Ethics Harmonization Update >> February 2013
8 February 2013
The BC Ethics Harmonization Initiative (BCEHI) is an MSFHR-funded and faciliated process aimed at developing a more effective, coordinated provincial approach to ethics approval of research involving human subjects.
This update from BCEHI director Patricia Tait provides a brief summary of key achievements in 2012 and upcoming activities in 2013. Look for more announcements over the coming months.
For more information, contact:
Director, BC Ethics Harmonization Initiative
Reciprocity Agreements are the first formal step in enabling collaborative/reciprocal review processes to occur across the partners.
>>An Agreement between the Universities of Victoria, Northern BC, BC, and Simon Fraser University was executed in September 2012. UBC has incorporated references to this affiliation agreement in their new forms launched Dec 15, 2012.
>>In addition to the BCEHI Agreements, UBC has recently executed a Reciprocity Agreement with the Universities of Alberta and Saskatchewan, which is in the process of implementation.
>>Development of an Agreement between all eight BCEHI partner institutions began in 2012, with an execution target date in early 2013.
In 2012, the Steering Committee drafted a "working" model for the review of multi-centre projects, incorporating feedback from Phase I experiences as well as examples from other jurisdictions, to guide model development discussions.
>>The review options for a “harmonized review model” are currently in development and revision by the partners, with the goal of agreement and implementation in early 2013.
>>The model will be implemented across BCEHI research ethics boards (REBs), for the review of minimal and above minimal risk multi-jurisdictional studies. Once the eight-partner Reciprocity Agreement is executed, the next steps are model agreement, implementation, and communication to stakeholders. Evaluation will occur throughout this implementation.
- In January 2013 the Minimal Risk Review Work Group finalized a guidance document for REBs: “Common Criteria in Determining if a Study is Minimal Risk.” Once approved by the steering committee, it will be distributed to the partner REBs to use as a resource when reviewing studies involving multi-jurisdictional health research that require multiple REB approvals. It will also be placed on the BCEHI webpage.
- In February, BCEHI is facilitating a meeting of REB Chairs from across the eight partner institutions (14 REBs in total). This will be an opportunity to connect with each other in person to discuss common and unique challenges, as well as collaborative review processes and agreements. The goal is that the meeting will generate ongoing communication and collaboration.
- The UBC/Fraser Health Common Clinical Informed Consent Form (ICF) template is currently under revision to expand its use to include Interior, Vancouver Island, and Northern Health Authorities. The goal is to have endorsement by all involved institutions by spring 2013.
- An Education/Best Practices work group will be formed in the coming months focused on building a repository of resources for REB staff and members, as well as research teams. This group will gather and review various potential resources and draft a proposal for the steering committee regarding the development of an online education resource. Those who have expressed interest in this working group will be contacted for potential participation.
- BCEHI evaluation – one aspect of the annual BCEHI evaluation plan is an on-line stakeholder survey. The invitation to participate will be emailed to the BCEHI stakeholder distribution list as well as available on the website in early May.