This Article  • Full text  • PDF  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Citing articles on HighWire  • Citing articles on ISI (98)  • Contact me when this article is cited  Related Content  • Related article  • Similar articles in JAMA  Topic Collections  • Medical Practice  • Law and Medicine  • Medical Ethics  • Statistics and Research Methods  • Alert me on articles by topic  Social Bookmarking   What's this?

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.

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati     What's this?

RELATED ARTICLE

Reforming Informed Consent to Genetic Research
George J. Annas
JAMA. 2001;286(18):2326-2328.
EXTRACT | FULL TEXT  

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

The Importance of Gene--Environment Interaction: Implications for Social Scientists
North and Martin
Sociological Methods Research 2008;37:164-200.
ABSTRACT  

Introducing Social and Ethical Perspectives on Gene--Environment Research
Henderson
Sociological Methods Research 2008;37:251-276.
ABSTRACT  

Self-assessed understanding as a tool for evaluating consent: reflections on a longitudinal study
Swartling and Helgesson
J. Med. Ethics 2008;34:557-562.
ABSTRACT | FULL TEXT  

Parental authority, research interests and children's right to decide in medical research - an uneasy tension?
Swartling et al.
Clin Ethics 2008;3:69-74.
ABSTRACT | FULL TEXT  

Managing incidental findings in human subjects research: analysis and recommendations.
Wolf et al.
J Law Med Ethics 2008;36:219-248.
 

Incidental findings in genetics research using archived DNA.
Clayton
J Law Med Ethics 2008;36:286-291.
 

Views on data use, confidentiality and consent in a predictive screening involving children
Helgesson and Swartling
J. Med. Ethics 2008;34:206-209.
ABSTRACT | FULL TEXT  

Duty to disclose what? Querying the putative obligation to return research results to participants
Miller et al.
J. Med. Ethics 2008;34:210-213.
ABSTRACT | FULL TEXT  

Will forensic use of medical biobanks decrease public trust in healthcare services? Some empirical observations
Bexelius et al.
Scand J Public Health 2007;35:442-444.
ABSTRACT  

Perceptions of potential donors in the Swedish public towards information and consent procedures in relation to use of human tissue samples in biobanks: A population-based study
Kettis-Lindblad et al.
Scand J Public Health 2007;35:148-156.
ABSTRACT  

Constructing Participation in Genetic Databases: Citizenship, Governance, and Ambivalence
Tutton
Science Technology Human Values 2007;32:172-195.
ABSTRACT  

Voluntary Participation and Informed Consent to International Genetic Research
Marshall et al.
Am. J. Public Health 2006;96:1989-1995.
ABSTRACT | FULL TEXT  

Enhancing the ethical conduct of genetic research: investigating views of parents on including their healthy children in a study on mild hearing loss.
Gillam et al.
J. Med. Ethics 2006;32:537-541.
ABSTRACT | FULL TEXT  

Human Genetic Research: Emerging Trends in Ethics
Knoppers and Chadwick
Focus 2006;4:416.
ABSTRACT | FULL TEXT  

Receiving a summary of the results of a trial: qualitative study of participants' views
Dixon-Woods et al.
BMJ 2006;332:206-210.
ABSTRACT | FULL TEXT  

Expanding the Ethical Analysis of Biobanks
Rothstein
J Law Med Ethics 2005;33:89-101.
 

The Ethics of Research Using Biobanks: Reason to Question the Importance Attributed to Informed Consent
Hoeyer et al.
Arch Intern Med 2005;165:97-100.
ABSTRACT | FULL TEXT  

Reporting of informed consent and ethics committee approval in genetics studies of stroke
Meschia and Merino
J. Med. Ethics 2003;29:371-372.
FULL TEXT  

The Charitable Trust as a Model for Genomic Biobanks
Winickoff and Winickoff
NEJM 2003;349:1180-1184.
FULL TEXT  

Problematic Variation in Local Institutional Review of a Multicenter Genetic Epidemiology Study
McWilliams et al.
JAMA 2003;290:360-366.
ABSTRACT | FULL TEXT  

American Society of Clinical Oncology Policy Statement Update: Genetic Testing for Cancer Susceptibility
JCO 2003;21:2397-2406.
ABSTRACT | FULL TEXT  

The science and art of molecular epidemiology
Slattery
J. Epidemiol. Community Health 2002;56:728-729.
FULL TEXT  

Commentary: Epidemiology and the Continuum from Genetic Research to Genetic Testing
Khoury
Am J Epidemiol 2002;156:297-299.
FULL TEXT  

Research on Stored Biological Samples Is Still Research
Sade
Arch Intern Med 2002;162:1439-1440.
FULL TEXT  

Pharmacogenetic Challenges For The Health Care System
Robertson et al.
Health Aff (Millwood) 2002;21:155-167.
ABSTRACT | FULL TEXT  

Ethical Issues in Human Genome Epidemiology: A Case Study Based on The Japanese American Family Study in Seattle, Washington
Austin
Am J Epidemiol 2002;155:585-592.
ABSTRACT | FULL TEXT  

The Media and Public Reaction to Genetic Research
Geller et al.
JAMA 2002;287:773-773.
FULL TEXT  

Reforming Informed Consent to Genetic Research
Annas
JAMA 2001;286:2326-2328.
FULL TEXT