Rosario Isasi, JD, MPH; and Maya Shukairy BSc.
*Updated July 29, 2015 by Rosario Isasi, JD, MPH; and Maya Shukairy BSc
- To assess the socio-ethical and legal issues relating to human cloning research and its potential applications
- To understand the distinctive roles and professional obligations or responsibilities of physicians and researchers with regard to human cloning research
- To expose the dimensions of possible conflicts of interest between the physician-researcher and the patient-research donor with regard to human cloning research
- To demonstrate the socio-ethical and legal implications of international research collaboration in human cloning research
Dr. Ramsey is a professor and researcher at a prestigious Canadian university, as well as the Director of "Creator," an infertility clinic also located in Canada. Dr. Ramsey is approached by Dr. Green, a stem cell researcher from Manchester, United Kingdom, to work on an international collaborative project.
Dr. Green wants to study the development of stem cell lines for eventual therapies for patients with diabetes through somatic cell nuclear transfer. Due to the lack of human eggs available to conduct the experiment in the United Kingdom, the somatic cell nuclear transfer lines will be derived using surplus eggs donated by Dr. Ramsey's infertility patients at "Creator." The somatic cells, however, will be donated by British patients recruited by Dr. Green. The research will be conducted in Dr. Green's laboratory in Manchester, and Dr. Ramsey will periodically travel to Manchester to oversee the research.
The Legal Context
In the United Kingdom, the derivation of new human embryonic stem cell lines from leftover embryos from fertility treatments or those created by somatic cell nuclear transfer ("therapeutic cloning") is allowed by law. In Canada, under the 2004 Assisted Human Reproduction Act, the creation of a "human clone" by "using any technique" and the "transplant of a human clone into a human being or into any non-human life form or artificial device" is criminally prohibited.1 However, the derivation of new embryonic stem cell lines from leftover embryos is allowed under the Act.
Furthermore, under Canadian law, the export of gametes (e.g., eggs and sperm) is allowed. The law is silent regarding exporting gametes for stem cell research or cloning experiments.
Both the United Kingdom and Canada have adopted a system of altruistic donation; hence, the commercialization of human gametes and cells is prohibited. However, these countries have adopted distinct policies for providing financial compensation to gamete donors. Notably, both countries prohibit human reproductive cloning.
- Given the different regulatory frameworks adopted in Dr. Ramsey's and Dr. Green's countries, do you think that Dr. Ramsey would be concerned about the ethical or professional ramifications associated with their scientific collaboration? Why?
- What are Dr. Ramsey's responsibilities as a researcher and physician with regard to the egg donors? Is he in a situation of conflict of interest? If so, how would you suggest that he handle it?
- What should Dr. Ramsey know about the informed consent process, if any is needed, for the donation of the gametes and somatic cells? Does it matter whether or not donors were informed that their gametes and tissues would be used in "cloning" experiments or that their gametes would be used abroad?
- Assisted Human Reproduction Act, March 29, 2004, c.2. (amended September 30th, 2012) Available from: http://laws-lois.justice.gc.ca/eng/acts/A-13.4/
- World Medical Association. International code of medical ethics. Pilanesberg, South Africa: World Medical Association; 2006. Available from:https://www.wma.net/policies-post/wma-international-code-of-medical-ethics/
- Williams JR. Medical ethics manual. World Medical Association; 2005. Available from: http://www.whcaonline.org/uploads/publications/em_en.pdf
- The Hinxton Group, an International Consortium on Stem Cells, Ethics and Law. Transnational cooperation in stem cell research [consensus statement]. The Johns Hopkins Berman Institute of Bioethics; 2006. Available from:http://www.hinxtongroup.org/au_cs.html
- Canadian Medical Association. CMA code of ethics (updated 2004). Ottawa: Canadian Medical Association; 2004. Available from: http://policybase.cma.ca/PolicyPDF/PD04-06.pdf
- Medical Research Council of Canada, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada. 2nd Edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2). Ottawa: Public Works and Government Services Canada; 2014. Available from: http://www.pre.ethics.gc.ca/pdf/eng/tcps2-2014/TCPS_2_FINAL_Web.pdf
- Reference re Assisted Human Reproduction Act. 2010 SCC 61,  3 S.C.R. 457; Supreme Court of Canada. http://scc-csc.lexum.com/scc-csc/scc-csc/en/item/7905/index.do
- Final Report of The National Academies' Human Embryonic Stem Cell Research Advisory Committee and 2010 Amendments to The National Academies' Guidelines for Human Embryonic Stem Cell Research. Washington, DC: The National Academies Press, 2010. http://www.nap.edu/catalog/12923/final-report-of-the-national-academies-human-embryonic-stem-cell-research-advisory-committee-and-2010-amendments-to-the-national-academies-guidelines-for-human-embryonic-stem-cell-research
- American Medical Association. Stem cell research [web page with cloning and stem cellresources and opinions]. American Medical Association; 2008. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1151030/
- Assisted Human Reproduction (Section 8 Consent) Regulations, June 14, 2007, SOR/2007-137 [under the Assisted Human Reproduction Act]. (p.1520). Available from: http://laws-lois.justice.gc.ca/eng/regulations/SOR-2007-137/index.html
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- StemGen International [website of online resources concerning ethical, legal and social issues in human genetics]. Database of laws and policies, and FAQs. Montreal: McGill University; [n.d.]. Available from: http://www.stemgen.org International Society for Stem Cell Research. Guidelines for the conduct of human embryonic stem cell research. Version 1: December 21, 2006. International Society for Stem Cell Research; 2006. Available from: https://www.forth.gr/_gfx/pdf/ISSCRhESCguidelines2006.pdf
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