Appendix H Current Situation of Bioethics in Genetic Research in Iran

Mohammad Reza Zali and Saeed Shahraz

There are a limited number of centers for genetic studies in Iran, although the number has rapidly increased in recent years. The most important of these research centers are now under the supervision of a research network.

Considering the growing trend toward genetic research, health care officials strongly sensed the need to draw up detailed guidelines on ethical issues related to such research. Recently, the Iranian Ministry of Health established a national ethics committee to develop regulations in the field of bioethics, and the committee issued a document with 27 clauses. A few provisions are directly related to genetic studies. In this regard, the Research Center for Gastroenterology and Liver Disease in Tehran is now preparing the first draft of a guideline that addresses the most challenging ethical implications in the field of genetic studies including informed consent, confidentiality, genetic counseling, and the potential for social harm or psychological distress imposed by disclosure of an individual’s genetic information.

Shiite, a branch of Islam and the official religion of Iran, embraces a number of rules and concepts about important issues of bioethics that are not in accordance with those of Western countries. In addition, gnostic concepts that are integrated in Persian literature and are firmly respected by the Iranian population present a different view of some aspects of bioethical issues. This paper addresses the current situation concerning the bioethical aspects of genetic studies and a logical way to prepare simple, applicable, and effective guidelines in this area.



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Appendix H Current Situation of Bioethics in Genetic Research in Iran Mohammad Reza Zali and Saeed Shahraz There are a limited number of centers for genetic studies in Iran, al- though the number has rapidly increased in recent years. The most im- portant of these research centers are now under the supervision of a re- search network. Considering the growing trend toward genetic research, health care officials strongly sensed the need to draw up detailed guidelines on ethi- cal issues related to such research. Recently, the Iranian Ministry of Health established a national ethics committee to develop regulations in the field of bioethics, and the committee issued a document with 27 clauses. A few provisions are directly related to genetic studies. In this regard, the Re- search Center for Gastroenterology and Liver Disease in Tehran is now preparing the first draft of a guideline that addresses the most challeng- ing ethical implications in the field of genetic studies including informed consent, confidentiality, genetic counseling, and the potential for social harm or psychological distress imposed by disclosure of an individual’s genetic information. Shiite, a branch of Islam and the official religion of Iran, embraces a number of rules and concepts about important issues of bioethics that are not in accordance with those of Western countries. In addition, gnostic concepts that are integrated in Persian literature and are firmly respected by the Iranian population present a different view of some aspects of bio- ethical issues. This paper addresses the current situation concerning the bioethical aspects of genetic studies and a logical way to prepare simple, applicable, and effective guidelines in this area. 77

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78 THE EXPERIENCES AND CHALLENGES OF SCIENCE AND ETHICS BRIEF HISTORY OF DEVELOPING BIOETHICAL GUIDELINES The German “Guidelines on Human Experimentation” (1931) is thought to be the first guideline for therapeutic and scientific research on human subjects. It remained in force until 1945, but it had no discussion of genetic research. The Nuremberg Code (1947), which considered gen- eral guidelines for experiments on human subjects, also had no discus- sion regarding genetic research. The World Medical Association issued the first historical predecessor of the Declaration of Helsinki in 1954. Since then, the Declaration has been issued and revised five times. Although the most important aspects of ethical issues concerning research on human subjects were discussed in the last version of the Declaration, special ethical considerations in the field of genetic research such as gene therapy, privacy of genetic informa- tion, sex selection, cloning, eugenics, and patent and licensing have not been included. Respect for persons, beneficence, justice, informed consent, disclosure of information, and volunteerism are some topics that were debated in the Belmont Report, issued by the National Commission for the Protec- tion of Human Subjects of Biomedical and Behavioral Research in 1979. The U.S. Department of Health and Human Services issued Regulations for the Protection of Human Subjects in 1991. In addition to more de- tailed explanations regarding some critical bioethical terminology cur- rently in use, this important document addressed the role of Institutional Review Boards (IRB) in addressing human subjects in biomedical research, requirements for and documentation of informed consent, and mother- fetus rights during pregnancy. The Summary Report of the International Summit Conference on Bio- ethics toward an International Ethic for Research involving Human Sub- jects of 1987 is a brief document that addresses international cooperation on both the elaboration of principles and on the implementation of ethics review processes involving human subjects. The Council for International Organizations of Medical Sciences, in collaboration with the World Health Organization, issued a series of guidelines for biomedical research involv- ing human subjects in 1993. No particular bioethical consideration in the area of genetic research can be seen in this document. In short, discus- sions of current topics of ethical problems of genetic research should be included in new versions of international bioethical guidelines.1 1 Reich, W.T., ed. Encyclopedia of Bioethics. Wiley Interscience, Georgetown: 1995.

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79 APPENDIX H IMPORTANT BIOETHICAL ISSUES IN THE FIELD OF GENETIC RESEARCH Gene Therapy Innovations in recombinant DNA research in the early 1970s and fer- tilization outside the human body in the 1980s brought closer the pros- pect of genetically manipulating human eggs, spermatozoa, and embryos. Various ethics committees have been set up in developing countries to weigh ethical issues associated with embryo research, reproductive tech- nologies, and genetic manipulations. There are two kinds of gene therapy: somatic cell gene therapy and germ-line gene therapy. Considering the ethical aspect, it is apparent that the latter type is more important than the former. National and international governmental and nongovernmental organizations have reached a range of conclusions about the ethical ac- ceptability of germ-line gene therapy.2,3,4 Privacy of Genetic Information In a strict sense, genetic data are information about the genetic code (DNA, RNA, and protein sequences) of the human chromosomes present in the nucleus and mitochondria of the cells of an individual, and about the number and state of the chromosomes. Such data determine the individual’s genetic identity. In the legal context the term “privacy” implies the following: 1) access to information about persons, 2) subsequent disclosure of this informa- tion to third parties, 3) third–party interference with personal choices, es- pecially in intimate spheres such as procreation, and 4) ownership of ma- terials and information derived from persons.5 The highly personal nature of the information contained in DNA can be illustrated by thinking of DNA as containing an individual’s “future diary.” 2 Juengst, E.T., “Can Enhancement Be Distinguished from Prevention in Genetic Medi- cine?” Journal of Medicine and Philosophy. April 1997, Vol. 22(2), pp. 125-142. 3 Wivel, Nelson A., and LeRoy Walters. “Germ-Line Gene Modification and Disease Pre- vention: Some Medical and Ethical Perspectives.” Science. 22 October 1993; Vol. 262 (5133), pp. 533-538. 4 Minister of Government Service of Canada, Royal Commission on New Reproductive Technologies. Proceed With Care (final report), Ottawa: 1993. 5 Anderlilk M.R., in Murray T.H., Mehlman M.J., editors. Encyclopedia of Ethical, Legal, and Policy Issues in Biotechnology. Vol. 1, John Wiley and Sons, Inc., New York: 2000.

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80 THE EXPERIENCES AND CHALLENGES OF SCIENCE AND ETHICS DNA databanks can be assumed to be entities that collect, store, ana- lyze, and control DNA samples and information derived from DNA samples. The term could also include entities that either only store DNA samples or only store information derived from genetic analysis. There- fore, to effectively protect genetic privacy, unauthorized collection and analysis of individually identifiable DNA must be prohibited unless the concerned individual specifically authorizes the collection of DNA. Sex Selection There are several different attitudes toward sex selection before birth. Liberals, and particularly liberal feminists, tend to support the pre-selec- tion of the sex of a future child as morally acceptable as is the use of con- traception for family planning. Others condemn any type of sex selection. Families themselves have different aspirations to have sons or daughters. However, the dominant trend to have one sex within families may lead to sex-ratio changes. New methods of pre-selecting sex will probably be introduced over a period of several decades. Thus, there will be time to improve our understanding of the consequences of small sex-ratio changes. Cloning The world of science and the public at large were both shocked and fascinated by the work of Ian Wilmut and his colleagues on the successful cloning of a sheep from a single cell of an adult.6 But it appears that the global sentiment is against cloning.7 The U.S. National Bioethics Advi- sory Commission is reviewing the troubling ethical and legal implications of cloning in the United States. The Director General of the World Health Organization characterized human cloning as “ethically unacceptable as it would violate some of the basic principles which govern medically as- sisted reproduction. These include respect for the dignity of human be- ings and the protection of the security of human genetic material.” 8 As in the United States, one cannot see a firm acceptance of cloning. 9 Despite 6 Wilmut, I., and Schnieke, A.E., “Viable Offspring Derived from Fetal and Adult Mam- malian Cells.” Nature. 27 Feb. 1997, Vol. 385 (6619) pp. 810-813. 7 Brock, D.W., et al in Murray, T.H., Mehlman, M.J., editors. Encyclopedia of Ethical, Legal, and Policy Issues in Biotechnology. Vol. 1, Wiley Interscience, New York: 2000. 8 World Health Organization Press Office, Geneva, Switzerland, March 11, 1997. 9 Anderlilk, M.R., in Murray, T.H., Mehlman, M.J., editors. Encyclopedia of Ethical, Legal, and Policy Issues in Biotechnology. Vol. 1, John Wiley and Sons, Inc., New York: 2000.

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81 APPENDIX H this negative atmosphere, all biotechnologists potentially understand the individual and social benefits of cloning such as allowing women who have no ova or men who have no sperm to produce an offspring that is biologically related to them.10 Eugenics According to Francis Galton, eugenics is the science of improving the human genome over time.11 Sterilization is the main topic discussed in the field of eugenics. Despite major opposition to sterilization laws from the side of some Catholic churches and Islamic fundamentalists and some other religions, sterilization has broad acceptance among people and leg- islators worldwide. Patents and Licensing The collection, treatment, storage, and use of genetic data are other issues troubling ethicists around the world. Tens of thousands of applica- tions for patents on human genes, living cells, plants, and animals have been made in recent years, especially in the United States and Japan. Hundreds of them have been granted. Should it be legal to patent genes and traditional knowledge? This is a very important question that should be answered by authorized organi- zations. Somehow the source of genetic data indicates the status of prop- erty. If the material obtained were from a non-human source, the law generally considers it as property. However, if the material is obtained from a human source, the law generally fails to recognize it as property. It has been recognized that a living organism not found in nature and created by the intervention of humans is a product of invention and not a product of nature.12 Now in the United States, artificial living organisms are qualified as patentable subject matter under the U.S. patent law.13 A tremendous bulk of information has been obtained from large projects such as the Human Genome Project, and considering studies of the human body, body parts, and biological materials all over the world, we believe that all governments should clarify their patent laws concern- ing such activities. 10 Robertson, J.A. Children of Choice: Freedom and the New Reproductive Technologies. Princeton University Press, Princeton NJ: 1994. 11 Gehrke, L.M., in Murray, T.H., and Mehlman, M.J., editors. Encyclopedia of Ethical, Legal, and Policy Issues in Biotechnology. Vol. 1, John Wiley and Sons, Inc., New York: 2000. 12 Kelves, D. In the Name of Eugenics. University of California Press, Berkeley: 1985. 13 Chakarabarty, D.V., 444 U.S. patent 397: 1980.

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82 THE EXPERIENCES AND CHALLENGES OF SCIENCE AND ETHICS ORGANIZATIONS IN IRAN CONCERNED WITH BIOETHICS The Ministry of Health and Medical Education, Office for Study for Humanistic and Islamic Science in Medicine and Medical Ethics This Office started its activity a few years ago and has drafted the previously mentioned 27-clause act entitled, “The Protection Code for Human Subjects in Medical Research.” The most important ethical con- siderations include: informed consent, human rights during research, cer- tifying research projects according to risks and benefits, privacy of infor- mation, paying compensation for harm imposed by research on human subjects, cultural and religious implications of research, rights of prison- ers and individuals with mental retardation and of psychotic patients, and research on the fetus. The Act has been customized according to the Code of Religious Laws in Shia and cultural issues peculiar to the Iranian population. An informed consent document in the form of a question- naire has been attached to the Act.14 Recently, the Ministry of Health and Medical Education has required all universities and biomedical research centers to develop bioethics com- mittees based on a uniform guideline. The Office of the Deputy for Re- search, Ministry of Health and Medical Education, has prepared the guideline. Iranian National Commission for UNESCO This organization is drafting a sixteen-clause guideline to establish a national bioethics committee that will discuss important issues. They in- clude priorities for national bioethical studies; coordination of activities of ministries, organizations, universities, and research centers that are involved in bioethical issues; lack of higher education in the field of bio- ethics; establishment of a basis for international scientific negotiations; and financial resources for research projects on bioethics. The committee will include representation of the Ministry of Science, Research, and Tech- nology; the Ministry of Health and Medical Education; the Organization for Protection of the Biological Environment; the Ministry of Agricultural Jihad; the Legal Medicine Organization of Iran; the Hozeh Elmieh of Qom (Qom Seminary); the Iranian Academic Center for Education, Culture, and Research (ACECR); and the Medical Council of Iran (as an NGO). Other permanent members will be two specialists in the philosophy of ethics, two lawyers, two biotechnologists, two biologists, and one specialist from 14 Protection Code of Human Subjects in Medical Research. Iran’s Ministry of Health and Medical Education: 1999.

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83 APPENDIX H each of the fields of immunology, genetics, pharmacology, biochemistry, psychology, and epidemiology.15 Research Centers Local ethics committees have been established in over 85 research cen- ters involved in research in biotechnology, molecular and cellular biol- ogy, and related fields. The number of such committees is increasing. Some centers such as the Research Center for Gastroenterology and Liver Disease and the Avecina Research Center have developed documentation for certifying proposals for genetic research. Meanwhile, the Molecular Medicine Network is a new organization that aims to coordinate and supervise the research centers involved in molecular and genetic research throughout the country. The current trend is to write a uniform guideline for the ethics committees of these centers. POTENTIAL SOURCES OF BIOETHICAL LAWS IN ISLAM AND SHIA Islam The modification and improvement of living organisms and the cre- ation of microorganisms through biotechnology challenge all religions— including Islam—to refine their doctrines and expand their ethical imagi- nation. In Islam, making bioethical decisions is based on ethical teachings of the Koran, the tradition of the Prophet Muhammad, and interpretation of Islamic law. Islamic bioethics is an extension of Shariah (Islamic law), which is itself based on two foundations—the Koran and the Sunna (the aspects of Islamic law based on the Prophet Muhammad’s words or acts. Consensus (ijmaa) and analogy (qiyas) might be considered as two other sources of Islamic law. Also, consideration is given to maslaha (public interest) and urf (local customary precedent) when appropriate. The Shia branch of Islam has in some cases developed its own interpretations, methodology, and authority systems; but on the whole its bioethical rul- ings do not differ fundamentally from the Sunni positions.16,17,18 15 Draft of “Guideline for Establishing a National Bioethics Committee.” Iranian National Commission for UNESCO: 2001. 16 Daar Abdallah, S., Al Khitamy, and A. Binsumeit. “Bioethics for Clinicians: 21 Islamic Ethics.” Canadian Medical Association Journal, 9 January 2001; Vol. 164(1) pp. 60-63. See also the Holy Koran 5:32. 17 Rahman, F. Legacy and Prospects in Islam. University of Chicago Press, Chicago: 1979. 18 Kamali, M.H. Urf (Custom) in Principles of Islamic Jurisprudence. Islamic Texts Society, Cambridge: 1991.

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84 THE EXPERIENCES AND CHALLENGES OF SCIENCE AND ETHICS Overall, Islam places no limitations on the pursuit of scientific knowl- edge, including genetics. According to Hassan Hathout and B. Andrew Lusting, there is a consensus among Islamic scholars that a governmental rule that refers to “changing God’s creation“ does not support a ban on genetic engineering. The scholars have concluded that genetic engineer- ing is permissible.19 However, Gamal Serour restricts the justifiability of gene therapy to its therapeutic uses since using biotechnology in genetic research for eugenic purposes would involve changes in the creations of God and has the potential of inducing imbalance into the universe or into humanity.20 Shia As mentioned above, Shia is a branch of Islam. While approximately one-fifth of the Iranian population belong to the Sunni branch of Islam, Shia has been the historical religion of the Iranian population for nine to ten centuries. Aql (the process of reasoning) and urf (custom) are two other important sources from which to draw Islamic law. However, in spite of the fact that Shia jurists have formally recog- nized aql as an independent source of the Islamic law and have examined it in detail within the framework of the methodology of the jurisprudence system, they are very cautious in practice. The role of community prac- tice (custom) as a supplementary tool in the process of inferring from Is- lamic law is, in principle, undeniable. In two cases the jurists commonly rely on custom. Historically, aql (literally, the act of withholding or re- straining and in terminology of the jurists, “human intellect,” and “rea- son”) is a source for inferring that current Islamic laws come from the early centuries of the development of Islamic law.21 CONCLUSION Today, all human beings should be able to benefit from the positive and valuable results of science. Hence, with the cooperation of the inter- national community, Iran should adopt principles and regulations to guar- 19 Hathout, H., in Lusting, B.A., et al., editors. Bioethics Yearbook, Vol. 3 pp. 133-148. Kluwer Academics, Dordrecht, The Netherlands: 1993. 20 Serour, G.I., in Lusting, B.A., et al., editors. Bioethics Yearbook, Vol. 5, pp. 171-188. Kluwer Academics, Dordrecht, The Netherlands: 1997. 21 Jafarzadeh, M., A Comparative Study under English Law, the Convention on Contracts for the International Sale of Goods 1980, Iranian and Shia Law. Shahid Beheshti University, Tehran, Iran: March 2001.

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85 APPENDIX H antee freedom of research and scientific progress and at the same time to safeguard the rights and dignity of human beings. Iran has an ancient past that history has not adequately documented. Iran has played host to various ethnic groups who, while retaining their own cultural identities, comprises the nation of Iran. They have been afforded equal rights. While preserving their own special culture, social, architectural, linguistic, and civilization characteristics, all have contrib- uted to the process of dialogue among civilizations.22 Similarly to other parts of the world, a great majority of intellectuals in Iran do not accept the role of Islamic legislation in making bioethical decisions. Nonetheless, one cannot deny the deep religious nature of atti- tudes and beliefs of the majority in the country. Considering that the source of Islamic law can be according to formal and pluralistic ideas, we believe that the results of international conventions and conferences might be accepted with little modification from the Iranian government and the religious legislators of the country. Fortunately, among the many controversial bioethical issues, only abortion has been banned in Iran. In exceptional situations, abortion can be authorized. Allograft transplantation is a legal action at present, and the legal issues of sperm transfer from a donor are under intensive inves- tigation. We are looking forward to join with international bioethical communi- ties in the development of modern bioethical committees and legislation. ACKNOWLEDGMENT The authors would like to thank Dr. Mirghasem Jafar Zadeh and Ms. Arefnia for their assistance in preparing this report. 22 Round Table of Ministers of Science on “Bioethics: International Implications.” Paris, 22-23 October 2001. Presentation by Mostafa Moin, Minister of Science, Research and Tech- nology, Islamic Republic of Iran.