Informed consent in embryonic stem cell research: Are we following basic principles?

CMAJ. Canadian Medical Association Journal

Volumn 176, Issue 12, 2007, Pages 1722-1725

  Caulfield, Timothy ^a,b,c   Ogbogu, Ubaka ^c   Isasi, Rosario M ^d  

^a Department Health Law and Policy ^*  (Canada)

^b Public Health City of Ottawa   (Canada)

^c UNIVERSITY OF ALBERTA   (Canada)

^d UNIVERSITÉ DE MONTRÉAL   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

CANADA; EMBRYO CELL; MEDICAL LITERATURE; MEDICAL RESEARCH; NOTE; PRACTICE GUIDELINE; STEM CELL;

EID: 34250176945     PISSN: 08203946     EISSN: 14882329     Source Type: Journal    
DOI: 10.1503/cmaj.061675     Document Type: Note

References (34)

1. Caulfield T, Bubela T. Why a criminal ban? Analyzing the arguments against somatic cell nuclear transfer in the Canadian parliamentary debate. Am J Bioeth 2007;7:51-61.
2. Isasi RM, Knoppers BM. Mind the gap; policy approaches to embryonic stem cell and cloning research in 50 countries. Eur J Health Law 2006;13:9-26.
3. Assisted Human Reproduction Act. SC 2004, C2. Available: http://laws.justice.gc.ca/en/ShowFullDoc/cs/a-13.4///en (accessed 2007 Apr 20).
4. Canadian Institutes of Health Research (CIHR). Updated guidelines for human pluripotent stem cell research, June 28, 2006, Ottawa: CIHR; 2006. Available: www.irsc.ca/e/31488.html (accessed 2007 Apr 20).
5. Lo B, Chou V, Cedars MI, et al. Informed consent in human oocyte, embryo, and embryonic stem cell research. Fertil Steril 2004 Sep; 82;559-63.
6. Canadian Institutes of Health Research. Minutes of the 7th meeting of the Stem Cell Oversight Committee (SCOC). Ottawa: CIHR; 2006 April 6-7. Available: www.cihr-irsc.gc.ca/e/31508.html (accessed 2007 Apr 20).
7. Human Fertilisation and Embryology Act 1990, C37. Available: www.opsi.gov.uk/acts/acts1990/Ukpga_19900037_en_1.htm (accessed 2007 May 2).
8. Human Fertilisation and Embryology Authority. Code of practice. 6th ed. London (UK): The Authority; 2003. Available: www.hfea.gov.uk/docs/ Code_of_Practice_Sixth_Edition_-_final.pdf (accessed 2007 May 2).
9. Medical Research Council (MRC). Code of practice for the use of human stem cell lines, September 15, 2006. London (UK): MRC; 2006. Available: www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC003132 (accessed 2007 May 2).
10. National Bioethics Advisory Commission. Ethical issues in human stem cell research, Vol.1. Rockville (MD): The Commission; 1999. Available: www.georgetown.edu/research/nrcbl/nbac/stemcell.pdf (accessed 2007 May 2).
11. Committee on Guidelines for Human Embryonic Stem Cell Research. Guidelines for human embryonic stem cell research. Washington (US): National Academies Press; 2005.
12. International Society for Stem Cell Research. Guidelines for the conduct of human embryonic stem cell research. Northbrook (IL): The Society; 2006. Available: www.isscr.org/guidelines/ISSCRhESCguidelines2006.pdf (accessed 2007 Apr 20).
13. Ciarlariello v. Schacter (1993), SCR, 119. Available: http://scc.lexum.umontreal.ca/en/1993/1993rcs2-119/1993rcs2-119.pdf (accessed 2007 Apr 20).
14. Reibl v. Hughes (1980), SCR, 880.
15. Norberg v. Wynrib (1992), SCR, 318.
16. McInerney v. McDonald (1992), SCR, 138.
17. Nisker J. The CMA code of ethics and the donation of fresh embryos for stem cell research. CMAJ 2005;173:621-2.
18. Litman MM. Fiduciary law and for - profit and not - for - profit health care. In: Caulfield TA, von Tigerstrom B, editors. Health care reform and the law in Canada: meeting the challenge. Edmonton: University of Alberta Press; 2002. p. 85-130.
19. Caulfield T, Grienet G. Conflicts of interest in clinical research: addressing the issue of physician remuneration. J Law Med Ethics 2002;30:305-8.
20. Lemmens T, Singer PA. Bioethics for clinicians: 17. Conflict of interest in research, education and patient care. CMAJ 1998:159:960-5.
21. World Medical Association. Declaration of Helsinki: Ethical principles for medical research involving human subjects. JAMA 2000;284:3043-5.
22. Council of Europe. Additional protocol to the Convention on Human Rights in Biomedicine, concerning biomedical research: Strasbourg 25.1.2005. Strasbourg (Germany): The Council; 2005. Available: http://conventions.coe.int/ treaty/en/Treaties/Html/195.htm (accessed 2007 Apr 20).
23. Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada. Tri-council policy statement: ethical conduct for research involving humans 1998 (with 2000, 2002, 2005 amendments). Ottawa: Public Works and Government Services Canada; 2005.
24. Canada, Governor-in-Council. Draft Assisted Human Reproduction (Section 8 Consent) Regulations, September 19, 2006. Copy on file with authors.
25. Policy Development Committee, Canadian Stem Cell Network. Use of human embryos for stem cell research. Ottawa: The Network; 2006. Available: www.stemcell-network.ca/aboutus/policy.php (accessed 2007 May 2).
26. Perley SN. From control over one's body to control over one's body parts; extending the doctrine of informed consent. N Y Univ Law Rev 1992;67:335-65.
27. UK Biobank. UK Biobank ethics and governance framework, version 2.0, July 2006. Available:www.ukbiobank.ac.uk/docs/ EGF_Version2_July%2006%20most%20uptodate.pdf (accessed 2007 May 2)
28. German National Ethics Council. Biobanks for research: opinion. Berlin: Nationaler Ethikrat; 2004. Available: www.ethikrat.org/_english/publications/ Opinion_Biobanks-for-research.pdf (accessed 2007 Apr 20).
29. The Washington University v. William J. Catalona et al, No 4: 03CV1065SNL (US District Court Opinions). Available: www.circare.org/lex/ 03cv01065_opinion.pdf (accessed 2007 Apr 20).
30. Code of federal regulations, 21: Eligibility determination for donors of human cells, tissues, and cellular and tissue-based products; final rule and notice, s. 1271.55. Washington (DC): US Food and Drug Administration, Department of Health and Human Services.
31. Halme DG, Kessler DA. FDA regulation of stem-cell-based therapies. N Engl J Med 2006;355:1730-5,1732.
32. Morelle R. Stem cells: Hope or hype? BBC News, UK version; 2006 Nov 9. Available: http://news.bbc.co.Uk/2/hi/health/6127772.stm (accessed 2007 Apr 20).
33. Amos J. Winston warns of stem cell "hype". BBC News, UK version; 2005 Sept 5. Available; http://news.bbc.co.Uk/2/hi/science/nature/ 4213566.stm (accessed 2007 Apr 20).
34. Caulfield T. Popular media, biotechnology, and the cycle of hype. Houst J Health Law Policy 2005;5:213-33.