To build on the BC Ethics Harmonization Initiative’s (BCEHI) achievements in establishing harmonized ethics review of health research, the Michael Smith Foundation for Health Research (MSFHR) is providing two new awards to support the initiative’s ongoing management, growth and continuous improvement.
An award has been made to Simon Fraser University (SFU) to carry out project coordination of the BCEHI for one year. Coordination efforts will support the BCEHI Advisory Committee to provide information and education related to the BCEHI, collect and analyze metrics, and develop common application materials and associated guidance documents. The BCEHI Advisory Committee steered the development and implementation of harmonized ethics review models and will continue to refine and advance the work of the initiative.
MSFHR has also provided an award to the University of British Columbia (UBC) to develop a common technology platform for harmonized ethics review over a period of 15 months. An evaluation of the minimal risk ethics review model pilot in 2015 revealed the need for a platform as an essential component of harmonized ethics review. The award will allow UBC to develop a common workspace within the UBC RISe system, an online research administration tool, that will direct the workflow for all studies that meet the definition of multi-jurisdictional research within BC. The aim is to create an efficient, effective and secure web‐based coordinated business system for harmonized ethics review, using common forms and templates customized to the needs, policies and processes of the BCEHI partner organizations.
Sarah Bennett, SFU’s manager, research ethics and Jean Ruiz, senior behavioural research ethics analyst at UBC will guide these efforts on behalf of the BCEHI partner organizations. Together these awards are meant to strengthen and sustain the BCEHI as it moves forward.
The BCEHI is a collaborative effort among British Columbia’s regional health authorities and four major research universities, who collectively conduct more than 80 percent of the province’s human subject ethics reviews. UBC represents the affiliated Research Ethics Boards at Providence Health Care, BC Cancer Agency and Children’s and Women’s Health Centre of BC.
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.