IRB perspectives on the return of individual results from genomic research

Lynn G. Dressler, Sondra Smolek, Roselle Ponsaran, Janell M. Markey, Helene Starks, Nancy Gerson, Susan Lewis, Nancy Press, Eric Juengst, Georgia L. Wiesner

    Research output: Contribution to journalArticle

    41 Scopus citations

    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.

    Original languageEnglish (US)
    Pages (from-to)215-222
    Number of pages8
    JournalGenetics in Medicine
    Volume14
    Issue number2
    DOIs
    StatePublished - Feb 2012

    Keywords

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

    ASJC Scopus subject areas

    • Genetics(clinical)

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  • Cite this

    Dressler, L. G., Smolek, S., Ponsaran, R., Markey, J. M., Starks, H., Gerson, N., Lewis, S., Press, N., Juengst, E., & Wiesner, G. L. (2012). IRB perspectives on the return of individual results from genomic research. Genetics in Medicine, 14(2), 215-222. https://doi.org/10.1038/gim.2011.10