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Federal government. Among the agencies, HHS (which supports the largest volume of research and which has devoted the most attention to the subject) is widely regarded as the "lead" agency. A fuller description of the policies and procedures of HHS is set forth in Appendix B, as well as a description of the rules and procedures of each of the other Federal entities, compared with those of HHS.

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Review of the Adequacy and Uniformity of the Rules' Implementation. The second half of the Commission's charge regarding the protection of human subjects is to determine how adequately the applicable rules are being implemented. This has been a major focus of the Commission's activities in 1981. The Commissioners have tried to learn, from a variety of approaches: (1) how well informed the funding agencies are about institutional compliance with the regulations (an inquiry that led the Commission to conduct a selective examination of grantee institutions' implementation of the regulations); (2) how able institutions are to handle charges of noncompliance, misconduct or in

jury; and (3) how the funding agencies respond to reports that the regulations have been violated or human subjects placed at risk through acts of research fraud or other misconduct.

As part of its survey of the rules and procedures of Federal agencies conducting or supporting research with human subjects, the Commission asked each agency about the extent to which it monitors either the actual conduct of research or the performance of the IRBs at grantee and contractor institutions. A summary and analysis of those responses is contained in Chapter Three.

Attempts to Clarify HHS Policies and Procedures for Responding to Reports of Misconduct. The Commission, through its Chairman and senior staff, for more than a year has been, and continues to be, engaged in correspondence and meetings with officials at the Department of Health and Human Services in an attempt to clarify current Departmental policies and procedures for responding to reports of misconduct by grantees and contractors. (See Appendix F.) The Commission is particularly interested in learning about the extent to which standards and procedures exist for: (a) alerting committees that review grants and contracts about serious allegations pending against a scientist; (b) protecting complainants and witnesses from retaliation; (c) protecting the subjects, if research activities must be suspended; (d) protecting the rights of those accused of misconduct; and (e) protecting the public interest by assuring the reliability of research results and the ethical conduct of Federally supported research.

Case Studies. The Commission also examined closely several reported incidents of misconduct in Federally funded research to determine what might be learned from these well-documented cases. Although the cases are few in number, particularly in light of the thousands of research projects conducted each year, the Commission found them instructive. Specifically, the cases indicate areas where procedures for responding to reports of misconduct need improvement at the institutional and the Federal levels. Problems identified in a review of these cases are described in Chapter Three; the cases themselves are described in Appendix E.

Commission Hearings. As an adjunct to its study of cases of misconduct in Federally supported biomedical research, the Commission held hearings during 1981 in Boston and Los Angeles, the locales of two such incidents. The purpose was to learn from administrators and IRB members at the research institutions involved, as well as from principal investigators and those who reported misconduct, how well they believe existing procedures worked and what im

provements they would recommend. A number of suggestions regarding the authority of IRBs, institutional mechanisms for investigating and adjudicating reports of misconduct, and Federal procedures for monitoring compliance were received and considered by the Commisssion. Furthermore, in addition to its hearings and deliberations on social and behavioral science research in July and September 1980, the Commission considered aspects of its Biennial Report at its regular meetings in October, November and December 1981, at which time periods were set aside for public comments as well as Commission discussion. (A list of witnesses appears in Appendix I.)

Conferences Attended. Senior professional staff particpated in a number of conferences on the role and responsibilities of IRBS, the need for improved education of investigators and members of IRBS, and the effect that the revised HHS regulations will have on IRB procedures. Such conferences included: a meeting sponsored by HHS of consultants on "Education for IRBs" (December 8, 1980); two conferences sponsored by Public Responsibility in Medicine and Research (PRIMR) on "The New Federal Regulations: What They Do and Do Not Regulate" (Boston, March 26-27, 1981 and Asilomar, November 2-4, 1981); and a workshop sponsored by the Institute for Society, Ethics and the Life Sciences (Hastings Center) on "Institutional Review Boards and Human Subjects Research" (Colorado College, July 12, 1981). In addition, the Commission's director participated in workshop discussions with research administrators and members of IRBs (e.g., the 1981 annual meeting of the National Council of University Research Administrators and the fourth annual University of California conference on IRBs).

Workshop on Whistleblowing in Biomedical Research. Because all Federal agencies rely on private individuals to report incidents of misconduct in research with human beings, the Commission decided to examine the availability of means for making such reports, the adequacy of procedures for evaluating the reports, and the protections afforded both the complainant and the person accused after allegations have been made. The Commission was also interested in the response of the Federal agencies once they receive either an allegation of serious misconduct or a formal finding by an institution that such misconduct has occurred.

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To clarify the issues and examine possible modes of response, the Commission held a two-day Workshop on Whistleblowing in Biomedical Research, co-sponsored by the Committee on Scientific Freedom and Responsibility of the American Association for the Advancement of Science and by Medicine in the Public Interest. Participants includ

ed physicians engaged in biomedical research; hospital administrators; professors of law, political science, sociology, and educational administration; practicing attorneys; officials of the National Institutes of Health and the Food and Drug Administration, a member of the President's Commission and senior staff of the sponsoring organizations. (See Appendix J.) The conclusions and recommendations of the Workshop were transmitted to members of the Commission and were taken into consideration in developing recommendations on this subject. (Conference papers, discussions and conclusions will be published as a separate volume in 1982.)

Assistance from Liaison Representatives to the Commission. Under section 1801(a)(2) of the Commission's enabling legislation, the heads of six agencies were directed to name officials to act as liaison to the Commission: the Department of Health and Human Services, the Department of Defense, the Central Intelligence Agency, the White House Office of Science and Technology Policy, the Veter- . ans Administration, and the National Science Foundation.5 The Commission and its staff wish to thank those who served in this capacity for their conscientious attendance at Commission meetings and their valuable assistance, both formal and informal, in the preparation of this report.

Contacts with the Office of Management and Budget. In response to an OMB proposal for government-wide debarment procedures applicable to Federal contractors, senior staff of the Commission have discussed with OMB its interest in developing government-wide debarment procedures that would apply to Federal grantees as well. The purpose would be to standardize debarment and sus

5 Liaison was provided by: Department of Health and Human Services-Charles R. McCarthy, Ph.D., Director, Office for Protection From Research Risks, Office of the Director, NIH, assisted by Richard Riseberg, Chief, NIH Branch, Office of General Counsel, John C. Petricciani, M.D., Assistant Director for Clinical Research, Bureau of Biologics, FDA, and Stuart Nightingale, M.D., Acting Associate Commissioner for Health Affairs, FDA; Department of Defense-Captain Peter A. Flynn, MC, USN, Special Assistant for Professional Activities, Office of the Assistant Secretary of Defense (Health Affairs); Central Intelligence Agency-Bernard M. Malloy, M.D., Chief of the Psychiatric Division, Office of Medical Services, assisted by Dennis Foreman, Office of General Counsel; Office of Science and Technology Policy-Gilbert S. Ommen, M.D., Ph.D., Associate Director for Human Resources and Social and Economic Services, OSTP, Executive Office of the President, succeeded by John Ball, M.D., J.D., succeeded by Denis Prager, Ph.D.; Veterans Administration-Dorothy C. Rasinski, M.D., J.D., Associate Director, Medical Legal Affairs; and National Science Foundation-Richard T. Louttit, Ph.D., Division Director for Behavioral and Neural Sciences.

pension procedures so that a scientist, debarred or suspended by one Federal agency (for misconduct in the course of Federally funded research) could be debarred by other agencies without burdening all concerned with additional debarment proceedings. Further, a consolidated list of persons debarred from individual agencies would be available to all Federal agencies. OMB officials have expressed interest in developing such government-wide system applicable to recipients of research grants. (See Appendices G and H.) Report on Compensating for Research Injuries

At the urging of the vice-chair of the Ethics Advisory Board in HHS, which was in the process of concluding its activities, the Commission decided at its first meeting to study the problem of providing compensation for researchrelated injuries, a subject closely related to the protection of human subjects.

A starting point was provided by the report of the HEW Secretary's Task Force on Compensation for Injured Research Subjects (1977), which concluded that there is an ethical obligation to provide compensation for persons injured as a result of their participation in Federally sponsored research. The question of how such compensation could be provided was not resolved either by the Task Force or subsequently within HHS. The Commission, therefore, confronted two distinct, but related, questions: (1) whether it agrees that an ethical obligation to provide compensation exists and, if so, the extent of that obligation; and (2) whether feasible mechanisms exist or could be developed that would meet that obligation.

A separate report on the Commission's study of these questions and the conclusions it reached is under preparation and will be released early in 1982.

Extent of Federal Involvement in
Research with Human Subjects

Annual expenditures for health-related research are now about $8 billion, of which the Federal government contributes more than 60%. Three-quarters of this amount comes from the Department of Health and Human Services, primarily through the National Institutes of Health (NIH).” The remaining quarter of Federal support for biomedical and other health-related research is contributed by some 17 other agencies, with major portions provided through the

646 Federal Register 37832 (July 22, 1981).

"U.S. Department of Health, Education, and Welfare, Basic Data Relating to the National Institutes of Health: 1980, U.S. Government Printing Office, Washington (1980) at 4.

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