In 2007, MSFHR facilitated a BC-wide process for exploring opportunities and stakeholder interest in developing a more effective, coordinated provincial approach to ethics approval of research involving human subjects. The need for ethics harmonization stemmed from widespread frustration with existing approval processes that require multiple time-consuming ethics reviews to the detriment of research in the province. The project was initiated at the request of the health research community and endorsed by the BC Ministry of Health and the BC Ministry of Advanced Education.

To inform the project, MSFHR conducted extensive research, including an environmental scan of existing mechanisms and structures across BC; exploration of harmonized ethics processes and structures in other jurisdictions (provincial, national and international); and a survey of BC researchers about their experiences relating to ethics review processes.

Ethics Workshop

On November 19, 2007 in Vancouver, MSFHR convened an invitational workshop involving researchers, VPs or directors of research, and chairs or managers of research ethics boards (REBs) from BC health research institutions and organizations.

MSFHR presented the results of the environmental scans and investigator survey, along with comments from expert informants. Participants discussed issues, barriers and options for coordinating a provincial approach to improving the quality, access, consistency, efficiency and capacity for ethical review of research involving human subjects in BC.

Dr. Greg Koski, a physician-investigator at Harvard Medical School, was the plenary speaker at the workshop. Speaking from his extensive experience with alternative approaches to REB harmonization in various jurisdictions, he challenged workshop participants to understand ethics review as a system, with shared responsibility spanning institutions, researchers, ethics review board staff and REB members.

To inform discussions at the workshop, MSFHR prepared three background documents:

• The Ethics Review Process in British Columbia: An Environmental Scan (PDF)
• Investigator Experience with Research Ethics Boards in British Columbia: Survey Report (PDF)
• Harmonization of the Ethics Review Process: An Environmental Scan (PDF)

Post-Workshop Activities

The task force that assisted MSFHR in planning the ethics initiative held its final meeting in February 2008. They reviewed and approved a report on the workshop's deliberations for release to the community:

BC Ethics Harmonization Initiative Introductory Workshop: Report on Proceedings (PDF)

The task force recommended that the ethics initiative continue, with efforts focused on four areas:

• Creating common forms (e.g., application forms, informed consent);
• Developing a shared/common IT platform and tools accessible to researchers and institutions at which human subject research is undertaken in BC;
• Exploring how ethics review for multi-centre trials can be more efficient, consistent and timely, possibly with some degree of inter-institutional reciprocity; and
• Developing common educational and training resources to be shared by research ethics boards.

MSFHR consulted with BC health research stakeholders to explore options for a second phase of this initiative, based on recommendations summarized in the workshop report. The Foundation also presented on the initiative at the National Forum of Health Research Funders in Ottawa in April 2008 and the Alberta Research Ethics Community Consensus Initiative conference on ethics in health research in May 2008.

• Task Force members (PDF)
• Task Force Terms of Reference (PDF)

BC Ethics Harmonization Initiative: Request for Proposal

In January 2010, MSFHR issued a request for proposal (RFP) to develop a collaborative provincial human subject ethics review process in BC.  The RFP was based on recommendations that arose from the November 2007 workshop (see above).

MSFHR invited one proposal from a team of BC organizations with research ethics boards; collectively these organizations must conduct at least 80 percent of human subject ethics reviews in BC. Funding for the first year was contingent on MSFHR receiving the $15 million pledged by the BC government on or before April 15, 2010. Proposal submission deadline was April 16, 2010.

Read the BC Ethics Harmonization RFP Guidelines (PDF)

The proposal — submitted as requested by a consortium of BC universities — was reviewed by an external panel, who recommended revisions involving a phased approach with the initial emphasis on streamlining review processes for multi-site clinical and population health research. This past summer, the MSFHR Board approved funding subject to the consortium providing an addendum to their proposal addressing the panel recommendations. An addendum with a revised plan, timeline and budget was received from the consortium in July 2010 and approved shortly thereafter.

 

Last updated November 26, 2010