An Ethics Safe Harbor for International Genomics Research?

Genome Medicine, 5:99, 2013

11 Pages Posted: 7 Aug 2015

See all articles by Edward Dove

Edward Dove

University of Edinburgh - School of Law

Bartha Knoppers

McGill University

Ma'n H. Zawati

McGill University - Centre of Genomics and Policy

Date Written: November 22, 2013

Abstract

Background: Genomics research is becoming increasingly globally connected and collaborative, contesting traditional ethical and legal boundaries between global and local research practice. As well, global data-driven genomics research holds great promise for health discoveries. Yet, paradoxically, current research ethics review systems around the world challenge potential improvements in human health from such research and thus undermine respect for research participants. Case reports illustrate that the current system is costly, fragmented, inefficient, inadequate, and inconsistent. There is an urgent need to improve the governance system of ethics review to enable secure and seamless genomic and clinical data sharing across jurisdictions.

Discussion: Building on the international privacy ‘safe harbor’ model that was developed following the adoption of the European Privacy Directive, we propose an international infrastructure. The goal is to create a streamlined and harmonized ethics governance system for international, data-driven genomics research projects. The proposed ‘Safe Harbor Framework for International Ethics Equivalency’ would consist in part of an agency supporting an International Federation for Ethics Review (IFER), formed by a voluntary agreement among countries, granting agencies, philanthropies, institutions, and healthcare, patient advocacy, and research organizations. IFER would be both a central ethics review body and also a forum for review and follow-up of policies concerning ethics norms for international genomics research projects. It would be built on five principle elements: (1) registration; (2) compliance review; (3) recognition; (4) monitoring and enforcement; and (5) public participation.

Summary: A Safe Harbor Framework for International Ethics Equivalency would create many benefits for researchers, countries, and the general public, and may eventually have application beyond genomics to other areas of biomedical research that increasingly engage in secondary use of data and present only negligible risks. Among the benefits, research participants and patients would have uniform adequate protection, while researchers would be ensured expert ethics review with a reduction in cost, time, administrative hassle, and redundant regulatory hurdles. Most importantly, society would enjoy the maximization of the potential benefits of genomics research.

Keywords: Ethics Safe Harbor, International Genomic Research, Genomics, Global, Improvements in human health

Suggested Citation

Dove, Edward and Knoppers, Bartha and Zawati, Ma'n H., An Ethics Safe Harbor for International Genomics Research? (November 22, 2013). Genome Medicine, 5:99, 2013, Available at SSRN: https://ssrn.com/abstract=2640249

Edward Dove

University of Edinburgh - School of Law ( email )

Old College
South Bridge
Edinburgh, EH8 9YL
United Kingdom

Bartha Knoppers

McGill University ( email )

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

Ma'n H. Zawati (Contact Author)

McGill University - Centre of Genomics and Policy ( email )

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

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