Health Research Ethics Harmonization Updates
For the past number of years, a Project Support Team at Alberta Innovates – Health Solutions (AIHS) has been actively managing the implementation of activities related to Health Research Ethics Harmonization (HREH). Much has been done, but several concurrent activities, outlined below, are still underway in relation to harmonizing health research ethics in Alberta.
The HREH Steering Committee held its first meeting on Monday, December 1, 2014.
Voting members of the HREH Steering Committee are:
- Pamela Valentine, Chief Partnership Officer, Alberta Innovates-Health Solutions (Chair)
- Kathryn Todd, Vice President, Research, Innovation and Analytics, Alberta Health Services
- Trevor Theman, Registrar, College of Physicians and Surgeons of Alberta
- Sheli Murphy, Senior Operating Officer, Rural Services, Covenant Health
- Walter Dixon, Associate Vice-President (Research), University of Alberta (U of A)
- Andre Buret, Associate Vice-President (Research), University of Calgary (U of C)
Non-voting members are:
- Sharlene Stayberg, Director, Clinical Innovation and Policy Unit, Alberta Health
- Hubert Eng, Senior Director, Life Sciences Industries, Economic Development and Trade
The Committee considered its Terms of Reference (ToR), and also those of its Change Management Subcommittee and its Nominating Subcommittee. It also approved a communication protocol.
A Health Research Ethics Board of Alberta (HREBA) Advisory Group, comprised of representatives from AIHS, AHS (Alberta Health Services) and CPSA (College of Physicians and Surgeons of Alberta), will shortly be created to provide strategic advice and offer a forum for matters such as the ethical oversight of research involving human participants or their personal health information.
The work of the HREBA Advisory Group will be further supported by the Committee Chairs who will oversee the operations of their respective Committees (Cancer Committee, Community Health Committee, and Clinical Trials Committee) and coordinate policies and practices across the Committees.
Alberta’s three Health Information Act-designated REBs, including the Conjoint Health Research Ethics Board (CHREB, U of C), the Health Research Ethics Board (HREB, U of A) and the Health Research Ethics Board of Alberta (HREBA, AIHS), are working to align and harmonize their processes with the principle of one application-one review-one approval. This includes:
- Where to Apply: An easy to use guidance document has been developed to assist PIs in determining where to submit their applications for ethics review of proposed studies;
- Developing processes to ensure institutional or local requirements are fulfilled.
- Preparations are well underway for HREBA’s Cancer Committee to receive all-cancer related trials, including studies that recruit pediatric participants.
Principal Investigators should remember that approval from an HIA-designated REB does not grant access to health records for research purposes. Also, other institutional and organizational requirements may be in place, which PIs must comply with or fulfill prior to the commencement of a study, including approvals for the allocation of resources. Inquiries regarding such requirements should be directed to the appropriate institutional or organizational body.
Efforts will be ongoing to identify potential improvements that can accelerate the full implementation of the Reciprocity Agreement across the three HIA-designated REBs. Feedback from the research community can be submitted to firstname.lastname@example.org
The Change Management Subcommittee will be forming, with the mandate to propose improvements to IRISS and REMO related to health research ethics processes, with the focus of ensuring consistency within the two online systems for researchers across the province.
The IRISS and REMO platforms send key administrative data to the Provincial Health Research Ethics Information System (PHREIS) to be aggregated and to provide reports on ethics review activities. Data validation is underway to ensure accurate and consistent reporting.