Consideration of the Extension of Federal Regulations Recommendations for Improving the Adequacy and Uniformity of Federal Laws and Regulations for the 1. All Federal Agencies Should Adopt the Regulations 2. The Secretary, HHS, Should Establish an Office to Coordinate and Monitor Government-Wide Imple- 3. Each Federal Agency Should Apply One Set of Rules Consistently to All Its Subunits and Funding 4. Principal Investigators Should Be Required to Sub- mit Annual Data on the Number of Subjects in Their Research and the Number and Nature of Ad- 5. The National Commission's Recommendations on Research Involving Children and the Mentally Dis- abled Should Be Acted Upon Promptly 6. "Private" Research Organizations Receiving Direct Federal Appropriations Should Be Required to Fol- low Regulations for the Protection of Human Sub- Recommendations for Improving Institutional and Federal Oversight of Research and the Response to 7. Institutions Should Be Free to Use Offices Other than IRBs to Respond to Reports of Misconduct and 8. IRBS Should be Required Only to Report to Appropriate Officials of Their Institution (Rather Than to the Funding Agency) When They Learn of Possible Misconduct and to Respond to the Findings of Those Officials 9. There Should be Government-Wide Procedures for Debarring Grantees and Contractors Found Guilty of Serious Misconduct, as well as a Consolidated List of Formal Debarments and Suspensions Actively Shared With Government Agencies, Professional Societies, and Licensing Boards Appendices 78 82 85 Tables 1. Extent of Biomedical and Behavioral Research Involving Human Subjects Conducted or Supported by Agencies with Statutory Liaisons to the Commission 13 2. Agencies Excluded from Review and Analysis in This Report 16 6. Summary of Institutional and HHS Responses to Reported Incidents of Research Fraud, Abuse or Violations of Regulations 54 Summary and 1 Research with human beings plays an essential part in combatting disease and in expanding the frontiers of knowledge. The Commission takes as given that only through research can proven advances be made in the prevention and cure of illness and in the relief of suffering, but in this Report it addresses another goal, which, like progress against disease, is highly valued in our society. For not only is research essential but it is equally essential that this important human activity be carried out without needless risk or distress and with the willing and enlightened cooperation of its subjects. This is an ideal to which the Federal government must be—and for many years, has been-committed. In this Report, the President's Commission responds to the request of the Congress that it report every two years on the degree to which Federal departments and agencies are meeting that high ideal. The Commission has reviewed the policies of all Federal entities involved in some fashion in research involving human subjects. It is impressed that the officials of these agencies are for the most part concerned about the careful execution of their responsibilities and concludes that the rules and policies of the agencies largely appear adequate for the protection of human subjects if properly implemented. Certain problems in the application and interpretation of the rules, however, have emerged from the Commission's study. This Biennial Report contains the Commission's recommendations to the President, the Congress and the heads of relevant departments and agencies concerning a number of these problems. The Commission intends to make additional proposals in its next Biennial Report on the basis of its continuing examination of this field. Some of the Commission's conclusions refer to particular federal entities. The Commission points to (1) the need for the Department of Health and Human Services (HHS) either to accept or reject certain recommendations made in 1978 by the National Commission for the Protection of Human Subjects that were intended to provide additional procedures and standards so that appropriate decisions may be made to protect children and persons institutionalized as mentally disabled when reserchers wish to involve them as subjects; (2) the need for the Department of Housing and Urban Development to establish clear standards by which its social policy research can be categorized and, when appropriate, reviewed; and (3) the urgency that several bodies, including the Department of Transportation, reach decisions on rules that have been "under study" for many years [Recommendations 3 and 5]. Most of what the Commission has to say, however, treats issues that cut across the spectrum of Federal entities involved in research. First, the Commission recommends that the movement toward "uniformity" in the regulations for the protection of human research subjects be carried to its logical conclusion, and that the Department of Health and Human Services and its present regulations become the focus of such uniform rules [Recommendations 1 and 2]. This will advance four important objectives: it will improve the protection of subjects, alleviate an unnecessary burden (and source of confusion) for researchers and their institutions, eliminate the multiplicity of Federal regulations in this field, and simplify Federal oversight. The first goal will be met as gaps in a few departments' rules to protect research subjects are filled. "Variations" now followed by other departments can be included in the new uniform rules if found useful by the government-wide task force that will formulate these rules. The remaining objectives are closely related. By eliminating more than 200 pages of governmental rules and policies that now largely repeat the HHS regulations, the steps recommended by the Commission would reduce waste and confusion as well as facilitate Federal oversight. The redundancy in agencies' current rules obscures those few variations that are actually important to the respective Federal entities. Under the Commission's recommendations, any special provisions that are needed only by a particular entity could then be highlighted as acceptable exceptions or additions to the "core" provisions of the uniform regulations. And the centralization of responsibility for implementation and oversight in HHS would relieve Federal agencies and research institutions alike of the unnecessary burdens created by multiple inspections and reporting requirements. |