Protecting Human Research Subjects: A Jurisdictional Analysis

2003 Health Law Journal 207

23 Pages Posted: 1 Aug 2013

See all articles by Jennifer Llewellyn

Jennifer Llewellyn

Schulich School of Law, Dalhousie University

Jocelyn Downie

Schulich School of Law & Faculty of Medicine

Robert Holmes

Dalhousie University - Schulich School of Law

Date Written: 2003

Abstract

The most recent speech from the throne contained a pledge from the federal government to "work with provinces to implement a national system for the governance of research involving humans, including national research ethics and standards." This commitment signals a desire on the part of the federal government to address concerns about the inadequacies of the current governance of health research involving humans (RIH). To this end, Health Canada's Ethics Division is currently exploring the ways in which such a national governance system for RIH might be implemented. It is important for the federal government, as it moves toward making good on its Throne Speech pledge, to have clarity concerning the jurisdictional authority to legislate with regard to RIH. Specifically, it needs to be clear about whether the constitutional jurisdiction over RIH rests with the federal government, the provinces or whether it is divided or shared between them. The answer to this jurisdictional question will shape the federal government's approach to any negotiations with the provinces concerning the creation and implementation of a national system of governance for RIH. Addressing the jurisdictional issues is an important precursor to any negotiation process for two reasons. First, the scope of federal and provincial power over RIH is key both to the design and implementation of a comprehensive national system of regulation over RIH. It is necessary to determine which sphere of government has the power to do what before deciding how to go about creating a national governance system. Second, knowing the extent and the scope of federal jurisdiction with respect to RIH might strengthen the negotiating position of the federal government vis a vis the provinces. It will provide clarity as to what the federal government could do in terms of regulating RIH if the provinces are unwilling to cooperate. In short, it will make clear whether, and to what extent, the federal government needs provincial agreement to regulate RIH and what options are available to the federal government if such agreement is not attained.

Keywords: research involving humans, health, ethics, jurisdiction

Suggested Citation

Llewellyn, Jennifer and Downie, Jocelyn and Holmes, Robert, Protecting Human Research Subjects: A Jurisdictional Analysis (2003). 2003 Health Law Journal 207, Available at SSRN: https://ssrn.com/abstract=2303705

Jennifer Llewellyn (Contact Author)

Schulich School of Law, Dalhousie University ( email )

6061 University Avenue
6061 University Ave
Halifax, Nova Scotia B3H 4H9
Canada
902-494-1013 (Phone)

Jocelyn Downie

Schulich School of Law & Faculty of Medicine ( email )

Halifax, Nova Scotia B3H 4H9
Canada

Robert Holmes

Dalhousie University - Schulich School of Law ( email )

6061 University Avenue
6061 University Ave
Halifax, Nova Scotia B3H 4H9
Canada

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