In Iran, ethical rules consist of fatwas, national laws or ethics codes, and international guidelines (
20). Iran’s Supreme Leader Ayatollah Khamenei issued a fatwa on hESCR in 2002. In the Fatwa, he declared that hESCR is not conflicting with Shia tradition and congratulated the scientists who had produced hESC lines (
3). This fatwa has enabled new fatwas, practices, and legislations that allow hESCR. After the first fatwa, Iran, the first Muslim state to allow hESCR, rapidly progressed in this branch of medical science. According to Ayatollah Khamenei, hESCR helps scientists to develop new therapeutic technologies for the benefit of the whole of humanity, and enables Iran to reach its goal of becoming a leading scientific nation in the Middle East (
3,
21,
22). However, according to Ayatollah Khamenei, reproductive cloning is prohibited. Although it is possible to destruct spare embryos for hESCR, and produce identical parts of human beings, research on human embryos should not lead to the production of a human being as a whole (
3) (supplementary file Appendix 19).
Iran’s Ministry of Health and Medical Education (MOHME) took a major step in 2000 for Iran to have a National Code of Ethics in Biomedical Research and has taken religion, law, ethics, and medical experts together. These experts have prepared a draft under the supervision of the Medical Ethics and Medical History Research Centre of Tehran University of Medical Sciences. In 2005, the Policymaking Council of MOHME successfully completed the review, and guidelines came into force (
20). “Ethical Guide to Gamete and Embryo Research in the Islamic Republic of Iran” and “Ethical Guide to Stem Cell Research in the Islamic Republic of Iran” play an important role in our study.
The first chapter of the “Ethical Guide to Gamete and Embryo Research in the Islamic Republic of Iran” (supplementary file Appendix 20) has the title of human dignity. According to Article 1, human gametes and embryos can be used for therapeutic research only when it aims to cure human diseases. Article 2 strictly forbids the purchase and sale of human gametes and embryos (supplementary file Appendix 21). Article 3 prohibits the production of human embryos for research purposes. Research on embryos is acceptable in surplus embryos only when they are not certainly be used for IVF in the future (supplementary file Appendix 22). However, the same article allows an exception to the prohibition of the production of human embryos for research purposes. According to this exception, the production of an embryo is allowed if there is no surplus human embryo that has the necessary stem cell for such therapeutic research, and research on a human embryo is essential. Article 4 regulates that research on human embryos is permitted until the 14th day starting from fertilization. As seen, in the pre-ensoulment stage, it is possible to perform hESCR with both spare/surplus embryos and embryos created for therapeutic research (supplementary file Appendix 23).
In Article 6, it is regulated that the number of embryos used for research should be as few as possible. With this Article, Iran has not regulated a restriction of numbers. This is logical because every research has its own requirements. However, the Article warns the researchers to minimize the number of embryos used in research, in order to provide protection to human embryos. Also, Article 7 aims to provide protection for human embryos and specifies other restrictions for hESCR, such as the prohibition of producing chimeras and changing the genetic content of the gametes or embryos for transfer to the uterus, except for the purpose of preventing a specific illness. In our opinion, such restrictions protect human embryos from research incompatible with human dignity. It is clear that Iran provides those restrictions for the same reason by regulating them in the section on human dignity.
The second chapter of the Ethical Guide to Gamete and Embryo Research in the Islamic Republic of Iran is about taking consent from donors and permission from the Ethics Committee. According to Article 8, it is not possible to use a human embryo in research without donors’ consent. A human embryo has the personal data of the sperm donor, ova donor, and the human-being if it realizes this potential. For this reason, the donors, whose personal data will be used in research, should be asked for their approval. Human embryos are not only holders of personal data. As mentioned before, they are also body pieces derived from donors. Patients' informed consent is a necessity for every medical treatment, and should be taken before starting treatment. However, for some medical treatments, the tissues and organs taken for the treatment can be used for different purposes; for such reasons and ways of use that appear later, informed consent should seek again. Article 8 mentions the necessity of taking informed consent. Article 9 also regulates that any research on human embryos requires the consent of embryo owners, and also the permission of the Ethics Committee. The articles 10, 11, and 12 regulate how informed consent should be taken (supplementary file Appendix 24).
“Ethical Guide to Stem Cell Research in the Islamic Republic of Iran” emphasizes informed consent, too. According to article 5, before the donation of gametes, the donor should give informed and free consent in order to allow the embryo to be used for hESCR. The guideline also highlights that informed consent should be objective, and ensure that other treatments should not be done for providing new stem cells for research. For this reason, Article 6 says that the physician who provides infertility treatment and derives surplus embryos from the treatment cannot be the same researcher individual who uses stem cells for research and treatment. Also, Article 7 says that the physician who makes the abortion decision should be completely independent of the group that conducts stem cell research. With articles 6 and 7, the legislator wants to be sure that researchers are using only surplus embryos, and not creating embryos for stem cell research. These two articles may help the misuse of other treatments such as abortion and IVF, for deriving more human embryos or stem cells.
As seen, Iran’s practice in hESCR is based on fatwas and guidelines, rather than parliamentary legislation. This situation is criticized in the doctrine. According to some views, the reason for Iran’s hESCR policy being apparently so open-minded is that the fatwas do not emerge out of the public and secular debate (
3). Guidelines are also criticized for the reason that they are still open to public debate and examination (
22). Yet, it is still valuable because a medical practice that is allowed by the state has some ethical restrictions for the protection of human dignity.
Although the guidelines seem clear, it is possible to notice some confusion between researchers. According to Saniei’s study, while some researchers, for example, an embryologist, claim that creating embryos for research for therapeutic purposes is forbidden, others, for instant an Ethics Committee member, claim that there is no prohibition in hESCR (
3). When the guidelines are considered, it is possible to say that both claims are mistaken. As mentioned before, according to the guidelines, it is prohibited to create human embryos for research purposes alone; however, for exceptional cases, it is possible to create human embryos for therapeutic research. It is also clearly stated under which circumstances such an exceptional case occurs: the research should have a therapeutic purpose; for research to reach its purpose, it should be necessary to do the research on a human embryonic stem cell, and the required human embryonic stem cell should not be found in the spare/surplus embryos. It is also possible to state that the Ethics Committee should decide whether or not these exceptional circumstances occur in the case. From our point of view, the reason for the confusion is the inability to distinguish the concept of “therapeutic cloning” from the concepts of “reproductive cloning” and “only research purposes”. Article 18 of the Oviedo Convention leads to a similar confusion in both Turkey and most other party states of the Convention. In my opinion, it is not enough to make regulations; researchers should be clearly informed by legal-ethical training about the limits.