International Coordination of Research Ethics Review: An Adequacy Model

Thorogood, Adrian, and Michael J. S. Beauvais. “International Coordination of Research Ethics Review: An Adequacy Model.” Philosophies 6, no. 4 (December 2021): 93. https://doi.org/10.3390/philosophies6040093.

19 Pages Posted: 1 Dec 2021 Last revised: 20 Dec 2021

See all articles by Adrian Thorogood

Adrian Thorogood

Universite du Luxembourg - Luxembourg Centre for Systems Biomedicine

Michael J.S. Beauvais

McGill University - Centre of Genomics and Policy

Date Written: December 1, 2021

Abstract

International direct-to-participant (DTP) genomics research involves the use of mobile technology to recruit, consent, and study participants remotely. This model can facilitate research across broad geographies and many countries, but must also comply with the norms of multiple recruitment jurisdictions, with each jurisdiction typically requiring at least one local research ethics review. Each additional research ethics review increases bureaucratic hurdles without necessarily strengthening the protection of participants rights and interests. For DTP genomic research, obtaining a review may in fact be impossible in the absence of a local research partner. This paper proposes an “adequacy” approach, inspired by data protection law, to coordinate the regulation and oversight of international DTP genomics research. This involves one country voluntarily assessing if another country’s research ethics reviews are equivalent to its own, in terms of objectives and effectiveness. Ethics approved projects led by researchers from countries recognized as adequate are deemed to comply with local norms, eliminating the need for a duplicative local review. Adequacy preserves the sovereignty of countries to determine their own regulatory aims and what other countries to trust. It therefore provides a voluntary, incremental path towards greater global coordination of health research oversight.

Note:
Funding Information: The research reported in this article has been made possible by grant No. 5R01HG009914-02, Regulation of International Direct-to-Participant Genomic Research, from the National Human Genome Research Institute of the National Institutes of Health, Mark A. Rothstein and Bartha Maria Knoppers, PIs.

Declaration of Interests: The authors have no conflicts of interest to declare.

Keywords: research ethics, direct-to-participant, international collaboration, genomics, research ethics committee, law

Suggested Citation

Thorogood, Adrian and Beauvais, Michael J.S., International Coordination of Research Ethics Review: An Adequacy Model (December 1, 2021). Thorogood, Adrian, and Michael J. S. Beauvais. “International Coordination of Research Ethics Review: An Adequacy Model.” Philosophies 6, no. 4 (December 2021): 93. https://doi.org/10.3390/philosophies6040093., Available at SSRN: https://ssrn.com/abstract=3928895 or http://dx.doi.org/10.2139/ssrn.3928895

Adrian Thorogood (Contact Author)

Universite du Luxembourg - Luxembourg Centre for Systems Biomedicine ( email )

2 Avenue de l'Université
Esch-sur-Alzette
Luxembourg

Michael J.S. Beauvais

McGill University - Centre of Genomics and Policy ( email )

740 Ave Dr Penfield
Montreal, Quebec H3A0G1
Canada

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