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Communications
Streamlining review of research involving humans: Canadian models
  1. Ma'n H Zawati1,
  2. Anne Junker2,
  3. Bartha Maria Knoppers1,
  4. Vasiliki Rahimzadeh1
  1. 1Faculty of Medicine, Department of Human Genetics, Centre of Genomics and Policy, McGill University, Montreal, Quebec, Canada
  2. 2Faculty of Medicine, Department of Pediatrics, University of British Columbia, Vancouver, British Columbia, Canada
  1. Correspondence to Ma'n H Zawati, Faculty of Medicine, Department of Human Genetics, Centre of Genomics and Policy, McGill University, 740 Dr Penfield Avenue, Room 5103, Montreal, Quebec, Canada QC H3A 0G1; man.zawati{at}mcgill.ca

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Introduction

Biomedical research post sequencing of the first human genome is increasingly eroding a traditional ecology of individualist science. It is, furthermore, normalising collective innovation and shared scientific discovery.1 ,2 Achieving sound statistical power in a genome-wide association study, for example, can often be well beyond the scope of any one researcher's capacity. For this reason and others, the scientific imperative of research collaboration can be more pronounced in the ‘omics’ disciplines,3 where millions of data points are needed to make global inferences about links between the human genome and disease.4 From the scientific necessity to adequately power a study through research collaborations is also born an ethical imperative to do so. That is, the anticipated benefits and harms of a particular study are justified based on the researchers’ sound predictions about potential outcomes and contributions to knowledge. Either underestimating or overestimating translational possibilities can disturb the benefit–harm balance due largely to insufficient statistical power.5

Two important milestones, therefore, rest on this bench-to-bedside continuum for ‘omics’ research, and are essential for any clinical translation endeavour: research ethics and data-access reviews. The former ensures appropriate ongoing ethical oversight and participant protections, while the latter enables research collaboration by providing researchers with access to data. Debates surrounding traditional issues facing such reviews are ubiquitous in the literature, yet little attention has been paid to how these issues are exacerbated when studies span across multiple jurisdictions. This is particularly true for research typified in the ‘omics’ disciplines, where international collaboration is the norm rather than the exception.

Here, a distinction between multi-site and multi-jurisdictional research should be emphasised. While multi-site research implies that the project takes place across many individual sites, multi-jurisdictional research involves sites in different legal jurisdictions. Multi-jurisdictional research along with the ethics review processes required to …

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