New Canadian Standard for Research Ethics Oversight of Biomedical Clinical Trials

The Canadian General Standards Board (CGSB) has published a new National Standard of Canada for Research Ethics Oversight of Biomedical Clinical Trials, CAN/CGSB-191.1-2013.  The voluntary standard aims to provide research ethics boards (REBs) in Canada with a common platform for governance, membership, operations, ethics review processes, and quality management. The intended users of this standard are those individuals and groups responsible for ensuring that biomedical clinical trial research meets the high standard of research ethics expected by Canadians.

The scope of the standard applies to REB s that evaluate applications for ethical acceptability.  If an REB grants approval to conduct biomedical clinical trials, it will provide research ethics oversight of biomedical clinical trials that are subject to Canada’s Food and Drugs Act and applicable regulations.  The standard is intended to serve as a reference for those with authority to monitor the quality of the research ethics oversight of biomedical clinical trial research. 

In 2006, Health Canada initiated the development of a voluntary standard for REB s in order to enhance harmonization and to increase the protection of clinical trial participants.  Canada approached CGSB as a Standards Development Organization accredited by the Standards Council of Canada. Using its significant experience in developing national standards, CGSB’s role in the development of the standard is one of facilitator, managing the development of a voluntary standard established by consensus and brings together a balanced matrix of technical experts who provide broad-based input to the standard. 

The CGSB Standards Committee on REBs Reviewing Biomedical Clinical Trials (Committee) consists of over 30 organizations from every region in Canada representing all aspects of the clinical trial community. Since 2006, the Committee worked exhaustively to develop the standard by considering the varied viewpoints and interests. The substantial majority of Committee members believe that the standard will make a positive contribution to enhance REBs in Canada by increasing efficiencies within REB operations and facilitating more mutual reco gnition among REBs.

CGSB and Health Canada would like to thank all members of the Committee for their invaluable contributions and for their determination and goodwill to complete the voluntary standard. In particular, the dedication and leadership of the Committee Chair, Dr. Glenn G. Griener, an Associate Professor from the University of Alberta, representing the National Council on Ethics in Human Research on the Committee, was instrumental to the success of this achievement.

This first edition National Standard of Canada is available for purchase through the CGSB e-store.