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Returning Genetic Research Results to Individuals: Points-to-Consider

13 Pages Posted: 4 Jan 2006  

Gaile Renegar

GlaxoSmithKline - Genetics Research

Christopher J. Webster

Millennium Pharmaceuticals Inc. - Regulatory Strategy and Intelligence

Steffen Stuerzebecher

affiliation not provided to SSRN

Lea Harty

Pfizer Global Research & Development

Susan E. Ide

Novartis Institutes for Biomedical Research

Beth Balkite

GlaxoSmithKline

Taryn A. Rogalski-Salter

Merck & Co., Inc. - USHH Outcomes Research & Management

Nadine Cohen

Johnson & Johnson

Brian B. Spear

Abbott Laboratories

Diane M. Barnes

Abbott Laboratories

Celia Brazell

GlaxoSmithKline - United Kingdom

Abstract

This paper is intended to stimulate debate amongst stakeholders in the international research community on the topic of returning individual genetic research results to study participants. Pharmacogenetics and disease genetics studies are becoming increasingly prevalent, leading to a growing body of information on genetic associations for drug responsiveness and disease susceptibility with the potential to improve health care. Much of these data are presently characterized as exploratory (non-validated or hypothesis-generating). There is, however, a trend for research participants to be permitted access to their personal data if they so choose. Researchers, sponsors, patient advocacy groups, ethics committees and regulatory authorities are consequently confronting the issue of whether, and how, study participants might receive their individual results. Noted international ethico-legal guidelines and public policy positions in Europe and the United States are reviewed for background. The authors offer "Points-to-Consider" regarding returning research results in the context of drug development trials based on their knowledge and experience. These considerations include: the clinical relevance of data, laboratory qualifications, informed consent procedures, confidentiality of medical information and the competency of persons providing results to participants. The discussion is framed as a benefit-to-risk assessment to balance the potential positive versus negative consequences to participants, while maintaining the integrity and feasibility of conducting genetic research studies.

Keywords: pharmacogenetic, genetic, research, exploratory, guidelines, policy

Suggested Citation

Renegar, Gaile and Webster, Christopher J. and Stuerzebecher, Steffen and Harty, Lea and Ide, Susan E. and Balkite, Beth and Rogalski-Salter, Taryn A. and Cohen, Nadine and Spear, Brian B. and Barnes, Diane M. and Brazell, Celia, Returning Genetic Research Results to Individuals: Points-to-Consider. Bioethics, Vol. 20, No. 1, pp. 24-36, February 2006. Available at SSRN: https://ssrn.com/abstract=871528 or http://dx.doi.org/10.1111/j.1467-8519.2006.00473.x

Gaile Renegar (Contact Author)

GlaxoSmithKline - Genetics Research ( email )

2200 Renaissance Blvd.
King of Prussia, PA 19406-2755
United States

Christopher J. Webster

Millennium Pharmaceuticals Inc. - Regulatory Strategy and Intelligence ( email )

40 Lansdowne Street
Cambridge, MA 02139
United States

Steffen Stuerzebecher

affiliation not provided to SSRN ( email )

No Address Available

Lea Harty

Pfizer Global Research & Development ( email )

Eastern Point Road
Groton, CT 06340
United States

Susan E. Ide

Novartis Institutes for Biomedical Research ( email )

100 Technology Square
Cambridge, MA 02139-3585
United States

Beth Balkite

GlaxoSmithKline ( email )

5 Moore Drive
RTP, NC 27709
United States

Taryn A. Rogalski-Salter

Merck & Co., Inc. - USHH Outcomes Research & Management ( email )

770 Sumneytown Pike
WP39-166
West Point, PA 19486
United States

Nadine Cohen

Johnson & Johnson ( email )

New Brunswick, NJ 08933
United States

Brian B. Spear

Abbott Laboratories ( email )

100 Abbott Park Road
Abbott Park, IL 60064-6008
United States

Diane M. Barnes

Abbott Laboratories ( email )

100 Abbott Park Road
Abbott Park, IL 60064-6008
United States

Celia Brazell

GlaxoSmithKline - United Kingdom ( email )

Stockley Park West
Uxbridge, Middlesex UB11 1BT
United Kingdom

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