than 2 years later that proposed uniform regulations were published.27 Final rules were published on June 18, 1991.28 A major factor in the delay has been (as before) the applicability of the IRB and consent requirements to education research and to demonstration projects designed to evaluate public benefit programs.29

LESSONS FOR THE FUTURE

The development of IRBs as a regulatory mechanism for protecting human subjects demonstrates that time, collegial interaction, and goodwill are important ingredients for successful rulemaking. When policy conflicts arise, participation in the deliberations by all who wish to be heard not only improves the substantive regulations, but also increases the likelihood of their acceptance and enhances public confidence in the process. In short, the success and credibility of the process are directly related to the extent to which all interested parties are afforded an opportunity to participate.

The hazards of proceeding unilaterally were demonstrated recently by the unsuccessful attempt of the NIH to establish ''guidelines" for dealing with conflicts of interest, without affording adequate opportunity to comment. The research community felt it had been blindsided. Responses reflected outrage, a sense of betrayal, and frustration.30 A much fuller airing of the concerns of all interested parties, as well as a public deliberative process, would more likely produce a broadly accepted set of rules. Such an approach also would enhance public confidence in the process and substance of the rulemaking. In the absence of a more thoughtful development of rules, mistrust and resistance probably will continue.

NOTES

1.  

See, for example, Jonsen, A., 1984, "Public policy and human research," pp. 3-19 in Biomedical Ethics Reviews, Humber, J. M. and R. T. Almeder (eds.). Humana, Clifton, N.J.

2.  

For a brief history of early antecedents, see President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, 1982, Compensating for Research Injuries, U.S. Government Printing Office, Washington, D.C., p. 30.

3.  

See President's Commission, Compensating for Research Injuries, 1982, pp. 30-33.

4.  

Pappworth, M. H., 1967, Human Guinea Pigs, Beacon, Boston.

5.  

Pappworth, Human Guinea Pigs, 1967, pp. 209-10; see also, President's Commission, Compensating for Research Injuries, 1982, pp. 32-33.



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