Final Report of the Experts Committee for Human Research Participant Protection in Canada

The Experts Committee for Human Research Participant Protection in Canada presents herewith its final report and recommendations concerning the development of a new comprehensive system in Canada. The final report is the product of some twenty months work. Beginning in September, 2006 and ending February, 2007 the Committee held monthly face-to-face meetings which it supplemented by conference calls and the circulation of draft texts by various members. During the course of its work, the Committee assessed the concerns that had been raised about the existing Canadian governance arrangements and then examined alternative models that might serve to deal effectively with these concerns. It also arranged to receive briefings from a number of organizations with relevant experience and expertise in its field, including the National Council on Ethics in Human Research (NCEHR), the Interagency Advisory Panel on Research Ethics (PRE), the Association for the Accreditation of Human Research Protection Programs (AAHRPP), and the Canadian Council on Animal Care (CCAC). The approach used by the Committee was to build on much work (analysis, consultations and consensus-building) that had been done over the preceding decade, particularly by NCEHR and PRE. Under the auspices of the Sponsors’ Table, a four month public consultation process was conducted. This process received 104 submissions totaling over 600 pages of comments. The Committee took seriously these comments as is evident in the changes in the final report. The Committee’s objective in developing its proposals was to achieve, not perfection, but workability. In our view, the most important thing at this stage is to put in place the best set of measures that can be devised and then let them evolve in the light of experience. The Committee’s conclusions and recommendations are set out in this report. The comprehensive system and organization that it proposes would, in the Committee’s judgment, provide the most effective way of enhancing the protection of human research participants in Canada.