Regulatory Landscape of International Direct-to-Participant (DTP) Genomic Research: Time to Untie the Gordian Knot?

J. Law Med.&Ethics, 47(2):2019

14 Pages Posted: 25 Apr 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

Bartha Maria Knoppers

McGill University - Centre for Genomics and Policy

Date Written: April 1, 2019

Abstract

Genomic research, especially on rare disorders, has been facilitated by the online recruitment of potential participants. Through cooperative arrangements with disease-specific patient organizations and internet postings, it has become a more efficient way to attract interested patients and their caregivers than traditional recruitment through physicians and hospitals. Eligible participants from remote locations can participate in genomic research by supplying a sample for genome sequencing along with their electronic health records. International direct-to-participant research promises to greatly increase the number and diversity of participants for research on rare diseases, but recruitment across borders is often thwarted by laws prohibiting research participation without ethics review in each country. Such a process, an essential part of traditional research, becomes burdensome and infeasible to enroll only a few participants in many countries. Thus, although global recruitment is a promising strategy, much work remains to be done on devising methods that are legally compliant and ethically acceptable for this novel research.

Keywords: Direct-to-participant, Genomic research, Informed consent, International law, Online recruitment, Privacy, Rare disorders

JEL Classification: K31, K32

Suggested Citation

Rothstein, Mark A. and Zawati, Ma'n H. and Knoppers, Bartha Maria, Regulatory Landscape of International Direct-to-Participant (DTP) Genomic Research: Time to Untie the Gordian Knot? (April 1, 2019). J. Law Med.&Ethics, 47(2):2019. Available at SSRN: https://ssrn.com/abstract=3360661

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

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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