Harmonization of Research Ethics Review Having a Positive Impact

BC’s efforts to harmonize health research ethics review is having a positive impact on making BC a more attractive research environment according to a Summative Evaluation of Phase II of the BC Ethics Harmonization Initiative (BCEHI). The BCEHI has been successful in developing and implementing two models for research ethics review of minimal risk and above minimal risk studies resulting in more timely and efficient processes.

The BCEHI is a collaboration among the provincial health authorities and BC’s four major universities, who collectively conduct more than 80 percent of the province’s human subject ethics reviews. Phase II of the BCEHI  was funded and facilitated by the Michael Smith Foundation for Health Research (MSFHR) up to March 31, 2016.

Improvements identified in the evaluation ranged from improved communication and collaboration between institutions to reduced duplication of effort, particularly for researchers. Evaluation findings revealed that the majority of researchers who submitted applications for harmonized ethics review had an overall positive experience.

A key strength of the initiative is that it built support from the ground up, and involved those who administer and review ethics applications and would be most affected by change. Evaluation data indicated that this grass roots approach has led to wide acceptance of harmonization.

In addition to these accomplishments, the evaluation identified some challenges. Communication about the harmonization process was not widely disseminated to the research community and many cited the need for a common technology platform to support harmonized reviews.

To provide a bridge to sustainability, MSFHR has funded a one-year BCEHI Project Coordination function and is supporting the development of a shared technology platform.

To read the BCEHI Summative Evaluation see below.

BC Ethics Harmonization Initiative Final Report (PDF)

Strengthening and Sustaining the BC Ethics Harmonization Initiative

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.