“Leveraging the appropriate bodies and expertise, undertake a feasibility assessment and proposal for a common application form, consent form template, elements of an accreditation system, and information/form sharing mechanisms for ethics review. Also support the work of Health Canada in evaluating standards and accreditation options and explore strategic issues like accreditation and harmonization”.
STREAMLINING RESEARCH ETHICS REVIEW FOR MULTI-CENTRE TRIALS
On September 2011, the Canadian Institutes of Health Research (CIHR), Canada’s Research- Based Pharmaceutical Companies (Rx&D), and the Association of Canadian Academic Health Care Organizations (ACAHO, now HealthCareCAN) held a national Clinical Trial Summit. The Summit resulted in an Action Plan. The Action Plan produced 9 recommendations aimed at strengthening and improving clinical trials in Canada and streamlining processes for companies and researchers.
Recommendation 4 under the 2011 Clinical Trials Summit Action Plan is to assess the feasibility of common ethics application and consent forms, and advance understanding of ethics accreditation. Under Canada’s Strategy for Patient-Oriented Research (SPOR), CIHR established the External Advisory Committee on Streamlining Health Research Ethics Review (SHRER) to gather information on streamlining initiatives in Canada and to make recommendations for improving the process of ethics review for multi-centre patient-oriented research.
The launch of the Canadian Clinical Trial Coordinating Centre (CCTCC) on April 24,2014 facilitates the opportunity to make progress on a national approach to improving ethics review processes, all while promoting the products developed by the SHRER Committee.
The SHRER Report for Discussion (February 2013 – Appendix A and B) represent the Committee’s time-limited reflection on two main bodies of work: (1) A study of ethics review streamlining initiatives across the country related broadly to patient-oriented research and(2) a study of the feasibility of common application and consent forms specifically for clinical trials.
In recognition that many Research Ethics Boards (REBs) and regional initiatives have already invested substantially in the development of their own forms for clinical trials and that the imposition of a new standardized template may not be practical, the SHRER Committee developed models of common elements for REB application forms and adult consent forms as a flexible tool to foster recognition of the commonality among these forms and thereby facilitate streamlining efforts.
A number of initiatives in Canada have been launched to improve the research ethics review process, providing an important springboard for what may be considered at the national level. It was clear to the SHRER Committee that there is a need to create a national approach that leverages and coordinates, rather than replaces or duplicates existing efforts.
Click here to learn about CCTCC REB Accreditation Working Group (WG) work on this issue.