Consent for genetic research in the Framingham Heart Study§

Authors

  • Daniel Levy,

    Corresponding author
    1. Center for Population Studies, National Heart, Lung, and Blood Institute, Bethesda, Maryland
    2. The National Heart, Lung, and Blood Institute's Framingham Heart Study, Framingham, Massachusetts
    3. Departments of Medicine, Cardiology, Preventive Medicine and Neurology, Boston University School of Medicine, Boston, Massachusetts
    4. Cardiology Division, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts
    • Framingham Heart Study, National Heart, Lung, & Blood Institute, 73 Mt. Wayte Avenue, Suite 2, Framingham, MA 01702.
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  • Greta Lee Splansky,

    1. The National Heart, Lung, and Blood Institute's Framingham Heart Study, Framingham, Massachusetts
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  • Nicolle K. Strand,

    1. Center for Population Studies, National Heart, Lung, and Blood Institute, Bethesda, Maryland
    2. The National Heart, Lung, and Blood Institute's Framingham Heart Study, Framingham, Massachusetts
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  • Larry D. Atwood,

    1. The National Heart, Lung, and Blood Institute's Framingham Heart Study, Framingham, Massachusetts
    2. Departments of Medicine, Cardiology, Preventive Medicine and Neurology, Boston University School of Medicine, Boston, Massachusetts
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  • Emelia J. Benjamin,

    1. The National Heart, Lung, and Blood Institute's Framingham Heart Study, Framingham, Massachusetts
    2. Departments of Medicine, Cardiology, Preventive Medicine and Neurology, Boston University School of Medicine, Boston, Massachusetts
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  • Susan Blease,

    1. The National Heart, Lung, and Blood Institute's Framingham Heart Study, Framingham, Massachusetts
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  • L. Adrienne Cupples,

    1. The National Heart, Lung, and Blood Institute's Framingham Heart Study, Framingham, Massachusetts
    2. Department of Biostatistics, Boston University School of Public Health, Boston, Massachusetts
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  • Ralph B. D'Agostino Sr.,

    1. The National Heart, Lung, and Blood Institute's Framingham Heart Study, Framingham, Massachusetts
    2. Department of Mathematics, Boston University, Boston, Massachusetts
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  • Caroline S. Fox,

    1. Center for Population Studies, National Heart, Lung, and Blood Institute, Bethesda, Maryland
    2. The National Heart, Lung, and Blood Institute's Framingham Heart Study, Framingham, Massachusetts
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  • Margaret Kelly-Hayes,

    1. The National Heart, Lung, and Blood Institute's Framingham Heart Study, Framingham, Massachusetts
    2. Departments of Medicine, Cardiology, Preventive Medicine and Neurology, Boston University School of Medicine, Boston, Massachusetts
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  • Greg Koski,

    1. Departments of Medicine and Anesthesiology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts
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  • Martin G. Larson,

    1. The National Heart, Lung, and Blood Institute's Framingham Heart Study, Framingham, Massachusetts
    2. Department of Mathematics, Boston University, Boston, Massachusetts
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  • Karen M. Mutalik,

    1. The National Heart, Lung, and Blood Institute's Framingham Heart Study, Framingham, Massachusetts
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  • Elizabeth Oberacker,

    1. The National Heart, Lung, and Blood Institute's Framingham Heart Study, Framingham, Massachusetts
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  • Christopher J. O'Donnell,

    1. Center for Population Studies, National Heart, Lung, and Blood Institute, Bethesda, Maryland
    2. The National Heart, Lung, and Blood Institute's Framingham Heart Study, Framingham, Massachusetts
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  • Patrice Sutherland,

    1. The National Heart, Lung, and Blood Institute's Framingham Heart Study, Framingham, Massachusetts
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  • Maureen Valentino,

    1. The National Heart, Lung, and Blood Institute's Framingham Heart Study, Framingham, Massachusetts
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  • Ramachandran S. Vasan,

    1. The National Heart, Lung, and Blood Institute's Framingham Heart Study, Framingham, Massachusetts
    2. Departments of Medicine, Cardiology, Preventive Medicine and Neurology, Boston University School of Medicine, Boston, Massachusetts
    3. Department of Mathematics, Boston University, Boston, Massachusetts
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  • Philip A. Wolf,

    1. The National Heart, Lung, and Blood Institute's Framingham Heart Study, Framingham, Massachusetts
    2. Departments of Medicine, Cardiology, Preventive Medicine and Neurology, Boston University School of Medicine, Boston, Massachusetts
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  • Joanne M. Murabito

    1. The National Heart, Lung, and Blood Institute's Framingham Heart Study, Framingham, Massachusetts
    2. Departments of Medicine, Cardiology, Preventive Medicine and Neurology, Boston University School of Medicine, Boston, Massachusetts
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  • This article is a US Government work and, as such, is in the public domain in the United States of America.

  • This paper was conceived and drafted during Dr. Levy's Fellowship in the Medical Ethics Fellowship Program at Harvard Medical School.

  • §

    How to cite this article: Levy D, Splansky GL, Strand NK, Atwood LD, Benjamin EJ, Blease S, Cupples LA, D'Agostino Sr. RB, Fox CS, Kelly-Hayes M, Koski G, Larson MG, Mutalik KM, Oberacker E, O'Donnell CJ, Sutherland P, Valentino M, Vasan RS, Wolf PA, Murabito JM. 2010. Consent for genetic research in the Framingham heart study. Am J Med Genet Part A 152A:1250–1256.

Abstract

Extensive efforts have been aimed at understanding the genetic underpinnings of complex diseases that affect humans. Numerous genome-wide association studies have assessed the association of genes with human disease, including the Framingham Heart Study (FHS), which genotyped 550,000 SNPs in 9,000 participants. The success of such efforts requires high rates of consent by participants, which is dependent on ethical oversight, communications, and trust between research participants and investigators. To study this we calculated percentages of participants who consented to collection of DNA and to various uses of their genetic information in two FHS cohorts between 2002 and 2009. The data included rates of consent for providing a DNA sample, creating an immortalized cell line, conducting research on various genetic conditions including those that might be considered sensitive, and for notifying participants of clinically significant genetic findings were above 95%. Only with regard to granting permission to share DNA or genetic findings with for-profit companies was the consent rate below 95%. We concluded that the FHS has maintained high rates of retention and consent for genetic research that has provided the scientific freedom to establish collaborations and address a broad range of research questions. We speculate that our high rates of consent have been achieved by establishing frequent and open communications with participants that highlight extensive oversight procedures. Our approach to maintaining high consent rates via ethical oversight of genetic research and communication with study participants is summarized in this report and should be of help to other studies engaged in similar types of research. Published 2010 Wiley-Liss, Inc.

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