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Workshop on Heritable Cancer Syndromesand Genetic Testing

Supplement to Cancer

Medical/Legal Issues in Genetic TestingWorkshop No. 3

Patrick Lynch, J.D., M.D. (Co-Chair)

TMatthew Severin, J.D., Ph.D. (Co-Chair)he workgroup considered a number of medical-legal issues ingenetic testing, including regulatory issues, legislative issues,

Alan Mills (Rapporteur)and emerging standards of patient care that perhaps have, or will,Linda Bosserman, M.D.*represent a ‘‘duty’’ on the part of the physician. These issuesDoreine Carson*share a degree of uncertainty as well as a lack of clear and sharedDonald C. Chambers, M.D.*standards, and in some instances are driven by competing inter-Myles Cunningham, M.D.*ests. The workgroup participants agreed that there was a pressingMay Sung, M.P.H.*

Nicholas J. Vogelzang, M.D.* need to further define and explore these issues, especially amongcompeting interests, and that there should be strong collaborativeinitiatives among appropriate organizations to establish guide-lines to assist the public and providers on issues related to riskassessment and clinical decision making.

RecommendationsDuties for the Physician/Provider1. All physicians should take a family history.2. Providers should have guidelines for recognizing ‘‘at risk’’ individu-

als, and responsibility for family reporting.3. Guidelines for referral for genetic counseling and testing services

are needed.4. ‘‘Gag rules’’ employed by managed care and similar entities, partic-

ularly as they apply to predisposition testing and clinical surveil-lance, are inappropriate.

Legislative Issues1. There should be legislative support for training and education to

enhance skills in genetic counseling.2. There should be informed consent standards for genetic testing,

and testing should only be offered in the context of pre- and post-* Workshop participant.

test counseling.3. The Americans with Disabilities Act should be amended to includePresented at the American Cancer Society

Workshop on Heritable Cancer Syndromes and genetic predisposition. The Equal Employment Opportunity Com-Genetic Testing, Chicago, Illinois, October 7–8, mission should prohibit employment discrimination based on ge-1996.

netic predisposition.Address for reprints: Patrick Lynch, J.D., 4. There is a need to support greater access to clinical trials, and stateM.D., Department of Gastrointestinal Medical insurance regulations should insure coverage for participants inOncology and Digestive Diseases, University

studies.of Texas M. D. Anderson Cancer Center,1515 Holcombe Boulevard, Box 78, Houston, Regulatory IssuesTX 77030.

1. There should be national regulatory mechanisms through the Foodand Drug Administration, or other appropriate body, that establishReceived April 10, 1997; accepted April 16,

1997. quality assurance standards for genetic testing.

q 1997 American Cancer Society

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Patient Rights2. A national tissue/samples data bank should be1. The American Cancer Society should work withcreated, with appropriate and strict safeguards other organizations to promulgate information on

on the use of materials and information. patient rights with regard to genetic testing.

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