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Account Res. 2007 Oct-Dec;14(4):255-67. doi: 10.1080/08989620701670179.

Offering results to research subjects: U.S. Institutional Review Board policy.

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  • 1School of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.

Abstract

BACKGROUND:

This study aims to determine the nature of United States Institutional Review Board (IRB) policy in a broad spectrum of research settings regarding the return of results to study participants.

METHOD:

IRB policies or standard operating procedures of 207 Medical School, Industry and Non-medical School IRBs were examined on-line to determine if they incorporated specific reference to the return of results to participants at the conclusion of the research.

RESULTS:

The majority of IRBs had no available policy regarding the return of research results to participants [56% (n = 116)]. A further third 136.3% (n = 75)] had policies that were defined as vague or that only indirectly mentioned the return of results. Medical School IRBs were more likely to have a policy than Industry or Non-medical University IRBs, respectively (odds ratio, 4.63; 95% confidence interval, 1.84 to 11.66 and odds ratio, 3.03; 95 % confidence interval, 1.75 to 5.25). Few provided any guidance as to the process of return of results. Of the IRBs that had a research results policy, 54.9% (n = 50) specifically addressed genetic research.

CONCLUSIONS:

Our findings demonstrate a marked lack of uniformity in IRB policy regarding the return of study results with over half providing no guidance.

PMID:
18246944
[PubMed - indexed for MEDLINE]
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