The Canadian Clinical Trials Coordinating Centre’s (CCTCC) 4th recommendation aims at improving efficiencies of ethics reviews and advance strategic issues such as accreditation.
In April 2015, the CCTCC established a working group to explore the development of a pan-Canadian accreditation system for Research Ethics Boards (REB) that review clinical trials. The working group was to investigate the critical questions involved in the development of strategies to improve ethics review efficiency [2011 Summit], strategies to standardize the research ethics review process and address accreditation of research ethics boards [Senate] or another approach to the development of a system for the evaluation and qualification of REBs [SPOR SHRER].
After initial meetings and discussion, the working group (WG) proposed that given the considerable efforts across many provinces to create more efficient ethics review systems, accreditation should be viewed as one potential component to increasing efficiency of ethics reviews, rather than assuming that accreditation is an end in itself. It was also agreed that REBs should be striving for excellence, knowledge and positive practices in the ethical oversight of research. Secondary drivers were concerns related to how we can know more precisely how many REBs are operating in Canada and a need for a mechanism to demonstrate baseline quality of REB reviews as a critical component of improving efficiencies of REB reviews of multi-site studies. Detailed recommendations & processes were drafted in an Interim-Report.
Summary of the recommendations:
- That the Canadian Association of Research Ethics Boards (CAREB) and CCTCC work collaboratively to develop a “registry” for REBs;
- The working group consult with various jurisdictions that have implemented accreditation programs to ascertain any evidence of the impact of accreditation upon compliance and upon enhancing the protection of research participants;
- The working group consult with the various provincial harmonization initiatives to obtain detailed information about the models of review being adopted to streamline multi-jurisdictional reviews;
- The working group examine the various standards and metrics currently being applied to REB operations both in Canada and in other jurisdictions;
- Inform the WG’s recommendations’ on the basis of the evidence it will have collected through the consultation and investigation processes described above.
The Working Group will report in April 2016 to Health Canada (HC) and the CCTCC sponsoring organizations: The Canadian Institutes of Health Research (CIHR), Canada’s Research-Based Pharmaceutical Companies (Rx&D) and HealthCareCAN. Please note that with respect to the first recommendation for development of an REB registry, discussions between CAREB and CCTCC are at a very preliminary stage and no final determination as to whether this will proceed has been made to date.