assisted reproduction developments in the islamic world

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Ž . International Journal of Gynecology & Obstetrics 74 2001 187193 Ethical and legal issues in reproductive health Assisted reproduction developments in the Islamic world G.I. Serour a,b , B.M. Dickens c,d,e, a International Islamic Center for Population Studies and Research, Al-Azhar Uni ersity, Cairo, Egypt b Faculty of Medicine, Al-Azhar Uni ersity, Cairo, Egypt c Faculty of Law, Uni ersity of Toronto, Toronto, Canada d Faculty of Medicine, Uni ersity of Toronto, Toronto, Canada e Joint Centre for Bioethics, Uni ersity of Toronto, Toronto, Canada Accepted 11 May 2001 Abstract A November 2000 workshop organized by the International Islamic Center for Population Studies and Research, Ž . Al-Azhar University, Cairo, considered use of assisted reproduction technologies ART in the Islamic world. The workshop reinforced a 1997 recommendation that a Standing Committee for Shari’a Medical Ethics be constituted to monitor and assess developments in ART practice. Among issues the workshop addressed were equitable access to services for infertile couples of modest means, and regulation of standards of equipment and personnel that ART centers should satisfy to gain approval to offer services. Acceptable uses of preimplantation genetic diagnosis were proposed, and follicular maturation research in animals, including in vitro maturation and in vitro growth of oocytes, was encouraged, leading to human applications. Embryo implantation following a husband’s death, induced postmenopausal pregnancy, uterine transplantation and gene therapy were addressed and human reproductive cloning condemned, but cloning human embryos for stem cell research was considered acceptable. 2001 International Federation of Gynecology and Obstetrics. All rights reserved. Keywords: Assisted reproduction; Access to services; Preimplantation genetic diagnosis; Follicular maturation; Embryo implanta- tion following husband’s death; Postmenopausal pregnancy; Uterine transplantation; Gene therapy; Reproductive cloning; Stem cell research. Corresponding author. Faculty of Law, University of Toronto, 84 Queen’s Park, Toronto, Canada M5S 2C5. Tel.: 1-416-978- 4849; fax: 1-416-978-7899. Ž . E-mail address: [email protected] B.M. Dickens . 0020-729201$20.00 2001 International Federation of Gynecology and Obstetrics. All rights reserved. Ž . PII: S 0 0 2 0 - 7 2 9 2 01 00425-8

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Ž .International Journal of Gynecology & Obstetrics 74 2001 187�193

Ethical and legal issues in reproductive health

Assisted reproduction developments in theIslamic world

G.I. Seroura,b, B.M. Dickensc,d,e,�

aInternational Islamic Center for Population Studies and Research, Al-Azhar Uni�ersity, Cairo, EgyptbFaculty of Medicine, Al-Azhar Uni�ersity, Cairo, Egypt

cFaculty of Law, Uni�ersity of Toronto, Toronto, CanadadFaculty of Medicine, Uni�ersity of Toronto, Toronto, Canada

eJoint Centre for Bioethics, Uni�ersity of Toronto, Toronto, Canada

Accepted 11 May 2001

Abstract

A November 2000 workshop organized by the International Islamic Center for Population Studies and Research,Ž .Al-Azhar University, Cairo, considered use of assisted reproduction technologies ART in the Islamic world. The

workshop reinforced a 1997 recommendation that a Standing Committee for Shari’a Medical Ethics be constituted tomonitor and assess developments in ART practice. Among issues the workshop addressed were equitable access toservices for infertile couples of modest means, and regulation of standards of equipment and personnel that ARTcenters should satisfy to gain approval to offer services. Acceptable uses of preimplantation genetic diagnosis wereproposed, and follicular maturation research in animals, including in vitro maturation and in vitro growth of oocytes,was encouraged, leading to human applications. Embryo implantation following a husband’s death, inducedpostmenopausal pregnancy, uterine transplantation and gene therapy were addressed and human reproductivecloning condemned, but cloning human embryos for stem cell research was considered acceptable. � 2001International Federation of Gynecology and Obstetrics. All rights reserved.

Keywords: Assisted reproduction; Access to services; Preimplantation genetic diagnosis; Follicular maturation; Embryo implanta-tion following husband’s death; Postmenopausal pregnancy; Uterine transplantation; Gene therapy; Reproductive cloning; Stem cellresearch.

� Corresponding author. Faculty of Law, University of Toronto, 84 Queen’s Park, Toronto, Canada M5S 2C5. Tel.: �1-416-978-4849; fax: �1-416-978-7899.

Ž .E-mail address: [email protected] B.M. Dickens .

0020-7292�01�$20.00 � 2001 International Federation of Gynecology and Obstetrics. All rights reserved.Ž .PII: S 0 0 2 0 - 7 2 9 2 0 1 0 0 4 2 5 - 8

( )G.I. Serour, B.M. Dickens � International Journal of Gynecology & Obstetrics 74 2001 187�193188

1. Introduction

In November 2000, a workshop organized bythe International Islamic Center for PopulationStudies and Research at Al-Azhar University inCairo, Egypt, addressed ethical implications ofnew and prospective assisted reproduction tech-nologies according to the Islamic tradition. Thiswas the third meeting the Center has organizedon issues in reproduction, the original being aconference on the ethics of research in human

� �reproduction, in 1991 1 and the second a semi-nar on technologies for treatment of infertility, in

� �1997 2 . The November 2000 workshop wasconcerned with rising rates of infertility amongMuslim populations, and the challenge of employ-ing new and prospective reproductive and genetictechnologies for relief consistently with religiousand enacted laws.

Several techniques for the relief of infertilityand to avoid the risk of transmission of deleteri-ous genes that have evolved outside the Muslimworld, particularly third-party sperm donation andmore recently ovum and embryo donation, areunacceptable inside. A central feature of Muslimidentity and family structure is authenticity oflineage. Individuals’ family names often disclosetheir paternity, and adoption into families andfamily names is not acceptable. Equally, spermdonation fractures links of family genetic lineage,and is analogous to adultery and condemned. Asagainst this, however, the capacity of preimplan-

Ž .tation genetic diagnosis PGD to identify em-bryos for implantation that do not possess patho-logical features was welcomed as a developmentthat would facilitate a couple at risk of transmis-sion of harmful genes to conceive a healthy childof their own. The workshop gave guarded ap-proval in considering the case of the parents inColorado, USA who were unable to find a bonemarrow donor suitable for their 6-year-old daugh-ter who was at risk of death from Franconianemia. They therefore contributed their ova andsperm for in vitro fertilization, and one of theseveral resulting embryos tested by PGD wasfound not to have the anemia, and also to be acompatible donor for their daughter. The embryowas successfully implanted, resulting in birth of a

son whose umbilical cord provided blood cellsthat were transplanted into his sister. This proce-dure gave her an 85�90% chance of recoveryfrom the disease.

The workshop considered a variety of innova-tive and potential reproductive technologies, in-cluding several dependent on transplantation andgenetic diagnosis and understanding. Attentionwas given to technical, ethical and religious as-pects of several variants of what generically is

Ž .described as in vitro fertilization IVF , includingPGD for sex and other selection, cryopreserva-tion of ovarian tissue and British Fertility Societyrecommendations on the matter, cryopreservationof gametes, testicular tissue and embryos, post-menopausal pregnancy, in vitro maturation andgrowth of oocytes and uterine transplantation,including the basis of limitation of this practicerecently introduced in Saudi Arabia. The work-shop’s concluding recommendations were basedon full discussion of the implications of applica-tion of these various present and prospectivetechniques in the Muslim world.

2. Standing Committee for Medical Ethics

The first recommendation of the workshop wasto endorse creation of a Standing Committee forShari’a Medical Ethics as recommended by the

� �1997 seminar, 3 which would monitor scientificdevelopments in assisted reproductive technologyŽ .ART , consider their religious and social implica-tions, and address the means to inspire and moni-tor appropriate research that is respectful of theneeds and interests of infertile couples. The com-position and terms of reference of the committeewere recommended to be wide, reflecting the factthat ‘Islam is not monolithic, and a diversity ofviews in bioethical matters does exist. This diver-sity derives from the various schools of jurispru-dence, the different sects within Islam, differ-ences in cultural background and different levels

� �of religious observance’ 4 . Composition of thecommittee should include representatives of reli-gious views, whose role might overlap that dis-charged by lawyers in purely secular ethicscommittees, and of social views, bearing in mind

( )G.I. Serour, B.M. Dickens � International Journal of Gynecology & Obstetrics 74 2001 187�193 189

the plurality of societies in which Islam isobserved. In addition, members should includethose familiar with public and private sectorhealth facility administration, health professionallicensure, and practical and economic realities ofcommonly experienced family life, and includeequitable representation of both sexes.

3. Equitable access

The workshop recommended that means beestablished to provide access to ART centers topoor families who require the services that thesecenters offer. Islam considers it a major duty offamilies to have children and rear them in reli-gious faith, and means are required to facilitatedischarge of this duty by impoverished families.Such means might include provision of services atgovernmental and university institutions, es-

Žtablishment of charitable projects Zakat Con-.tribution , and appropriate collaboration with

drug companies and other commercial enterprisescommitted to causes of social justice. Arrange-ments might also be considered by which privateART centers, perhaps as a condition of statelicensure, would be required to offer a proportionof their services at no cost or very low cost torecipients. For instance, governmental or othersubsidies might be paid to private ART centerswhere public facilities are few, or fees privatecenters charge to those with adequate means topay might include a surcharge to fund services forpatients unable to pay the full, or any, fees.

Concerns of equitable access to ART go be-yond economic equity. The professional skills andsophisticated equipment that are required to es-tablish an ART center make centers few in num-ber in most countries, and largely concentrated inmajor private centers. Residents of rural areasoften find services they can afford, geographicallyinaccessible. The challenge of taking ART ser-vices to rural areas appears almost insurmount-able. More should be done to prevent infertilityin rural areas, and clinical care of treatable infer-tility should be promoted, but equitable provisionof ART to overcome irreversible infertility amongrural and remote populations presents a continu-ing challenge.

4. Regulation of ART centers

The capacity of ART centers to produce effec-tive results, measured in terms of ‘take-homebabies,’ depends on them being adequatelyequipped with personnel and technical resources,and on maintaining appropriate performancestandards. In addition to explanations offered byART practitioners of levels of technical profi-ciency that ART centers must achieve, the work-shop heard how the Egyptian Medical Syndicate,in collaboration with the national Ministry ofHealth, proposes to regulate ART centers andstaff to ensure continuing compliance with condi-tions of licensure. Rules will address, among otherthings, proper conditions for cryopreservation ofgametes and embryos, elimination of risks ofsperm mixing and misidentification, and qualifi-cations and experience of clinic leadership.

The workshop affirmed the importance of anational or other appropriate licensing body foreach country adopting and applying rigid regula-tions for the establishment and maintenance ofART centers, including approval of their location,equipment and categories of personnel. The bodyshould have authority to ensure that centersobserve professional standards of operation, andthat they respect and protect the rights of all oftheir patients. The workshop also recommendedthat licensing bodies should develop guidelinesfor best clinical practices that centers should berequired to observe. Several participants alsourged that central bodies should be entitled toreceive and publish ART centers’ outcome data.

( )5. Preimplantation genetic diagnosis PGD

The workshop recognized the importance ofPGD, but was guarded about its use on non-medical grounds such as sex-selection or familybalancing, considering that each case should betreated on its own merits. The medical applica-tion of PGD was seen as marking progress in thefield of ART, and as a welcome alternative toprenatal diagnosis that results in abortion. Mus-lims have not accepted the opinion the Roman

( )G.I. Serour, B.M. Dickens � International Journal of Gynecology & Obstetrics 74 2001 187�193190

Catholic church adopted in 1869 that human lifebe considered to begin at conception, but adhereto the view that human life requiring protectioncommences two to three weeks from conceptionand uterine implantation. Accordingly, decisionsnot to attempt implantation of embryos producedin vitro on grounds that they show serious chro-mosomal or genetic anomalies, such as aneu-ploidy, cystic fibrosis, muscular dystrophy orhemophilia, are acceptable. PGD is encouraged,where feasible, as an option to avoid clinicalpregnancy terminations of couples at exceptio-nally high risk.

More contentious is non-medical PGD, particu-larly for purposes of sex selection. Sex selectiontechnologies have been condemned on the groundthat their application is to discriminate againstfemale embryos and fetuses, so perpetuating prej-

� �udice against the girl child 5 and social devalua-tion of women. For instance, the Convention onHuman Rights and Biomedicine of the Council of

� �Europe provides that ‘ t he use of techniques ofmedically assisted procreation shall not be al-lowed for the purpose of choosing a future child’ssex, except where serious hereditary sex-related

� �disease is to be avoided’ 6 . The workshop en-dorsed the condemnation of such discriminationand devaluation, but considered that universalprohibition would itself risk prejudice to womenin many present societies, especially while birthsof sons remain central to women’s well-being.Family balancing was considered acceptable, forinstance where a wife had borne three or fourdaughters and it was in her and her family’s bestinterests that another pregnancy should be herlast. Employing PGD to ensure the birth of a sonmight then be approved, to satisfy a sense ofreligious or family obligation and to save thewoman from increasingly risk-laden pregnancies.The workshop considered that an application forPGD for sex selection should be disfavored inprinciple, but resolved on its particular merits.

6. Follicular maturation research

The workshop recommended that research inanimal models be advanced on follicular matura-

Ž .tion, in vitro maturation of oocytes IVM and inŽ .vitro growth of oocytes IVG . Further, it recom-

mended that, with due caution, such research beundertaken with human patients who are suitablefor the procedure and able to provide their ownfree and informed consent, where medical condi-tions warrant. The culturing to maturity of imma-ture oocytes by IVG was estimated probably totake over 6 months with human primordial folli-cles, while IVM might be achieved with fullygrown oocytes collected from unstimulated folli-cles in little more than a day. However, a combi-nation of immature oocyte cryopreservation, IVGand IVF will make oocyte banking feasible, forinstance to avoid the need for women’s repeatedinduced superovulation, and so reduce not onlythe cost of IVF but also the physical and psycho-logical stress on patients, and on service providers.

7. Embryo implantation following husband’s death

Workshop participants enjoyed a vigorous,principled debate on whether a couple’s pre-served embryo could properly be implanted in awife after her husband’s death. The strict viewwas that marriage ends at death, and procuringpregnancy in an unmarried woman is forbiddenby religious laws, for instance on children’s rightsto be reared by two parents, and on inheritance.After due time, the widow might remarry, butcould not then bear a child that was not her newhusband’s. An opposing view, advanced as re-flecting both Islamic compassion and women’sinterests as widows, was that a woman left alonethrough early widowhood would be well andtolerably served by bearing her deceased hus-band’s child, through her enjoying companion-ship, discharge of religious duties of childrearing,and later support. Unable itself to resolve theconflicting views, the workshop recommended thatthe question be forwarded to the Islamic Re-search Council regarding whether an ART centercould agree to a widow’s request for thawing andimplantation of an embryo created while her hus-band was alive.

The Grand Mufti of Cairo, in a personal com-munication with Professor Serour, stated that

( )G.I. Serour, B.M. Dickens � International Journal of Gynecology & Obstetrics 74 2001 187�193 191

permission had once been given for embryo im-plantation in a wife following her husband’s death,based on the circumstances of the particular case.However, this should not be taken as a general-ization, and each case should be considered on itsown merits.

8. Postmenopausal pregnancy

Related to the last issue of ovum preservationis the prospect this opens of postmenopausalpregnancy, but here the workshop was able toagree on its recommendation. Its agreementmarked a point of development, since earlier thepossibility of postmenopausal pregnancy was con-sidered dependent on ovum donation, which wasdisapproved in principle at the 1991 conference� �7 , and the 1997 seminar similarly found that� �‘ p regnancy . . . after menopause is extremelydangerous for both mother and child, also involv-ing a third party and, accordingly, is unacceptable

� �in the Muslim world’ 8 . Neither the 1991 nor1997 meetings took account of the prospect ofcryopreservation and in vitro growth if necessaryof a woman’s own ovum for IVF and postmeno-pausal implantation. The 2000 workshop con-sidered this as a still remote but feasible prospect,and shaped its recommendation accordingly.

The workshop considered the special care nec-essary for the safe induction and completion ofpregnancy in a woman who was of advanced, orbeyond normal, childbearing years, and of theeasier case where premature menopause affects awoman who would otherwise be of suitable ma-ternal age. The workshop took account of chil-dren’s needs of parents likely to survive at leastinto their mid-adolescence. It accordingly recom-mended that research efforts be concentrated onthe prevention of premature menopause and thatpostmenopausal pregnancy be permissible to at-tempt in exceptional cases justified by mainte-nance of integrity of a child’s genetic parentage,the pressing nature of the circumstances, the rel-ative safety to mother and child, and parentalcapacity to discharge childrearing responsibilities.

9. Uterine transplantation

The workshop recommended that research inuterine transplantation in animals could go for-ward. However, if and when it should prove to besafe and effective for possible use in humans,within approved transplantation guidelines, fur-ther consideration of the use of this procedureshould be referred to the Islamic Research Coun-cil for discussion. An issue would be whether suchtransplantation would violate the prohibitionagainst third-party involvement in a married cou-ple’s reproduction. Involvement might not be aspersonal as gamete donation or surrogate moth-erhood, but may not simply be analogous to, forinstance, anonymous kidney donation that en-ables a person to survive and become a parent,due to the influence the uterine environment mayhave on the child’s biological development andpersonality.

Less novel but worthy of serious attention areconditioning issues of donors’ competent, freeand informed consent to total hysterectomy, theirtissue compatibility with potential recipients, andtheir child-bearing or postmenopausal status. Amenopausal uterus can function normally underhormonal stimulation and, once transplanted intoa recipient without rejection, could receive anovum released by the recipient and fertilized byher husband in the normal way. A mother mightthereby donate to her daughter to allow birth ofher grandchild. The workshop was aware of anapparently abusive and disastrous pioneering at-tempt at uterine transplantation in Saudi Arabia,� �9 illustrating the potential for exploitation ofdonors, and also considered recipients’ indica-tions for the procedure. These would includecongenital absence of the uterus, extreme uterinehypoplasia, previous medically compelled hys-terectomy, destruction of the endometrium byinfection such as tuberculosis, and excessivecurettage following dilation and curettage.

10. Cloning

The workshop condemned reproductive cloningfor creation and birth of a new person who would

( )G.I. Serour, B.M. Dickens � International Journal of Gynecology & Obstetrics 74 2001 187�193192

be the genetic twin of one born previously, but itencouraged research in non-reproductive cloning,particularly for stem cell creation, study and re-search intended for human benefit. Encourage-ment was not limited by recognition that use ofdeliberately created embryos is likely to be in-volved. Study and research were anticipated tohave a beneficial impact on reproduction, in thatunderstanding of the origins of genetic defects inembryonic and fetal development would facilitateprevention and correction of defects, and, whenprevention or correction were impossible, selec-tion of healthy gametes, embryos and fetuses,such as by PGD. Islam allows abortion on theground of severe fetal abnormality.

Some workshop members were sympathetic toconsideration of reproductive cloning of cells of achildless sterile man if his wife was willing so tobear the child, to permit discharge of religiousduties and relieve family distress and risk of mar-riage breakdown through the wife’s right of di-vorce. There would be no violation of the rulesagainst third-party involvement or against confu-sion of lineage. However, the genetic father wouldbe the husband’s father, introducing problems ofhis consent and perhaps of inheritance laws. Onbalance, it was considered premature to recom-mend departure from the prevailing condemna-tion of reproductive cloning.

11. Gene therapy

Allied with stem cell research is the prospect of� �gene therapy 10 . Progress in somatic cell gene

therapy, which alters the genes only of a treatedpatient, has suffered recent setbacks, and germ-line gene therapy, which would affect all futuregenerations of a patient’s offspring, remains littleshort of universally condemned and prohibited.The workshop recognized that genetic alterationof embryos before their cells have reached dif-ferentiation, that is while they are still totipotent,would constitute germline manipulation. Theworkshop found that little would be added toreiterate prevailing condemnation, and offeredless of a recommendation than an observation.The workshop stated that gene therapy is a devel-

oping area that may be used with ART in thefuture. It is critical that its use be clearly benefi-cial, focused on alleviating human suffering.

The focus on therapeutic applications wouldexclude purely cosmetic uses and goals of en-hancement of non-pathological conditions. Allevi-ation of genetic diseases and pathological condi-tions alone would exclude such applications as tomake people who would be within the normalrange of physique, capacity and aptitude taller,stronger, more likely to achieve athletic successor to be more intelligent or artistically sensitiveor gifted. The background concept was that genetherapy might be legitimate, not to promote ad-vantage or privilege, but to redeem genetically orotherwise physiologically inherited disadvantage.

12. Promotion of research

The workshop’s concluding recommendationhad a compound aspect. Observing that researchis essential for the progress of ART, the work-shop strongly encouraged that research be under-taken, but within a proper ethical framework.Reflecting the unstructured ethical governance ofresearch in several of the countries from whichART practitioners at the workshop had come,participants recommended that countries shouldeach form a national research ethics committeeto which any proposed research involving the useof gametes or embryos outside the body shouldbe submitted for prior review and approval. Thenational committee should be balanced to includeappropriately qualified scientific, religious andother members, including lay members able torepresent the interests of potential subjects ofresearch, who primarily would be women, andtheir communities. Other areas of ART researchwere recommended to be reviewed by local insti-tutional or other ethics review committees.

This conclusion amplified a major thrust of theinitial 1991 conference organized by the Interna-tional Islamic Center for Population Studies andResearch at Al-Azhar University, which launchedthe first such local ethics review committee in theregion at the university. The workshop’s recom-mendations built on this foundation to propose

( )G.I. Serour, B.M. Dickens � International Journal of Gynecology & Obstetrics 74 2001 187�193 193

that national research ethics committees could beconstituted by drawing on the experience thatmembers of local ethics review committees hadacquired. This would provide investigators andtheir institutions with a common resource forethics consultation, and offer concerned officialsand residents of countries an assurance of ethicaloversight of particularly sensitive ART researchproposals.

References

� �1 Serour GI, editor. Ethical guidelines for human repro-duction research in the Muslim world. Cairo: The Inter-national Islamic Center for Population Studies and Re-search, Al-Azhar University, 1992.

� �2 Serour GI, editor. Ethical guidelines of use of assistedreproductive technology for treatment of human infertil-ity. Cairo: The International Islamic Center for Popula-tion Studies and Research, Al-Azhar University, 1997.

� �3 Serour GI, editor. Ethical implications of use of assistedreproductive technology for treatment of human infertil-ity. Final Communique, Recommendation 1 at 166.Cairo: The International Islamic Center for PopulationStudies and Research, Al-Azhar University, 1997.

� �4 Daar AS, Al Khitamy AB. Islamic bioethics. Can MedŽ .Assoc J 2001;164 1 :60�63 at 61.

� �5 Fathalla MF. The girl child. Int J Gynecol Obstet2000;70:7�12.

� �6 Council of Europe, Directorate of Legal Affairs. Con-vention for the Protection of Human Rights and Dignityof the Human Being with regard to the Application ofBiology and Medicine: art. 14. Strasbourg: Conventionon Human Rights and Biomedicine, 1996.

� �7 Serour GI, editor. Ethical implications for human repro-duction research in the Muslim world. Ethical Guide-lines IV Bioethics in infertility research and medicallyassisted procreation, paras. 5 and 6, at 30. Cairo: TheInternational Islamic Center for Population Studies andResearch, Al-Azhar University, 1992.

� �8 Serour GI, editor. Ethical guidelines of use of assistedreproductive technology for treatment of human infertil-ity. Final Communique at 166. Cairo: The InternationalIslamic Center for Population Studies and Research,Al-Azhar University, 1997.

� �9 Kandela P. Uterine transplantation failure causes SaudiArabian government clampdown. Lancet 2000;356:838.

� �10 El Bayoumi AA, Al Ali K. Gene therapy: the state ofthe art. Rabat, Morocco: Islamic Educational, Scientific

Ž .and Cultural Organization ISESCO , 2000.