title: Research ethics across the 49th parallel: the potential value of pilot testing "equivalent protections" in Canadian research institutions.
abstract: Canada and the United States share the world's largest trade partnership and an increasing concern about divergent regulatory approaches to common industries. Canadian research institutes receive more research funding from the U.S. National Institutes of Health than any other country, much of it to fund multi-centre and collaborative research between the two countries. Because of these close economic and research ties, and the extensive similarities between the two countries in the review and oversight of ethics in human subjects research, we propose that Canada would be an ideal country for a pilot-test of the feasibility of "equivalent protections," a U.S. regulation that permits comparison of protections for human subjects between institutions in the two countries. The "equivalent protections" has been advocated by various bodies in the United States as a potentially beneficial mechanism for improving oversight of foreign trials. As well, we argue that "equivalent protections" could prove to be valuable for Canada in five specific ways: (1) by potentially reducing administrative burden on Canadian research institutions administering U.S. federal research funding; (2) by creating symbolic value of an explicit recognition by the United States that procedures normally followed for the protection of human subjects in Canadian research institutions are at least equivalent to those provided by the U.S. regulations; (3) by lowering the opportunity cost of investing in research in Canada; (4) by affording Canada an opportunity to enhance its leadership role in international research by offering an alternative to the U.S. regulatory model for the protection of human subjects; and (5) by providing a model for how the idea of equivalent protections might be addressed for research funded by Canadian agencies but conducted in other countries.
authors.affiliation: Centre for Research on Inner City Health, St. Michael's Hospital, Toronto, Canada. laveryj@smh.toronto.on.ca
authors.forename: James V
authors.initials: JV
authors.lastname: Lavery
authors.forename: Michael
authors.initials: M
authors.lastname: McDonald
authors.forename: Eric M
authors.initials: EM
authors.lastname: Meslin
mesh_terms: D002170:Canada; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D026724:Ethical Review / Q000331:legislation & jurisprudence; D033161:Government Regulation; D006805:Human Experimentation / Q000941:ethics / Q000331:legislation & jurisprudence*; D006801:Humans; D007391:International Cooperation / Q000331:legislation & jurisprudence; D010865:Pilot Projects; D012109:Research Support as Topic; D014481:United States; D014483:United States Dept. of Health and Human Services