Above Minimal Risk harmonized ethics review pilot launched

1 June 2015

BC’s work to harmonize research ethics review took another step forward this week with the launch of a pilot for the review of above minimal risk studies.

The model, developed under the ongoing BC Ethics Harmonization Initiative (BCEHI), provides a mechanism for streamlined approval of studies that span multiple BC jurisdictions and require full-board ethics review. To meet this requirement while promoting high quality and efficient review, the model calls for a single application that will be reviewed using a “Board of Record +1” process.

The Board of Record will be joined by at least one voting member from each partner research ethics board named in the application to ensure all relevant jurisdictions are represented. As with the Minimal Risk model pilot, the feedback of all reviewers will be combined into a single summary that is sent to the researcher by the Board of Record.

Under the current approach to multi-jurisdictional ethics review, separate applications are submitted to each research ethics board. The harmonized approach developed by BCEHI will allow researchers to submit one application and receive consolidated feedback. The result will be a faster and more efficient process that encourages multi-jurisdictional research and removes impediments to collaborative studies.

In addition to its benefits for researchers, this approach will allow maximum flexibility for research ethics board reviewers, with the opportunity to participate either in person or remotely via teleconference or videoconference. The model also provides knowledge sharing between participating ethics board members who can observe how other research ethics boards conduct ethical reviews.

The Above Minimal Risk model will be piloted through the end of 2015.

To support researchers and ethics board staff in applying the new model, a variety of supporting materials are available for download on the BCEHI website.

Minimal Risk pilot extended

The introduction of an Above Minimal Risk model ensures harmonized review is now available for all multi-jurisdictional studies in BC. A pilot model for Minimal Risk studies launched in December 2014 and has been well received by researchers.

“We are very grateful for the fast turnaround and for all of the quick and helpful responses to any questions that came up along the way,” says UBC researcher Barbara Purves. “Compared to previous applications that I have made involving multiple jurisdictions, this has been extremely smooth.”

The Minimal Risk pilot, which was scheduled to end May 31, has been extended to the end of July 2015. Results of the evaluation of this pilot will be reported back to the research community in the fall.

BCEHI funding extended

The Michael Smith Foundation for Health Research (MSFHR) is pleased to announce that funding for BCEHI has been extended through March 31, 2016. The initiative is a key example of MSFHR’s strategic commitment to increasing coherence and collaboration across BC’s health research enterprise.

For more information on ethics harmonization in BC, visit: www.bcethics.ca