Canadian Research Ethics Boards and Multisite Research: Experiences from Two Minimal-Risk Studies (In the Field) (Report‪)‬

Numerous studies have identified the challenges researchers face when attempting to obtain ethics approval for multisite studies. For instance, Greene and Geiger have identified delays in achieving ethics approval across sites, excessive associated costs and resource expenditures for achieving review at multiple sites, and variability in requested changes by local research ethics boards (REBs) to study materials, including consent forms. (1) Some researchers have stressed the impracticality of submitting study materials to multiple REBs, while others have pointed out that variability across REBs actually results in less protection for research participants. (2) In Canada, the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) lays out the ethical requirements for publicly-funded human subjects research. The TCPS mandates that "All research involving living human subjects requires review and approval by an REB." (3) The implication of this policy for multisite studies created the requirement (also found in other research ethics guidelines) for local REB review at each study site. Accordingly, the TCPS states that each local REB is held "responsible for the ethical acceptability of research undertaken within its institution." (4) The recently revised TCPS (draft second edition) adds an entire chapter on the review of multisite research that responds to concerns in gaining ethics approval for multisite ("multijurisdictional") research. (5) It is unclear, however, if the proposed changes rely on the experience of Canadian researchers or on evidence about existing challenges or solutions that work. Indeed, there is scant evidence about how researchers have dealt with the TCPS's standards for obtaining REB review for multisite studies. In order to inform the debate about multisite REB review, we report our own experiences dealing with REB approval of two multisite, minimal-risk studies.