Report on the Canadian experience of Research Ethics Boards (REBs) harmonisation and centralisation
CCTCC and Health Canada have developed a joint public response to the FRs outlining the steps the two organizations can take to address the FRs.
The FRs, and CCTCC and Health Canada's joint response can be accessed here.
As next steps, the CCTCC and Health Canada:
- are distributing widely the FRs and the SPOR SHRER Report Committee Recommendations in fulfillment of FR I, and
- will work jointly in 2017 to further consider the feasibility of FR VII - Establishing of a National Strategic Leadership Forum - which underpins all other FRs.
About the CCTCC REB Accreditation WG:
Established in April 2015, by the CCTCC in collaboration with Health Canada, the REB Accreditation WG was to identify strategies to improve efficiencies of ethics reviews and advance strategic issues like accreditation on a pan-Canadian level for Research Ethics Boards (REB) that review clinical trials.
In its Interim Report, the REB WG concluded that given the REB centralization and harmonization initiatives that have been taking place across Canada, accreditation should be viewed as one potential component to increasing efficiency of ethics reviews, rather than being an end in itself. The Interim Report can be accessed here.
Therefore, the WG set out to investigate:
- impact of these provincial initiatives
- models of review being adopted by these initiatives, and
- standards and metrics currently being applied to REB operations (in Canada and USA)
by conducting interviews with relevant stakeholders across Canada and the US. The interviewees included REB members, administrators and experts from the academic and research ethics community. Interviews were also conducted with representatives from independent IRBs.
The WG developed its Draft Preliminary Recommendations (DRPs) based on the findings from the interviews. Following that a consultation with stakeholders across Canada took place to ensure that the DRPs resonate with needs of the REB and research community. The CCTCC Advisory Group also provided feedback.
The CCTCC and Health Canada provided joint public feedback to the resulting FRs.
CCTCC work on REB issues can be traced back to Recommendation 4 from the 2011 Clinical Trials Summit Action Plan, which called for assessing the feasibility of common ethics application and consent forms, and advancing understanding of ethics accreditation. More information is available here.