Structuring the Review of Human Genetics Protocols Part II: Diagnostic and Screening Studies

IRB: A Review of Human Subjects Research, Vol. 19, Nos. 3-4, pp. 1-13, 1997

12 Pages Posted: 13 Jun 2008

See all articles by Kathleen C. Glass

Kathleen C. Glass

McGill University

Charles Weijer

Dalhousie University

Trudo Lemmens

University of Toronto - Faculty of Law

Roberta M. Palmour

McGill University - Faculty of Medicine

Stanley H. Shapiro

McGill University - Faculty of Medicine

Abstract

Building on the authors' previous work, this article is intended to assist investigators and IRB members in their review of genetic diagnostic and screening protocols. The authors provide a general description of diagnostic and screening studies and identify five operational levels of genetic testing. They then set out a checklist identifying issues for IRB review and discuss in greater detail several points of controversy raised by this kind of research. These issues include the uncertainty of clinical prediction, research with communities, the confidentiality of test results, and the potential impact on insurance.

Suggested Citation

Glass, Kathleen C. and Weijer, Charles and Lemmens, Trudo and Palmour, Roberta M. and Shapiro, Stanley H., Structuring the Review of Human Genetics Protocols Part II: Diagnostic and Screening Studies. IRB: A Review of Human Subjects Research, Vol. 19, Nos. 3-4, pp. 1-13, 1997, Available at SSRN: https://ssrn.com/abstract=1143576

Kathleen C. Glass

McGill University ( email )

1001 Sherbrooke St. W
Montreal, Quebec H3A 1G5
Canada

Charles Weijer

Dalhousie University ( email )

Department of Bioethics
Halifax, Nova Scotia B3H 4H7
Canada
902.494.3801 (Phone)
902.494.3865 (Fax)

Trudo Lemmens (Contact Author)

University of Toronto - Faculty of Law ( email )

78 and 84 Queen's Park
Toronto, Ontario M5S 2C5
Canada

Roberta M. Palmour

McGill University - Faculty of Medicine ( email )

United States

Stanley H. Shapiro

McGill University - Faculty of Medicine ( email )

United States

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