Introduction


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This Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans describes the policies of the Medical Research Council (MRC), the Natural Sciences and Engineering Research Council (NSERC), and the Social Sciences and Humanities Research Council (SSHRC). The document replaces SSHRC's Ethics Guidelines for Research with Human Subjects, MRC's Guidelines on Research Involving Humans, and MRC's Guidelines for Research on Somatic Cell Gene Therapy in Humans.

The Councils will consider funding (or continued funding) only to individuals and institutions which certify compliance with this policy regarding research involving human subjects.

This joint policy expresses to the continuing commitment by the three Councils to the people of Canada, to promote the ethical conduct of research involving human subjects. This commitment was first expressed in the publication of guidelines in the late 1970s. Work on the joint Policy was started by formation of the Tri-Council Working Group in 1994. The Councils published three documents prepared by the Working Group: an Issues Paper in November 1994, a Discussion Draft in May 1996, and its Final Report (Code of Ethical Conduct for Research Involving Humans) in July 1997. Each of these documents stimulated extensive discussion in the academic community. The present Policy Statement was prepared by the Councils by revision of the Working Group's Final Report in the light of consultations between mid-1997 and May 1998.

The Councils believe that this policy statement will benefit research through addressing the paramount need for the highest ethical standards. The key is sensitive and thoughtful implementation of the spirit and requirements of the document. Nonetheless, the Councils recognize that considerations around the ethical conduct of research involving human subjects are complex and continually evolving. We therefore welcome comment and discussion, and commit to regular updates of this document.

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