Assessing the understanding of biobank participants

Authors

  • K.E. Ormond,

    Corresponding author
    1. Center for Genetic Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois
    2. Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois
    3. Medical Humanities and Bioethics, Feinberg School of Medicine, Northwestern University, Chicago, Illinois
    • Department of Genetics, Stanford University, 300 Pasteur Drive H315, Stanford, CA 94305-5208.
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  • A.L. Cirino,

    1. Center for Genetic Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois
    2. Brigham and Women's Hospital, Boston, Massachusetts
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  • I.B. Helenowski,

    1. Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois
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  • R.L. Chisholm,

    1. Center for Genetic Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois
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  • W.A. Wolf

    1. Center for Genetic Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois
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  • K.E. Ormond, A.L. Cirino, and W.A. Wolf contributed equally to this work.

  • How to cite this article: Ormond KE, Cirino AL, Helenowski IB, Chisholm RL, Wolf WA. 2009. Assessing the understanding of biobank participants. Am J Med Genet Part A 149A:188–198.

Abstract

Biobanks have been developed as a tool to better understand the genetic basis of disease by linking DNA samples to corresponding medical information. The broad scope of such projects presents a challenge to informed consent and participant understanding. To address this, 200 telephone interviews were conducted with participants in the NUgene Project, Northwestern University's biobank. Interviews included a modified version of the “quality of informed consent measure” (QuIC) and semi-structured questions which were analyzed thematically for 109 of the interviews. The QuIC, originally applied to cancer clinical trials, objectively assessed some of the components of informed consent for a biobank, and interview questions provided rich data to assist in interpreting participant understanding. The best understood domains included: the nature of the study, benefit to future patients, and the voluntary nature of participation. Lower knowledge scores included: potential risks and discomforts, experimental nature of the research, procedures in the event of study-related injury, and confidentiality issues. Qualitatively, confidentiality protections of the study were described as good by most (>50%). Although some cited concerns with employer (12%) or insurance discrimination (25%), most considered the risks to privacy low (25%) or none (∼60%). Only 10% of participants explicitly stated they had no expectation for personal benefit, and when asked whether they expected to be contacted with study results, respondents were split between having no expectation (39%), being hopeful for results (37%) and expecting to be contacted with results (12%). These findings are informative to those establishing and implementing biobanks, and to the IRBs reviewing such studies. © 2009 Wiley-Liss, Inc.

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