Course EPIB-6602008
Practical Aspects of Protocol Development
Session 7: Consultations on Ethics (all protocols) Monday, June 16, 8h30-10h00
10h15 -11h45
Dr. K Glass, Dr. MR Becklake
The need for ethical guidelines in human research has become increasingly evident over recent years, and universities, hospitals and granting agencies require ethics approval for all studies involving human subjects and animals. Different councils and committees have prepared guidelines for different domains of research. For instance, all research in Canadian universities must conform to the requirements of the Tri Council Policy Statement on Ethical Conduct for Research involving Humans, issued in 2003. Ethics Committees and Institutional Review Boards (IRB’s), appropriately constituted are responsible for these tasks. The Canadian Medical Association Journal (CMAJ) has also published a series of articles on Bioethics for Clinicians. The Encyclopedia of Occupational Health and Safety, published by the International Labour Office in 1992 covers issues related to the workplace. All these references may be useful in identifying the specific issues raised in your research protocol.
Before this Session, Dr.Glass will have reviewed the short outlines of all the class’s protocols, (handed in on Friday, June 15th). Discussion will be organised round groups of protocols raising similar ethical issues. Each group should prepare a short (5 minutes) presentation on the ethical issues which, in your view, are raised by your protocol. The class will act as your Institutional Review Board (IRB). Dr.Glass will preside over the Session.
Readings (enclosed)
1..National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research: The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. 1978 (pages xxi - xxiii enclosed)
2. Weijer C, Dickens B, Meslin EM. Bioethics for clinicians: 10.Research ethics. Can Med Assoc J 1997, 156:1153 - 1157
3.Weijer C, Shapiro SH, Glass KC, Enkin MW. Education and Debate: For and Against: Clinical equipoise and not the uncertainty principle is the moral underpinning of the randomised clinical trial. CMAJ 2000, 321: 756-758..
Other useful references
1..Tri-council Policy Statement: Ethical Conduct for Research Involving Humans(2003). Public Works and Government Services Canada. ISBN 0-662-34936-9
2. International Labour Office, Geneva. Encyclopedia of Occupational Health and Safety. 4hed. Jeanne Mager Stellman. Editor-in-Chief. Part 1. The Body. 19. Ethical issues: (Chapter Editor: Georges H Coppice) ISBN 92-2-109814
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