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8. IRBs Should be Required Only to Report to Appro

priate 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 Active-
ly Shared With Government Agencies, Professional
Societies, and Licensing Boards

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Appendices

85

13

16

Tables
1. Extent of Biomedical and Behavioral Research

Involving Human Subjects Conducted or Supported
by Agencies with Statutory Liaisons to the Com-

mission
2. Agencies Excluded from Review and Analysis in

This Report 3. Agencies Included in This Report's Review and

Analysis 4. Agency Conformity with HHS Regulations 5. Agency Procedures for Monitoring Performance of

Extramural IRBs
6. Summary of Institutional and HHS Responses to Re-

ported Incidents of Research Fraud, Abuse or Vio-
lations of Regulations

17

29

45

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1

Summary and
Conclusions

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.

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