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May 10, 2000

Protection for Human Subjects in Medical Research—Reply

Author Affiliations

Phil B.FontanarosaMD, Deputy EditorIndividualAuthorStephen J.LurieMD, PhD, Contributing EditorIndividualAuthor

JAMA. 2000;283(18):2387-2390. doi:10.1001/jama.283.18.2387

In Reply: Dr Kaufman indicates that his current IRB is able to devote enough time to provide a careful review of each study that comes before it. This is not inconsistent with the claim that many IRBs are overtaxed. A recent study undertaken for the National Institutes of Health surveyed 491 multiple project assurance IRBs and found that the "49 highest-volume IRBs accounted for 34,500 initial reviews, 34 times more than the 1,000 reviews conducted in the 49 lowest-volume IRBs."1

I agree with Dr Pelligra that there are problems in interpreting and applying the concept of minimal risk. However it is not an activity's degree of risk that determines whether it is research but whether the activity is "designed to develop or contribute to generalizable knowledge." It should not be left to researchers to exempt their own activities from review on the basis of personal judgments about the degree of risk in the activity.

I am sympathetic with Dr Reingold's view that it is desirable to have a more centralized system of review for multisite studies. I believe it is important, however, that such a system allow for some kind of input by local IRBs. I disagree with his view that "possible embarrassment" is a trivial risk for a research subject.

Dr Sackett wants me to review the "evidence base" regarding harms and benefits to research subjects. Unfortunately, such an evidence base is not available. There is no comprehensive publicly available database of adverse event reports; moreover, not all adverse events are reported.

Drs Shapiro and Meslin defend NBAC's recommendation "that federal regulations be changed to allow IRBs to grant waivers of the consent process even if it is practicable to obtain consent" for research using already existing human biological materials. They argue that the distinction between "the involvement of persons" in research and "the use (rather than involvement) of tissue specimens" justifies NBAC's differing recommendations on consent processes for research involving persons with mental disorders and for research using human tissue specimens. NBAC's recommendation on tissue research, however, applies to tissue specimens that are coded (ie, identifiable) or identified, so persons are involved, and in the case of genetic research, not just the person who is the tissue source is involved, but family members as well. To be sure, genetic research and other innovative research may be judged not to pose minimal risk and therefore not come under NBAC's recommendation. But judgments about minimal risk are highly variable, so this concept provides little protection for the identifiable individuals whose tissues are being studied. Moreover, researchers who will use prospectively collected specimens may ask why the practicability of obtaining consent should be a factor in NBAC's recommendation that consent be obtained for all such research, even minimal-risk research, if NBAC believes that practicability is irrelevant in deciding about waivers of consent for (virtually identical) research with already existing specimens.

Bell  JWhiton  JConnelly  S Final Report: Evaluation of NIH Implementation of Section 491 of the Public Health Service Act: Mandating a Program of Protection for Research Subjects. June 15, 1998:9. Available at http://grants.nih.gov/grants/oprr/hsp_report/hsp_final_rpt.pdf. Accessed March 30, 2000.
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These letters were shown to Dr Ellis, who declined to reply.—ED.