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6.3 Cloning

Rosario Isasi, JD, MPH; and Maya Shukairy BSc.

*Updated July 29, 2015 by Rosario Isasi, JD, MPH; and Maya Shukairy BSc

Learning Objectives

  1. To assess the socio-ethical and legal issues relating to human cloning research and its potential applications
  2. To understand the distinctive roles and professional obligations or responsibilities of physicians and researchers with regard to human cloning research
  3. To expose the dimensions of possible conflicts of interest between the physician-researcher and the patient-research donor with regard to human cloning research
  4. 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.


  1. 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?
  2. 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?
  3. 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?


Q1. 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?

This is an international scientific collaboration project on therapeutic cloning. More specifically, it is a study on the development of embryonic stem cell lines using cloning technologies in order to better understand and treat diabetes.

Canadian law prevents Dr. Ramsey from conducting or participating in a cloning research project in Canada because cloning is criminally banned under the Assisted Human Reproduction Act.1 In the present case, however, the cloning process will take place in the United Kingdom. With a few exceptions, such as underage sex tourism, pedophilia and human trafficking, there is no extraterritorial jurisdiction for activities deemed as crimes in Canada. So in this case, if Dr. Ramsey were to participate in a research project on cloning abroad, he would not be violating Canadian law because the research will not take place in Canada.

According to the "International Code of Medical Ethics" of the World Medical Association, one of the general duties of any physician is to respect local and national codes of ethics. 2 Furthermore, the Association's Medical Ethics Manual distinguishes between ethical and legal duties;3 though sometimes both types are closely related, they might prescribe different standards of behaviour or actions. For instance, an ethical professional duty might require a physician to disobey laws that demand unethical behaviour.

Individuals are ultimately responsible for making their own ethical decisions and for implementing them. The Medical Ethics Manual reminds us that, in the end, unlike law, ethics are relative and vary from one individual to another, and it is up to individuals to choose their ethical standards or values, but that will be at their own risk. 3

In the present case, Dr. Ramsey will not be directly violating Canadian laws because his actions abroad are lawful. The key question thus lies in the morality or ethics of his actions. Are his actions ethical? Is it morally acceptable for a doctor-researcher to perform outside of his country an act that is prohibited in his own country? Is he, morally or ethically speaking, violating his professional duties? What does it mean in terms of ethical or professional duties for a researcher (like Dr. Ramsey) to opt to conduct research abroad because the research is legally prohibited in his own country? Should this be understood as an encouragement to all researchers to violate their countries' rules and to perform such research in a country that allows the act to be performed? The answers to these questions are not easy, and this case study presents a moral dilemma. There are equally compelling reasons supporting the different moral or ethical choices presented to the physician-researcher; hence, a balance must be achieved.

In assessing the ethics of the physician-researcher's behaviour, it is important to weigh its costs and benefits as well as other factors at stake (e.g., academic freedom). If participating in specific research on therapeutic cloning serves the worthwhile purpose of serving the advancement of science by finding a treatment for a disease and if the chances of success for the research seem to be very high, then participation may not be as unethical as it might seem to be at first glance. The benefits to be gained from committing the act may outweigh those of not doing it. However, this cost-benefit analysis does not take into account the potential negative consequences of the physician-researcher's behaviour in terms of professionalism, such as indirectly encouraging "research tourism."

While there is no consensus on the issue of whether it is appropriate for a physician-researcher facing restrictions in his home country to conduct research in countries where the activity is allowed ("research tourism"), there is some support for this idea. The Hinxton Group, for instance, is of the opinion that a researcher should be free to conduct such type of work without the threat of facing prosecution or any other form of sanction, whether imposed by government, peers or employers.4 The Hinxton Group's opinion thus emphasizes autonomy and the freedom of academic research as fundamental rights. This opinion should be interpreted in connection to another privilege: self-regulation. As pointed out by the Canadian Medical Association in the "CMA Code of Ethics," self-regulation of a profession is a privilege and, hence, each physician has a continuing responsibility to merit this privilege and to support its institutions.5

As an autonomous agent, a physician-researcher has the right to disagree with the position taken by his country and, consequently, to reject the ethical premises that underline a national regulatory framework. Based on this, he could decide to conduct his research abroad. But whether this act will be considered ethical or not will depend, as stated above, on the balance of the social and individual costs and benefits at stake. Indeed, although a physician is a free and autonomous agent, she or he is still bound to her or his primary professional duty, which is to respect the national or local laws and codes of professional ethics.

Q2. 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?

The physician has the legal and ethical duty to place the best interest of the patient first, a duty that compels him to avoid or mitigate situations in which such duty could be breached. This could be achieved by full disclosure to the appropriate people or institutions; thereby moderating the circumstances that create possible conflicts of interest.

In circumstances whereby a physician assumes a dual role of physician-researcher, real, potential or perceived conflicts of interest could arise. The nature of the conflict depends on the distinct duties of each professional role, as well as in the asymmetry of knowledge and power between physician-researcher and patient.

The separation of roles between the medical personnel in charge of an assisted reproduction clinic and the research team is a common principle across the globe. The (perceived) need for a demarcation between professional roles arises in situations in which the interests of the patient or the donor/research subject are likely to be promoted or compromised. The physician's fiduciary duty of care to the patient and focus on the patient's wellbeing could potentially conflict or diverge from the researcher's duty and focus on the potential social and scientific benefits of the research activity. According to the World Medical Association's Medical Ethics Manual, the physician's role in the physician-patient relationship is different from the researcher's role in the researcher-research subject relationship, even if the physician and the researcher are the same person.3 The primary interest of the first role is the wellbeing of the patient, whereas the interest of the latter is the generation of knowledge, which may or may not contribute to the research subject's health and wellbeing.

The motivation or rationale behind separating the interests of the assisted reproduction medical team and the researchers is to prevent doctors from taking actions that could affect the best interests of their patients or diminish the patients' fundamental rights (for instance, by putting undue influence on their patients to donate their eggs). The rationales also reside in the need to respect, foster and protect patients' or donors'/research subjects� autonomy and, hence, to foster a truthful, voluntary, competent and informed consent process. On this point, the Canadian Medical Association cites the wellbeing of the patient as well as the contribution to the development of the medical profession as examples of some of the fundamental responsibilities of a physician.5 Likewise, the World Medical Association affirms that the primary ethical principle underlying most ethical guidelines is that conflict of interest between a patient and a physician should be resolved in the patient's favour.3

Furthermore, the TCPS2 highlights that conflicts of interest must be assessed when conducting research as they could jeopardize not only the protection conferred to research participants but also the integrity of the research6.
Q3. 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?

According to the Medical Ethics Manual of the World Medical Association, informed consent is one of the central concepts of present-day medical ethics.3 Therefore, explicit consent for the donation of human biological material (i.e., oocytes and somatic cells) for research purposes must be obtained at the time of donation. The informed consent process must also disclose all the material information necessary to allow the donor to make a voluntary and informed decision. According to article 2.1 (a) of the Canadian "Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans," prospective subjects should have the opportunity to give free and informed consent about participation, and their free and informed consent should be maintained throughout their participation in research.6

Given the heightened socio-ethical concerns surrounding cloning, the physician-researcher should always explicitly disclose to the donors that their donated gametes will be or might be used in research involving human cloning, albeit therapeutic. The physician-researcher should also disclose whether the research will take place in Canada or abroad.

According to the "CMA Code of Ethics," physicians and researchers must make sure to give the subjects or participants all the relevant material information to enable informed decision-making.5 The following are examples of the material information required to be disclosed to donors by national and international policies (see Resources section below):

  • that the study (and donation) involves cloning research and the purpose of the research;
  • the potential health risks to the donor/patient;
  • that the donation is made without any restriction or direction regarding who may be the recipient of the cell transplants, except in the case of autologous transplantation;
  • the specific measures taken to protect the donor's privacy and confidentiality;
  • that neither consenting nor refusing to donate materials for research will affect the quality of care provided to potential donors;
  • that the donated materials will not be used to produce a pregnancy; and
  • the possibility that resulting cells or cell lines may have commercial potential, and the donor will not receive financial benefits from any future commercial development.


  1. Assisted Human Reproduction Act, March 29, 2004, c.2. (amended September 30th, 2012) Available from:
  2. World Medical Association. International code of medical ethics. Pilanesberg, South Africa: World Medical Association; 2006. Available from:
  3. Williams JR. Medical ethics manual. World Medical Association; 2005. Available from:
  4. 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:
  5. Canadian Medical Association. CMA code of ethics (updated 2004). Ottawa: Canadian Medical Association; 2004. Available from:
  6. 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:


  • Reference re Assisted Human Reproduction Act. 2010 SCC 61, [2010] 3 S.C.R. 457; Supreme Court of Canada.
  • 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.
  • American Medical Association. Stem cell research [web page with cloning and stem cellresources and opinions]. American Medical Association; 2008. Available from:
  • Assisted Human Reproduction (Section 8 Consent) Regulations, June 14, 2007, SOR/2007-137 [under the Assisted Human Reproduction Act]. (p.1520). Available from:
  • Caulfield T, Bubela T. Why a criminal ban? Analyzing the arguments against somatic cell nuclear transfer in the Canadian parliamentary debate. American Journal of Bioethics 2007; 7(2): 51�61.
  • Devolder K, Savulescu J. The moral imperative to conduct embryonic stem cell and cloning research. Cambridge Quarterly of Healthcare Ethics 2006; 15(1): 7.
  • Isasi R.M., Knoppers B.M. Monetary payments for the procurement of oocytes for stem cell research: In search of ethical and political consistency. Stem Cell Research 2007, 1:37-44.
  • ESHRE Task Force on Ethics and Law, et al. ESHRE Task Force on Ethics and Law 12: oocyte donation for non-reproductive purposes. Human Reproduction 2007; 22(5): 1210�3.
  • Ethics Committee of the American Society for Reproductive Medicine. Human somatic cell nuclear transfer and cloning. Fertil Steril. 2012 Oct;98(4):804-7.
  • Easley CA, Simerly CR, Schatten G. Gamete derivation from embryonic stem cells, induced pluripotent stem cells or somatic cell nuclear transfer-derived embryonic stem cells: state of the art. Reprod Fertil Dev. 2014 Dec;27(1):89-92.
  • Cibelli JB. Human somatic cell nuclear transfer is alive and well. Cell Stem Cell. 2014 Jun 5;14(6):699-701
  • Lomax GP, DeWitt ND. Somatic cell nuclear transfer in Oregon: expanding the pluripotent space and informing research ethics. Stem Cells Dev. 2013 Dec;22 Suppl 1:25-8.
  • The Ethics Committee of the American Society for Reproductive Medicine. Informed consent and the use of gametes and embryos for research. Fertility and Sterility 2004; 82 (Suppl 1).
  • 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: 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:
  • Mathews DJ, Donovan P, Harris J, Lovell-Badge R, Savulescu J, et al. Science and law: integrity in international stem cell research collaborations. Science 2006; 313: 921�2.
  • Skene L. Undertaking research in other countries: national ethico-legal barometers and international consensus statements. PLoS: Medicine 2007; 4(2): 243�7.
  • United Nations. United Nations declaration on human cloning. United Nations; 2005. Available from: