Legal and Ethical Challenges of International Direct-to-Participant Genomic Research: Conclusions and Recommendations

J.L. Med & Ethics, 47(4) 2019

75 Pages Posted: 22 Nov 2019

See all articles by Mark A. Rothstein

Mark A. Rothstein

University of Louisville - Institute for Bioethics, Health Policy, and Law; University of Louisville - Louis D. Brandeis School of Law

Ma'n H. Zawati

McGill University - Centre of Genomics and Policy

Laura M. Beskow

Duke University - Institute for Genome Sciences & Policy

Kathleen Brelsford

Vanderbilt University - Center for Biomedical Ethics and Society

Kyle Brothers

University of Louisville - School of Medicine

Catherine Hammack

Independent

James Hazel

Center for Genetic Privacy & Identity in Community Settings, Vanderbilt University Medical Center

Yann Joly

McGill University - Centre for Genomics and Policy

Michael Lang

McGill University - Faculty of Law

Dimitri Patrinos

affiliation not provided to SSRN

Andrea Saltzman

Masssachusetts Institute of Technology and Harvard University - Broad Institute

Bartha Maria Knoppers

McGill University - Centre for Genomics and Policy

Date Written: November 8, 2019

Abstract

Direct recruitment of participants using the internet has proven to be an effective strategy for increasing the number and diversity of participants in genomic research, especially research on rare diseases. Institutional review boards and research ethics committees (RECs) have approved this strategy for domestic research, but they have been reluctant to approve it for international research because they do not know whether it is legal to use direct recruitment in other countries without obtaining approval from an REC in each country from which participants may be enrolled. To inform this question, we obtained legal and ethics opinions from experts in 31 diverse countries, and their responses to our standard questions are separately published in this symposium. Although none of the countries has a law specifically addressing this emerging issue, it appears that local ethics approval would be required in many countries. This article presents the argument that single-site ethics review in the researcher’s country will facilitate this valuable research while still protecting the welfare and interests of participants and their countries.

Keywords: direct-to-participant research, Genomic research, international law, international research, IRBs, Research ethics

JEL Classification: K31, K32

Suggested Citation

Rothstein, Mark A. and Zawati, Ma'n H. and Beskow, Laura M. and Brelsford, Kathleen and Brothers, Kyle and Hammack, Catherine and Hazel, James and Joly, Yann and Lang, Michael and Patrinos, Dimitri and Saltzman, Andrea and Knoppers, Bartha Maria, Legal and Ethical Challenges of International Direct-to-Participant Genomic Research: Conclusions and Recommendations (November 8, 2019). J.L. Med & Ethics, 47(4) 2019. Available at SSRN: https://ssrn.com/abstract=3485051

Mark A. Rothstein (Contact Author)

University of Louisville - Institute for Bioethics, Health Policy, and Law ( email )

Louisville, KY 40202
United States

HOME PAGE: http://www.louisville.edu/bioethics

University of Louisville - Louis D. Brandeis School of Law ( email )

Wilson W. Wyatt Hall
Louisville, KY 40292
United States

Ma'n H. Zawati

McGill University - Centre of Genomics and Policy ( email )

740 Dr. Penfield Avenue, Suite 5200
Montreal, Quebec H3A 0G1
Canada

Laura M. Beskow

Duke University - Institute for Genome Sciences & Policy ( email )

240 North Building
Box 90141
Durham, CA 27708
United States

Kathleen Brelsford

Vanderbilt University - Center for Biomedical Ethics and Society ( email )

2525 West End Avenue
Suite 400
Nashville, TN 37203
United States

Kyle Brothers

University of Louisville - School of Medicine ( email )

550 South Jackson Street
Louisville, KY 40202
United States

Catherine Hammack

Independent ( email )

No Address Available

James Hazel

Center for Genetic Privacy & Identity in Community Settings, Vanderbilt University Medical Center ( email )

2301 Vanderbilt Place
Nashville, TN 37240
United States

HOME PAGE: http://https://www.vumc.org/getprecise/people/team

Yann Joly

McGill University - Centre for Genomics and Policy ( email )

740 Dr. Penfield Avenue, Suite 5200
Montreal, Quebec H3A 0G1
Canada

Michael Lang

McGill University - Faculty of Law ( email )

3644 Peel Street
Montreal H3A 1W9, Quebec
Canada

Dimitri Patrinos

affiliation not provided to SSRN

Andrea Saltzman

Masssachusetts Institute of Technology and Harvard University - Broad Institute ( email )

415 Main Street
Cambridge, MA 02142
United States

Bartha Maria Knoppers

McGill University - Centre for Genomics and Policy ( email )

740 Dr. Penfield Avenue, Suite 5200
Montreal, Quebec H3A 0G1
Canada

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