Elsevier

Genetics in Medicine

Volume 14, Issue 2, February 2012, Pages 215-222
Genetics in Medicine

Original Research Article
IRB perspectives on the return of individual results from genomic research

https://doi.org/10.1038/gim.2011.10Get rights and content
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Abstract

Purpose

Return of individual research results from genomic studies is a hotly debated ethical issue in genomic research. However, the perspective of key stakeholders—institutional review board (IRB) professionals—has been missing from this dialogue. This study explores the positions and experiences of IRB members and staff regarding this issue.

Methods

In-depth interviews with 31 IRB professionals at six sites across the United States.

Results

IRB professionals agreed that research results should be returned to research participants when results are medically actionable but only if the participants want to know the results. Many respondents expected researchers to address the issue of return of results (ROR) in the IRB application and informed-consent document. Many respondents were not comfortable with their expertise in genomics research and only a few described actual experiences in addressing ROR. Although participants agreed that guidelines would be helpful, most were reticent to develop them in isolation. Even where IRB guidance exists (e.g., Clinical Laboratory Improvement Act (CLIA) lab certification required for return), in practice, the guidance has been overruled to allow ROR (e.g., no CLIA lab performs the assay).

Conclusion

An IRB–researcher partnership is needed to help inform responsible and feasible institutional approaches to returning research results.

Genet Med 2012:14(2):215–222

Keywords

disclosure of results
genetic research
genomic research
institutional review boards
return of results

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