Regulation and ethics of medical research and biotechnology : guidelines and regulations

6 Pages·2002·0.16 MB·English

by  Lemmens, Trudo

REGULATION AND ETHICS OF MEDICAL
RESEARCH AND BIOTECHNOLOGY:
GUIDELINES AND REGULATIONS
PROFESSOR TRUDO LEMMENS
FACULTY OF LAW
UNIVERSITY OF TORONTO
FALL 2002
These materials are reproduced solely for the use of students in the
Faculty of Law, University of Toronto
Digitized by the internet Archive
in 2018 with funding from
University of Toronto
https://archive.org/details/regulationethicsOOIemm
REGULATION AND ETHICS OF MEDICAL
RESEARCH AND BIOTECHNOLOGY:
GUIDELINES AND REGULATIONS
PROFESSOR TRUDO LEMMENS
FACULTY OF LAW
UNIVERSITY OF TORONTO
FALL 2002
These materials are reproduced solely for the use of students in the
Faculty of Law, University of Toronto

REGULATION AND ETHICS OF MEDICAL
RESEARCH AND BIOTECHNOLOGY:
GUIDELINES AND REGULATIONS
Professor Trudo Lemmens,
Faculty of Law, University of Toronto
Fall 2002
__TABLE OF CONTENTS_
Tri Council Policy Statement: Ethical Conduct for Research Involving Humans, Ottawa: Public
Works and Government Services Canada, 1998.1
Update of May 2000. 89
Association of Canadian Universities for Northern Studies, Ethical Principles for the Conduct of
Research in the North. Ottawa: ACUNS, 1982, reprinted 1988.90
Royal Commission on Aboriginal Peoples. Appendix B: “Ethical Guidelines for Research," in
Integrated Research Plan. Ottawa: RCAP, 1993. 95
International Conference on Harmonisation, Guideline for Good Clinical Practice, ICH
Harmonised Tripartite Guideline, May 1, 1996. 98
Code of Federal Regulations (United States):
Title 45 Public Welfare; Dept of Health and Human Services, National Institutes of Health,
Office for Protection from Research Risks, Part 46 Protection of Human Subjects,
Revised November 13, 2001 (Effective December 13, 2001).155
Title 21 Food and Drug Administration, Dept of Health and Human Services, Part 50
Protection of Human Subjects, Revised as of April 1, 2002.182
Title 21 Food and Drug Administration, Dept of Health and Human Services, Part 54,
Financial Disclosure by Clinical Investigators, Revised as of April 1, 2002.193
Title 21 Food and Drug Administration, Dept of Health and Human Services, Part 56,
Institutional Review Boards, Revised as of April 1, 2002.196
The Nuremberg Code. Reprinted from Trials of War Criminals before the Nuremberg Military
Tribunals under Control Council Law No. 10, Vol. 2, pp. 181-182. Washington, D C.: U.S.
Government Printing Office, 1949. 206
World Medical Association (WMA) Declaration of Helsinki: Recommendations Guiding Medical
Doctors in Biomedical Research Involving Human Subjects, Adopted by the 18th WMA General
Assembly, Helsinki, Finland, June 1964 and amended by the 29th WMA General Assembly,
Tokyo Japan, October 1975; 35 th WMA General Assembly, Venice, Italy, October 1983; the
41st WMA, Hong Kong, September 1989; the 48n WMA, Somerset West, Republic of South
Africa, October 1996; and the 52nd WMA, Edinburgh, Scotland, October 2000. Note of
Clarification on Paragraph 29 added by the WMA General Assembly, Washington, 2002. 207
Council for International Organizations of Medical Sciences (CIOMS): International Ethical
Guidelines for Biomedical Research Involving Human Subjects, Geneva, August 2002. 211