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Informed Consent for Population-Based Research Involving Genetics
Laura M. Beskow, MPH;
Wylie Burke, MD, PhD;
Jon F. Merz, MBA, JD, PhD;
Patricia A. Barr;
Sharon Terry, MA;
Victor B. Penchaszadeh, MD, MSPH;
Lawrence O. Gostin, JD;
Marta Gwinn, MD, MPH;
Muin J. Khoury, MD, PhD
JAMA. 2001;286:2315-2321.
Bridging the gap between gene discovery and our ability to use genetic information to benefit health requires population-based knowledge about the contribution of common gene variants and gene-environment interactions to the risk of disease. The risks and benefits associated with population-based research involving genetics, especially lower-penetrance gene variants, can differ in nature from those associated with family-based research. In response to the urgent need for appropriate guidelines, the Centers for Disease Control and Prevention formed a multidisciplinary group to develop an informed consent approach for integrating genetic variation into population-based research. The group used expert opinion and federal regulations, the National Bioethics Advisory Commission's report on research involving human biological materials, existing consent forms, and literature on informed consent to create suggested language for informed consent documents and a supplemental brochure. This language reflects the premise that the probability and magnitude of harm, as well as possible personal benefits, are directly related to the meaning of the results for the health of the participant and that appropriate disclosures and processes for obtaining consent should be based on an assessment at the outset of the likelihood that the results will generate information that could lead directly to an evidence-based intervention. This informed consent approach is proposed to promote discussion about how best to enable potential participants to make informed decisions about population-based research involving genetics and to suggest issues for consideration by research sponsors, institutional review boards, and investigators.
Author Affiliations: Office of Genetics and Disease Prevention, Centers for Disease Control and Prevention, Atlanta, Ga (Ms Beskow and Drs Gwinn and Khoury); University of North Carolina at Chapel Hill School of Public Health (Ms Beskow); Department of Medical History and Ethics, University of Washington, Seattle (Dr Burke); Center for Bioethics, University of Pennsylvania, Philadelphia (Dr Merz); Genetic Alliance, Washington, DC (Ms Terry); PXE International Inc, Sharon, Mass (Ms Terry); Division of Medical Genetics, Beth Israel Medical Center, New York, NY (Dr Penchaszadeh); and the Center for Law and the Public's Health, Georgetown University and Johns Hopkins University, Baltimore, Md (Mr Gostin). Ms Barr was formerly with Barr, Sternberg, Moss, Lawrence, Silver, and Saltonstall PC, Bennington, Vt.
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