Minimal-risk model a milestone for ethics harmonization in BC

25 November 2014

BC has taken a significant step towards a more efficient and coordinated research ethics review process.

On December 1, a new model for harmonized ethics review of minimal-risk studies will begin pilot implementation, representing a major milestone in the ongoing BC Ethics Harmonization Initiative (BCEHI). The model has been endorsed by the senior leaders of the partner organizations for a six-month pilot implementation across their research ethics boards (REBs).

BCEHI aims to create streamlined, high-quality processes that encourage multi-jurisdictional human health research and remove impediments to collaborative research studies. The goal is to improve the timeliness and efficiency of ethics review to make BC a more attractive environment for research.

By allowing researchers to submit a single ethics application, regardless of the number of BC jurisdictions involved in a project, the new minimal-risk model will reduce the research team’s administrative workload and allow applications to be more efficiently reviewed and approved.

The minimal-risk model was developed collaboratively by members of the BCEHI Advisory Committee, building on work initiated by research ethics board chairs and administrators at a January 2014 forum. The Advisory Committee developed the criteria for identification of the Board of Record for each minimal-risk, harmonized review. The Board of Record is pivotal to the ethics review process and acts as the central contact for the research team and other REBs. A toolkit with documentation that defines the roles for participating REBs in a harmonized review, and documentation to support harmonized procedures, has also been created to support REB administrators and members and researchers during the pilot implementation.

In addition, work is underway on a harmonized review model for above-minimal-risk studies. Pilot implementation and evaluation of this model is expected to begin in early 2015.

Survey to provide insight into model’s effectiveness

To assess the effectiveness of the minimal-risk model in meeting BCEHI’s priority objectives, an evaluation of the model processes will be undertaken throughout the pilot implementation.

An online survey has been developed that measures the minimal-risk ethics review process from beginning to end. Several factors will be measured in evaluating the model’s implementation. These include ease of use of the process for researchers, acceptability of the Board of Record review by other ethics boards, use and effectiveness of communication channels, and the workload associated with the harmonized process.  The data collected through the survey will allow improvement of the model and hopefully demonstrate its effectiveness to the research ethics community.

Participants in the ethics review process for multi-jurisdictional studies will be invited to take part in the survey. Feedback is critical for gauging the model’s effectiveness and identifying areas for improvement.

Metrics will be gathered over the course of the pilot implementation. A final report will be provided to the Senior Leaders Team with recommendations for full implementation of the minimal-risk ethics review model.