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

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.