Theme 1: Research Ethics Review

“Research ethics review must innovate in parallel to the evolving research environment it purports to govern.”

Theme Lead:

Bartha Maria Knoppers, Faculty of Medicine, Department of Human Genetics, McGill University

Theme Team:

Gillian Bartlett,Dept. of Family Medicine, McGill University
Vardit Ravitsky, Bioethics Programs; School of Public Health, Université de Montréal
Jonathan Kimmelman, Biomedical Ethics Unit, McGill University
Ma’n H. Zawati, Centre of Genomics and Policy, McGill University
Kristine Votova, Project Director, SpecTRA-Genome Project
Emmanuelle Levesque, Centre of Genomics and Policy, McGill University
Vasiliki Rahimzadeh, Centre of Genomics and Policy, McGill University

The collaborative and often international nature of -omics research, its reliance on ‘Big Data,’ and the multi- site/jurisdictional aspects are challenging for Research Ethics Boards (REB). Rather than enabling collaborative innovation, a fragmented architecture of research ethics review in Canada introduces procedural delays that affect recruitment, participation, and translation. Theme 1 aims to develop models to harmonize research ethics review procedures and approval processes across Canada based on current REB needs, namely reduction in REB duplication, inconsistency, variability and cost.

Objectives:

 
(1) Elucidate ethics review/approval barriers
(2) Determine possible reciprocal/mutual recognition and REB harmonization
(3) Propose REB templates for approval of -omics clinical translation and GE3LS projects
(4) Create online training modules for researchers and for REB members reviewing -omics and GE3LS research.

Objectives will be achieved by building upon the Ethics Review Equivalency (ERE) initiative of the Global Alliance for Genomics and Health (GA4GH) to analyse Canadian specific issues leading to the creation of Canadian modalities for ERE. This will take place in consultation with the Canadian Association of Research Ethics Boards and the CIHR Standing Committee on Ethics. Members of the 17 Genome Canada Genomics and Personalized Health projects will be involved via meetings and workshops.

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