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ARTICLE |

Genetic Testing for Susceptibility to Adult-Onset Cancer:  The Process and Content of Informed Consent

Gail Geller, ScD; Jeffrey R. Botkin, MD, MPH; Michael J. Green, MD, MS; Nancy Press, PhD; Barbara B. Biesecker, MS; Benjamin Wilfond, MD; Generosa Grana, MD; Mary B. Daly, MD, PhD; Katherine Schneider, MPH; Mary Jo Ellis Kahn, RN, MSN
JAMA. 1997;277(18):1467-1474. doi:10.1001/jama.1997.03540420063031.
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Objective.  —To provide guidance on informed consent to clinicians offering cancer susceptibility testing.

Participants.  —The Task Force on Informed Consent is part of the Cancer Genetics Studies Consortium (CGSC), whose members were recipients of National Institutes of Health grants to assess the implications of cancer susceptibility testing. The 10 task force members represent a range of relevant backgrounds, including various medical specialties, social science, genetic counseling, and consumer advocacy.

Evidence.  —The CGSC held 3 public meetings from 1994 to 1996. At its first meeting, the task force jointly established a list of topics. The cochairs (G.G. and J.R.B) then developed an outline and assigned each topic to an appropriate writer and reviewer. Writers summarized the literature on their topics and drafted recommendations, which were then revised by the reviewers. The cochairs compiled and edited the entire manuscript. All members were involved in writing this report.

Consensus Process.  —The first draft was distributed to task force members, after which a meeting was held to discuss its content and organization. Consensus was reached by voting. A subsequent draft was presented to the entire CGSC at its third meeting, and comments were incorporated.

Conclusions.  —The task force recommends that informed consent for cancer susceptibility testing be an ongoing process of education and counseling in which (1) providers elicit participant, family, and community values and disclose their own, (2) decision making is shared, (3) the style of information disclosure is individualized, and (4) specific content areas are discussed.

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