A Deadline Is a Deadline Is a DeadlineAuthor(s): Carol LevineSource: IRB: Ethics and Human Research, Vol. 3, No. 6 (Jun. - Jul., 1981), p. 11Published by: The Hastings CenterStable URL: http://www.jstor.org/stable/3564351 .

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June/July 1981

A Paradox in Ethical Review of Social Experiments

John Robertson ("Social Experi- ments and Prior Ethical Review," IRB, April 1981, pp. 1-3) concludes that "the continued requirement of IRB review of both large- and small-scale social ex- periments is sound policy

... ." As

cogent as his arguments are that social experiments involve substantial ethical issues, an undiscussed paradox under- lies his conclusion, namely that he would give greater protection to the few participants of social experiments than to the many members of the gen- eral public even when the conse- quences to each group are identical.

This paradox may be illustrated using Robertson's example of an exper- iment proposed by the Judicial Con- ference of the United States (JCUS). In this experiment a committee headed by Judge J.L. King of Miami would test, by means of a pilot program, whether special bar-examination and trial-experience requirements could improve the competence of lawyers practicing in federal courts. Ethical problems surrounding the experiment were noted in a letter to Judge King by the Institute for Public Representation located at the Georgetown University Law Center. These problems included: lack of an adequate definition of com- petency, poor methodology, and no technique for measuring the negative effect of the changes. Robertson notes, however, that JCUS had the statutory authority to recommend to the Su- preme Court changes in the rules of practice in the federal courts and that the Supreme Court could adopt the changes if it saw fit. Thus, I conclude, these changes could have been enacted without resort to a pilot program.

Here is the paradox. If JCUS and the Supreme Court implemented changes for all federal courts instead of just a few, there would be no controversy over informed consent, rights of partic- ipants, or risk-benefit analysis. The de- cision might be viewed as foolish or wise, legal or illegal, constitutional or unconstitutional, but not ethical or un- ethical. How is it "sound policy" to protect, by means of an IRB, the few involved in social experiments but not the many affected by legislative, ad- ministrative, and judicial actions where no such experiment is con- ducted?

By my lights all legislation is experi- mental, not in the sense that a control group exists but rather because the full range of consequences are unknown. If so, why confine ethical review to social

experiments? Some large percentage of proposed federal, state, and local legis- lation and similar administrative and judicial decisions present substantial risks and benefits to citizens. The prob- lem is that Robertson's locus for invok- ing ethical considerations lies in the research process rather than in the re- lationship between the governed and the governing.

Lauren H. Seiler Associate Professor of Sociology Queens College

LETTERS TO IRB

We welcome letters from our readers and we publish as many as space permits. In general, shorter communica- tions have a better chance of being published. We reserve the right to edit or abridge letters as necessary.

A Deadline Is a Deadline Is a Deadline

According to an intra-agency memo the sixty-day deadline for filing form 596 certifying IRB review and approval of a grant proposal submitted to DHHS will be more consistently enforced at ADAMHA and NIMH. This policy has been written in federal regulations since 1974 but has been enforced more or less strictly by different agencies.

Section 46.103 (f) of the new regula- tions states: "Within 60 days after the data of submission to HHS of an appli- cation or proposal, an institution with an approved assurance covering the proposed research shall certify that the application or proposal has been re- viewed and approved by the IRB. Other institutions shall certify that the application or proposal has been ap- proved by the IRB within 30 days after receipt of a request for such a certifica- tion from the Department."

If institutions do not meet the dead- line for filing the certification, the pro- posal will be deferred until the next receipt date, or approximately three to four months.

Carol Levine

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