 (which as noted earlier probably range from 15 to 400 a year). Staff recommend that HHS could focus further by using the AEC summaries of isotope distribution to eliminate plant and animal studies from the Radiation Study Section experiments and to provide additional information on isotopes use. AEC data may also identify journal articles based on certain experiments and additional co-funded projects by cross-checking with AEC annual reports and related reports. This option requires copies of AEC reports and minimal staff time. It produces additional information regarding investigators, location, and support. (3) Option Three: Prioritize document retrieval related to extramural records, for now, by focusing on non-isotope experiments HHS's review of the Radiation Study Section grants awarded before 1961 also can be focused by eliminating isotope experiments for now and retrieving records related to the non-isotope experiments. Staff recommends this option because HHS may be an important source of information on non-isotope experiments. This option requires a search strategy that identifies non-isotope experiments on human subjects; may require more costly literature search; and may involve a series of investigative strategies, including for example, research on citations used in the literature for whole or partial body irradiation experiments, interviews, secondary literature searches, and an examination of AEC or other relevant governmental reports. The option may also require selection of either particular experiments or development of selection criteria applicable to the data available. The selection criteria might, for example, include the principal investigator's name, title of the experiment, location, purpose of experiment, cooperation of investigator's institution, and a search at these institutions for records. This option could produce detailed experimental records, as in the Cincinnati case study. (4) Option Four: Limit search of Clinical Center documents In order to focus the HHS search of intramural records, the Committee could recommend that HHS exclude, for now, experiments whose use of ionizing radiation involves only medical procedures that can be considered routine, diagnostic, or therapeutic either by today's or contemporaneous standards. In the alternative, the Committee could recommend that HHS begin collecting records related to the 200 projects noted by the NIH staff The Committee could also consider requesting that HHS limit its document retrieval efforts to experiments that have been identified as having available consent forms. 24 This option requires the Committee to recommend selection criteria to be applied by HHS staff; skilled personnel to make evaluative selection judgments; and time to review the intramural records. This option produces faster retrieval of records that are potentially of greater interest to the Committee. This option can be exercised alone or in combination with options One, Two, or Three. (5) Option Five: Interview knowledgeable individuals with a particular purpose Interviews with former and current researchers and administrators could provide significant new leads, as already demonstrated by the interview strategies being implemented to date by HHS. The resources and usefulness of the interviews can be maximized if the interviews are conducted with an objective in mind, for example, with regard to understanding co-funding relationships, particular types of experiments, specific investigators, certain programs, or policies and practices that applied to those researchers who conducted secret or classified biomedical research in the relevant period, if any. This option produces recollections of commonly accepted research practices and policies at the time; relationships between the agencies; recollection of specific experiments; and voluntary provision of documents. Option Six: Written documentation from Helpline callers The Committee could recommend that HMS respond with a second follow up letter to the. Helpline callers requesting any documentation or written statements that the callers may have. This option requires minimal staff time and produces potentially useful contacts with former subjects; dates and locations of experiments; and an expanded list of potential interviewees. It can also assist HHS in determining if the callers have relevant information or were somehow associated with a radiation experiment. (B) Direct Committee Action Option Seven: Develop Criteria for HHS Experiments of Greatest Interest The Committee can develop criteria for selecting from the list of known HHS experiments those which arc of greatest interest to the Committee. This option requires Committee discussion based on case studies and summary lists to be provided by HHS, and agency allocation of appropriate staff to apply selection criteria It may produce documents of more immediate use to the Committee. It may also assist HHS in focusing its search. 25 (C) Committee Directed Staff Action (1) Option Eight: Continuing Oversight The Committee staff can continue contact with agency staff regarding agency response to Committee recommendations concerning revision of search strategy; prioritization of the existing search strategy; and collection of relevant documents related to staff tasks as designated by the Committee. (2) Option Nine: Information Exchange Between Agencies The Committee staff can be authorized to facilitate exchange of information among agencies (e.g., provision of DOE's Isotope Distribution Reports to HHS). The Committee staff can be authorized to coordinate search strategies among agencies (e.g., HHS focuses on non-isotope experiments while DOE focuses on isotope experiments). (3) Option Ten: Development of Selection Criteria The Committee staff can be authorized to develop possible criteria for selecting experiments of immediate interest to the Committee, based on Committee discussion at meeting on May 18-19, 1994; and further discussion with agency staff. (4) Option Eleven: Development of Database The Committee staff can be authorized to develop a uniform database for cataloging and indexing documents on specific experiments. 26