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May 14, 1997, Vol 277, No. 18 >
ARTICLE | May 14, 1997

Genetic Testing for Susceptibility to Adult-Onset Cancer: Title and subTitle BreakThe Process and Content of Informed Consent FREE

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
[+] Author Affiliations

Reprints: Gail Geller, ScD, Johns Hopkins University School of Medicine, 550 N Broadway, Suite 511, Baltimore, MD 21205.


JAMA. 1997;277(18):1467-1474. doi:10.1001/jama.1997.03540420063031
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References

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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Figures

Tables

Interactive Graphics

Video

Country-Specific Mortality and Growth Failure in Infancy and Yound Children and Association With Material Stature

Use interactive graphics and maps to view and sort country-specific infant and early dhildhood mortality and growth failure data and their association with maternal

1 +
Levine AJ.  The genetic origins of neoplasia . JAMA . 1995;;273:592.
2 +
Rowley JD, Aster JC, Sklar J.  The clinical applications of new DNA diagnostic technology on the management of cancer patients . JAMA . 1993;;270: 2331-2337.
3 +
Liu B, Parsons RE, Hamilton SR, et al.  hMSH2 mutations in hereditary nonpolyposis colorectal cancer kindreds . Cancer Res . 1994;;54:4590-4594.
4 +
Papadopoulas N, Nicolaides NC, Wei Y-F, et al.  Mutation of a mutL homolog in hereditary colon cancer . Science . 1994;;263:1625-1629.
5 +
Nicolaides NC, Papadopoulas N, Liu B, et al.  Mutations of two PMS homologues in hereditary nonpolyposis colon cancer . Nature . 1994;;371:75-80.
6 +
Miki Y, Swensen J, Shattuck-Eidens D, et al.  A strong candidate for the breast and ovarian cancer susceptibility gene BRCA1 . Science . 1994;;266:66-71.
7 +
Wooster R, Neuhausen SL, Mangion J, et al.  Localization of a breast cancer susceptibility gene, BRCA2, to chromosome 13q12-13 . Science . 1994;; 265:2088-2090.
8 +
Malkin D, Li FP, Strong LC, et al.  Germ line p53 mutations in a familial syndrome of breast cancer, sarcomas and other neoplasms . Science . 1990;;250: 1233-1238.
9 +
Burke W, Petersen G, Lynch P, et al.  Recommendations for follow-up care of individuals with an inherited predisposition to cancer, I: hereditary nonpolyposis colon cancer . JAMA . 1997;;277:915-919.
10 +
Burke W, Daly M, Garber J, et al.  Recommendations for follow-up care of individuals with an inherited predisposition to cancer, II: BRCA1 and BRCA2 . JAMA . 1997;;277:997-1003.
11 +
National Advisory Council for Human Genome Research.  Statement on use of DNA testing for presymptomatic identification of cancer risk . JAMA . 1994;;271:785.
12 +
Garber JE, Schrag D.  Testing for cancer susceptibility . JAMA . 1996;;275:1928-1929.
13 +
Li FP, Garber JE, Friend SH, et al.  Recommendations on predictive testing for germ line p53 mutations among cancer-prone individuals . J Natl Cancer Inst . 1992;;84:1156-1160.
14 +
Lerman C, Narod S, Schulman K, et al.  BRCA1 testing in families with hereditary breast-ovarian cancer: a prospective study of patient decision making and outcomes . JAMA . 1996;;275:1885-1892.
15 +
 Statement of the American Society of Human Genetics on genetic testing for breast and ovarian cancer predisposition . Am J Hum Genet . 1994;;55:i-iv.
16 +
Presymptomatic genetic testing for heritable breast cancer risk. Press release of the National Breast Cancer Coalition. Washington, DC, September 28, 1995.
17 +
Kahn P.  Coming to grips with genes and risk . Science . 1996;;274:496-498.
18 +
Geller G, Kass NE.  Informed consent in the context of prenatal HIV screening . In: Faden RR, Geller G, Powers GM, eds. AIDS, Women and the Next Generation: Towards a Morally Acceptable Public Policy on HIV Screening of Pregnant Women and Newborns . New York, NY: Oxford University Press; 1991;.
19 +
Garber JE, Patenaude AF.  Ethical, social and counselling issues in hereditary cancer susceptibility . Cancer Surv . 1995;;25:381-397.
20 +
Lippman A.  Prenatal genetic testing and screening: constructing needs and reinforcing inequities . Am J Law Med . 1991;;17:15-50.
21 +
Hofman KA, Tambor ES, Chase GA, Geller G, Faden RR, Holtzman NA.  Physicians' knowledge of genetics and genetic tests . Acad Med . 1993;;68: 625-632.
22 +
Lee JM.  Screening and informed consent . N Engl J Med . 1993;;328:438-440.
23 +
Holtzman NA.  Are we ready to screen for inherited susceptibility to cancer? Oncology . 1996;; 10:57-64.
24 +
 ASHG/ACMG Report. Points to consider: ethical, legal and psychosocial implications of genetic testing in children and adolescents . Am J Hum Genet . 1995;;57:1233-1241.
25 +
Appelbaum PS, Lidz CW, Meisel A. Informed Consent: Legal Theory and Clinical Practice . New York, NY: Oxford University Press; 1987;.
26 +
Faden RR, Beauchamp TL, King NP. A History and Theory of Informed Consent . New York, NY: Oxford University Press, 1986;:86.
27 +
Elias S, Annas GJ.  Generic consent for genetic screening . N Engl J Med . 1994;;330:1611-1613.
28 +
Andrews LB, Fullarton JE, Holtzman NA, Motulsky AG, eds. Assessing Genetic Risks: Implications for Health and Social Policy . Washington, DC: National Academy Press; 1994;:259-282.
29 +
Press N, Browner CH.  Risk, autonomy, and responsibility: informed consent for prenatal testing . Hastings Cent Rep . 1995;;25:S9-S12.
30 +
Marteau TM.  Towards informed decisions about prenatal testing: a review . Prenat Diagn . 1996;;14: 1215-1226.
31 +
Holtzman NA, Faden RR, Chwalow JA, Horn SD.  Effect of informed consent on mothers' knowledge of newborn screening . Pediatrics . 1983;;72:807-812.
32 +
Sharp NF.  Informed consent and Huntington disease: a model for communication . Am J Med Genet . 1994;;50:239-246.
33 +
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