The US Department of Health and Human Services (DHHS) issued the DHHS Regulations for the Protection of Human Subjects in 1991. The document includes detailed explanations regarding important bioethical terminology. In addition, it outlines the role of the Institutional Review Boards (IRB) in supporting patients undergoing biomedi-cal research. These include the requirements and documentation for informed consent and maternal-fetal rights during pregnancy. The Summary Report of the International Summit Conference on Bioethics towards an International Ethic for Research involving Human Subjects of 1987 addressed the growing importance of international agreements and cooperation on both the elaboration of principles and on the implement-tation of ethics review processes in medical research involving human subjects. The Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization issued a series of guidelines for biomedical research involving human subjects in 1993. No particular bioethical consideration in the area of genetic research can be found in this document.

In short, we believe that discussions on ethical topics relating to genetic research should be included in the international bioethical guidelines.¹

Gene therapy

In a strict sense, genetic data is information about the genetic code of the human chromosomes present in the nucleus and mitochondria of the cells of an individual. It also refers to the number and gross state of the chromosomes. It is this genetic data that determines the individual’s genetic identity.

In the legal context, the term “privacy” includes at least four categories: 1) access to persons and personal spaces; 2) access to information by third parties and any subsequent disclosure of this information by third parties; 3) third-party interference with personal choices, especially in intimate spheres such as procreation; and 4) ownerships of materials and information derived from persons.⁵ What is important is that the highly personal nature of the information contained in DNA can be illustrated by thinking of DNA as containing an individual's "future diary".

DNA databanks can be assumed as entities that collect, store, analyze and control DNA samples and information derived from DNA samples, although the term could also include entities that either only store DNA samples or information derived from genetic analysis. Therefore, to effectively protect genetic privacy, unauthorized collection and analysis of individually identifiable DNA should be prohibited. DNA samples or genetic information about an individual should not be stored unless that individual specifically authorizes the collection of DNA.

There are many differing attitudes toward sex selection before birth. While liberals support sex preselection as morally acceptable in family planning, others condemn any type of sex selection The popularity of having either a son or daughter among families may lead to sex-ratio changes. New methods of preselecting sex will probably be introduced over a period of several decades. Thus, there will be time to improve our understanding of the consequences in affecting the sex ratio.

The world of science and the public at large were both shocked and fascinated by the work of Wilmut and colleagues when they successfully cloned a sheep, in spite of the global consensus against cloning.⁷ The National Bioethics Advisory Commission is reviewing the ethical and legal implications of cloning in the USA. 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 assisted reproduction. These include “respect for the dignity of human beings and the protection of the security of human genetic material”.⁸ As in the USA, one can not see a firm acceptance of cloning throughout the world.⁵ Despite this negative sentiment, biotechnologists can understand the personal and social benefits of cloning such as allowing women who have no ova or men who have no sperm to produce offspring that are biologically related to them.⁹

According to Francis Galton, eugenics is the science of improving human heredity over time.¹⁰ Sterilization is the main topic discussed in the field of eugenics. Despite major opposition to sterilization laws from the Catholic Church, as well as Islamic conservatives and some other religions, sterilization is otherwise globally accepted.

The collection, treatment, storage and use of genetic data are other issues troubling ethicists around the world. Tens of thousands of applications for patents on human genes, living cells, plants and animals have been made in recent years, and hundreds of them have been granted, especially in the USA and Japan.

Numerous amounts of information are available from massive sources such as the Human Genome Project; however, biologic studies occur around the world. Hence, patent laws for obtaining information directly from patients and/or institutions should be clarified by each individual government.

All universities and biomedical research centers in Iran were recently required by the Ministry of Health and Medical Education to develop bioethics committees based on a uniform guideline. The guideline was prepared by the office of Deputy Research, Ministry of Health and Medical Education.

The Iranian National Commission for UNESCO is another bioethics organization in Iran. This organization is drafting a 16-clause guideline for constitution of a national bioethics committee. It aims to resolve some issues such as priority setting of national bioethical studies, coordinating all ministries, organizations, universities and research centers with bioethical issues, solving the problem of higher education in the field of bioethics, establishing a reasonable base for international negotiations in this area of science and trying to draw the financial resources toward the research projects on bioethics. A delegation from the Ministry of Science, Research and Technology, Ministry of Health and Medical Education, Organization for Protection of the Biologic Environment, Ministry of Agricultural Jihad, Legal Medicine Organization of Iran, Hozeh Elmieh of Qom (Qom Seminary), Iranian Academic Center for Education, Culture and Research (ACECR) and Medical Council of the Islamic Republic of Iran (as an NGO) constitute the permanent members of the committee. Other permanent members include: two specialists in philosophy and ethics, two lawyers, two biotechnologists, two biologists, and one specialist each from the fields of immunology, genetics, pharmacology, biochemistry psychology and epidemiology.¹⁴

Finally, bioethics organizations are also present in Research Centers: local ethics committees have been established in over 85 research centers involved in biotechnology, molecular and cellular biology and related fields, and the number of these centers is increasing. Some of these centers, including the Research Center for Gastroenterology and Liver Disease and the Avecina Research Center, have developed an article of association and also standard inquiries for certifying research proposals on genetics.

Meanwhile, the Molecular Medicine Network is a new organization which coordinates and supervises the research center laboratories involved in molecular and genetic research. The current trend is to write a uniform guideline for ethics committees of all these centers supervised by the Network.

In short, Islam places no limitations on the pursuit of scientific knowledge, including genetics. According to Hathout and 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. They concluded that genetic engineering is permissible.¹⁸ However, Serour restricts the justifiability of gene therapy to its therapeutic uses since using biotechnology in genetic research for eugenic purposes would involve a change in the creation of God’s creation, which would cause imbalance in the universe or humanity.¹⁹

As mentioned above, Shia is a branch of Islam. although approximately one-fifth of Iranians belong to the Sunni branch of Islam, Shia was the historical religion of the Iranian population nine to 10 centuries ago. Aql (the process of reasoning) and urf (custom) are two other important sources of drawing Islamic law.

Shia jurists have formally recognized aql as an independent source of the Islamic law and have examined it in detail with the strong support of jurisprudence. The role of community practice (custom) as a supplementary tool in the process of inferring the Islamic law, is in principle, undeniable. Historically, relying on aql (literally, the act of withholding or restraining and, in terminology of the jurists, human intellect or reason) as a source of inferring the Islamic laws takes us back to the early centuries of Islamic law development.²⁰

Today, all human beings should be able to benefit from the positive and valuable results of this scientific development. Hence, with the cooperation of the international community, principles and regulations should be adopted to guarantee the freedom of research, allowing scientific progress while at the same time safeguarding the rights and dignity of human beings.

Iran has an ancient history and throughout its historical past of biologic and geographic diversity, has also hosted various ethnic groups who still retain their own cultural identities, while enjoying equal rights. While preserving their own special culture as well as social, architectural, linguistic and civilization characteristics, they have also contributed to the process of dialogue among civilizations.²¹

Similar to other parts of the world, a great majority of intellectuals in Iran make claim on the protection of bioethics laws when representing international intellectual societies. However, one cannot deny the real religious nature of attitudes and beliefs of the majority of the population in the country. We believe that the outcome of international conventions and or conferences may only result in only a few or even no modifications from the Iranian government and the religious legislators of the country.

Fortunately, among the many bioethical controversial issues, only abortion is banned outright in Iran. However, under exceptional circumstances, such as endangerment of the mother’s life abortion is authorized. Allograft transplantation constitutes a legal action at present, and the legal issues concerning the transfer of sperm from a non-spouse donor are under intense investigation.

We look forward to collaborating and cooperating with international bioethical communi-ties to share and witness development and progression of modern bioethical committees and legislations.