Ethics review of multi-centre clinical trials in Canada.

from any of the three federal Canadian funding agencies must be reviewed and approved in advance by a human research ethics board (REB). The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) requires that each institution be fully responsible for the ethics review of human research conducted under its auspices (Article 1.2). This provision has been interpreted to mean that one institution cannot pro forma accept the REB decision of another institution when the same research is proposed for conduct at both institutions. This interpretation is most clearly at issue in cases of multi-centre clinical trials, wherein researchers from two or more institutions are invited to participate in trials using standardized research protocols.