Report shows success of harmonized ethics review
15 June 2016
BC’s approach to harmonizing research ethics review represents a major step towards achieving greater efficiency, a new evaluation report finds.
Published by the project staff of the BC Ethics Harmonization Initiative (BCEHI), the report highlights outcomes of an eight-month pilot during which BCEHI partner organizations used new harmonized processes for reviewing minimal-risk studies involving human subjects. Prior to the pilot, research ethics review processes required that researchers apply for ethics approval from each BC jurisdiction involved in a project. The harmonized pilot model was designed to allow a single application, regardless of the number of jurisdictions. This, together with a streamlined review process, opened the door to a timelier and more efficient review process.
Researchers surveyed for the evaluation found the harmonized model easy to navigate and appreciated receiving consolidated feedback on their applications. Among reviewers surveyed, the model was seen as saving time by allowing the various research ethics boards involved in a review to share comments and feedback. This collaborative process was also seen to enhance the quality of the review. The harmonization process was also found to promote a high degree of trust among BC’s research ethics board administrators due to the cooperative effort required to coordinate reviews.
The report’s recommendation that the minimal-risk model be adopted by BCEHI partner organizations has been accepted with some minor modifications. Specifically, the lack of a common technology platform was seen as a barrier to greater efficiency. Respondents also suggested the need for more training that would improve researchers’ understanding of the multi-jurisdictional review process and support administrators to apply the model consistently in each BCEHI partner organization. These recommendations are currently being considered in sustainability planning for the BCEHI.
The evaluation plan was developed in consultation with Engage Associates Consulting Group. Surveys were issued to the key stakeholders involved in ethics review to analyze the minimal-risk review process from application to approval, and interviews were conducted with research ethics board members and administrators.
The report examined the eight-month pilot phase that extended from December 2014 to July 2015. During this period, 26 studies underwent ethics review using the harmonized minimal-risk model.