Academic journal article Health Law Review

Research Ethics across the 49th Parallel: The Potential Value of Pilot Testing "Equivalent Protections" in Canadian Research Institutions

Academic journal article Health Law Review

Research Ethics across the 49th Parallel: The Potential Value of Pilot Testing "Equivalent Protections" in Canadian Research Institutions

Article excerpt

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.

**********

Introduction

Geographically, Canada and the U.S. share the world's longest undefended border, the majority of which straddles the 49th parallel. Canada and the United States share the world's largest trade partnership, amounting to approximately $650 billion dollars per year in goods and services between the two countries. (1) This partnership is often characterized as a one-directional flow of exports from Canada to the United States, since Canada exports approximately 85% of its goods to the U.S., whereas the U.S. exports about 25% of its good to Canada, but in 2003 Canada's imports from the United States exceeded those of all 25 countries of the European Union. (2) Canada and the U.S. have a long and respected tradition of bilateral arrangements in scientific exchange, industrial partnership, national security and the environment, to say nothing of the more recognizable commonalities in culture, sports, and entertainment.

Recently, in light of the increasingly well recognized economic interdependence between Canada and the United States and our status as the world's largest trade partnership, there have been some quiet calls for improved harmonization of the vast and often divergent approaches to regulating common industries between the two countries. (3) Currently more than 300 treaties and agreements are in force to provide frameworks for partnerships in a vast range of enterprises. (4)

Although its precise economic value is seldom considered and difficult to quantify, health research conducted with human subjects is clearly an important strategic priority for both governments, and has a considerable economic impact in both countries. Collectively in 2003, Canadian research institutions received almost $50 million dollars (U.S.) in federal research funding from the National Institutes of Heath (NIH), more than institutions in any other country, and approximately 25% of the $200 million awarded to foreign institutions. (5) Much of this funding supports research involving human subjects, and so the value of common, or comparable, standards in the protection of human subjects in research is readily apparent. …

Search by... Author
Show... All Results Primary Sources Peer-reviewed

Oops!

An unknown error has occurred. Please click the button below to reload the page. If the problem persists, please try again in a little while.