Regulation of medical research overseas

14.32 Despite significant differences, the approach taken to the regulation of the conduct of medical research in Australia is broadly similar to that in Canada, the United Kingdom and the United States. In each jurisdiction, national ethical standards have been established by government regulation or by government bodies. These national norms are applied to research proposals by multi-disciplinary ethics committees. In each jurisdiction, public funding serves as the primary means by which compliance with ethical standards is enforced, whether directly or indirectly.

14.33 The centrepiece of regulation in Canada is the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (Tri-Council Policy Statement).[32] Under the Tri-Council Policy Statement all research that involves living human subjects requires review and approval by a Research Ethics Board.[33] The Canadian research councils require, as a minimum condition of funding, that researchers and their institutions apply the ethical principles and articles of the Tri-Council Policy Statement.[34]

14.34 In the United Kingdom, the Research Governance Framework for Health and Social Care[35] applies to all research relating to the responsibilities of the Secretary of State for Health.[36] Research within the National Health Service (NHS) must have the prior approval of an NHS Research Ethics Committee (REC).[37] Ethics review by RECs is also required for research funded by the Medical Research Council[38] and General Medical Council.[39]

14.35 In the United States, the centrepiece of regulation of the conduct of medical research is known as the ‘Common Rule’.[40] The Common Rule applies only to research that is supported in some way by the federal government. Importantly, this includes research funded by the National Institutes of Health, the focal point for federally funded medical research.

[32] Natural Sciences and Engineering Research Council of Canada and Social Sciences and Humanities Research Council of Canada, Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, Canadian Institutes of Health Research, 8 May 2002.

[33] Ibid, art 1.1.

[34] Ibid, art 1.1(a).

[35]Department of Health (UK), Research Governance Framework for Health and Social Care, <>, 7 May 2002.

[36]Ibid, 3.

[37] Ibid, 33.

[38] Medical Research Council, Medical Research Council Guidelines for Good Clinical Practice in Clinical Trials, <>, 8 May 2002.

[39] General Medical Council, Research: The Role and Responsibilities of Doctors, <
standards/standards_frameset.htm>, 8 May 2002.

[40]Federal Policy for the Protection of Human Subjects (Basic DHHS Policy for Protection of Human Research Subjects) 45 CFR Pt 46 Subpt A.