Ethical Guidelines for Human Reproduction Research in the Muslim World, reprinted in Serour GI (ed). Proceedings of the First International Congress on Bioethics in Human Reproduction Research in the Muslim World. 11 IICPSR (1992).
G.I. Serour - FRCOG, FRCS, M. Aboulghar - MD & R. Mansour - MD, The International
Islamic Center for Bioethics, Population Studies and Research; The Egyptian
IVF & ET Center, Maadi, Cairo.
{JIMSA, VIOLUME 2, NO.2, AUGUST 1996}
Bioethics is the study of ethical issues arising in health care and the biological sciences. It also includes the study of social, legal and economic issues related to these ethical issues. Since the birth of the first test tube baby, Louise Brown, in England in July, 1978 (1) medically assisted conception (MAC) has evoked great interest among the public as well as in the medical profession.
The origin of MAC or artificial reproduction can be traced to attempts to fertilize human oocytes outside the body. Although mammalian oocytes were fertilized extracorporeally at the end of the last century (2), in vitro fertilization of human occytes was accomplished only in 1994 by Rock and Menkin (3). Ever since, the handling of human gametes had been refined and led to various techniques of MAC available today.
There are different modalities of artificial reproduction, i.e. in vivo artificial reproduction where fertilization of the husbands’ and wives’ gametes occurs within the body of the wife, in vitro artificial reproduction where fertilization of the gametes is extracorporeal and artificial reproduction involving a third party.
In each modality of MAC there are different techniques. Pregnancy and childbirth had been achieved through in vivo fertilization by different procedures; intrauterine insemination (IUI), intratubal insemination (ITI), gamete intrafallopian transfer (GIFT), Fallopian replacement of eggs with delayed intrauterine insemination (FREDI), and peritoneal oocyte and sperm transfer (POST) (4,5,6,7,8).
Pregnancy and child birth had also been achieved by different techniques involving extracorporeal fertilization, namely in vitro fertilization and embryotransfer (IVF & ET), pronuclear-stage tubal transfer (PROST), zygote intrafallopian transfer (ZIFT) and tubal embryo stage transfer (TEST) (1,9,10,11,12,13,14,15,16).
More recently pregnancy and child birth have been reported after micromanipulation techniques including partial zone drilling (PZD), subzonal sperm injection (SUZI) and finally intracytoplasmic sperm injection (ICSI). Micromanipulation using spermatid cells have also been reported to produce pregnancy and childbirth (17,18,19,20,21).
MAC involving a third party had also resulted in pregnancies and childbirths by using both in vivo and in vitro fertilization techniques. The contribution of the third party was by providing a sperm cell, an egg, an embryo or even a uterus to carry the pregnancy till childbirth (22,23,24,25,26,27,28). MAC, whether in vivo or in vitro, has seperated the bonding from the reproductive aspects of sex. This challenged the age old ideas and provoked discussion. MAC involving a third party, has created and provoked a debate, disagreement and controversy among all societies and religious sectors all over the world. Philosophical and religious debate continues today.
REPRODUCTIVE CHOICE IN MEDICALLY ASSISTED CONCEPTION
It is the right of the person to freely choose his/her reproductive performance including his/her reproductive potentials. Though reproductive choice is basically a personal decision yet it is not merely so. This is because reproduction itself is a process which does not involve the person who makes the choice alone. It also involves the other partner, the family, the society and the world at large. It is therefore, not surprising that reproductive choice is affected by the diverse contexts, mores, cultures, religions as well as the official stance of the different societies.
The reproductive choice of the person may even conflict with the interest of his/ her choice if it does not enjoy the approval and support of the society. In reproduction, one cannot always have what he chooses to be done within his/her own society or country (29).
Every day many people fly over or cross the borders to fulfill a reproductive choice which may not be permitted in their own societies or countries. Such an act is by no means restricted to one country or followers of one religion. Whether a few or many Muslims fly over to Europe or to the United States to fulfill a reproductive choice which they cannot have in their own country is a well known fact for physicians working in the field of medically assisted conception. The same pattern also exists in Europe among residents of different European countries with different regulatory mechanisms of the process of reproduction.
The recent birth of a baby by a postmenopausal British woman who has had medically assisted conception in Italy had struck the news recently all over the world.
ISLAMIC BACKGROUND AND MEDICALLY ASSISTED CONCEPTION
The teaching of Islam covers all the fields of human activity; spiritual and material, individual and social, educational and cultural, economic and political, national and international (32). Instructions which regulate everyday activity of life to be adhered to by good Muslims is called Shari`ah. There are two sources of Shari`ah in Islam; the primary sources and the secondary sources. The primary sources of Shariah in a chronological order are:
1. The Holy Qur'an, the very word of Allah (SWT).
2. The Sunnah and Hadith which is the authentic traditions and sayings of the Prophet Muhammad (s.a.w.s.) as collected by specialists in Hadith.
3. Ijma` which is the unanimous opinion of Islamic scholars or A'immah.
4. Qiyas (Analogy) which is the intelligent reasoning used to rule on events not mentioned by the Qur'an and Sunnah by matching against similar or equivalent events ruled on.
A good Muslim resorts to secondary sources of Shari`ah in matters not dealt with in the primary sources.
The secondary sources of Shari`ah are:
1. Istihsan: which is the choice of one of several lawful options.
2. Views of Prophet’s (s.a.w.s.) Companions (r.a.).
3. Current local customs if lawful.
4. Public welfare.
5. Rulings of previous divine religions if not contradicting the primary sources of Shari`ah.
The Shari`ah classifies all human actions without exception into one of five categories:
1. Obligatory as fasting and praying.
2. Recommended as marriage and family formation.
3. Permitted as breaking fast when sick and travelling.
4. Disapproved but not forbidden as divorce.
5. Absolutely forbidden as killing and adultery.
Even if the action is forbidden, it may be undertaken if the alternative would cause harm. The Shari`ah is not rigid. It is flexible enough to adapt to emerging situations in different times and places. It can accommodate different
honest opinions as long as they do not conflict with the spirit of its primary sources and are directed to the benefit of humanity (32).
MAC was not mentioned in the primary sources of Shari`ah. However, these same sources have affirmed the importance of marriage, family formation and procreation (33,34,35,36,37). Also, in Islam adoption is not acceptable as a solution to the problem of infertility (38).
In Islam infertility and its remedy with the unforbidden is allowed and encouraged. It is essential if it involves preservation of procreation and treatment of infertility in one partner of the married couples (39). This is applicable to MAC which is one line of treatment of infertility. The modern techniques of MAC including micromanipulation of the oocyte to facilitate fertilization whether by partial zona drilling (PZD), zona puncture and direct injection of sperm into the perivitelline space of the ovum (SUZI) or into the ooplasm (ICSI) are no exceptions. The prevention and treatment of infertility are of particular significance in the Muslim world. The social status of the Muslim woman, her dignity and self-esteem are closely related to her procreation potential in the family and in the society as a whole. Childbirth and rearing are regarded as family commitments and not just biological functions.
NEEDS FOR MAC IN THE MUSLIM WORLD
Although estimates of the prevalence of infertility are not very accurate and vary from region to region approximately 8 - 10% of couples experience some form of infertility problem during their lives. When extrapolated to the global population, this means that 50 - 80 million people may be suffering from infertility (40,41). It is expected that 29.4 - 44.1 million of these infertile couples are Muslims due to a relatively high prevalence of infertility of 10 - 15% among Muslims in developing countries (42,43,44). The rate of tubal occlusion in sub-Saharan Africa with a predominant Muslim population was over three times that seen in other regions with the exception of the Eastern Mediterranean (41). All the developing countries, where most of the Muslim population is located, had rates of tubal infertility higher than those in the developed ones. The patterns of male infertility are less clear, but regional variation is seen in the rates of varicocele and accessory gland infection (41). Different modalities of MAC are among the different therapeutic measures, available today, for couples with tubal or male infertility. Sometimes, MAC is the only available method for the treatment of these conditions. In both situations the choice of treatment of the couple and their treating physician is governed by:
1. Availability of the method.
2. Success rate.
3. Implications and complications involved.
4. Cost.
5. Social, legal and ethical aspect of artificial reproduction.
The first four factors interact and affect directly or indirectly the last group of factors. The success rate of artificial reproduction is of particular importance because of the misconceptions which the public not uncommonly has about the results of the technique being misled by the mass media and dishonest advertisements.
BIOETHICS IN MEDICALLY ASSISTED CONCEPTION
Any debate on the social, legal and ethical issues surrounding MAC must consider these new techniques within the general context of reproductive health care. In providing this new technology one must observe the principles of respect for the dignity of human being, security of human genetic material, inviolability of the person, inalienability of the person and necessary quality of services. These principles demand a measure of protection for the human embryo that is consonant with national, cultural, religious and social mores. Ethical discourse is necessary for any society to form its responses to any scientific or medical innovation (45). The four ethical principles involve the traditional principles of justice, autonomy (respect for persons), beneficence (duty to do good) and nonmaleficence (avoid harm). There are two ethical levels concerned; the microethical and macroethical level. The microethical level: Applying to relations between individuals. The macroethical level: Applying to the relationships among community themselves and between communities and their members (46).
Also, there are three moral principles which provide an ethical basis for artificial reproduction. The principle of liberty which guarantees a right to freedom of action; the principle of utility which defines moral rightness by the greatest good for the greatest number, and the principle of justice which requires that everyone has equitable access to necessary goods and services. However, one must remember that ethics and morality are only valid when individuals can act freely. Medical ethics are based on the moral , religious and philosophical ideals and principles of the society in which they are practised (47). It is therefore not surprising to find what is ethical in one society might not be ethical in another society. It is mandatory for the practising physicians and critics of conduct to be aware of such backgrounds before they make their judgement on different medical practice decisions (48). The ethical attitude of the individual is coloured by the attitude of the society which reflects the interest of theologians, demographers, family planning administrators, physicians, policy makers, sociologists, economists and legislators. Responsible policy makers in the medical profession in each country have to decide on what is ethically acceptable in their own country guided by the international guidelines which should be tailored to suit their own society. Truly ethical conduct consists of personal searching for relevant values that lead to an ethically inspired decision (49). Those for whom religion is important and it is for the Muslims, need to distinguish between medical ethics and humanitarian considerations on the one hand, and religious teachings and national laws on the other hand. The physician is always concerned about the legal basis of his acts undertaken on the basis of ethical precepts.
BIOETHICS OF MEDICALLY ASSISTED CONCEPTION: PRACTICE IN THE MUSLIM WORLD
The basic concept of Islam is to avoid mixing genes as Islam enjoins the purity of genes and heredity. It deems that each child should relate to a known father and mother. Adoption is not allowed as it implies deceit of children about their true genetic linkage and heredity. Based on the options accepted in the Islamic World and relying on the Views of fuqaha’, physicians, ethicists, lawyers and specialists, one may conclude the following:
1. Screening of potential candidates for utilization of MAC: The physicians should limit access to MAC where clinical circumstances present significant risks to potential offspring. This should be on grounds of conscience and not on any social discrimination (50).
2. Since marriage is a contract between the wife and husband during the span of their marriage, no third party intrudes into the marital functions of sex and procreation (39,43,50,51,52,53,54).
3. A third party is not acceptable whether he/she is providing a sperm, an egg, an embryo or a uterus (50).
4. If marriage contract has come to an end because of divorce or death of the husband, A.R. cannot be performed on the female partner even using sperm cells from the former husband (39,43,50,51,52,53,54).
5. Cryopreservation: The excess number of fertilized eggs (pre-embryo) can be preserved by cryopreservation. The frozen pre-embryos are the property of the couple alone and may be transferred to the same wife in a successive cycle but only during the validity of the marriage contract (50).
6. Multifetal pregnancy reduction: multifetal pregnancy reduction is only allowed if the prospect of carrying the pregnancy to viability is very small. It is also allowed if the life or health of the mother is in jeopardy (50,55,56).
7. Surrogate motherhood: Though at a time it was allowed, (51) the present status in the Islamic World is that surrogacy is forbidden.
PREGNANCY IN THE POST-MENOPAUSE
Medically assisted conception allows post-menopausal women to become pregnant and have children of their own. Pregnancy in the post-menopause appeals to the egalitarians as it is just for old women to have children since older men have always been able to father children. However, the issue is not that simple. Men are not directly involved in the process of pregnancy, childbirth and to a great extent in the process of mothering the newly born child at least in the first few months of life. Such physiological processes no doubt embark and exhaust the health reserves of women. Also pregnancy in the post-menopause may be unjust to the child as it violates the rights of the newly born child in getting his/her share of adequate love, care and tenderness. For all these reasons ethical issues are to be discussed concerning the suitability of older women as mothers.
Pregnancy in the post-menopause using donated eggs is ethically unacceptable in the Muslim World. Apart from mixing genes it exposes mothers to increased maternal risks and complications and is rather unjust to the newly born child.
Pregnancy in the post menopause using couple’s frozen embryos, is associated with increased maternal risks and needs further evaluation.
BIOETHICS OF MEDICALLY ASSISTED CONCEPTION RESEARCH IN THE MUSLIM WORLD
1. Embryo Research
The main ethical concern has been the alleged immorality of using embryos for research purposes.
However, embryo research has non procreative interests which includes:
1. Improvement of knowledge in treatment of infertility.
2. Improvement of contraception.
3. Treatment and prevention of cancer.
4. Treatment and prevention of birth defects.
Embryo research denigrates the importance of human life by treating embryos as a means rather than an end. Embryo research could harm children, if the embryos used in research are then placed in the uterus of the woman (57).
The ethical concerns which surround embryo research include:
1. Creation of embryos solely for research purposes.
2. Limits on purposes of embryo research.
3. Transfer to the uterus after research.
4. Keeping embryos alive in vitro for more than fourteen days.
Research would occur only on spare embryos created as a by-product of IVF treatment of infertility.
However, the wide use of cryopreservation of extra embryos has limited the number of embryos donated for research. The other source of embryos for research would be creation of embryos solely for research purposes. This would pose an important question: Is creating embryos, for research purposes solely, a reproductive liberty?
Creating embryos for research purposes solely is not a reproductive liberty. It is an act of liberty in the use of one’s reproductive capacity.(57) One would certainly ask: Is there a significant moral difference between research on embryos created solely for research purposes and research on spare, discarded embryos?
Though most commissions now accept a wide degree of embryo research, ethical controversy continues to surround the production of embryos solely for research purposes. Does the symbolic benefits of protecting embryos from being created solely for research purposes justify this loss? Legally, only a few European nations and Victoria, Australia, prohibit the creation of embryos solely for research purposes (57). Embryo research had been discussed in depth at the first International Conference on Bioethics in Human Reproduction Research in the Muslim World held in Cairo, 10 - 13 December 1991. Two hundred physicians, Muslim Ulemas and theologians, ethicists, lawyers, social scientists and policy-makers participated in this conference (50,58). The participants endorsed the following statements on this issue guided by previous recommendations and the recent development in this rapidly developing scientific field:
1. Cryopreserved pre-embryos may be used for research purposes with the free informed consent of the couple.
2. Research conducted on pre-embryos should be limited to therapeutic researches. The treated embryos shall be transferred only to the uterus of the wife who is the owner of the ova and only during the validity of marriage contract. This should be applicable to research involving microsurgical techniques as sperm pronuclear extraction to correct polyspermy (59) and genetic diagnosis of a portion of the embryo; one blastomere or its nucleus for a specific genetic defect (60).
3. Researches aimed at changing the inherited characteristics of pre-embryos including sex selection are forbidden.
4. The free informed consent of the couple should be obtained before pre-embryos are subjected to non therapeutic researches. These pre-embryos are not to be transferred to the uterus of the wife or that of any other woman.
5. Research of a commercial nature or those not related to the health of the mother or child are not allowed. The research should be conducted in research institutes of sound repute such as specialized research institutes. The research should have medical justification and should be conducted by a skilled researcher.
Respect for the origin and human character of the fertilized ovum (pre-embryos) dictates the restrictions placed on the research conducted on them. Research should be conducted with specific goals, on a very limited scale and under strict control.
2. Gene Therapy
Genetic research on human embryos are part of medical research in general and the ethical requirements and rules of medical research should apply to them (61). They should be governed by previous international guidelines relevant to this problem such as the Nuremberg and Helsinki Declarations (1963 and 1975), the CIOMs (1982), the Inuyama Declaration (1990) and the Cairo Declaration (1991) for the Muslim Countries (50).
There are four well known categories of human gene therapy which are helpful to delineate and focus the ethical gene therapy discussion (62, 63, 64). These include:
1. Somatic cell gene therapy
2. Germ line gene therapy
3. Enhancement genetic engineering
a. Somatic cell enhancement
b. Germ line enhancement
4. Eugenic genetic engineering
Genetic manipulation is desirable to remedy genetic defects. Serious ethical questions begin to arise at the borderline cases when the aim of genetic manipulation shifts from therapy to the creation of a new human type (65). Though there is a rather general approval of somatic cell gene therapy, ethics has not been able to solve the dilemmas of germ line gene therapy (61). From a Muslim perspective human gene therapy should be restricted only to therapeutic indications. Somatic cell gene therapy is encouraged as it involves remedy and alleviation of human suffering. However enhancement genetic engineering or Eugenic genetic engineering would involve a change in the creation of God which may lead to an imbalance of the whole universe and should be prohibited (61). Gene therapy to manipulate hereditary traits such as intelligence, stupidity, stature, beauty or ugliness is a serious attempt as it may imbalance the life of man (66).
3. Research on Foetal Tissue Abortion
Is research performed on foetuses or foetal tissue obtained from abortion permissible? Examples of these are research connected with transplantation of fetal tissues into patients suffering from Parkinson’s disease (67, 68). From a Muslim perspective such research and practice are permitted provided the free informed consent of the couple, the owners of the foetal tissue is obtained (50).
Foetal ovarian tissue transfer would enable the provision of eggs for use and research in artificial reproduction. It also provides the possibility of creating children who will have a fetus as their genetic mother. The genetic grandparents of these children will be the contemporaries of their birth parents. Though research on foetal ovarian tissue for the improvement of the results of artificial reproduction and other therapeutic purposes is ethically acceptable in the Muslim world, yet its use for creation of children is unacceptable as these children will not be related to their genetic parents (50).
CONCLUSION
Islam is a flexible religion adaptable to the necessities of life and what is unethical in one situation may become ethical in another situation or at another time (48). Islam is a religion which has given a great importance to what is known today as the ethical principles of autonomy, beneficence, non-maleficence and justice. When the pace of scientific advancement is catching ethicists unaware and posing many questions that seem unanswerable, Muslims are in the fortunate position of falling back on their Shari`ah to tap its unexhaustible resources of Islamic answer (69). Muslims should also take the initiative of sharing what they have with the rest of the world and making their contribution in an attempt to solve common problems. This is indeed an Islamic injunction, for Allah (SWT) said to His Prophet (s.a.w.s.):
"We sent thee not, but as a Mercy for all creatures." (70)
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(This paper was presented at the 15th Annual Convention of the
Islamic Medical Association of South Africa, 7 - 9 July 1995)