Towards an Ethics Safe Harbor for Global Biomedical Research

Journal of Law and the Biosciences, 3, February 2014

49 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: February 14, 2014

Abstract

Although increasingly global, data-driven genomics and other ‘omics’-focused research hold great promise for health discoveries, current research ethics review systems around the world challenge potential improvements in human health from such research. To overcome this challenge, we propose a ‘Safe Harbor Framework for International Ethics Equivalency’ that facilitates the harmonization of ethics review of specific types of data- driven international research projects while respecting globally transposable research ethics norms and principles. The Safe Harbor would consist in part of an agency supporting an International Federation for Ethics Re- view (IFER), formed by a voluntary compact 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 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. The Safe Harbor would create many benefits for researchers, countries, and the general public, and may eventually have application beyond (gen)omics to other areas of biomedical research that increasingly engage in secondary use of data and present only negligible risks.

Keywords: Biomedical research, Ethics, Genomics, Governance, Harmonization, Safe Harbor

Suggested Citation

Dove, Edward and Knoppers, Bartha and Zawati, Ma'n H., Towards an Ethics Safe Harbor for Global Biomedical Research (February 14, 2014). Journal of Law and the Biosciences, 3, February 2014, Available at SSRN: https://ssrn.com/abstract=2640234

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

Do you have a job opening that you would like to promote on SSRN?

Paper statistics

Downloads
11
Abstract Views
426
PlumX Metrics