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Phil B.FontanarosaMD, Deputy EditorIndividualAuthorStephen J.LurieMD, PhD, Contributing EditorIndividualAuthor
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.
These letters were shown to Dr Ellis, who declined to reply.—ED.
Woodward B. Protection for Human Subjects in Medical Research—Reply. JAMA. 2000;283(18):2387–2390. doi:10.1001/jama.283.18.2387
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