TABLE 1. Extent of Biomedical and Behavioral Research Involving Human Subjects Conducted or Supported by Agencies with Statutory Liaisons to the Commission. * Agency reports that data are not available. a The Department of Defense provided data only for their "R&D" programs; data b This figure may be high due to duplication, i.e., institutions may hold contracts with more than one service. These figures relate solely to intramural research conducted by NIH, ADAMHA, Information on the number of human subjects involved in research supported by This figure may be low. It refers to the number of principal investigators that conduct research involving human subjects. Departments of Agriculture, Defense and Energy and the Veterans Administration.8 The amount of such research that involved human subjects is, however, unknown. In fact, the Commission has been hampered in its study of the magnitude of the problem of research injuries because data have not been systematically accumulated on the number of subjects involved in Federally funded research. In an attempt to obtain an impression of the extent of Federal involvement in research with human subjects, the Commission asked the five agencies with official liaisons to the Commission to provide the following information for FY 1980, to the extent obtainable: (1) the number of research projects involving human subjects that were supported by their departments under grants or contracts (extramural research) or that were conducted either by departmental employees or at facilities operated by their departments (intramural research); (2) the number of IRBs that reviewed such research; (3) the amount of money spent; and (4) the number of subjects involved. Table 1 reflects the information provided by the liaison offi cers. As the table makes apparent, data are not available on the number of human subjects involved in Federally supported research except for several intramural programs within HHS (e.g., the NIH Clinical Center and the Centers for Disease Control), the R&D programs (but not the several thousand clinical investigations) conducted by the Department of Defense, and the research conducted by the C.I.A. On the other hand, all five agencies were able to provide the number of grants and contracts they funded for research involving human subjects. In Chapter Five of the Report, the Commission recommends procedures for assuring that all Federal agencies collect and retain in a central location data on the number of subjects participating in research that the agencies conduct or support. 8Id. at 5. The Adequacy A survey of the regulations and policies for the protection of human subjects of Federally funded and regulated research was conducted by the Commission in 1980-81 in response to the legislative mandate that the Commission report biennially to the President, the Congress and the heads of relevant agencies on both the adequacy and the uniformity of the rules and policies of all Federal agencies regarding the protection of human subjects of biomedical and behavioral research.1 It is generally accepted, among Federal officials and commentators, that the benchmark of "adequacy" is provided by the regulations of the Department of Health and Human Services. Based upon the thorough review of human research regulations of HHS (then, the Department of Health, Education, and Welfare) performed by the National Commission for the Protection of Human Subjects in 1974-78,2 and the conscientious manner in which HHS has responded to the National Commission's recommendations regarding the review standards and procedures for research involving competent, non-institutionalized adults, the Pres 1The statutory definition of "Federal agency" excludes the U.S. Courts; therefore, the Commission did not review the activities of the Federal Judicial Center regarding research or experimentation in the justice system. The Commission notes, however, that the Federal Judicial Center has recently received a report on this subject, with recommendations, from an advisory committee on Experimentation in the Law, U.S. Government Printing Office, Washington (1981). 2 National Commission for the Protection of Human Subjects, Report and Recommendations: Institutional Review Boards, U.S. Government Printing Office, Washington (1978) [hereinafter cited as IRB Report]. TABLE 2. Agencies Excluded from Review and Analysis in this Report AGENCIES THAT CONDUCT OR SUPPORT ONLY SURVEYS, Department of Justice: Bureau of Justice Statistics United States Parole Commission Department of the Treasury: Internal Revenue Service General Services Administration: National Archives and Records Service National Transportation Safety Board Office of Personnel Management Tennessee Valley Authority AGENCIES THAT ARE ONLY INVOLVED AS SPONSORS OF RESEARCH CARRIED OUT BY OTHER FEDERAL AGENCIES. Nuclear Regulatory Commission Smithsonian Institution AGENCIES THAT PERMIT THE USE OF THEIR FACILITIES AND ACTION U.S. Postal Service ident's Commission is satisfied that the basic regulations of that Department are adequate if not above improvement. Therefore, the Commission has focused its attention on determining the "uniformity" among other Federal agencies measured by the extent to which their rules conform to the basic regulations of HHS. Methods Scope of the Survey. The methods used to conduct the survey of Federal agencies were similar to those used by the National Commission in 1975. The 1980 survey was, however, broader in scope, including 11 of the 13 cabinet-level departments,3 the Central Intelligence Agency in the Executive Office of the President, and 56 of 87 independent commissions and agencies listed in the Congressional Directory. Agencies were excluded from the survey only when there was reason to be confident that they do not conduct or support research with human subjects. (See Appendix C.) In March 1980, the twenty still existing Federal agencies which had reported to the National Commission 3 The Departments of Labor and of the Interior reported in 1976 they do not conduct or support research with human subjects. See letters to Charles U. Lowe, M.D., from John T. Dunlop, Secretary of Labor (October 1, 1975) and from Rayston C. Hughes, Assistant Secretary of the Interior (October 14, 1975). TABLE 3. Agencies Included in this Report's Review and Analysis AGENCIES THAT CONDUCT OR SUPPORT BIOMEDICAL OR American National Red Cross Central Intelligence Agency Consumer Product Safety Commission Department of Agriculture Department of Commerce Department of Defense: Army, Navy, Air Force Department of Education Department of Energy Department of Health and Human Services Department of Housing and Urban Development Department of Justice: Bureau of Prisons Office of Justice Assistance, Research, and Statistics Coast Guard Federal Aviation Administration Federal Highway Administration National Highway Traffic Safety Administration Environmental Protection Agency National Aeronautics and Space Administration National Science Foundation U.S. International Development Cooperation Agency Food and Drug Administration (which regulates research on new drugs and medical devices) that they support or conduct research involving human subjects were provided with a copy of the 1977 summary of their policies and regulations. They were asked to provide information and supporting documentation regarding any additions or deletions necessary to bring the summary upto-date. Federal agencies not surveyed by the National Commission or who had reported in 1975 that they neither conduct nor support research involving human subjects were asked whether or not they currently conduct or support such research. In order to improve the consistency of response, agency heads were provided with the following definitions which had been developed by the National Commission: 1. Scientific research is a formal investigation designed to develop or contribute to generalizable knowledge. Comment: A research project generally is described in a protocol that sets forth explicit objectives and formal procedures designed to reach those objectives. The protocol may include therapeutic and other activities intended to benefit the subjects, as well as procedures to evaluate such activities. Research objectives range from |