Vulnerable subjects and Canadian research governance

IRB Ethics and Human Research

Volumn 27, Issue 6, 2005, Pages 9-11

  Wilson, Mark ^a  

^a Medical Ethics for Health Research Associates   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 28844499136     PISSN: 01937758     EISSN: None     Source Type: Journal    
DOI: 10.2307/3563535     Document Type: Note

References (25)

1. Bravo G, Dubois MF, Paquet M. The conduct of Canadian researchers and institutional review boards regarding substituted consent for research. IRB; Ethics & Human Research 2004;26(1):1-8.
2. Tomossy GF, Weisstub D, Gauthier S. Research involving cognitively impaired elderly subjects: Canada as a case study. In: Weisstub D, Thomasma S, Gauthier S, Tomossy GF. Aging: Decisions at the End of Life. Dordrecht: Kluwer Academic Press, 2001, p. 227-254;
3. Tomossy GF, Weisstub D. The reform of adult guardianship laws: The case of non-therapeutic experimentation. International Journal of Law and Psychiatry 1997;20(1):113-140.
4. Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. Ottawa: Minister of Supply and Services, 1998. http://www.pre.ethics.gc. ca/english/policystatement/policystatement.cfm.
5. Plan d'action Ministerial. (1998), [sec. 21 C.c.Q] Conditions d'exercice des comités éthique de la recherche désignés ou institués par le ministre de la Santé et des Services sociaux en vertu de l'article 21 du Code civil [sec. 21 C.c.Q]. Also see ref. 3 for composition of REBs laid out in the TCPS. For federal regulations regarding REB composition see Regulations Amending the Food and Drug Regulations (1024 Clinical Trials) http://www.hc-sc.gc.ca/hpfb-dgpsa/inspectorate/ food_drug_reg_amend_1024_gcp_e.pdf.
6. See ref. 1, Bravo et al. 2004.
7. Bravo G, Dubois MF, Paquet M. Knowledge of the legislation governing proxy consent to treatment and research. Journal of Medical Ethics 2003;29:44-50.
8. See ref. 1, Bravo et al. 2004.
9. See ref. 2, Tomossy et al. 2001.
10. McDonald M. The Governance of Human Research Involving Human Subjects. Ottawa, Law Commission of Canada, 2000.
11. For a synopsis of salient features of the report also see McDonald M. Canadian governance of health research involving human subjects: Is anybody minding the store? Health Law Journal 2001;9:122.
12. See ref. 9, McDonald 2000.
13. See ref. 9, McDonald 2000.
14. See ref. 9, McDonald 2000.
15. Warring D, Lemmens T. Integrating values in risk analysis of biomedical research: The case for regulatory and law reform. University of Toronto Law Journal 2004;54: 249-290.
16. Wilson M. Getting a fix on good governance. Journal of Medical Ethics 2004;30(2):232.
17. Downie J, McDonald F. Revisioning the oversight of research involving humans in Canada. Health Law Journal 2004;12:159-81.
18. Weijer C. Placebo tribulations. Canadian Medical Association Journal 2002;167:456-457.
19. Corman J, Blajchman M, Knight A. Placebo tribulations. Canadian Medical Association Journal 2002;167:455-456.
20. U.S. Office for Human Research Protections, http://www.hhs.gov/ohrp/ detrm_letrs/YRo3/julo3z.pdf.
21. 21 U.S. Food and Drug Administration, http://www.fda.gov/foi/ warning_letters/g3946d.htm.
22. Downie J. Contemporary health research: A cautionary tale. Health Law Journal 2003;Special Edition:1-20.
23. Bisby M. From the National NCEHR Conference. Communiqué 2005;13(1):18. http://www.ncehr-cnerh.org/english/communique.php. The Canadian Institute of Health Research is a primary federal sponsor of medical research in Canada.
24. A Canadian system of oversight for the governance of research involving human subjects. http://www.hc-sc.gc.ca/sab-ccs/feb2002_governance_subject_e.pdf.
25. See ref. 13, Warring and Lemmens 2004.