Nov. 2, 2012

dmonton, Alberta) November 02, 2012…Alberta has taken an important step toward creating a more competitive and attractive environment for health research and clinical trials investment.

The province has launched harmonized ethics review processes for multi-site human health research. The newstreamlined processes for ethics review of multi-site applications were developed by the partner organizations of the Alberta Health Research Ethics Harmonization (HREH) initiative. Using the new processes will help the province’s six Health Information Act-appointed Research Ethics Boards (REBs) to better coordinate ethics review for multi-site, human health research proposals.

The new streamlined processes are a boost to Alberta’s clinical trials program and other types of health research that involve multiple sites because of the potential savings of time, administrative processes, and costs to researchers and research sponsors.

For a researcher participating in the conduct of an industry sponsored multi-site clinical trial, this means that after an ethics application to their home institution’s REB is approved, he or she need only notify the sponsor who can then inform researchers at any affiliated study sites in Alberta to access their REB’s reciprocal review process. A reciprocal, or delegated, review results in shorter protocol review timelines.

The only difference for other types of multi-site health research is that once their home REB grants approval, the researcher is responsible for informing the REBs at other participating institutions when submitting their ethics applications. As before, this triggers the reciprocal review process for the application to be fast-tracked.

The new processes bring Alberta one step closer to a harmonized health research ethics system, an objective identified in Alberta’s Health Research and Innovation Strategy as a means of streamlining the ethics review process and enhancing Alberta’s clinical trials program.

The harmonized system for ethics review will ultimately benefit the province as a whole through:
•Reduced project start up times for researchers and research sponsors;
•Improved capacity to attract, support, and retain top researchers and stimulate new research investment;
•Support for an increased level of innovative, high-quality research that will help enhance healthcare for Albertans.

This milestone achievement would not have been possible without the cooperation of all levels of Alberta’s Research Ethics Boards. The processes will be reviewed in approximately a year, when all six REBs will be using a common electronic platform for ethics application, review and reporting.

Please click here to read the full report and here for a summary of the multi-site application process.

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For more information:
Karine Morin, LLM, Executive Director, Platforms
Karine.Morin@albertainnovates.ca
(780) 429-9349