The Road to Reciprocity: Research Ethics Review in the Era of Big Data

Author: Vasiliki Rahimzadeh1, PhD Candidate; Dr. Gillian Bartlett1, Supervisor

1. Department of Family Medicine, McGill University, 5858 Cote des Neiges Floor 3, Montreal, QC H3S 1X1

Ethics review is a requisite component of conducting health research involving human subjects in Canada, and indeed in most jurisdictions around the world. The Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans (TCPS2) serves as the national policy framework for research ethics review in Canada, and outlines three potential oversight models: independent, delegated and reciprocal. The former poses a number of practical, theoretical and interpretive challenges for researchers and ethics review boards alike, namely in the increasingly collaborative science typified by genetic and genomic studies using “Big Data”. Despite this, the independent model is the most widely adopted for ethics review in Canada. While the independent model preserves provincial and institution-specific oversight in matters pertaining to health and health policy, it contributes to a fragmented and system ofresearch ethics governance; exacerbates procedural delays; does not proportionately respond to the ethical considerations inherent to participating in genetic/genomic research; and impedes clinical innovation. The reciprocal model of research ethics review, albeit underutilized, is purported to best serve both research agendas and participant protections in Big Data according to recent frameworks. No evidence in the literature elucidates current trends in ethics review of Big Data protocols in Canada as yet, nor why a reciprocal model is not more widely adopted considering its aforementioned theoretical advantages in the Big Data research disciplines. As such, an explanatory mixed methods study using a sequential design is proposed to fill these knowledge gaps. In specific, this study proposes to i) examine the prevalence of multi-site genetic/genomic research protocols over the last 10 years submitted to the ethics review boards in 4 Canadian provinces (QC, NF, ON, BC) and ii) to explore the perceptions of REB Chairs from academic medical centers in these provinces on principles of reciprocity for ethics review oversight in Canada.