DISCLAIMER The following is a staff memorandum or other working document prepared for the members of the Advisory Committee on Human Radiation Experiments. It should not be construed as representing the final conclusions of fact or interpretation of the issues. All staff memoranda are subject to revision based on further information and analysis. For conclusions and recommendations of the Advisory Committee, readers are advised to consult the Final Report to be published in 1995. TAB I Staff Memorandum--Methodological Review of Agency Data Collection Efforts: Department of Veterans Affairs ******STAFF MEMORANDUM****** TO: Members of the Advisory Committee on Human Radiation Experiments FROM: Advisory Committee Staff DATE: June 7,1994 RE: Initial Report on the Department of Veterans Affairs Document Search This initial report includes: (1) background on the sources of information for this report; (2) a brief description of the history and organization of the Department of Veterans Affairs ("VA"); (3) a description of the status of the search now being performed within VA; (4) staff analysis of the VA search; and (5) staff recommendations for future action. Information contained in this initial report is based on staff's best understanding of the VA search at present, and is subject to expansion and revision. EXECUTIVE SUMMARY Records: VA records are maintained at VA medical centers throughout the country, at regional offices, at the Central Office, and at Federal Records Centers and National Archives. As discussed herein, the VA search to date has focused on identifying possible records at field locations, and has not fully assessed Central Office-related documents, including Central Office files available at Federal Records Centers or National Archives. Search Strategy: VA's search strategy has focused on surveys of medical centers, with limited review of Central Office- related documentation. Search Limits: At the field level, the search has been limited by the large number of field locations, the difficulty in identifying experiments and related records, and the difficulty in determining where to focus field efforts (e.g., research records, patient records). At the Central Office level, the search has been limited by difficulty in determining the nature and location of Central Office records. VA acknowledges that its efforts, both in determining additional field activities and in proceeding with Central Office activities, have been on hold pending Committee advice. Quality Controls: The January VA directive mandates the designation, at the field level, of a senior staff person, with no prior involvement in any radiation-related research, to oversee that station's location and retrieval effort In addition, the Central Office has done some review of medical centers' responses to check for inconsistencies with radioisotope licensing information. Search Opportunities: VA has located documentation that shows a 1947 decision, following a meeting with General Leslie Groves and military medical staff, to create a Central Advisory Committee on Radioisotopes, whose members included former members of the Manhattan Project's medical team. This Committee recommended that VA organize a confidential Atomic Medicine Division, and publicize only the Radioisotope Section to be created within that Division. The former was to explore problems related to potential atomic energy-related disability claims; the latter was to employ radioisotopes for research, diagnosis and treatment at VA hospitals. In his February 8, 1994 testimony before the House Committee on - 1 - Veterans' Affairs, Secretary Brown expressed his concern "that VA apparently did not reveal for an undetermined length of time the existence of this Atomic Medicine Division;" Secretary Brown further stated that he had "directed a thorough review of the records to attempt to piece together why this was done; what, if any, secret activities it engaged in; and the consequences of those activities." VA, however, has not yet searched systematically for documentation related to the plans, programs and policies that flowed from the creation of these entities. In addition to the coordination implied by the role of the Manhattan Project and military officials in 1947, information obtained from other agencies indicates that VA has assisted investigators who were performing experiments that were also supported by other agencies. VA has not yet attempted to narrow its search by looking for instances of work coordinated with other agencies. VA has used AEC radioisotope license records to help identify field locations for experiments, but it has apparently not used the full range of data (in span of years) that is available. VA has identified a number of individuals who may have knowledge of earlier developments, but has not yet sought to interview them formally. VA has located a number of early compendia of VA research summaries, but has not yet sought to use this data (particularly in coordination with data available from other agencies) to focus its search further (e.g., by grouping experiments by categories). Veterans' medical problems have periodically been the subject of study by groups such as the National Academy of Sciences/National Research Council. VA has not sought to avail itself of the expertise and documentation that these groups might offer to the VA search team. Classification: VA lacks original classification authority. However, it does, on occasion, receive classified materials from other agencies. Committee staff is, at present, unaware of whether any pertinent documents in VA's possession are classified. I. INFORMATIONAL SOURCES VA representatives briefed Committee staff on the status of their internal search in meetings on May 16, 19941 {1 Advisory Committee staff (Dan Guttman, Faith Bulger, Denise Holmes and Jonathan Moreno) met with Harold Gracey (Chief of Staff), Dennis Duffy (Congressional Affairs), Dan Smith (Public Affairs), Roland Halstead, John Klein, Neal Lawson and Jack Thompson (General Counsel), Susan Mather, Fran Murphy and Neil Otchin (Environmental Medicine & Public Health) of VA.} and May 25, 1994.2 {2 Faith Bulger, Jim David, Denise Holmes, and Jeremy Sugarman met with Harold Ramsey and Celia Walker (FOIA officers) and Neil Otchin of VA.} They provided informational documents at those meetings and in response to telephone requests. In addition, Committee staff independently located VA Annual Reports and other documents at the National Archives and the Washington National Records Center..Committee staff has not verified or audited whether work reported by VA representatives as completed was in fact completed. - 2 - II. HISTORY/ORGANIZATION OF THE DEPARTMENT OF VETERANS AFFAIRS A. General Providing pensions for veterans with disabilities can be traced back to the English colonies. Construction of the Naval Home in Philadelphia in 1811 marked the first step toward a national medical assistance program for such veterans. An 1862 law created a systematic benefits policy for veterans, their dependents and survivors; that year also saw the establishment of the National Cemetery System. In 1921, Congress created the Veterans' Bureau to consolidate various benefits offered to veterans, their dependents and survivors through three agencies (the Public Health Service, the Federal Board of Vocational Education and the Bureau of War Risk Insurance, that was previously within the Treasury Department). In 1930, further consolidation of the Veterans' Bureau, the Bureau of Pensions (of the Interior Department), and the National Homes for Disabled Volunteer Soldiers produced the Veterans Administration.3 {3 Throughout this Memorandum, "VA" will also be used as an abbreviation for this predecessor of the current Department} Brig. Gen. Frank T. Hines was named the first Administrator, reporting directly to the President. The second Administrator, Gen. Omar Bradley, launched a major expansion and reorganization of medical services in 1945. The director of medical programs, Maj. Gen. Paul Hawley, instituted residency programs and teaching fellowships in VA hospitals, and established the policy of locating VA hospitals adjacent to, and affiliating them with, leading medical schools. Hospital-based research began, increasing in scope in the next decade. In 1988, legislation was enacted to elevate the Veterans Administration to cabinet status; the Department of Veterans Affairs was established on March 15, 1989. VA operates both nationwide health care and assistance programs for veterans and their families (e.g., pensions, disability compensation, vocational rehabilitation, education payments, and life insurance) and 113 national cemeteries. VA estimates that seventy million people - almost one-third of the United States' population - are eligible for VA benefits and services by virtue of their status as veterans, dependents or survivors of deceased veterans. VA is divided into three main divisions: the Veterans Health Administration ("VHA"), the Veterans Benefits Administration, and the National Cemetery System; our primary focus is the VHA. B. History of VA Radiation Research The relevant department, the Department of Medicine & Surgery, was established in 1946, and was succeeded in 1989 by the Veterans Health Services and Research Administration. Since 1991, this branch has been known as the VHA. VA has provided two documents which relate to the 1947 creation of an atomic research unit within the agency. VA reports, and the documents indicate, that the unit was, at least in part, "confidential." However, VA at present lacks further documentation According to a 1952 report4 {4 This document is appended as Attachment A.} by George Lyon, then- Assistant Chief Medical Director ("ACMD") for Research and Education, Gee Hawley in the fall of 1946 "became deeply concerned about the problems that atomic energy might create for the Veterans Administration due to the fact that the Armed Services were so actively engaged in matters of atomic energy." - 3 - (Attachment A, p. 553) Lyon states that Hawley therefore began to explore these "problems" (at pp. 554-55, further identified as veterans' service-related disability claims) with representatives of the Manhattan Project.5 {5 Lyon's report lists the attendees at a key August 7, 1947 meeting in General Hawley's office as Gen. Leslie Groves and Col. James Cooney of the Manhattan Project, the military and Public Health Service Surgeons General and Lyon himself (then a Special Assistant to the Chief Medical Director for Atomic Medicine). Staff notes that an independent scholar has found the following entry in General Groves' diary for August 6, 1947: "1:00 - Lunch - General Hawley - A[rmy]N[avy] Club; 2:0() - Meeting - General Hawley, General Bliss, Surgeon General of the Army, Colonel Cooney, and representatives of Surgeon General of[fice] of Navy and Public Health."} A second document provided by VA, an April 1985 history6 {6 This document is appended as Attachment B.} of VA's Nuclear Medicine Department written by A. Graham Moseley, Jr., corroborates the stated reasons for the creation of this unit A former radiological safety monitor in Operation Crossroads, Moseley joined VA in July 1948 as Assistant Chief of the Radioisotope Section (within the Department of Medicine and Surgery, further described below), and held various positions in VA until his 1966 retirement. Lyon's report states that, in the fall of 1947, VA created a Central Advisory Committee on Radioisotopes, consisting of Dr. Hymer Friedell, Dr. Perrin Long, Dr. Hugh Morgan, Dr. Shields Warren and Dr. Stafford Warren; the Committee was to report to Gen. Hawley.7 {7 Staff notes that the creation of this VA Committee followed 0peration Crossroads, in which atomic bombs were detonated at Bikini (in the Marshall Islands) in 1946-47. The tests demonstrated, among other points, that soldiers and sailors who were called upon to clean up after bomb detonations could be exposed to substantial radiation hazards. The medical director of Operation Crossroads was Stafford Warren, who had served in a similar capacity in the Manhattan Project. The nonradiological safety director was George Lyon.} According to Lyon, at its first meeting on September 5, 1947, the Central Advisory Committee recommended (1) establishment of an Atomic Medicine Division within the Department of Medicine and Surgery, (2) establishment of a Radioisotope Section (within that Division) to implement the Radioisotope Program, and (3) "that, for the time being, the existence of an Atomic Medicine Division be classified as `confidential' and that publicity be given instead to the existence of a Radioisotope Program administered through the Radioisotope Section" (Attachment A, p. 554). These recommendations were adopted by Gen. Hawley, and the Radioisotope Program was launched that fall with Dr. Lyon as Chief, Radioisotope Section. Moseley's history places the Radioisotope Section within the Research Service. Staff notes that it has attached another document drafted by Dr. Lyon in 1950,8 {8 This document is appended as Attachment C.} that lists expenditures over the first three and one-half years for personnel, and for equipment and supplies. Lyon became ACMD for Research and Education in 1950. Lyon states that the Radioisotope Program was designed both to respond to service-related disability claims and to support VA's civil defense responsibilities.9 {9 Because VA had been named lead agency in public education about nuclear preparedness, the Radioisotope Section developed training materials on the radiological safety aspects of civil defense.} According to Lyon, the "specific objective of the Radioisotope Program has been, and is, to employ radioisotopes within selected hospitals of the Veterans Administration, (a) in medical research, (b) in clinical diagnosis, and (c) in the medical treatment of veteran - 4 - patients." (Attachment A, p. 555) The Administrator's Annual Report for FY 1955, located by Committee staff at the National Archives, states that, "[i]n hospitals having radioisotope units. .. , [a]t least 50 percent [emphasis added] of these activities involve[d ] procedures contributing directly to the clinical diagnosis or medical treatment of veteran-patients"; this statement suggests that up to half of the activities involving radioisotopes were research. Radioisotope laboratories were to be established only in those VA hospitals affiliated with medical schools. Thus, VA began working with radioisotopes shortly after the Atomic Energy Commission ("AEC") made radioisotopes available for medical research; VA has been involved with nuclear medicine ever since. (i) Radioisotope Laboratories in VA Dr. ME. Morton opened the first VA radioisotope laboratory at the VA Hospital in Van Nuys, California10 {10 his hospital was later destroyed by an earthquake.} in February 1948; seven additional radioisotope laboratories at Framingham, MA (closed during the Johnson Administration), Cleveland, OH, Minneapolis, MN, Bronx, NY,11 {11 Drs. Bernard Roswit and Rosalyn Yalow began to perform research with radioisotopes at the Bronx VA hospital in 1947; Dr. Yalow received the Nobel Prize for Medicine in 1977.} Hines, IL, Dallas, TX, and Los Angeles, CA were conducting research by year's end. That number grew to 14 by 1951, to 33 by the end of 1953, and to 48 by 1958. A December 31, 1993 VA press release lists the fourteen key sites in the early 1950s as Framingham, Buffalo, Minneapolis, Cleveland, Iowa City, Little Rock, Bronx, Atlanta, Philadelphia, Chicago, Houston and three "still being researched." Lyon's 1952 report states that, during the program's first four years, representatives from each site met twice per year with the Central Advisory Committee to discuss, among other matters, "the planning, organization, and conduct of research with isotopes, and the results of research work and clinical investigations in which radioisotopes were used." (Attachment A, p. 556) VA states that the 1957 Administrator's Annual Report cited 399 radioisotope studies or research projects in 1955 and 560 in 1956. According to an April 6, 1994 VA directive, discussed below, in at least one instance reported to Congress, VA patients were research subjects in studies performed by an affiliated institution; VA staff has stated that this apparently referred to the University of Cincinnati, but that the Cincinnati VA medical center has not been able to confirm participation of any VA patients in such research. In 1960, a nuclear reactor was installed at the Omaha VA hospital. Further investigation is needed to determine whether, and to what extent, this reactor might have been utilized to support VA's radioisotope research. Although Moseley cites Omaha as "the first" to have a reactor, Committee staff at present is unaware of either the installation or utilization of any additional reactors at other VA sites. Subsequently, Moseley's history (Attachment B, p. 3) states, [i]n 1965 the Atomic Energy Commission licensing division began to relax the stringent requirements for individual licensing of each radioisotope and each use, and we selected the VA Center in Los Angeles as the first to apply for a broad medical license, the uses and isotopes within a stated group, to be approved by a local Isotope Committee. This was approved by the AEC and several other VA hospitals were approved within the next six months or so. - 5 - At present, the history is unclear, but it appears that the Atomic Medicine Service was dissolved in 1960. (ii) Review Procedures for Human Research at VA According to Lyon's 1952 report, radioisotope research projects were reviewed locally by a Radioisotope Committee (a subcommittee of a Deans Committee, formed at every VA facility affiliated with a medical school) that included non-VA representatives. After that initial review, research proposals were forwarded to the Director of the Research Service in the Department of Medicine and Surgery for final review. VA provided a copy of a November 1952 article on research at the VA's Houston facility from The Voice (the Houston VA medical center publication); the article states that Drs. Shields Warren, Hymer Friedell, and Stafford Warren offered unspecified "advisory services" to the individual facilities' radioisotope units in the eastern, central and western regions, respectively. In his 1950 report, Lyon lauded the three advisors, noting that they had "rendered, and continue(d] to render, a roost invaluable service in this capacity" (Attachment C, p. 409); in 1952, Lyon referred to the three as "special consultants to the hospital programs" (Attachment A, p. 557) The FY 1961 Annual Report, Medical Research in the Veterans Administration, located by Committee staff at the National Archives, states that a Research and Education Committee at each VA medical center submitted minutes of its meetings to the Central Office on a monthly basis; detailed summaries and annual research reports were to be submitted annually by each. That Annual Report further states that, "[t]hrough... visits (to the Central Office to meet with members of the Research Service], minutes and reports, site visits, the annual research conference,... and other means of communication, a close liaison between the investigators in the stations and the Research Service is maintained." (iii) Research with or by Affiliated Medical Schools As discussed in greater detail in Section III (D)(3), below, VA research prior to 1955 was performed largely, if not exclusively, on a contract basis; VA staff has stated that little of the contracted work involved radioisotopes. VA staff has given Committee staff a list of affiliated medical schools, including the starting date of affiliation. Further investigation is necessary to ascertain the current and historical procedures for patient recruitment for participation in research, as well as to identify actual research projects performed with or by the affiliated medical schools. (iv) Research in Conjunction with Other Agencies The Administrator's Annual Report for FY 1965 notes that the "VA medical research program has representation on the Committee on Scientific and Technical information of the President's Federal Council for Science and Technology, and enjoys close working relationships with the Bureau of Standards, the U.S. Atomic Energy Commission, and other Federal agencies." Further investigation is needed to determine the nature and extent of VA coordination of research with other agencies. III. DESCRIPTION OF VA SEARCH A. Guidelines/Logic On January 6, 1994, VA Secretary Jesse Brown instructed all 172 VA medical center directors generally to review all records relating to radiation research. A January 7, 1994 VHA memorandum and a January 28, 1994 VHA directive instructed all VHA facilities to search local research and nuclear medicine - 6 - records for information about radioisotope, nuclear medicine or radiation research between 1947 (when VA began its radioisotope/nuclear medicine program) and 1979 (when institutional review procedures for the protection of human subjects were well established). The scope of the request included notifying and locating records of VA grantees, contractors,, and other agents engaged in VA-funded research. A subsequent directive dated April 6, 1994 broadened the substance of the search to encompass other research involving ionizing radiation; this directive also expanded the sites to include affiliated institutions which may have utilized VA patients as research subjects. The directives asked centers only to locate and preserve records; they have not yet been asked to review documents or to transfer them to the Central Office for review. A June l, 1994 memorandum12 {12 A copy of this memorandum is appended as Attachment D.} from Secretary Brown to the Acting Under Secretary for Health stresses the "need to revitalize (VA's] efforts." B. Search Organization/Staffing In late January, Secretary Brown established within VA a Radiation Information Coordinating Committee to oversee VA's compliance with the President's mandate. This Committee is chaired by the General Counsel, Mary Lou Keener; other members include Harold Gracey (Chief of Staff), Dr. Susan Mather (ACMD, Environmental Medicine and Public Health), Dr. Dennis Smith (Research Service), and representatives of four additional divisions. This Committee met weekly for the first six weeks, and has met every two to three weeks since. With the assistance of two members of her staff, Dr. Mather is coordinating the effort of individual medical centers. According to statements made at a meeting with VA staff, VA does not have any personnel working on this project on a full-time basis. C. Document Retention/Destruction Policies and Practices A January 24, 1994 white paper on document retention prepared by the Records Management Service states that, "[f]rom a records management perspective, there is no distinction between records involving radiation research including research records pertaining to human subjects and any other research records." Staff has received five documents from VA regarding agency policy for retention of specific types of documents. Staff's best understanding is that (1) general policy documents (e.g., directives, circulars and manuals) are maintained indefinitely; (2) medical records must be retained for 75 years; (3) research records must be retained for ten years; and (4) published and unpublished VA legal opinions dating back to the 1940s (and before) are retained in the law library. Staff will obtain additional clarification at a meeting (to be scheduled) with VA staff responsible for records management. However, actual practices may not precisely mirror written VA policy. VA's decentralized research facilities and/or individual researchers may well have retained copies of documents. Accordingly, because many research experiment files were kept at individual hospitals and/or at the homes of retired staff members, this may be a viable avenue to explore further, perhaps once we have identified some key VA researchers or institutions. For example, VA staff have stated that Dr. Belton Burrows, who performed research at Framingham, has retained his research files in his garage. D. Results of the Search to Date (1) Central Office: A January 7, 1994 memorandum from the Acting Under Secretary for Health, attached to the January 28, 1994 VHA Directive 10-94-007, states that a "review of centrally held research and nuclear - 7 - medicine records has revealed no information on specific research projects, protocols, or human subjects." An undated VHA "Review of Historic Research Documents" states that VA staff reviewed the Administrator's Annual Reports and the 1957-1960 annual reports of Medical Research in the Veterans Administration(Prepared by the Research Service in the Department of Medicine and Surgery), and identified therein some research which VA staff deemed pertinent. This document further states that the 1957 report identified 52 studies involving X-rays and also included narrative reports from 32 VA medical centers concerning their radioisotope research. VA staff found that the 1958 report included similar narrative descriptions, and listed publications by principal author. VA staff further found that the 1959 report, the first to include radiation in the index, indicates that in 1958, 10% of all VA-funded projects involved radioisotopes; those projects received $2.23 million, or 20.5% of the research budget. The 1959 report also cites four contracts for extramural research, which apparently was limited in the late 1950s. The 1960 report expanded to two volumes detailing over 6000 projects. VA staff expressed concern that the lack of indices for these reports may allow some pertinent projects to be overlooked; further, abstracts of research projects sometimes fall to indicate whether subjects were human or animal. (2) VA Medical Centers: Two surveys have been sent out to VA medical centers. The first requested information about radioisotope/nuclear medicine research between 1947 and 1979, and the second asked about human radiotherapy experiments between 1947 and 1979.13 {13 Copies of these surveys are appended as Attachment E.} As of June 3, 1994, responses had been received from all sites for the first survey, and from most sites for the second. VA has given Committee staff several sample responses, and will furnish complete set within the near future. Of the 137 facilities with nuclear medicine capability, 49 have located some protocols for radioisotope research performed between 1947 and 1980, 24 have names of some patients who participated in radioisotope research, and 54 have identified some publications on pertinent research. According to the survey responses, none of the 137 located any evidence of research involving plutonium. The medical centers' responses were cross-checked against licensing information obtained from the AEC and its successor, the Nuclear Regulatory Commission("NRC"), for inconsistencies, and returned, as needed, to medical centers for further review and reconciliation. Medical centers reporting possible human radiation experiments were also asked to provide details about the experiments, including the purpose and nature.14 {14 A sample response is appended as Attachment F.} VA has also given Committee staff a list of AEC licenses dating from 1956 to 1989; the list shows license number, researcher, date and radionuclide for 27 VA medical centers. VA staff states that it proposes to recover from NRC archives copies of all VA license applications and actions. There is no evidence that VA has searched for records regarding its pre-1956 authorization to use radioisotopes. It is unclear what, if any, effort has been made to obtain relevant records, whether general policy documents or specific research project files, from VA-affiliated medical schools. This merits further investigation. (3) Contractors: Based on the surveys returned by VA medical centers, there is no evidence that VA contracted out any radioisotope research. However, according to the FY 1965 Annual Report, Medical Research in the Veterans Administration, independently located by Advisory Committee staff at the National Archives, all medical research prior to 1955 was performed pursuant to contract with medical school faculties. A January 4, 1994 VA memorandum entitled "Radioisotope Program in VA" states that "[f]unding - 8 - for early studies came from research funds that were initially managed by a Special Assistant to the Chief Medical Director." VA has stated that this may have been Dr. George Lyon and/or his successors. The FY 1965 Annual Report further states that intramural research began in 1955, and the contract program was converted to a wholly intramural effort by 1956. The FY 1965 Report must be reconciled with that for FY 1955, which discusses intramural research between July 1952 and August 1954. VA staff has stated that the early radioisotope research was primarily, if not wholly, intramural. (4) Federal Records Centers/National Archives: VA has not yet reviewed any records now within Federal Records Centers or at the National Archives. Staff plans to schedule a follow-up meeting with VA staff responsible for records management in order to identify more clearly the extent and nature of VA documents held at these sites. (5) Classified Material: According to a document provided by VA staff, VA lacks original classification authority. However, VA sometimes receives classified materials from other agencies. Therefore, it does not appear that we are faced with a significant declassification issue. At present, Committee staff is unaware of whether any pertinent VA documents are classified; VA staff has stated that it knows of no such documents. E. Evaluation of Calls Referred to VA by Department of Energy 1-800 Helpline As of June 3, 1994, DOE had forwarded approximately 1200 inquiries to VA, most of which related to ionizing radiation exposure during military service; approximately 300 concerned possible radiation research/treatment in VA facilities. Of approximately 8,200 calls from individuals to VA regional offices and/or VA's own 800 number, approximately 1000 concerned possible radiation exposure at a VA facility. These inquiries will be reviewed by the office of the ACMD for Environmental Medicine and Public Health for follow-up and appropriate action. VA developed standards for reviewing research conducted on human subjects within VA's intramural program in the early 1960s. According to documents provided by VA staff, every research protocol must initially be reviewed and approved locally by an individual medical center's Research and Development Committee and by its Subcommittee on Human Studies (or review board, if the medical center is affiliated with a medical school); the Radioisotope Committee would also review and approve any research involving ionizing radiation. Since 1968, VA has required that patients sign an informed consent form for participation in research. A 1975 VA Circular required that a research subject "consenting be given sufficient details, in language (that] the person can understand, to arrive at a reasonable decision." Further investigation is necessary into policies and procedures prior to the early 1960s, and into whether a standard consent form has been used by all VA medical centers since 1968. Current VA policy is codified at 38 C.F.R. Secs. 17.34, 7331. IV. AGENCY OBSERVATIONS AND CONCERNS VA has expressed two main concerns. First, due to agency downsizing, VA questions how burdensome the search effort will be for its staff. In light of this concern, VA seeks precise instruction as to the scope of the search, so that personnel, particularly in the field, are not misdirecting their efforts. Second, - 9 - VA is particularly concerned about protecting veterans' privacy. Pursuant to the Privacy Act and a special VA confidentiality statute, names and addresses of VA patients must be kept confidential. V. STAFF OBSERVATIONS ABOUT ThE VA SEARCH Although VA has cast its net far and wide, to date its search effort appears to have been focused largely on locating and securing records of individual research projects at individual medical centers. While the identification of decentralized documents thus far is commendable, Committee staff nonetheless believes that greater effort must be devoted to locate and retrieve records now in the Central Office, as well as Central Office records which have been transferred to the National Archives or Federal Records Centers. Committee staff cannot accurately assess the volume or significance of such materials. However, staff offers the following observations about the VA search: (1) VA has not identified any documentation (other than the two reports discussed above) regarding the 1947 creation of the Atomic Medicine Division. (2) VA's Research Service reports that it has found "little information" in its files, although that division appears historically to have played a key role in planning, monitoring and evaluating radiation research and/or experiments. As previously noted, the Research Service developed a central review process for research, including radiation research, and made a distinct effort to keep in close touch with each research unit at each VA medical center. (3) VA has not, to date, searched for general policy documents either in the Central Office or at Federal Records Centers or the National Archives. (4) VA has not begun to work diligently with other agencies to determine how their activities were coordinated in the late 1940s and early 1950s. (5) VA has not, to staffs knowledge, conducted extensive, formal interviews of any former or current VA staff who might be knowledgeable about human radiation research or experiments, particularly in the early years. (6) VA has not relied on any pre-1956 AEC isotope licensing or distribution data. The reason for this is unclear. (7) VA has not made any inquiries of entities that have historically considered veterans' medical problems (e.g., National Academy of Sciences/National Research Council. (8) VA does not appear to have reviewed the summary research data available to it in order to cut out experiments. VI. STAFF Recommendations The options that follow include suggestions for (a) Committee advice/direction to VA, and (b) Committee direction to staff. In each case, it is expected that implementation of the option would be subject to discussion with appropriate VA staff, and under the direction of the appropriate Committee Subcommittee. - 10 - Committee Advice/Direction to VA: OPTION ONE: VA should proceed, as Secretary Brown instructed, to trace the story of the Atomic Medicine Division from its creation in 1947. At the very least, it, would seem that Administrator's records, Gen. Hawley's files and/or Department of Medicine and Surgery files might contain relevant documents. OPTION TWO: VA should immediately expand its search effort to encompass high-level, long-range policy documents. For example, in light of the Research Service's pivotal role in the early history, VA should locate and review the historical records of the Research Service. VA should also search its general policy files, which should prove a rich source of information. In the event that no such materials have been retained at the Central Office, VA should locate and review Central Office materials which have been transferred to Federal Records Centers and the National Archives. Staff notes that it has independently located some Administrator's and Research Service records at the Federal Records Center in Suitland, MD. OPTION THREE: VA should work closely with other agencies to trace the coordination of their efforts in the late 1940s and early 1950s with respect to radioisotope research. OPTION FOUR: VA should conduct formal interviews with key persons regarding the early history and interagency coordination. A January 3, 1994 VA memorandum from the program director of the Nuclear Medicine Service identifies Dr. William Blahd (Los Angeles), Dr. Belton Burrows (Boston), Ms. Helen Malaskiewicz (Environmental Health), and Dr. James Smith (former program director) as people from whom VA could seek the early institutional history. VA itself has suggested obtaining oral histories from 1940s and 1950s researchers. Alternatively, these individuals could be interviewed by Committee staff, at the Committee's direction. OPTION FIVE VA should trace the history of its Omaha nuclear reactor, as well as that of any other nuclear reactors. It should identify the purposes for which the reactor(s) was/were installed, and how VA utilized the reactor(s). OPTION SIX: Staff recommends that the Committee direct it to continue communications with VA on the matters discussed in this Memorandum. Staff can assist with revision and prioritization of the search strategy, as well as collection of relevant documents. - 11 - OPTION SEVEN: Staff recommends that the Committee direct it to facilitate the exchange of information between VA and other agencies. OPTION EIGHT: Staff recommends that the Committee direct it to engage in fact-finding to enable the Committee to determine whether (and, if so, when and how) to follow (1) specific VA researchers over time, (2) VA links to research performed by affiliated medical schools, and (3) the use of VA patients by other medical school researchers. c:\wpwin60\wpdocs\val (DEH) - 12 - ATTACHMENTS TO STAFF MEMORANDUM ON VA SEARCH June 7, 1994 (A) December 1952 Report on Medical Research Programs of the VA by Dr. George Lyon (B) January 24, 1994 Memorandum from Dr. Susan Mather attaching 1985 history of VA Nuclear Medicine Program by A. Graham Moseley (C) November 1950 Report on VA Radioisotope Program by Dr. George Lyon (D) June 1, 1995 Memorandum from VA Secretary Jesse Brown to Acting Under Secretary for Health (E) Copies of two surveys sent by VA to its medical centers pursuant to January 28, 1994 VA Directive (F) Sample medical center response to VA Central Office request for information about possible human radiation experiments c:\wpwin60\wpdocs\attachmt DEH)