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Genet Med. 2012 Feb;14(2):215-22. doi: 10.1038/gim.2011.10. Epub 2012 Jan 5.

IRB perspectives on the return of individual results from genomic research.

Author information

1
Institute for Pharmacogenomics and Individualized Therapy, University of North Carolina, Chapel Hill, NC, USA. lynn_dressler@unc.edu

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.

PMID:
22241094
PMCID:
PMC3493147
DOI:
10.1038/gim.2011.10
[Indexed for MEDLINE]
Free PMC Article
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