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This paper was published with
modifications in JAMA,
November 2001 |
“The findings and conclusions in this report are those of the author(s) and do not necessarily represent the views of the funding agency."
Authors:
Laura M. Beskow, MPH, Office of Genomics and Disease Prevention, Centers for Disease Control and Prevention, and The University of North Carolina at Chapel Hill School of Public Health
Wylie Burke, MD, PhD, Department of Medical History and Ethics, University of Washington
Jon F. Merz, MBA, JD, PhD, Center for Bioethics, University of Pennsylvania
Patricia A. Barr, formerly of Barr, Sternberg, Moss, Lawrence, Silver and Saltonstall, PC
Sharon Terry, MA, Genetic Alliance and PXE International, Inc.
Victor B. Penchaszadeh, MD, MSPH, Division of Medical Genetics, Beth Israel Medical Center
Lawrence O. Gostin, JD, Center for Law and the Public's Health, Georgetown University and Johns Hopkins University
Marta Gwinn, MD, MPH, Office of Genomics and Disease Prevention, Centers for Disease Control and Prevention
Muin J. Khoury, MD, PhD, Office of Genomics and Disease Prevention, Centers for Disease Control and Prevention
Corresponding Author:
Laura Beskow, c/o Office of Genomics and Disease Prevention, Centers for Disease Control and Prevention, 4770 Buford Highway NE, Mailstop K-89, Atlanta, GA 30341-3724, tel: 770-488-3235, fax: 770-488-3236; email: laura_beskow@unc.edu
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The following materials accompany the article, "Informed Consent for Population-Based Research Involving Genetics," which appears in the November 14, 2001 issue of JAMA.
- If you are a JAMA subscriber, you can click here
 to log on to their website and view the full text of the article.
- If you are not a JAMA subscriber, please be aware that the article contains important information about the rationale for each section of the informed consent template, including the types of research for which it may and may not be appropriate. This informed consent approach is based on federal policy for the protection of human research participants and a number of other sources as cited in the article. It follows closely the document "Consent for CDC Research: A Reference for Developing Consent Forms and Oral Scripts"
(last accessed 2/2008) and the National Bioethics Advisory Commission's report and recommendations on "Research Involving Human Biological Materials: Ethical Issues and Policy Guidance.
" This informed consent approach is provided to promote discussion and the language in the template must be modified to address the specific issues that arise within any individual study.
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.
Informed Consent Article
Supplemental Brochure
Informed Consent Template
Return to Public Health Perspective Page
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