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OHRP Guidance - IRB Knowledge of Local Research ContextAugust 27, 1998 [Updated July 21, 2000]
TO: Division of Human Subject Protections, OPRR
FROM: Director, Division of Human Subject Protections, OPRR
SUBJECT: IRB Knowledge of Local Research Context
Department of Health and Human Services (DHHS) regulations at 45 CFR 46.103(d) require that the adequacy of Institutional Review Boards (IRBs) be evaluated in light of the anticipated scope of the institution's research activities, the types of subject populations likely to be involved, . . . and the size and complexity of the institution.
The regulations further require at 45 CFR 46.107(a) that IRBs be (i) sufficiently qualified through . . . the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel; and (ii) able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice.
IRBs must also be capable of ensuring that
(i) selection of subjects is equitable;Institutions have a profound responsibility to ensure that all IRBs designated under an OPRR-approved Assurance possess sufficient knowledge of the local research context to satisfy these requirements. This responsibility endures regardless of the IRB's geographic location relative to the institution and the research. It is particularly critical where the research involves greater than minimal risk to subjects or vulnerable categories of subjects.
(A) OPRR considers the following standards when evaluating the adequacy of IRBs designated under an institutional Assurance, particularly when the IRBs are geographically removed from the local research context. These standards reflect minimum levels of adequacy. More stringent standards may be required, depending upon the nature of the proposed research or the relevant research context.
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