REGULATING BIOMEDICAL ADVANCES: EMBRYONIC STEM CELL RESEARCH DIANNE NICOL,[ ] DONALD CHALMERS[ ] AND BRENDAN GOGARTY[ INTRODUCTION

Each breakthrough in biomedical technology emphasises the accelerating rate of µscience time¶. The pace of scientific development has been directly promoted by substantial increases in OECD (Organisation for Economic Cooperation and Development) government funding for genetic and biotechnological research. Meanwhile, cohorts of government committees and individuals struggle with the scientific, ethical, legal and social implications of these advances in a slower ethics timeframe. Legislators, and in an increasing trend, judges, are having to develop or apply rules to avoid the perils and secure the promises of this new scientific age. This µlaw time¶[1] operates within national boundaries, whereas science is quintessentially international. Assisted reproductive technology (ART) and embryo research have posed many challenges to the different timeframes of science, ethics and law. Stem cell technology is the latest development in this controversial branch of science. The unique properties of human stem cells have aroused considerable optimism about their potential as new pathways for alleviating human suffering caused by disease and injury. Submissions to an inquiry by the Australian House of Representatives on stem cell research and cloning proclaimed it to be µthe greatest and most exciting medical breakthrough¶ and µone of the biggest breakthroughs in human medicine¶, promising µvery great potential benefits¶.[2] Similar sentiments were expressed at a recent conference in Europe organised by the European Commission.[3] However, some of the expressions of optimism may prove to be overstated. Embryonic stem cell technology is still at a preliminary research stage and announcements about its potential may be premature. In other research areas, commercial pressures have resulted in a changed culture with regard to scientific announcements. Scientists no longer wait until the publication of their results in refereed journals before making press statements. In fact, press statements frequently precede official publications. This has led the National Health and Medical Research Council (NHMRC) to publish guidelines on the requirement for appropriate qualifications to scientific announcements to avoid unrealistic expectations in the community for the early introduction of medical products.[4] Stem cells may be derived from adult tissues but the most potent are extracted from developing human embryos. The ethical and legal controversies that were aroused in the ART debates during the 1980s have been re-ignited with the development of stem cell technology. Experts from around the world are assessing the difficult issue of the extent to which embryonic stem cell research should be allowed to proceed, and to date there is little international consensus on this matter. How, then, should embryonic stem cell research be regulated in Australia? This issue was considered by the House of Representatives Standing Committee on Legal and Constitutional Affairs in its report entitled Human Cloning: Scientific, Ethical and ]

Regulatory Aspects of Human Cloning and Stem Cell Research (hereafter the Andrews Report, after the Chair of the Committee, Mr Kevin Andrews, MP) released in September 2001. The report arose out of a recommendation for the Committee to review the report of the Australian Health Ethics Committee (AHEC) of the NHMRC entitled Scientific, Ethical and Regulatory Considerations Relevant to Cloning of Human Beings (hereafter the AHEC Report).[5] In this article we examine embryonic stem cell research and explore the current regulatory framework associated with this research in Australia, with particular reference to the Andrews Report. We consider these issues in the contexts of: The increasing public scrutiny and accountability of biomedical research;[6] the use of human embryos in research; the lack of uniform national regulation for embryo research in this country; and the general public debate about reproductive cloning. In these contexts, the current ART regulatory system is also considered. STEM CELL RESEARCH The Nature of Stem Cells Stem cell technology in humans derives from earlier and complementary work in animal studies.[7] The defining properties that have aroused excitement in stem cells is their capacity for µ... prolonged proliferation with retention of their undifferentiated form ... together with a stable developmental potential to give rise to derivative cells ...¶.[8] Stem cells are claimed to have valuable attributes. For example, in a Report by the UK Chief Medical Officer¶s Expert Group[9] (hereafter Stem Cell Research: Medical Progress with Responsibility), reviewing the potential of developments in stem cell research, stem cells were described thus: [a] stem cell is an unspecialised cell at an early stage of development. Under certain conditions, stem cells can divide and differentiate into a large number of cell types that make up the tissues and organs of the body. In addition, they can undergo self-renewal, a process by which an unspecialised stem cell divides to produce two further unspecialised stem cells. The ability of stem cells to self-renew in this way means that a relatively small number of stem cells can be grown in the laboratory into the very large number of stem cells that would be needed for clinical applications.[10] The US National Academies Committee on the Biological and Biomedical Application of Stem Cell Research also released a Report in September 2001 entitled Stem Cells and the Future of Regenerative Medicine (hereafter Stem Cells and Regenerative Medicine) addressing the potential of stem cells. That report stated that: [s]tem cell research offers unprecedented opportunities for developing new medical therapies for debilitating diseases and a new way to explore fundamental questions of biology.[11] Human stem cell research enables researchers to maintain and grow in culture undifferentiated cells derived from a range of sources including early-stage human embryos,[12] foetal tissue,[13] certain adult organs[14] and the umbilical cord and placenta. Some stem cells, particularly those derived from early embryos are referred to as being totipotent, having the potential to differentiate into all different cell types, including placentas. At a later stage these cells are sometimes referred to as being pluripotent[15] or multipotent, having the potential to differentiate into a wide range of different cell types.

Others, particularly those derived from adult organs, appear to be more limited in their potency to differentiate into multiple cell types.

Stem Cells: Potentiality and Actuality
Stem cell research offers the prospect of programming cells to differentiate into a whole range of cell types that can then be used for transplantation purposes.[16] Examples of desirable cell types for transplantation therapy include nerve, muscle, various blood cell types, liver, pancreas and heart.[17] The technology is being promoted as having potential for the treatment of diseases of the ageing such as Parkinson¶s disease and Alzheimer¶s disease. The proportional increases in the aged population within most OECD countries means that there is growing interest in the diseases of the aged and mental health. Other diseases and injuries that are potential targets for stem cell therapy include diabetes, heart disease and spinal code injury.[18] Despite this promise, the actualisation of the potential of human stem cell technology in transplantation therapy or any other derivative therapy is still a long way off. In fact, stem cell technology is still at a very embryonic stage of development and a great deal more research needs to be done before it is achieved.[19] This has been recognised by the European Life Sciences Group of the European Commission.[20] Similarly the Stem Cells and Regenerative Medicine Report noted that: [b]ecause human ESCs have only recently become available for research, most of what is known about ESCs come from studies in the mouse, which ... cannot be presumed to provide definitive evidence of the capabilities of human cells.[21] Further caution was expressed about the possibility of tumour development and µ[m]ajor questions remain about the genetic or environmental factors in the body that control the fate of ESCs and about the importance of different factors during various stages of cell differentiation¶.[22]

Embryonic and Adult Stem Cell Research
Research using adult stem cells is ethically less problematic than research using embryonic stem cells and raises no significantly different ethical issues than those associated with other research involving humans. Indeed, stem cells offer such promise as research tools that some commentators have said that there is an ethical imperative to allow such research to continue.[23] The isolation of stem cells from adults involves minimal invasiveness and little or no physical harm. On balance, research involving adult stem cells is therefore likely to be ethically sound. Arguments have been put that embryonic stem cell research is not necessary because the ethically less problematic adult stem cell research offers equal promise. However, embryonic stem cells have the advantage of being relatively easy to isolate from early embryos and to maintain in an undifferentiated state in culture. Some of the difficulties with adult stem cell technology were discussed in the Stem Cells and Regenerative Medicine Report. In summary, a number of factors are relevant:

‡ in some situations the use of adult stem cells would be inappropriate, for example where a person carries a genetic condition, making self-transplantation undesirable. Transplantation from a donor would also be unfavourable because the recipient would be subject to immune reaction; ‡ the technology is new and preliminary conclusions as to therapeutic potential are tentative; ‡ adult stem cells are rare and difficult to isolate; ‡ the appropriate culture conditions have not yet been fully elucidated; ‡ the level of plasticity of stem cells isolated from particular adult tissues is not clear; ‡ the functionality of the cells that differentiate from cultured adult stem cells is uncertain; ‡ adult stem cells tend to differentiate quickly in culture; and ‡ there is scant evidence that human adult stem cells can in fact differentiate into multiple tissue types.[24] These important scientific differences between adult and embryonic stem cell research were recognised in the Andrews Report. A number of submissions to the Committee supported the need for continuing research using embryonic as well as adult stem cells.

Sources of Embryonic Stem Cell Lines
There are four possible sources of embryonic stem cells for research: ‡ cells extracted from embryos surplus to ART programs; ‡ cells extracted from embryos created specifically for that purpose; ‡ cells extracted from embryo-like entities created using cloning techniques akin to those used to create Dolly the sheep;[25] and ‡ cell lines already in existence. In the first category, embryos that are surplus to ART programs are routinely stored for a period and then discarded. For example, the Victorian Infertility Treatment Act 1995 mandates destruction after 5 years of storage.[26] It has been estimated that there are some 65,000 embryos in storage in Australia at the present time.[27] The volume of embryos is well in excess of demand for ART. However, there are severe restrictions on any use of these surplus embryos (see discussion of existing regulation, below). Generally, in the second category, embryos may only be created for the purpose of infertility treatment or for approved research purposes.[28] In the third category, there are some doubts (certainly in Australia) as to whether existing regulation would allow for the creation of cloned embryo-like entities for this purpose (see discussion below). Some researchers argue that this option should not be foreclosed because of the major advantage it offers in producing histocompatible tissue for transplantation.[29] Use of such tissue avoids the medically serious and potentially life-threatening immunological responses to tissue created from stem cells from foreign donors.[30] However, adult stem cell technology may be equally promising in this regard. The particular complicated ethical and scientific issues associated with the extraction of stem cell lines from embryos led to a strangely ambivalent approach in the US. In August 2001

President Bush announced that federal funding could be used for research involving embryonic stem cells, but only to the extent that it make use of cell lines in existence at that time[31] (that is, the fourth category of cell lines mentioned above). This decision does not allow the destruction of any stored embryos or the creation of new embryos for the purpose of extracting new embryonic stem cell lines. Interestingly, this limitation only applies to publicly funded research and not to private research. The decision fails to recognise that the useful life of stem cell cultures may be finite. Although cell lines maintained in culture could, in theory, survive indefinitely, the Stem Cells and Regenerative Medicine Report notes that other types of cell lines tend to accumulate harmful genetic mutations.[32] Moreover, existing stem cell lines have generally been cultured in mouse serum, and consequently they cannot safely be used for therapeutic purposes because of the risk of spread of mouse-borne disease.

Stem Cell Research in Australia
Australian scientists are at the forefront of stem cell research in both the private and public sectors.[33] Australian research efforts were recently boosted by Commonwealth Government funding of a National Centre for Advanced Cell Engineering.[34] The Centre will act as a repository of stem cells for national and international research as well as coordinating collaborative research between Monash Institute of Reproduction and Development, Monash University, Adelaide University, BresaGen and ES Cell International. This funding reflects a recognition by the Commonwealth Government of the benefits of stem cell research.[35] Notably, some of the stem cell lines developed by BresaGen and by the Monash Institute were included in President Bush¶s list.[36] STEM CELL RESEARCH AND HUMAN CLONING: NEW ADDITIONS TO THE LEXICON The scientific claims about the potential benefits of stem cell technology are being tested. The next stage is to discuss the ethics and to determine an appropriate regulatory framework for this biomedical advance. This technology has its genesis in animal studies, is related to human ART and has been conflated, at times, within the human reproductive cloning debate. These intersections have created linguistic imprecision.[37] This is not unexpected in new areas of scientific endeavour. However, some agreement must be reached about the new terms to be included in the lexicon or we may end up like Humpty Dumpty, making words µmean just what [we] choose [them] to mean ± neither more nor less¶.[38]

Human Cloning
Human reproductive cloning has been the subject of intense international debate in recent years. The technology of somatic cell nuclear transfer (SCNT)[39] and the arrival of Dolly the sheep[40] have engendered most concern. SCNT technology involves the introduction of a nucleus from a somatic cell in a fully developed organism into an enucleated egg cell, which then develops into another living being. In fact, the technology for cloning animals is not new, being first developed in the 1950s. Further major advances were made in the 1970s and 1980s.[41] Essentially two techniques were developed: embryo splitting and embryonic nuclear transfer. As the term implies,

The development of this technology has forced reappraisal of the commonly held belief that differentiated cells are genetically irreversible. rather the nucleus of an embryonic cell (which is used for embryonic nuclear transfer). Rather. that the DNA from adult cells cannot be cloned.[43] As an example. This confusion has been exacerbated with the recognition that a combination of embryonic stem cell technology and SCNT could be used to provide cells for transplantation that have sufficient genetic similarity to the recipient to avoid complications associated with rejection. These ambiguous uses were recognised in the Andrews Report and the Committee opted to avoid use of the term altogether. The progeny of nuclear transfer. created for assisted reproductive technology and surplus to requirements. The term clone is used in this sense to mean that the organisms. or from so-called spare embryos.[46] It clearly has some ambiguity.[45] Some doubt has been expressed about the usefulness of term therapeutic cloning. . ‡ adult stem cell research. The progeny of embryo splitting are said to be clones of each other. share common genetic origins. The innovative aspect of SCNT is that the nucleus from an adult cell is used. having been used to include: ‡ the production of embryo-like entities by SCNT or other techniques for the purpose of research or therapy. is not to create a whole human being but to develop organs for transplant. Reproductive Cloning The term reproductive cloning is generally used to describe the production of living progeny by means either of embryo splitting or of nuclear transfer. and ‡ the combined use of SCNT and embryonic stem cell technology. There has been no serious scientific support for the application of this procedure to produce a human being. a promising early step in this combined technology[44] was the subject of extensive media commentary at the end of 2001. on the other hand. it separated out each of these techniques and considered their ethical validity and regulatory framework. be they siblings or parents and offspring.embryo splitting involves the separation of the cells of a single embryo to produce two or more viable progeny. and. The term is used to differentiate reproductive from therapeutic outcomes where the intention.[42] Therapeutic Cloning Therapeutic cloning has been used as a synonym for stem cell research. involving stem cells derived either from embryos which are created specifically for that purpose. a team led by Dr Severino Antorini has been promoting the technology. in the latter. consequently. ‡ embryonic stem cell research. As a consequence. along with a handful of academic commentators. The same approach is adopted here. are said to be clones of the donor of the nucleus. However. stem cell research has been drawn into the debate associated with reproductive cloning.

Not for a moment do they share the humanists¶ sense of the fluidity and ambiguity of language . Professor Jasanoff has remarked that: the two sides of the science wars are separated today by almost unbridgeable differences in their habits of reading and interpretation. Australia would do well to avoid the adversarial confrontations between scientists and the proponents of the social study of science in the US. there are continuing public debates on what is and is not ethically appropriate. like all rebuttals. however. citing them out of context or distorting them through unnatural juxtapositions.[54] One of the difficulties in this area is that the various religions of the world have divergent views on when human life commences. which remain in principle. ironically..[48] Professor Jasanoff concluded that: science studies as a field has not been especially effective thus far in challenging the monopoly of reading claimed by its critics . these have been forced to operate in the most part with the conceptual limitations set by the attackers.. responding bit by bit to the atomizing vision.[51] The UK Report Stem Cell Research: Medical Progress with Responsibility drew a stark distinction between [a] significant minority of people [who believe] that the use of any embryo for research purposes is unethical and unacceptable on the grounds that an embryo is a human being entitled to full human status from the moment of its conception [with] the right to life and. The critics¶ constant fear is that science studies misrepresent the words and works of scientists. in complex webs of meaning.[50] Deep philosophic questions remain about the moral status of the embryo. led to the introduction of the Commonwealth Human Embryo Experimentation Bill in 1985. However.[52] Australia has generally followed a conservative approach recognising the special status of the human embryo.[53] Concerns about a lack of respect for the embryo. Regulators have struggled for many years to find a balance between the special status of the human embryo and the demands of research. subject to revision on the basis of later observations.. than experimental results.even scientific language . on the other end of the spectrum those who consider that an early embryo is simply a collection of cells... and possible extensions of experimentation on embryos. The dogged defenders of science read with a stem literalism that construes all verbal expressions as fixed in form and immovable in meaning ± more so. despite strict regulation on research involving human embryos. The .[47] A leading proponent of science and technology studies. it is vital that the ethical and legal debates are conducted with a clear understanding of the procedures and the terms used. [49] ETHICAL ISSUES It is well recognised that biomedical research involving human participants must be conducted ethically.Broader Research Issues In the broader research framework. entitled to no greater rights than any other collection of human cells.

[59] However. scientifically sound. the isolation of embryonic stem cells involves destruction of the embryo.[62] Furthermore. were unable to agree on a single position on this issue. it is unlikely that the isolation of new embryonic cell lines could ever be achieved without damaging or destroying a human embryo.[65] Some of these procedures continue to offend the moral sensibilities of some members of the community. aside from the ethical sensitivities associated with the use of embryos. Indeed.[55] Other religious groups place the onset of human life at a later stage of pregnancy. on the basis that it is unethical to destroy embryos for research purposes. the deliberate creation of new embryos is unnecessary because of the large number of surplus embryos already in existence. provided that research is µcarefully regulated. embryos surplus to ART programs present a source of research material and access should only be denied if there is clear consensus that it is ethically inappropriate to use them.[60] This view is consistent with that of the European Life Sciences Group which has accepted the use of µspare¶ human embryos for the preparation of embryonic stem cell lines (even though it has expressed respect for the special moral status of the embryo. The Andrews Report concluded that. research involving human embryos that is aimed at reducing human suffering may be ethically acceptable provided that it is conducted appropriately.[63] For these reasons. for instance. directed towards substantial goals and ethically controlled¶.[61] A distinction is generally drawn between embryos already in existence and the deliberate creation of embryos for research purposes.[56] For those groups. even prior to implantation). There are also similar diverging views as to the moral status of the embryo based on non-religious reasoning. Importantly. EXISTING REGULATION Assisted Reproductive Technology ART was subjected to extensive scrutiny both in Australia and elsewhere in the 1970s and 1980s.Catholic view is that human life begins at conception and that the moral obligation to preserve human life outweighs the obligation to reduce other forms of human suffering. and . As noted above. provided that clear and stringent guidelines are in place. some time after implantation.[57] Members of the Andrews Committee. As a result. It has been noted elsewhere that an Australian woman now has the freedom to make a large range of reproductive choices. with no intention of producing living human beings. this is the case even when the embryos in question are surplus to ART requirements. For the minority. equally some are now well accepted.[64] It is now widely accepted as a means of alleviating suffering caused by infertility.[58] Four members forming the minority (including the Chair) concluded that Australia should follow the US lead and only sanction embryonic stem cell research using existing cell lines. peer reviewed. even when the sole purpose is for extracting embryonic stem cells. embryos surplus to ART programs could be used for the purpose of extracting stem cells. from the research perspective. the majority refused to sanction the creation of embryos or of embryo-like beings using SCNT. the use of SCNT to create embryo-like entities for research purposes is expensive and inefficient. the six-member majority of the Andrews Committee recognised that. the question of the ethical appropriateness of embryonic stem cell technology may be intractable and impossible to answer in a way that satisfies the Australian community as a whole.

Creating Children. Although infringement of the provisions of either set of guidelines is not a legal offence. In 1995 this Act was replaced by a new Infertility Treatment Act.[68] The Tate Report envisaged a national body issuing research protocols and conditional research licences for experimentation of any kind undertaken on human embryos.[73] This is not to say that the conduct of ART in those jurisdictions is unregulated. This view was supported in the final report of the Senate Select Committee chaired by Senator Michael Tate on Human Embryo Experimentation in Australia. socio-economic background and general health of the woman. the National Statement and ART Guidelines are only enforceable against institutions receiving NHMRC funding or other public funding. no such nationally consistent regulatory regime emerged in Australia. The Victorian lead was later followed by South Australia[71] and Western Australia. and the maintenance of records. The Victorian Infertility (Medical Procedures) Act 1984 included a strict system of regulation based on criminal penalties. and the NHMRC Ethical Guidelines on Assisted Reproductive Technology 1996 (hereafter the ART Guidelines) apply.[66] The desirability of consistent regulation across all the jurisdictions of Australia was recognised from an early stage of the debate associated with ART.[67] recommended a national multi-disciplinary body be established to deal with matters relating to reproductive technology. The Victorian Parliament was the first legislature in the world to introduce legislation aimed at regulating the application of ART per se. There is also a degree of regulation through the constraints of the Fertility Society of Australia. which introduced a system of licensing of ART service providers by the Victorian Infertility Treatment Authority. . with the co-operation of the States and the Northern Territory. The legislation in all three States strictly regulates various aspects of the application of ART addressing issues such as access to the procedures. self-regulation is now a major platform of public policy making. the Family Law Council Report on Reproductive Technology. Indeed. sexual orientation. a series of detailed reports by their Law Reform Commission. which in turn requires compliance with NHMRC guidelines.[69] Regrettably. in the case of New South Wales. sanctions for infringement usually involve the loss of access to research funds or publication of the names of infringers in Parliament.[74] The Society has a separately constituted Reproductive Technology Accreditation Committee. The National Statement and associated guidelines are regarded as national standards of acceptable practice and are responsive to what is a rapidly changing technology. as it is argued that strict government regulation can now neither be afforded nor supported as an effective deterrent. Three States have introduced legislation in Australia.[70] What has resulted is a pot pourri of different legal and non-legal regimes regulating ART across Australia. which accredits ART clinics provided that they comply with its Code of Practice. the National Statement on Research Involving Humans 1999 (hereafter the National Statement). In all jurisdictions. For example. which recommended regulation at the Commonwealth level. supplemented by codes of practice.can be carried out regardless of marital status.[72] The legislation adopted in those States introduced a system of licensing reproductive technology programmes. The remaining States and Territories have not introduced similar legislation despite having established committees of inquiry into ART or.[75] Those States and Territories without formal legislation continue to rely on the Reproductive Technology Accreditation Committee accreditation system. That said.

live born and viable.[78] such as reproductive cloning of human beings shall not be permitted¶. expressed the view that the remaining States and Territories should introduce legislation complementary to that in Victoria.[77] Human Cloning International Regulation The development of SCNT has led to widespread opposition to reproductive. the definition of cloning in each statute is different.Nevertheless. The South Australian Reproductive Technology Act 1988 and Code of Ethical Research Practice prohibit cloning. a duplicate (or duplicates) or descendants that are genetically identical.[81] On the other hand. South Australia and Western Australia each include provisions relating to human cloning.[82] NBAC cautioned that µany regulatory or legislative actions undertaken to effect the foregoing prohibition on creating a child by somatic cell nuclear transfer should be carefully written so as not to interfere with other important areas of scientific research¶.[79] Similarly. The AHEC has. it should be noted that there has always been an underlying suspicion that selfregulation is no regulation. the National Bioethics Advisory Commission (NBAC) recommended legislation combined with a moratorium. Australian Regulation The regulatory regime associated with this technology in Australia is messy and ambiguous. the Council of Europe added an Additional Protocol to its Convention on Human Rights and Dignity with regard to the application of Biology in Medicine. However.[83] A similar sentiment underlies the British[84] and Australian[85] reports. The Act contains a list of offences including any procedure directed at human cloning. outside the human body. from one original. In Western Australia. In the US. The ART-specific statutes in Victoria. In fact. the Andrews Report stated that the nature of ART was too complex to be dealt with adequately by a non-statutory regime. The Protocol on Prohibition on Cloning of Human Beings states that µ[a]ny intervention seeking to create a human being genetically identical to another human being.[76] Similarly. on two public occasions. defining it as any procedure directed at producing two or more . during the public consultation leading to the development of the ART Guidelines. whether living or dead.[80] A large number of European countries have specific legislation which prohibits cloning intended to produce genetically identical individuals. The UNESCO Declaration on the Human Genome and Human Rights provides in Article 11 that µ[p]ractices which are contrary to human dignity. The Victorian Infertility Treatment Act 1995 defines cloning as the formation. South Australia and Western Australia. is prohibited¶. the Human Reproductive Technology Act 1991 and Code of Practice define cloning as reproductive technology for the purpose of producing. of a human embryo that is genetically identical to another human embryo or person. The Act specifies that a person must not carry out or attempt to carry out cloning. concern was expressed that the Reproductive Technology Accreditation Committee system was not sufficiently independent. some major jurisdictions have been less hasty in introducing legislation banning the procedure.

thereby bypassing any definition that deals with identicality or substantial identicality. Section 1(1) provides that: In this Act. In 1999 the South Australian Council on Reproductive Technology established a working party on cloning to discuss the apparent loopholes in its legislation. This proposed definition was described in the Andrews Report as µminimis[ing] the difficulty caused by the focus in existing provisions on genetic identicality¶. Whilst SCNT does involve alteration of the genetic structure of an ovum and replacement of the nucleus of an ovum. except where otherwise stated ± .genetically identical embryos from the division of one embryo. the South Australian working party noted that the fluid nature of the technology could potentially circumvent strict legal definitions.[91] The issue for consideration was whether an organism created by SCNT (which the Court referred to as cell nuclear replacement or CNR) fell within the definition of an embryo in the Human Fertilisation and Embryology Act 1990.[86] In seeking a definition to cover reproductive cloning.[88] Nevertheless. including: ‡ altering the genetic structure of a cell while that cell forms part of an embryo or an ovum in the process of fertilisation. However. or substantially identical to. there must still be some doubt as to whether SCNT would be covered by any of these prohibitions. living or deceased¶. and ‡ placing reproductive material in the body of an animal. Nuclear transfer does not in fact produce a completely faithful genetic facsimile of the original. An additional difficulty comes from the use of the term genetically identical.[89] The Committee further warned of the potential for a clone to be specifically engineered not to be genetically identical. this does not occur during the process of fertilisation.[87] The working party suggested a new definition be given to cloning so as to prohibit µforming an embryo or an entity capable of embryogenesis which is genetically identical to. This is because genetic material (DNA) is contained in small organelles known as mitochondria in the cytoplasm of the cell as well as in the nucleus. the Andrews Committee found that this definition lacked a suitable demarcation between the intention to create a live born and viable offspring and other outcomes. the process of fertilisation is avoided entirely. the resulting offspring retains the mitochondrial DNA from the host egg cell as well as nuclear DNA from the donor and therefore cannot strictly be said to be genetically identical to the donor. another human being. When SCNT is used. ‡ replacing the nucleus of a cell of an embryo or of an ovum in the process of fertilisation with any other nucleus. In fact. The Code does contain further prohibitions. and that scientific advances in cloning techniques could defeat the purpose of the legislation. by inserting sufficient genetic material from another human being into the clone. This definition probably limits the prohibition on cloning to embryo splitting.[90] The UK Experience The difficulty with using ART-specific legislation as a means of prohibiting reproductive cloning was highlighted in a UK decision in late 2001.

as is demonstrated by the actions of the UK Parliament in this case. and.[97] Before the appeal was heard the UK parliament rushed through sui generis legislation on 4 December 2001. to include them did not µstrain the language [of the statute] to breaking point¶. Section 1(1) provides: A person who places in a woman a human embryo which has been created otherwise than by fertilisation is guilty of an offence. Whilst the Report did not specifically address the issue of whether this definition covered organisms created by SCNT. Effectively. the Council of Australian Governments agreed to develop nationally consistent provisions to prohibit human . Interestingly. The case followed the release of the report by the UK Chief Medical Officer¶s Expert Group (referred to herein as Stem Cell Research: Medical Progress with Responsibility). This wording appears to circumvent some of the semantic difficulties discussed above. it focuses on outcomes.[98] Towards National Regulation in Australia In July 2000 Australian Health Ministers agreed to develop a national framework µto prevent the exploitation of human cloning¶[99] and subsequently. As a result of this decision. and. cloning and reproductive cloning. legislatures do have the capacity to respond rapidly to such new technological developments if they see fit to do so.[94] The Court in that instance found that. for this purpose. and (b) references to any embryo include an egg in the process of fertilisation.[96] Whether a similar approach would be taken by the Australian Courts in this respect is unknown. Crane J noted that it was clear that this was assumed by the Group. Instead. The references to fertilisation and the process of fertilisation were fatal.[92] and that the Government¶s response to the Report had also proceeded on the basis that SCNTorganisms were covered by the definition.[93] The claimant conceded that an organism created by SCNT was an embryo. Justice Crane¶s decision was unanimously overturned by the Court of Appeal on 18 January 2002. There may come a time when it will not be necessary for a foetus to develop to term in a woman¶s uterus.[95] This extended use of the purposive approach to statutory interpretation was warranted in the UK by virtue of the Human Rights Act 1998 which extends purposive interpretation where necessary. Nevertheless. what it achieves is a prohibition on the implantation. that time is a long way off. on the live birth. fertilisation is not complete until the appearance of a two cell zygote. because there is no fertilisation in the production of an SCNT-organism. organisms produced by SCNT appeared to be left outside the comprehensive statutory licensing framework existing at the time in the UK for the purpose of regulating ART and embryo research.(a) embryo means a live human embryo where fertilisation is complete. The Human Reproductive Cloning Act 2001 has only two sections. However. although embryos created by nuclear transfer were not envisaged by the original drafters of the legislation. of a cloned embryo. It avoids altogether use of the terms genetically identical. Crane J concluded that the specific wording of s1(1) could not be stretched to cover such organisms. and as a consequence. in June 2001.

the one attempt by the Commonwealth Parliament to prohibit cloning is marred by many of the semantic difficulties discussed above. but it has not yet entered into force. The only debate would be on the precise wording of nationally consistent legislation..[104] Whilst the Government acted in respect of reproductive cloning. Consistently. principally because it is uncertain in its application.[101] In contrast to the UK position.[106] The consensus view in Australia is for prohibition on reproductive cloning. the knowing or reckless undertaking of an activity which µwill result in the cloning of a whole human being¶ is prohibited. The other States and the Territories are also close to finalising their Acts. Instead the Government chose to allow the vacuum and exhaust the appeal process before attempting to overhaul the existing regime. arising out of the constitutional limitations on federal law-making powers. The role of the Human Fertilisation and Embryology Authority (HFEA) in the regulation of embryonic stem cell research was confirmed in the House of Lords Select Committee Report on Stem Cell Research. The Committee recommended that the use of SCNT as a research tool: . presumably because its Reproductive Technology Act is deemed to adequately covers this issue.[105] The consultation for the AHEC Report did not identify any support for reproductive cloning. it should be noted that the South Australian Act excludes the prohibition on cloning.[102] Under section 192B of the GTA. the production of embryolike entities by SCNT will be covered by the licensing regime under the Human Fertilisation and Embryology Act 1990. little progress has been made to date. The Pro-Life Alliance case[103] and the response by the UK Parliament demonstrate the considerable differences in political reactions to cloning for reproductive and nonreproductive purposes. Victoria. This is being remedied by the enactment of compatible legislation by the States and Territories. could then be debated at length in a measured way.[100] However. To date. released on 13 February 2002. However. As well as these definitional problems associated with the cloning provisions in the GTA. The Andrews Report referred to a sense of frustration at the lack of regulatory activity by some State and Territory governments over this technology. The complex issues associated with other aspects of embryo research. no such legislative reaction eventuated with respect to non-reproductive cloning.. which might well result in the prohibition of the process¶.cloning. The Gene Technology Act (GTA) was passed late in 2000. Whilst it may be possible to read the term genetically identical as meaning substantially genetically identical. use of this terminology is unsatisfactory. In an eleventh hour policy change in the Senate. The section further defines cloning of a whole human being as the production of duplicates or descendants genetically identical to the original. the Pro-Life Alliance was attempting to create a legal vacuum where the Government would be µforced to introduce legislation to deal with the practice of creating embryos. In the UK. the Andrews Report concluded that µno case has been made in favour of cloning for reproductive purposes¶. particularly embryonic stem cell research. the Government moved an amendment to the Bill to include reproductive cloning and other human-related technology. The purpose of the Act is to regulate the use of genetically modified organisms. Queensland and South Australia all have Gene Technology Acts in force. there is the additional difficulty of lack of uniform coverage across Australia. The Tasmanian Parliament has also passed a Gene Technology Act. as a result of the appeal in the Pro-Life Alliance case. In bringing its case before the Court.

is a sufficiently serious and important objective. on the other hand. it does not totally prohibit all research involving embryos. to justify the use of [SCNT]. Both States allow limited application for permission to carry out research. if licensed by HFEA. The legislation in Victoria. the Act provides that all embryos must be discarded after five years of storage.[108] EXISTING REGULATION TOUCHING ON EMRYONIC STEM CELL RESEARCH Extraction of Stem Cells from Embryos Legislation As with cloning. The legislation was only incidentally concerned with regulating embryo research. which seems to suggest that they are intended only to cover reproductive cloning.[109] The original purpose of this ART legislation was primarily directed towards the key issues of familial relationships. The Victorian Infertility Treatment Act 1995 contains stringent provisions with regard to research using embryos.[107] It is only if an embryo created by SCNT or an equivalent technology is implanted into a woman that the Human Reproductive Cloning Act 2001 comes into play.[117] Both States also require that research on an embryo can only be undertaken for a . South Australia and Western Australia focuses on the act of manipulation of the embryo. both of which have set up Reproductive Technology Councils. Whilst this legislation recognises the special status of the human embryo.[114] In South Australia. Any embryo created must be done so for the purposes of reimplantation[110] or µapproved research¶. Similarly. However.[112] This effectively prevents the extraction of embryonic stem cells from any embryo. even if all of the definitional difficulties outlined above are ignored. The Commonwealth GTA and equivalent State GTAs. consent to the use of gametes and accountability of ART providers. including development of human embryonal stem cell lines with the aim of producing a clone of individuals¶. research cannot be µdetrimental¶ to the embryo. generally falling within the ambit of the many and varied ART regulatory frameworks.. embryo¶ and there must be µexisting scientific and medical knowledge indicat[ing] that no detrimental effect on the well-being of [it] is likely thereby to occur¶. Legislation in Victoria. and would therefore seem to include cloning for both reproductive and non-reproductive purposes. provided that (as with embryos created by IVF for research) embryos are not created by [SCNT] unless there is a demonstrable and exceptional need that cannot be met by the use of surplus embryos. particularly if the potential of adult stem cells is to be realised. the existing regulatory framework across Australia relating to the extraction of stem cells from embryos lacks consistency and is incomplete.[113] A slightly more permissive system exists in Western Australia and South Australia.[116] Similarly in Western Australia research upon an embryo must be µtherapeutic for that .[115] a term which raised the ire of some researchers. The situation is more uncertain in Australia. both legislatures place paramount importance on the protection of the embryo and its ability for reimplantation into a woman. the ART Guidelines prohibit µ[e]xperimentation with the intent to produce two or more genetically identical individuals. At the same time..[111] which does not diminish the capacity of that embryo to be reimplanted into a woman. South Australia and Western Australia relating to ART includes provisions regulating research on embryos. focus on the production of a whole human being.

the National Statement and ART Guidelines apply to research undertaken at publicly funded institutions. and hence that research upon them is prohibited. Whilst the current regimes effectively prohibit destructive embryo research within jurisdiction. Therefore.period not exceeding fourteen days from fertilisation. nor do they regulate the use of the products of that research activity within jurisdiction. The Code states that all research in accredited private institutions should comply with the NHMRC guidelines.[125] it is questionable whether this policy reflects the law in Victoria or in any other State. Research Using Stem Cell Lines Already in Existence or Created Out of Jurisdiction The propagation of cells from stem cell lines already in existence would be outside any of the legislative controls on research because they do not contain human reproductive material or embryos. they neither regulate such research outside jurisdiction.[122] The Guidelines limit embryo experimentation to µtherapeutic procedures which leave the embryo. . it is likely that those companies and institutions undertaking stem cell research will find it simpler to import embryonic stem cell lines from overseas than to brave the uncertainties of the Australian regime. or embryos. acknowledging that there is a diversity of views on what constitutes the moral status of a human embryo. ‡ the use of a restricted number of embryos.[121] The ART Guidelines refer specifically to the special status of the embryo.[120] Extraction of Stem Cells from Embryos ± Research Guidelines and Codes of Practice In all States and Territories.[124] Approval in such circumstances requires a human research ethics committee to establish: ‡ evidence of a likelihood of significant advance in knowledge or improvement in technologies for treatment as a result of the proposed research. with an expectation of implantation and development¶[123] except in µexceptional circumstances¶. particularly in its early stages of development. Although the Victorian Infertility Treatment Authority has suggested that totipotent stem cells are equivalent to embryos. with the stem cell lines used at the Monash Institute of Reproduction and Development having been produced offshore in a collaborating Singapore laboratory. this has already occurred in Australia. and ‡ consent to the specific form of research on the part of the gamete providers and their spouses or partners.[118] Embryos may only be stored for three years in Western Australia and ten years in South Australia. pointing to: the recognition that any experimentation and research involved in these technologies should be limited in ways which reflect the human nature of the embryo.[119] Various other Commonwealth and State and Territory statutes impinge on aspects of research involving embryos. In fact. They also apply in respect of research conducted at private reproductive technology institutions by virtue of the Fertility Society of Australia¶s Reproductive Technology Accreditation Committee Code of Practice.

[127] and introduced into practice.[131] It further recommended that the importation of embryonic stem cells should only be allowed where the derivation of the cell lines is compliant with the Australian regulatory framework. research that destroys or diminishes the potential for reimplantation of an embryo cannot be undertaken. mandating the destruction of embryos with the passage of time. It falls within the ambit of research involving humans under the National Statement and therefore requires consent from participants. stem cells. it must be regulated by a nationally consistent regime .This is not to say that research using stem cell lines is entirely unregulated. Nor should the answer to such fundamental questions depend on geography or source of funding. whilst allowing for destructive experimentation in µexceptional circumstances¶ also emphasise the obligation to maintain the well being of the embryo. The legislation in Victoria. ENABLING REFORMS TO FACILITATE STEM CELL RESEARCH There is a confusing lack of consistency in the regulations in different States and Territories. particularly Principles 15. The Andrews Report. Within the States that have ART legislation.1-15.[129] These issues are important. on the one hand. once stem cell technology has been properly evaluated scientifically and ethically. prohibiting research that has general therapeutic value but may result in harm to a particular embryo. especially if there are available sources of stem cell lines already in existence.[126] In addition. can represent a perpetual record of an individual¶s entire genetic code.8 dealing with human tissue. strongly endorsed the view that the current regulatory framework cannot be allowed to continue. particularly in Victoria. agreed that. This has particular impact on stem cell research. if research of this nature is to be allowed. particularly of a destructive type. including those in dissent on the issue of use of surplus embryos. The ART Guidelines. Despite the considerable benefits likely to arise from embryonic stem cell research. Nowhere in Australia is there a UK type regime that allows research.[128] Finally. concluding that: [t]he questions raised by human cloning and research involving the use of embryos are complex social and ethical questions and should not be left to individual ethics committees to decide. it most likely offends the spirit if not the letter of the ART Guidelines. US and AHEC Reports and the Statement of the European Life Sciences Group. whilst on the other hand. as with other human tissue. review by a Human Research Ethics Committee and compliance with the other Principles of the National Statement. it will be governed by clinical practice guidelines and the by State and Territory Human Tissue Acts. consistent with the UK. There is a certain irony in. in the first 14 days of development of the embryo.[130] The Andrews Report proposed that the deliberate creation of embryos for research purposes should be banned and that there should be a three-year moratorium on the use of SCNT to create embryos specifically for research or therapy. South Australia and Western Australia only permits the storage of embryos for a limited and seemingly arbitrary time period after which they must be destroyed. but are beyond the scope of this article. This fact raises particular concerns associated with privacy and potential for discrimination and stigmatisation. because the procedure required to extract stem cells from the embryo is likely to destroy or damage that embryo.[132] All members of the Committee.

This position is questionable for two reasons. The advancement of stem cell research in Australia cannot be achieved under the current patchwork of regulation. In essence this is the major recommendation of the Andrews Report. First. ‡ Cloning for reproductive purposes should be prohibited. biomedical practice. based on the existing section 192B of the GTA. Apart from calling for a uniform national approach to regulation. it fails to recognise that thousands of embryos are stored and destroyed every year in this country.[134] Consent of all relevant persons is. the Tate Report in relation to embryo experimentation and the AHEC Report on cloning.that applies equally to the public and private sector. Secondly. but it is acceptable for embryos to be destroyed overseas so that we may experiment upon them here. enforceability. It must display the features of accountability.[133] The Andrews Report proposed a national licensing scheme. In stem cell research. It is important to separate these different activities. At each of these stages. different regulatory considerations arise. practicality and consistency. it assumes that it is unacceptable to destroy an embryo within Australia. A number of key requirements are suggested for this national regulatory regime. separate from the regulation of ART. responsiveness. a paramount consideration. A licensing authority is the most appropriate vehicle to achieve this end. . provided that strict requirements are followed. quite obviously. We are in a highly ambivalent situation in this country. whereby individual researchers are licensed for each research project that involves use of an embryo.[135] The Committee proposed that adult stem cell technology would not be subject to this regulatory framework. Such licences would allow the use of surplus embryos from ART for research or therapeutic purposes. but would be governed by existing regulatory schemes. but in more felicitous terms.[136] CONCLUSIONS A tension has always existed between the promotion of freedom in research and the imperative of doing no harm.[137] How is a society to harness the promise of potential benefits of technology and research and. flexibility. A nationally consistent regulatory regime for the extraction of stem cells from embryos surplus to ART requirements is an essential precondition to the development of stem cell technology and future related technologies. as well as different degrees of harm. where governmental funding is being directed to stem cell research but researchers are forced to look overseas for their stem cell lines. minimise or avoid the threat of possible risks? Australian and international reports in relation to stem cell research highlight the need to avoid conflating research. and product development. This technology directs the searchlight onto the continuing dilemma over the status of the embryo and the permissible limits of research on embryos. should be governed by the same rules and that the researchers should be accountable. On this basis alone. at the same time. there is justification for allowing the extraction of stem cells from embryos surplus to ART requirements. the major concerns are with social and moral harm. The Andrews recommendation flows in the same direction as the conclusions of the Family Law Council Report in relation to ART. whether publicly or privately funded. these Reports recommended that all bodies conducting research. ‡ The creation of embryos solely for research purposes should also be prohibited.

and effective agreement between Commonwealth. However. a risk that some research will not be covered if Commonwealth legislation alone is introduced. ‡ There needs to be clarification of the nature and extent of any consent by the couple creating an embryo to the use of their embryo for research purposes. There is. Whilst the AHEC Report recommended complementary State and Territory based legislation.[140] There was also agreement. ‡ The use of embryos surplus to ART requirements for extracting stem cells should be allowed but only under strict oversight. As the Andrews Report noted. The Office of the Gene Technology Regulator. In the interim there should be a moratorium on the creation of embryo-like entitles using SCNT. State and Territory Governments. unincorporated organisations. ‡ Research using stem cell lines. albeit somewhat more tentative. The scheme for regulating the use of gene technology across Australia through the Commonwealth and State Gene Technology Acts may provide a suitable model. at the last COAG meeting on 5 April 2002 a general consensus emerged amongst the government leaders that the use of embryos surplus to ART requirements for embryonic stem cell research should be allowed. A number of issues must be settled before proposed legislation can be introduced. nevertheless. that therapeutic cloning should be prohibited. ‡ The body responsible for overseeing the extraction of embryonic stem cells should have statutory power to carry out its functions. at least in the short term. at the lack of appropriate regulation in this area. Some of the points of contention are: . These Acts set up a detailed system for the control. established and authorised under the Commonwealth GTA. there is a µconsiderable frustration¶ by all key stakeholders. should follow the same regulation as for human tissue. licensing and prohibition of the use of genetically modified organisms in this country. This will only be achieved with the requisite political motivation. ‡ All organisations proposing to extract embryonic stem cells should be subject to the same regulation. One of the difficulties is the constitutional hurdle that must be overcome to establishing a suitable legislative mechanism. irrespective of their location or status.[139] The Commonwealth does have significant heads of relevant constitutional power.[138] the Andrews Report stated that the Commonwealth has both the obligation and the constitutional power to take the lead in regulating this area. provided that those lines have been extracted in accordance with Australian law. including researchers and public interest bodies. The legislative scheme to achieve these heads of agreement remains to be settled.‡ Any decision about the use of SCNT for stem cell research should not be foreclosed until the usefulness of such technology can be fully evaluated. consensus as to the permissible limits of this research has been more difficult to achieve. has national coverage. Although government leaders across Australia have resolved at a number of Council of Australian Governments (COAG) meetings to properly regulate cloning and stem cell research. most notably the corporations power and trade and commerce power. whether they are adult or embryonic in origin. The creation of a new regime will require further debate and consultation among key stakeholders. but only in limited circumstances and subject to strict regulation. A similar national office should be created by legislation to oversee and license the use of surplus embryos for research purposes. particularly when it is conducted by privately funded.

The Prime Minister initially stated that only those surplus embryos already in existence could be used. or at least closely harmonised. commercial development. The complexity of the science and the commercialisation of stem cell and genetic technology will require an equally complex regulatory response. However. The Ethical Canary: Science. ethics. PhD (Dal). [1] M Somerville. medical and health application. interwoven with policy. LLM (Tas) Lecturer. human rights. Major vehicles will be administrative controls. legal and social issues such as the status of the embryo. In the complex territory of modern biomedical technology (which includes both stem cell technology and human genetic technology). it should be acknowledged that these challenges must be considered beyond national boundaries. Finally. ‡ what body should be charged with responsibility for overseeing the use of embryos for these purposes. Regulation is not limited to formal lawyers¶ techniques of legislation or judicial pronouncement. [ ] LLB (Hons) (Lond). given that members will be free to give a conscience vote. [ ] BSc (Hons) (UM). principle. the Premiers of a number of States were opposed to this restriction. that apply principles[144] consistent with developing international norms. because of the possibility that new embryos could be created solely for research purposes.[145] Stem cell technology offers a panoply of possibilities for the treatment of human disease and injury. the States will create their own regulatory regimes in the same piecemeal manner as for ART.[141] A compromise was reached at the COAG meeting: that there should be a temporary moratorium on the use of newly created embryos for research purposes. LLM (PNG) Professor. Society and the Human Spirit (2000). enforceable and voluntary guidelines and review structures (such as research ethics committees and national bioethics bodies). benefits and risks must be identified at the international as well as the national level. University of Tasmania. The Prime Minister has nominated the NHMRC.‡ the appropriate limits on the use of embryos for research purposes. above. . and new special perspectives. traditional legal regulation will not be the sole vehicle for protecting the common good. international regulations and standards. spanning pure research. It is highly desirable that these core international issues should be governed by the same. University of Tasmania. there must be some doubt as to whether it has the competence to achieve the outcomes in point 6.[142] The agreement provides that a committee of experts will develop guidelines as to the use of embryos created after 5 April 2002. if the Commonwealth fails to move quickly and appropriately. LLB (Hons) (Tas). ‡ whether.[143] ‡ whether appropriate legislation will actually be passed by the Commonwealth Parliament. ‡ whether the prohibition on therapeutic cloning may cause some scientists to leave Australia. privacy and accountability. However. International scientific research on stem cells and human genes is throwing up the same core ethical. MSc (Dal). [ ] LLB (Tas) Graduate Student. University of Tasmania. this technology should not become an enemy of its own promise.

34].1-1.21. Professor D Chalmers was Chair of AHEC and Chair of the working party of AHEC on Human Cloning during the time of this report. UK. M Evans and M Kaufman. Page references refer to PDF version available at <http://books.int/comm/ research/quality-of-life/stemcells/pdf/press_release_en. See G Martin. µEstablishment and Culture of Pluripotential Cells from Mouse Embryos¶ (1981) 292 Nature 154. Scientific. USA (hereafter Stem Cells and Regenerative Medicine) 1. Ethical and Regulatory Aspects of Human Cloning and Stem Cell Research (2001) [3. See particularly the text of the preamble and Principles 1. Human Cloning: Scientific. Stem Cell Research: Medical Progress with Responsibility (2000). He was invited to make submissions to the Andrews Committee on this report. [3] European Life Sciences Group Statement (20 December 2001).pdf> at 21 December 2001. See generally Chapter 2 on the Background Science to the Cloning of Human Beings in General and Stem Cell Technology in Particular. . [6] This was one of the primary reasons for the revisions and public consultation leading to the promulgation of the National Health and Medical Research Council¶s National Statement for Ethical Conduct in Research Involving Humans (1999). [11] National Academies Committee on the Biological and Biomedical Application of Stem Cell Research. Washington DC.nap.eu. Parliament of Australia. <http://europa. [7] The isolation of embryonic stem cells from mouse embryos was reported as early as 1981. [12] First reported by J A Thomson. et al.html#pagetop> at 8 May 2002. Ethical and Regulatory Considerations Relevant to Cloning of Human Beings A Report to the Commonwealth Minister (1998) (hereafter the AHEC Report) [2. See also the Government Response to the Recommendations Made in the Chief Medical Officer¶s Expert Group Report µStem Cell Research: Medical Progress with Responsibility¶ Cm4833 (2000). [5] Report to the Australian Commonwealth Minister for Health and Aged Care dated 16 December 1998.23-3. [10] Ibid 17. [4] The most obvious example of a pre-publication announcement was the reporting of the Dolly experiment in the US press. [9] Department of Health.[2] See generally: House of Representatives Standing Committee on Legal and Constitutional Affairs. µIsolation of a Pluripotent Cell Line from Early Mouse Embryos Cultured in Medium Condition by Teratocarcinoma Stem Cells¶ (1981) 78 Proceedings of the National Academy of Science 7634.17]. [8] See Australian Health Ethics Committee. µEmbryonic Stem Cell Lines Derived from Human Blastocysts¶ (1998) 282 Science 1145.edu/books/0309076307/html/R1. Stem Cells and the Future of Regenerative Medicine (2001) National Academies Press.

brain. [27] Andrews Report. 17-29. See generally Stem Cells and Regenerative Medicine. liver. N Terada. blood.22]. 5. [26] Infertility Treatment Act 1995 (Vic) s 52. [21] Stem Cells and Regenerative Medicine. AHEC Report. [17] A great deal of scientific literature exists in this area. above n 11. [20] European Life Sciences Group Statement. above n 23.44].1038/Nature730. above n 11. above n 11.1038/Nature729. µChanging Potency By Spontaneous Fusion¶ (2002) Nature DOI: 10. et al. the eye and the lining of the gastrointestinal tract. skeletal muscle. [14] Including bone marrow. 22. [15] Although there was a flurry of interest in the distinction between totipotency and pluripotency there now seems to be a preference for the term pluripotency in the lexicon. [29] Stem Cells and Regenerative Medicine. [16] See Stem Cell Research: Medical Progress with Responsibility. [28] See for example Infertility Treatment Act 1995 (Vic) s 49.30-7. [22] Ibid 23. Ethical and Regulatory Aspects of Human Cloning and Stem Cell Research (2001) (hereafter the Andrews Report) [7. On the issue of the questionable pluripotency of adult stem cells see particularly Q-L Ying. above n 11. pancreas. haemopoetic (blood) stem cells and progenitors of pancreatic islet cells. above n 11.21±2. above n 11. See Stem Cells and Regenerative Medicine. . [7. 17. [23] See House of Representatives Standing Committee on Legal and Constitutional Affairs. The term ESCs is used as an abbreviation for embryonic stem cells in this context. [24] See Stem Cells and Regenerative Medicine.[13] Including neural stem cells. [2. A useful collection of articles can be found in a recent edition of Nature: (2001) 414 Nature 87-138.54]. above n 9. et al. Human Cloning: Scientific. [25] The AHEC Report referred to these entities as µembryoid bodies¶. 12. 8. [19] Ibid 23-4. Stem Cell Research: Medical Progress with Responsibility above n 9. above n 8. 9. above n 3. µBone Marrow Cells Adopt The Phenotype Of Other Cells By Spontaneous Cell Fusion¶ (2002) Nature DOI: 10. [18] Stem Cells and Regenerative Medicine. 31. neural crest cells. 16-20. See Stem Cells and Regenerative Medicine above n 11. Parliament of Australia. skin. [30] Ibid.

Science and Medicine (1998).15]). See Roy Morgan Research. µViable Offspring Derived from Fetal and Adult Mammalian Cells¶ (1997) 385 Nature 810.72] for an extraction of President Bush¶s statement. [4. 2001. µNuclear Transplantation in Mammalian Eggs and Embryos¶ (1995) 10 Current Topics in Developmental Biology 147. 24 July. The Bulletin. 27. µPM Signals Shift on Stem Cell Research¶ The Age. [41] F Z Sun and R M Moor. [10. [33] For example. <http://wwwspo. above n 23. See also S McLean. 3421. [32] Stem Cells and Regenerative Medicine. the UK Human Genetics Advisory Commission first promoted the use of the term therapeutic cloning. [38] From Lewis Carroll Through the Looking Glass (1871). [39] In Stem Cell Research: Medical Progress with Responsibility. above n 11. above n 9. [36] Note also that stem cell research is at the forefront of public debate in Australia. 34. 2 June 2001. 3421. Finding No.8-4.monash. [37] For example. which was the preferred term from the joint report of the Human Genetics Advisory Commission and the Human Fertilisation and Embryology Authority Cloning Issues in Reproduction. See Andrews Report.edu.au/news/Story. µWhat is Wrong with Reproductive Cloning?¶ (2002) 2(4) Genetics Law Monitor 6. above n 23. et al. Science and Medicine (1998). . See the joint report by the Human Genetics Advisory Commission and the Human Fertilisation and Embryology Authority Cloning Issues in Reproduction. Monash University and the Monash Institute of Reproduction and Development in Victoria are recognised leaders in the field. 6. This has proved to be a misleading and imprecise expression. based in Adelaide. [35] S Douez. A recent study showed that 72% of Australians agreed with the utilisation of stem cells extracted from embryos to treat diseases.asp?ID=373> at 10 January 2002. 24 July 2001. which showed 52% approval of the creation of cloned embryos for therapeutic purposes without actually making clear whether there was genuine public understanding of the distinction between embryonic stem cells and cloned embryos. research teams at BresaGen Ltd. µLiberty.10]. Identity and Human Cloning¶ (1998) 76 Texas Law Review 1371. Finding No.[31] See Andrews Report. See µFour-nation Study Finds Support for Controversial Treatment¶.adm. [42] A leading US academic has argued that there may be constitutional arguments based on the claimed US right to reproduction: J Robertson. [34] Monash Newsline (September 2001). See µFour-nation Study Finds Support for Controversial Treatment¶. the acronym SCNT was replaced by CNR (cell nucleus replacement. Note that this potential for linguistic imprecision was reflected in the µRoy Morgan Research Finding No. (Melbourne). The Bulletin. at [1. 3421¶ survey. and there is cautious approval by the Australian public of stem cell technology. [40] I Wilmut. above n 37. See Roy Morgan Research.

[45] See. above n 9. Times Literary Supplement. 496. [44] Reported in: J B Cibelli. Science and Medicine (1998). See also S Fish. the author confessed a µfarrago of deliberately concocted solecisms.jsp?id=ns99991605 at 30 November 2001. 8. See also T Hughes and T Pinch (eds) The Social Construction of Technological Systems (1987). J B Cibelli and M D West. (London). µProspects for the Use of Nuclear Transfer in Human Transplantation¶ (1999) 17 Nature Biotechnology 1171. µThe Legal Status of the Embryo¶ (1987) 32 Loyola LR 357. B Latour.com http://www.com/news/news. and the materials at the website <ww. above n 11. para 4. December 13 1996. (New York). where µthe special status of an embryo as a potential human being is accepted. for example. µProfessor Sokal¶s Bad Joke¶. µDeveloping Ethical Public Policy on Reproduction and Prenatal Research: Whose Interests Deserve What Protection?¶ (1989) 8 Medicine and Law 553. A Eser. Rather than a postmodernist philosophical and political analysis of 20th century physical theories. µThe Warnock Report: A Philosophical Appraisal¶ in M Lockwood. µThe Moral Status of the Embryo¶ (1985) King's Counsel 21. µA House Built on Sand: Exposing Postmodernist Myths about Science¶ (1999) 24 Science. M Lockwood. Moral Dilemmas in Modern Medicine (1985). The UK report talks at p 36 about the µmiddle¶ ground.2. µWhat the Sokol Hoax Ought to Teach Us¶.[43] The rationale for this is that the stem cells would produce only the patient¶s own proteins and hence there would be no immunological response. D Carrington First Cloned Human Embryos Created (2001) NewScientist. [50] See R Lee and D Morgan (2001).edu/faculty/sokal>. µThe Legal Status of the Embryo in Comparative Perspective¶ (1992) 11 Medicine and Law 579. D Giesen.physics. µAramis or the Seasons¶ (1997) 276 Science 750. [47] This unbridgeable division reached a searing pitch in the US with the Sokal incident. NBCC Human Embryo Experimentation: A Background Paper and Select Bibliography (1990) Commonwealth of Australia. [51] See I Kennedy. et al µSomatic Cell Nuclear Transfer in Humans: Pronuclear and Early Embryonic Development¶ (2001) 2 Journal of Regenerative Medicine 25. above n 48. Ch 3. 14. µTransgressing the Boundaries: Towards a Transformative Hermeneutics of Quantum Gravity¶ (1996) 46/47 Social Text 217-252. [49] Jasanoff. Alan Sokal. Technology and Human Values 495. New York Times. May 21 1996.newscientist. 500. [52] Stem Cell Research: Medical Progress with Responsibility. See also R P Lanza. [46] See the joint report of the Human Genetics Advisory Commission and the Human Fertilisation and Embryology Authority Cloning Issues in Reproduction. [48] S Jasanoff. howlers and non sequiturs stitched together so as to look good and to flatter the ideological preconceptions of the editors¶. See Stem Cells and Regenerative Medicine. above n 37. but the significance of the respect owed to . L Andrews. [53] Ibid.nyu. See T Boghossian.

above n 64. Human Fertilisation and Embryology: Regulating the Reproductive Revolution (2001). [68] Senate Select Committee on the Human Embryo Experimentation Bill 1985.developing human life is regarded as increasing in proportion to the degree of the development of the embryo¶ (emphasis added). para.107-7.25. embryo donation.110. [62] Ibid paras 7. See also Lee and Morgan. gamete intra-fallopian transfer and zygote intra-fallopian transfer.. in vitro fertilisation. 266. the Bill was never passed by Parliament. [63] Ibid. adopting a child.112-7. These procedures include: taking contraceptive measures. [66] Skene.eu. ch 1.12. [67] Family Law Council. [64] See generally: R Lee and D Morgan. [54] However. Legal Issues in Human Reproduction (1989). [61] See Statement from the European Life Sciences Group at <http://europa. Controversies in Health Care (1999) 266. Creating Children: A Uniform Approach to the Law and Practice of Reproductive Technology in Australia (1985). [65] L Skene. chapter 4.116-7.115. 4. S McLean (ed). . [57] See Stem Cell Research: Medical Progress with Responsibility. above n 65. [58] See the Andrews Report above n 23. above n 11. Medical Legal Aspects of Reproduction and Parenthood (1990) Chapters 9-11. possible to reconcile to opposing views on the moral status of the embryo and on the use of embryos in research¶ above n 9. that reported that in the UK it is not µ.. Parliament of Australia Human Embryo Experimentation in Australia (1986) (hereafter the Tate Report). [59] Ibid paras 7. [56] See Stem Cells and Regenerative Medicine. terminating a pregnancy. as well as use the various ART techniques of artificial insemination by donor. New Reproductive Techniques: A Legal Perspective (1988). µWhy Legislate on Assisted Reproduction?¶ in I Freckelton and K Petersen (eds). para 4. undergoing surgical sterilisation. 29.114.pdf> at 21 December 2001.int/comm/research/ quality-of-life/stemcells/pdf/press_release_en.109-7. [69] Ibid. paras 7. [60] Ibid paras 7. D Cusine. J K Mason. [55] See particularly Veritatis Splendor (1993).119.

1991.[70] The Tate Committee was established in response to the Human Embryo Experimentation Bill. Germany: Federal Embryo Protection Act. Switzerland is currently considering legislation. Act No. 13-4. [82] See National Bioethics Advisory Commission Report Cloning Human Beings (1997) Recommendation II. 1994. [73] For an analysis of the contents of these reports see D Chalmers µProfessional SelfRegulation and Guidelines in Assisted Reproduction¶ (2002) 9 Journal of Law and Medicine in press. 1988. [80] The Convention for the Protection of Human Rights and Dignity with regard to the application of biology and medicine was approved by the Council of Europe in November 1996 and has been signed by some 20 of the 40 member states. Sweden: Law No. Controversies in Health Care (1999) 243-244. introduced as a Private Member¶s Bill by Senator Brian Harradine. 44-6. <http:// www. [76] See letters to Federal Minister accompanying the ART Guidelines and the AHEC Report. µGoodbye Dolly? The Ethics of Human Cloning¶ (1997) 23 Journal of Medical Ethics 353. The Tate Committee recommended that the Bill should not be further considered and it lapsed together with the wider recommendations of the Committee.health. Norway: Law No. [75] Code of Practice for Units using Assisted Reproductive Technology.50. paras 9.au/nhrmc/publications/pdf/e28/pdf>. [72] Human Reproductive Technology Act 1991 (WA) ss 15-21.edu/nbac/pubs. 1992. 4060 Medically Assisted Procreation.37-9.Georgetown. . 35 Assisted Reproduction Procedures. 503 on the Scientific Ethical Committee System and the Handling of Biomedical Research Projects. [78] On the vagueness of this term see J Harris. The Draft Additional Protocol on the Prohibition of Cloning Beings was adopted by the Parliamentary Assembly of the Council of Europe on 22 September 1997 and has been signed by 19 member states. [77] Andrews Report above n 23. [81] Denmark: Act No. 1994.gov. 115.html>. [83] Ibid. including influential dissenting reports from Senators Crowley and Zakaroff.in µEthical Guidelines on Assisted Reproductive Technology¶ National Health and Medical Research Council. [71] Reproductive Technology Act 1988 (SA) ss 10. µRegulation of Assisted Reproductive Technology¶ in I Freckelton and K Petersen (eds). 1997. <http:// bioethics. 27-41. 56 Medical Use of Biotechnology. [79] The Declaration was proclaimed at the 29th Session of the General Conference of UNESCO on 11 November 1997. 1990. Slovakia: Health Care Law. [74] See H Szoke. Spain: Law No. Recommendation III.

however.[84] See Stem Cell Research: Medical Progress with Responsibility. particularly Article 11.39. [86] South Australian Council on Reproductive Technology. [85] The AHEC Report recommended that the Commonwealth Government should reaffirm the UNESCO Declaration on the Human Genome and Human Rights. [87] Ibid para 2.health. Enquiry into Scientific. [99] Hon Dr Michael Wooldridge Commonwealth Minister for Health. . C Foster. [88] Andrews Report above n 23. SCNT performed for nonreproductive purposes will come within the ambit of the Human Fertilisation and Embryology Act 1990.htm>. 31 July 2000) <www. especially on public policy concerns. [100] See the Andrews Report above n 23. [97] However. Parliament of South Australia. para 11. [90] Ibid. [93] Ibid para 4. para 8. Ethical and Regulatory Aspects of Human Cloning (1999). S McLean.40. As a result of the appeal. National Framework Agreed to Prevent the Exploitation of Human Cloning (Press Release. [98] It should be noted. for example.au/mediarel/yr2000/mw/mwhmc2006. [89] Ibid para 8. that the appropriateness of this action by the UK Parliament has been subject to some criticism.38. µWhat is Wrong with Reproductive Cloning?¶ (2002) 2(4) Genetics Law Monitor 6. [91] The Queen on the application of Bruno Quintavalle on behalf of Pro-Life Alliance v Secretary of State for Health [2001] EWHC Admin 918. See. [92] Ibid para 3. [95] Ibid 27. the Court also relied on other considerations.gov. See also the joint report of the Human Genetics Advisory Commission and the Human Fertilisation and Embryology Authority Cloning Issues in Reproduction. [94] R (on the application of Quintavalle on behalf of Pro-Life Alliance) v Secretary of State for Health [2002] EWCA Civ 29. together with the Government Response to the Recommendations Made in the Chief Medical Officer¶s Expert Group Report Cm 4833 (2000). Science and Medicine (1998). µThe HFEA 1990 Begins to Leak: ex parte Quintavalle and the Human Reproductive Cloning Act 2001¶ (2002) 2(4) Genetics Law Monitor 1. which are likely to be a relevant to the Australian context.1. [96] Ibid.

[109] Andrews Report. the preamble of the Human Reproductive Technology Act 1991 (WA) states inter alia that µParliament considers . R (on the application of Quintavalle on behalf of Pro-Life Alliance) v Secretary of State for Health [2002] EWCA. [114] Reproductive Technology Act 1988 (SA) s 10(2) states that µ[t]he welfare of any child to be born in consequence of an artificial fertilization procedure must be treated as of paramount importance. [102] Commonwealth. [116] P Kasimba. . [104] R (on the application of Quintavalle on behalf of Pro-Life Alliance) v Secretary of State for Health. [115] Reproductive Technology Act 1988 (SA) s 14(2)(b). 1 December 2000..co. [106] Andrews Report. 9.43. [105] Ibid.. above n 23. Similarly. Senate. above n 75.. above n 94. <http:// www.74. [110] Infertility Treatment Act 1995 (Vic) s 49..parliament.50.3. [Parliament] does not approve the creation of a human egg in the process of fertilisation or an embryo for a purpose other than the implantation in the body of a woman¶. [108] ART Guidelines.the-stationaryoffice. [111] Infertility Treatment Act 1995 (Vic) s 22. [113] Infertility Treatment Act 1995 (Vic) s 52. 20464 (Grant Tambling). [103] The Queen on the application of Bruno Quintavalle on behalf of Pro-Life Alliance v Secretary of State for Health [2001] EWHC. [117] Human Reproductive Technology Act 1991 (WA) s 14(2). in the formulation of the code of ethical practice¶. para 8.htm>. [107] House of Lords Select Committee Report on Stem Cell Research (2002) Parliament of the United Kingdom. this legislation should respect the life created by this process by giving an egg in the process of fertilisation or an embryo all reasonable opportunities for implanting . µThe South Australian Reproductive Technology Act 1988¶ (1988) 62 Law Institute Journal 728. [112] Infertility Treatment Act 1995 (Vic) s 24.uk/ pa/Id200102/Idselect/Idstem/83/8301. above n 23. para 11. Recommendation 8. and accepted as a fundamental principle. Parliamentary Debates. paras 6.[101] Ibid para 11.70-6.

that the donation of foetal tissue. 22 April 2000. [122] Ibid guideline 6. however. is mandatory for publicly funded research or research conducted in public institutions. [134] Ibid paras 12.78. para 9. [124] Ibid guideline 6. News Week. namely tumour formation and immune rejection. identified two serious risks associated with stem cell transplants. Public Health and Development.41-12.4. above n 75. . Reproductive Technology Act 1988 (SA) s 10(c). [131] Ibid para 12.42. guideline 2. and ova . for example. paras 8.2. above n 23. Director. spermatozoa.63. whether they arise from fertilisation of nuclear transfer or any other means¶.[118] Reproductive Technology (Code Of Ethical Research Practice) Regulations 1995 (SA) reg 4. to N Tonti-Filippini. Letter from Professor John Catford. µBioethics: Move to Harvest Human Embryo Stem Cells¶. [129] Chapter 16 of the National Statement above n 6. [133] Ibid para 11. [123] Ibid guideline 6. [127] The Stem Cells and Regenerative Medicine Report above n 11.68-8. [121] Code of Practice for Units using Assisted Reproductive Technology.121. [132] Ibid para 7. 24. in P Byrne. See.42-12.69-12. 14 October 1999. Reproductive Technology ( Code of Ethical Research Practice) Regulaions 1995 (SA) s 4(b). [125] The Authority has indicated its interpretation of the Act is such that it µbans destructive embryo research [and that] [t]otipotent stem cells are considered equivalent to embryos.50.98. Human Tissue Act 1985 (Tas) s 5. [120] See the Andrews Report. [126] Compliance with the National Statement above n 6. [119] Human Reproductive Technology Act 1991 (WA) s 24(4).is expressly excluded from the provisions of the Human Tissue Acts dealing with donations of tissue from living persons. identifies ethical considerations that are of particular concern in genetic research.44. [128] Note.1. [135] Ibid paras 12. [130] Andrews Report above n 23.

htm> at 10 April 2002. avoidance of harm and promotion of justice rank highly in this hierarchy..com. See µAnderson Denies Split as Leaders Approve Stem Cell Research¶ (2002) ABC Online at <http://abc. [143] For commentary on this issue see J Kerin. [137] In this respect see article 12 of the Declaration of the Human Genome and Human Rights. [140] µAnderson Denies Split as Leaders Approve Stem Cell Research¶ (2002) ABC Online at <http://abc.4082694%255E2702.au/common/story_page/0. [144] Respect for persons. The applications of research .theaustralian.au/au/journals/MqLJ/2002/2.au/articles/2002/04/04/1017206244840.smh.[136] Ibid para 12.austlii.15.6. [139] Andrews Report above n 23. M Grattan and L Doherty µHoward's Decision Incites Revolt by Premiers¶ (2002) Sydney Morning Herald at <http://www. [142] The duration of the moratorium has been reported to be for a one year period.html > at 5 April 2002.news. AustLII: Feedback | Privacy Policy | Disclaimers URL: http://www.00 .net. [145] See B Knoppers. which is necessary for the progress of knowledge is part of freedom of thought.html>.au/news/justin/weekly/newsnat-5apr2002-51.html .com. µStates Sign Up To Stem-cell Plan¶ (2002) The Australian at <http://www. paras 12. shall seek to offer relief from suffering and improve the health of individuals and humans as a whole.net.12-12.edu. which states that µfreedom of research.¶ [138] AHEC Report Recommendations 2 and 3. µProfessional Norms Towards the Canadian Constitution¶ (1995) 3 Health Law Journal 1.htm> at 10 April 2002.au/news/justin/weekly/newsnat-5apr2002-51. [141] See M Metherell.5744..

these special regulations allow IRBs to approve research that is of minimal risk or that will benefit the subjects directly.e. research to which Subpart D applies). pregnant women. and human in vitro fertilization [45 CFR 46 Subpart B]. in consultation with appropriate experts. prisoners. Some of the other departments and agencies have incorporated all provisions of 45 CFR 46 into their policies and procedures as well. Investigations involving these subjects that present significantly greater than minimal risk without direct benefit to them must be reviewed and approved by the Secretary of Health and Human Services. Terminally III Patients H. pregnant women. For research to which the DHHS regulations are applicable. [See Federal Policy §___. research to which Subparts B and C apply). Special Note Regarding Applicability of DHHS Regulations.e. does not apply to research involving children (i. however. Prisoners Suggestions for Further Reading F. such as children. or observation of public behavior..101(b). Institutions with DHHSapproved Assurances on file must abide by the provisions of 45 CFR 46 Subparts A-D. Women C. pregnant women. except for research involving observations of public behavior when the investigator(s) do not participate in the activities being observed. Cognitively Impaired Persons E. for research involving survey or interview procedures. footnote 1. Children and Minors D. Students. the exemption at 45 CFR 46. do not apply to research involving prisoners.] Return to Top of Page . Also. In general.111]. and children [45 CFR 46 Subpart D]. fetuses. prisoners [45 CFR 46 Subpart C]. the DHHS regulations set forth specific provisions on research involving fetuses. or economically or educationally disadvantaged persons [Federal Policy §___. Elderly/Aged Persons I.101. Traumatized and Comatose Patients G. mentally disabled persons..Institutional Review Board Guidebook * CHAPTER VI * SPECIAL CLASSES OF SUBJECTS Introduction A. Fetuses and Human In Vitro Fertilization B. or human in vitro fertilization (i. and Normal Volunteers K. Employees. Minorities J.101(b)(2). International Research INTRODUCTION The federal regulations require that IRBs give special consideration to protecting the welfare of particularly vulnerable subjects. The exemptions at 45 CFR 46.

The fetus has a unique and inextricable relationship to the mother. Implantation is confirmed through a presumptive sign of pregnancy such as missed menses or a positive pregnancy test [45 CFR 46."] DEFINITIONS Dead Fetus: An expelled or delivered fetus that exhibits no heartbeat. It cannot consent to be a research subject.. fetal membranes.A. Although it may be presumed that an expelled or delivered fetus is nonviable at a gestational age less than 20 weeks and weight less than 500 grams [Federal Register 40 (August 8. cannot possibly survive to the point of sustaining life independently. Minimal Risk: A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater. These circumstances have aroused lengthy public debate on the ethics of fetal research.) The term "fetus" generally refers to later phases of development. tissues. it is designated an infant [45 CFR 46. for research purposes. FETUSES AND HUMAN IN VITRO FERTILIZATION INTRODUCTION Research involving the human fetus raises special concerns for IRB reviewers. The fetus may also be an indirect subject of research when women who may be pregnant participate. the risk of drawing a small amount of blood from a healthy individual for research purposes is no greater than the risk of doing so as part of routine physical examination. For example. the term "embryo" is usually used for earlier phases of development. "Women. spontaneous respiratory activity.203(b)]. Research involving pregnant women is also regulated by 45 CFR 46 Subpart B. spontaneous movement of voluntary muscles. Nonviable Fetus: An expelled or delivered fetus which. (Hereafter. 1975): 33552]. investigators would presume that a living fetus was present until evidence to the . and the umbilical cord. amniotic fluid. Generally. and led to special federal regulations that guide IRB deliberations about fetal research [45 CFR 46 Subpart B]. the term "fetus" will refer to a living fetus unless otherwise specified. in and of themselves. Fetal Material: The placenta. although it is living. Section B. Fetus: The product of conception from the time of implantation until delivery. and cells (referred to collectively as fetal tissue) remain alive for varying periods of time after the total organism is dead. Human In Vitro Fertilization: Any fertilization involving human sperm and ova that occurs outside the human body. [See Guidebook Chapter 6. Pregnancy: The period from confirmation of implantation of a fertilized egg within the uterus until the fetus has entirely left the uterus (i. than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests [Federal Policy §___.102(i)]. If the delivered or expelled fetus is viable.203(f)].203(c)]. a specific determination as to viability must be made by a physician in each instance.e. even with the support of available medical therapy. or pulsation of the umbilical cord (if still attached) [45 CFR 46. some organs. but. has been delivered). This "confirmation" may be in error.

regulations concerning competent adult subjects define minimal risk in terms of those risks encountered in everyday life or in routine physical or psychological examinations [Federal Policy §___. given the benefit of available medical therapy. the investigators may have no part in . If the risks exceed the level considered minimal. may publish guidelines to assist in the determination of viability. the term "viable infant" means likely to survive to the point of sustaining life independently. if feasible. In an effort to impart some objectivity. Risks to the fetus from any research procedure must not be more than minimal (e. HHS. 1975): 33552]. Subsequent DHHS regulations on this subject implemented fully the recommendations of the National Commission. Partly in response to these concerns. from time to time. Although fertilization occurs a week or more before implantation. considerable national concern was expressed about the ethics of fetal research and about reports of ethically questionable procedures involving human fetuses. and imposed a moratorium on federally funded fetal research until regulations based upon the Commission's recommendations were in place. Such guidelines were published in 1975. The concept of minimal risk is evaluative rather than objective. Viable Infant: When referring to a delivered or expelled fetus. the current inability to detect the fertilization event or the presence of a newly fertilized egg makes a definition of pregnancy based on implantation necessary. similarly. special provisions apply. and. This judgment is made by a physician. Congress established the National Commission for the Protection of Human Subjects in 1974. IRB CONSIDERATIONS In addition to the general requirements for review of research by the IRB. If risk to the fetus is deemed to be more than minimal and without anticipated medical benefit to the mother or the fetus.102(i)]. the Secretary. Determinations of minimal risk to a fetus. however. OVERVIEW In the early 1970s. required that it study the subject of fetal research and make recommendations concerning such research to the Department of Health. regardless of its life prospects. The Commission also affirmed the legitimacy and importance of fetal research for improving the health of fetuses both in the present and the future. and affirmed that it should be treated respectfully and with dignity. Education and Welfare (the precursor of DHHS). If abortion is involved. impose further limitations on research involving the human fetus. Congress may. prior research with animal subjects.g. Although the Commission did not define the "personhood" of the fetus. can challenge an IRB. considerable room for interpretation exists. and specify an estimated gestational age of 20 weeks or more and a body weight of 500 grams or more as indices of fetal viability [Federal Register 40 (August 8. research with nonpregnant persons should form the basis of the risk/benefit assessment for fetal research.. These indices depend on the state of present technology and may be revised periodically. a number of states have laws affecting such research. they must be justified by anticipated benefit for the health of the mother or the particular fetus. In accordance with DHHS regulations. from ultrasound or changes in maternal diet). it recognized the genetic heritage and vulnerability of the fetus. The proposed research should seek information not obtainable in any other way.contrary was clear.

Research involving a nonviable fetus that would either artificially maintain vital functions or hasten their failure is forbidden... [See 45 CFR 46 Subpart D. the Secretary may authorize support of the research if the knowledge to be gained can be obtained in no other way and is important enough to justify the risk involved [45 CFR 46.] A fetus is judged nonviable if it cannot possibly survive to the point of sustaining life independently. a new technique for fetal transfusion for Rh incompatibility).g.208 (activities directed toward fetuses in utero as subjects)]. Ethics Advisory Board. given the benefit of available medical therapy)." An IRB may approve research directed toward the fetus in utero if: (1) the purpose of the research is to meet the health needs of the fetus and is conducted in a way that will minimize risk (e. The research may be directed toward the pregnant woman (in which case the fetus is indirectly involved). Research Directed Toward the Fetus In Utero...g. even with the support of available medical therapy. likely to survive to the point of sustaining life independently.either the decision to abort or decisions about the timing or the method to be used. Research protocols that require a waiver or modification of the regulatory requirements are similarly restricted.g. the risks should be justified by a reasonable possibility of benefitting the fetus (e. The Guidebook will provide updated information on the status of an Ethics Advisory Board as information becomes available. expired in 1980 and has not been renewed as of this writing. research involving greater than minimal risk where therapeutic benefit to the fetus is lacking) must be approved by the Board. minor changes in maternal diet or use of ultrasonography) and the purpose of the activity is the development of important biomedical knowledge that is unobtainable by other means [45 CFR 46.. the fetus (in which case it is directly involved) or both.e. and will therefore die. free care) may be offered to a woman to induce her to terminate her pregnancy for research purposes. No monetary or other inducements (e. "Women. Research directed toward the pregnant woman is discussed in Guidebook Chapter 6. it is then called an infant. If the Board approves the request. Section B. Many possibilities for intrauterine treatment of fetuses are presently being explored.g. increased chance of survival or avoidance of severe disability). The initial efforts in this field will inevitably be innovative and experimental. no change in the abortion procedure that would present more than minimal risk to the fetus or its mother can be introduced for research purposes. Research in which the welfare of a fetus in utero must be considered may involve the fetus either directly or indirectly.208].204].207 (activities directed toward pregnant women as subjects) and 45 CFR 46. The Board's charter. requests for modification or waiver of the regulatory requirements (e. however. Similarly. Applications involving human in vitro fertilization must be reviewed by the Ethics Advisory Board before they can be funded [45 CFR 46. an IRB must be guided by regulations and policies dealing with children. At this point. the regulations pertaining to both subjects apply [45 CFR 46. The DHHS regulations mandate the establishment of a national Ethics Advisory Board whose responsibility is to render advice to the Secretary on various issues. Applications for federally-sponsored research involving human in vitro fertilization and embryo transfer may therefore not be funded until a Board is reestablished. or (2) the research poses no more than minimal risk to the fetus (e. When proposals for research on fetal therapy come before an IRB. If an ex utero fetus is judged viable (i..211]. Ethical . Research Involving the Fetus Ex Utero.g. Where it is directed toward both the pregnant woman and the fetus in utero.

Department of Health and Human Services. Public Health Service. Informed Consent y y y Potential recipients of such tissues.considerations call upon investigators to maintain the dignity of this dying human subject and to avoid unseemly intrusions in the process of dying for research purposes [45 CFR 46. Fetal tissue from induced abortions should not be used in medical research without the prior consent of the pregnant woman. and transportation of the tissues. A moratorium on federally-funded research involving the therapeutic transplantation into humans of fetal tissue obtained from induced abortions. macerated fetal material. Her decision to donate fetal remains is sufficient for the use of tissue.210]. March 19. A panel convened by NIH to deliberate on the concerns that gave rise to the moratorium issued recommendations regarding the ethical use of fetal tissue from induced abortions in therapeutic transplantation research [U. and the Placenta. Fetal Material. Prohibiting Payments and Other Inducements y Payments and other forms of remuneration and compensation associated with the procurement of fetal tissue should be prohibited. or organs excised from a dead fetus are governed by state laws and regulations [45 CFR 46. The panel's report was approved by NIH in December 1988. The National Commission recommended that. Fetal Tissue Transplantation Research. National Institutes of Health (1988b)]. provide as follows: Separating Abortion from Research y y The decision to terminate a pregnancy and procedures of abortion should be kept independent from the retrieval and use of fetal tissue. as well as research and health care participants. research involving dead fetuses be compatible with commonly held views about respect for the dead. tissue. NIH has issued interim guidelines for the support and conduct of therapeutic human fetal tissue transplantation research [NIH Guide for Grants and Contracts 22 (No.209].S. should be properly informed about the source of the tissues in question. . storage. The timing and method of abortion should not be influenced by the potential uses of fetal tissue for transplantation or medical research. which closely follow the panel's recommendations. Research activities involving the dead fetus. was lifted on January 22. The decision and consent to abort must precede discussion of the possible use of the fetal tissue and any request for such consent that might be required for that use. 1993)]. 11. except payment for reasonable expenses occasioned by the actual retrieval. 1993)]. Research With Dead Fetuses. unless the father objects (except in cases of incest or rape). preparation. The interim guidelines. in addition to conforming to such laws. Research involving the use of human fetal tissue obtained from induced abortions into patients suffering from such disorders as Parkinson Disease and juvenile diabetes has been the subject of considerable debate in the biomedical community. or cells. by presidential memorandum [Federal Register 58:7457 (February 5. which was imposed by the Assistant Secretary for Health in 1988. 1993.

Experimental transplants performed with fetal tissue from induced abortions provided by a family member. and tests performed on animals . Some people believe such research exploits already difficult (some consider the situation morally unacceptable) circumstances. Resources discussing the ethical issues involved in the use of human fetal tissue for transplantation are provided in the "Suggestions for Further Reading" section at the end of this chapter. Anonymity between donor and recipient should be maintained. two ethical problems in this . including use for transplantation purposes. There are conflicting views about whether research in anticipation of abortion is permissible. Research in Anticipation of Abortion. There are. Ethical Review of Research y Customary review procedures should apply to research involving transplantation of tissue from induced abortions. experimental drugs must be tested in women to see whether they cross the placenta.. It has been suggested that such tests pose less risk to a fetusto-be-aborted than to a fetus going to term.are not always a reliable indicator of what will happen in humans. however. many states have adopted legislation governing the use of fetal tissue. Acceptable preliminary data must be presented to an appropriate Institutional Review Board. Prohibiting Directed Donations y y y The pregnant woman should be prohibited from designating the transplant recipient of the fetal tissue. while the research may save other fetuses from considerable risk. For example. so that the donor does not know who will receive the tissue. some drugs produce birth defects if taken during pregnancy because they pass through the placenta to the fetus. IRBs should be aware of and adhere to any legal requirements relevant to their review of protocols that include the use of fetal tissue. Determining When Progress to Clinical Studies is Justified y Sufficient evidence from animal experimentation is needed to justify proceeding to human clinical trials.even primates . because there is not time for the harm (e. NIH Initial Review Group. In addition to any federal requirements concerning the use of fetal tissue in research. To evaluate this effect accurately. friend.g.y Consent should be obtained in compliance with state law and with the Uniform Anatomical Gift Act. and the identity of the donor is concealed from the recipient and transplant team. others feel that the opportunity to test drugs or procedures on fetuses whose mothers have already made a decision to abort poses little real risk to those fetuses. Restrictions on the use of fetal material for research purposes is an evolving area of the law. birth defect) to materialize prior to abortion. and National Advisory Council before Public Health Service funds would be available. Abiding by State and Local Laws y Researchers in states with statutes appearing to ban fetal tissue transplants should seek clarification of the law. or acquaintance should be prohibited.

In all research in which human fetuses are the subjects of research.208(b)]. the consent of the mother on behalf of the fetus is required. (2) the father will be held legally responsible for the health needs of the child. regardless of life prospects. In such cases it is not necessary for the IRB or the research investigator to attempt to establish paternity.g. (2) the father is not reasonably available. the father ought to have a voice in determining to what risks the fetus should be exposed. risk to fetuses carried to term is minimized. The father does not acknowledge that he is the father of the fetus. it is acceptable to select only fetuses-to-be-aborted as subjects. If the IRB determines that the risk is acceptable for fetuses that will be carried to term. or (3) the pregnancy resulted from rape [45 CFR 46. Consent for Research Involving Fetuses. Exceptions to the requirement that the father provide consent are permitted if: (1) the father's identity or whereabouts cannot reasonably be ascertained. the consent of the father on behalf of the fetus is also required before a fetus may be enrolled in research. the right of the mother to change her mind about abortion is protected. . by selecting only those fetuses destined for abortion as subjects. No further assessment of the facts is required]. As a general rule. the woman may change her mind about having the abortion after taking the experimental drug.. a fetoscopic procedure initiated after administering drugs to initiate abortion). Investigators should document their reasons for deciding that a father was not "reasonably available" and should feel free to consult with the IRB in cases where applicability of the requirement for paternal consent is not clear.107(b) and 45 CFR 46. Therefore. The father has assumed no responsibility for the pregnancy and has manifested no interest in or has denied responsibility for the well-being of the fetus. research procedures that take place at the same time and during the same process as the abortion itself most fully meet these conditions (e. In practical terms." Some examples of situations in which a father is customarily judged not to be "reasonably available" will assist the IRB in providing direction to investigators: y y y y Paternity is uncertain. The father's whereabouts cannot be readily ascertained. The drafters of the regulations reasoned that the father's consent should be obtained in cases where the father is known and reasonably available for several reasons: (1) as co-progenitor. By limiting the risk to what is acceptable for the fetus to be carried to term.situation. Second. the fetus is an unconsenting subject. The National Commission for the Protection of Human Subjects wrestled with this problem and concluded that there is no difference between the moral status of a fetus destined for abortion and that of a fetus to be carried to term. only those research procedures that would be acceptable for a fetus going to term may be performed in anticipation of abortion. an additional risk for the fetus. First. and since these health needs may be affected by participation in research. and (3) involvement of a fetus in research in cases where the parents are not in agreement concerning participation is likely to disrupt the family unit as a whole. The IRB should provide guidance to investigators to assist in determining when a father is "reasonably available. [Note: It may be sufficient for an investigator to obtain a statement to this effect from the mother. the father has an interest second only to that of the mother in the well-being of the fetus.

In all studies. the Board did not foresee many of the issues that have since been identified. "they [will] be used for research purposes.] The only waiver granted to date was in 1979 for research designed to assess the risk of fetoscopy as a method of prenatal diagnosis of genetic disorders.) Subjects were to be women who had already decided to undergo an abortion. Research Involving Human In Vitro Fertilization. The Board's report on this matter. Waiver of Specific Requirements by the Secretary. no medical benefit to the women or their fetuses was contemplated. 315-319]. One issue of importance to IRBs is what Levine calls "the problem of 'spare' embryos" [pp. so far as possible.204(d)]. moreover. in turn. required review and approval of the Ethics Advisory Board. as well as resources for further reading. Risks to the mother should be. IRBs reviewing privately funded in vitro fertilization research might consider consulting with the new ACOG/AFS advisory board. HHS. the limits of knowledge about the extent of those risks should be clearly presented. may modify or waive specific conditions or requirements of the regulations governing fetal research on the advice of a national Ethics Advisory Board and after an opportunity for public comment [45 CFR 46. IRBs should ensure that the information provided to the parent(s) clearly distinguishes procedures performed for research purposes from procedures performed as a part of the standard care of medicine.g. The Secretary subsequently granted the waiver and provided support for the research. 1979): 47732]. The primary considerations are whether the risks to the subject are so outweighed by the sum of the benefit to the subject and the importance of the knowledge to be gained as to warrant the modification or waiver.211]. which plans to establish guidelines for research in this area. Congress imposes additional restrictions on fetal research from time to time. The lapse in the Board has precluded federal funding of human in vitro fertilization research. the Department could not support the research without a waiver by the Secretary. with its conclusion that the research was ethically acceptable. DHHS regulations require all research involving human in vitro fertilization or embryo transfer to be reviewed by a national Ethics Advisory Board before it can be funded by the Department [45 CFR 46. investigators should . Levine (1986) provides an overview of the issues presented by in vitro fertilization. they [will] be implanted in the uterus of another woman. distinguished from risks to the fetus. Additional Restrictions on Fetal Research. or they [will] be destroyed"). IRBs should assure that investigators have clearly addressed what will happen to embryos that are not used in the particular embryo transfer procedure for which they were created (e. above. [See discussion of the Ethics Advisory Board. IRBs should therefore consult with OPRR if they are unsure of the current status of such research. Since the risk of the procedure was undetermined. 1979)]. He notes that while the Ethics Advisory Board found research on in vitro fertilization ethically acceptable and set forth criteria for conducting such research [see Report (June 18. was published in the Federal Register for public comment [Federal Register 44 (August 14. it could not be said to be minimal. that. The American College of Obstetricians and Gynecologists (ACOG) and the American Fertility Society (AFS) have recently established a National Advisory Board on Ethics in Reproduction. and whether the benefits of the research can be gained only if the modification or waiver is granted. The Secretary.. Thus. (It involved inserting a hollow tube into the uterus and extracting a small blood sample from the fetus for examination and testing.

. Levine describes how these questions were reviewed by the IRB at the Yale University School of Medicine [pp.. In research with a nonviable fetus ex utero. timing or method) that is related to the research? 6. in writing. If there is any risk to a fetus. state. has research with nonpregnant women been completed? 2. to the resolution of this question.g. POINTS TO CONSIDER 1. Do any applicable federal. that they "belong" to the laboratory and may not be removed by the parents. 317-319]. is any intervention proposed that would shorten or prolong the natural course of dying? 5. or local laws restrict such research? 8. From whom must consent be obtained? .g.g. Investigators should also clarify to participants the ownership of the embryos that are not used in the procedure (e.ensure that participants are informed of and consent. are free care or services offered)? 7. Is abortion encouraged for research purposes (e. Is animal research an appropriate prerequisite? Has it been completed? Where appropriate and feasible.. is the information sought judged to be important? Could it be obtained by any other means? 3. Are the investigators involved in any decisions about an abortion process (e. or that they "belong" to the biological mother). Is risk to the fetus minimal? 4.

mankind can now depend on various forms of reproductive technologies to assist them in their plight against infertility. intra cytoplasmic sperm injection (ICSI) and the most recent possibility includes the use of nuclear transfer technology for reproductive purposes in humans. He creates what He wills and (plans). Introduction "To Allah belongs the dominion of the heavens and earth. International Islamic University Malaysia. The variety of treatments provides better success rates in couples trying to have a child. as technology permits the fertilization of the sperm and the eggs to occur outside the womb. Third Party Involvement in the Reproductive Process : Comparative Aspects of the Legal and Ethical Approaches to Surrogacy . He bestows (children) male or female according to His will (and plan). Email: Z. the possibility to procreate is no longer restricted to married couples only. However. The greatest breakthrough in modern reproductive technologies must have been the birth of the first test tube baby. the welfare of the resulting child will be the primary concern and the existence of a father is regarded as an important aspect of qualifying for the treatment. in vitro fertilization (IVF). the Act is also seen to adopt a tone of temperance by considering not only married couples in matters pertaining . Louise Brown in 1978. and for a long time nothing much could be done to alleviate the sufferings that it brought on many unfortunate couples. These technologies include artificial insemination (AI)."[1] At a time where choices were once limited. Ahmad Ibrahim Kulliyyah of Laws. scientists have been able to come up with better ways to help childless couples fulfill their dreams of having a child. Or He bestows both males and females. Moving from the more traditional use of herbal concoctions.Majdah ZAWAWI Lecturer. Although the problem of infertility has not been totally eliminated. with better accuracy. with every suffering Allah has provided a cure as He promises: "For every disease there is a treatment"[2] Indeed. among others mentions that in considering a woman for treatment. zygote intra-fallopian transfer (ZIFT). However.my 1. Nevertheless. man has proven the truth of this promise with the advancement in science and technology. such as section 13(5)[3] of the Human fertilization and Embryology Act 1990. infertility was a malady that was feared by many. Since then. scientists have made tremendous progress in assisted reproductive technologies and have developed various types of procedures to better address the problem of infertility. True. and He leaves barren whom He wills: for He is full of Knowledge and power.majdah@edu.13. Islamic Law Department.2. legislations in certain countries. gamete intra-fallopian transfer (GIFT).

its position under the civil laws. even more pressing problems arise when the sperm of the man is used to fertilize the ovum that did not belong to his wife and where the husband and wife has agreed to a surrogacy agreement. The situation becomes even more complicated as question then arises as to the status of the commissioning father. Other techniques include GIFT and ZIFT. This is based on the differences found in the philosophy of the law. Despite attempts to reconcile the issues of reproductive rights to that of respecting human dignity. his wife and the woman hired to carry the baby. the commissioning parents. comparisons will be made to the legal situation under the Shari'ah and the Malaysian civil laws to that of the UK and US. which previously seemed to adopt a rather conservative approach to surrogacy if compared to their American counterpart. The third part will focus on the legal and ethical position of surrogacy under the Malaysian laws. there is evidence to show that surrogacy arrangements are more popularly accepted now than it was when first introduced. Due to its controversial nature of surrogacy. Although initially frowned upon. Nevertheless. when brought to trial. has in the past couple of years been more open and accommodative to surrogacy arrangements. However. My argument will be that despite the acceptance of the procedure by certain quarters. more often than not. These techniques bring about issues of the legitimacy of the resulting child and parental responsibilities of the parties involved. the surrogate mother and her family. Whilst Islamic law aims at protecting the five important interests in human life (Kulliyyah al-Khamsah)[5] and it does this by strict compliance to predetermined legal principles which is steeped in moral basis. the fact remains that surrogacy arrangements are selfish and exploitative in nature and should not be encouraged nor condoned.[4] In spite of the general importance placed on marriage. the ethical debate rages on and this may be attributed to the impact that surrogacy arrangements have left on the resulting child. Artificial insemination and in vitro fertilization techniques using donor sperms or with donor egg for example allows third party involvement even from the beginning of the reproductive process. this paper aims at primarily looking into the legal and ethical implications of surrogacy arrangements in the UK and the US whilst comparing it to the position under Malaysian laws. primarily its position under the Shari'ah or Islamic laws and secondly. but also couples who are in a stable and subsisting relationship. The similarities and differences between these two jurisdictions shall be highlighted in the first and second part of this article. The involvement of third parties in the reproductive process can began as early as conception. Here.to parental orders. which allows embryo donation. Western law places more emphasis on man made laws with differing moral standards which concentrates more on the exercise of individual freedom. the Court is faced with a difficult duty to dispense justice to parties who have agreed to an inequitable contractual bond where the injustice cannot be undone. As cases have shown. the UK. The change in attitude can be seen not only in the rise of surrogacy contracts in both the UK and the US but also in the judicial attitudes of the judges and law makers of both countries. . the fact remains that the possibility to procreate is now wider and in some cases is extended to involve third parties who are not originally a part of a subsisting family.

[14] It is in this instance that Gena Corea was correct when she used the term. Nevertheless. where the sperm of the commissioning father is taken and used to fertilize the ovum of his wife through in vitro fertilization. Aside from that. the need for surrogate mothers could indeed be real.[15] In such a circumstance. "breeder woman" to describe surrogate motherhood. Why Surrogacy? Surrogacy is a situation where "one woman carries a child for another[6] with the intention that the child should be handed over after birth[7] " in return for which the surrogate mother is paid a determined amount of money for bearing and delivering the child. a woman's life may be put to danger if she was to carry the child herself[11] or she might want a child but does not want the inconvenience of pregnancy due to her career. this article will be concluded with a comparison of these three systems which will end with a contention that there is a vital need to include moral and ethical considerations in determining the legality of the type of reproductive technologies used by couples in their plight against infertility. In order to perfect cloning techniques.[9] It is the man's desire to have a child genetically related to himself.[10] Other reasons for resorting to surrogacy include health or career impediments on certain women. 3. scientists would need real women to carry the clones to term in order to ensure that the resulting clone child is normal.Thus. The resulting child will thus be the true genetic child of the commissioning parents but . In cloning. such a service could also be desirable for single men or homosexual couples who want to build families of their own. The resulting zygote is then implanted into the surrogate mother to be brought to term. This type of surrogacy is also known as full surrogacy and is usually considered when the wife of the commissioning father is infertile in that she is unable to provide an ovum and there is a problem to her uterus. For example. The childless couple (usually married[8] ) will then have a child although not born by them. which appears to be the prime motivation for many surrogacy arrangements. Apparently there are several reasons why childless couples resort to surrogacy arrangements. but will be genetically related to both or at least one of them. There is clearly a biological relation between the surrogate mother and the child as she not only gestates it but also provides half of the genetic material of the child. This type of surrogacy involves taking the sperm of the commissioning father and artificially inseminating the surrogate mother who will then carry the resulting embryo to term. 2.[12] Another more novel reason for surrogacy comes with possibilities created by the latest cloning[13] technology. Types of Surrogacy Arrangements Surrogacy pregnancies could be achieved through several procedures. depending on the condition of the parties involved. surrogate mothers are akin to breeder cows. The second type of surrogacy is known as partial surrogacy. Surrogacy that most closely resembles 'natural' reproduction is one that is achieved by way of artificial insemination. the general impression suggests that the inspiration and driving force behind these types of arrangements comes from the husband or the male partner of the infertile woman.

[21] Both parties entered into the agreement with knowledge and precise information on the nature of the contract. contracts of surrogacy have been resorted to. The main aim of these types of contracts is to determine the placement of the child after his birth. Finally.[18] It is because of the impact it left on the concept of mother and child relationship. If the surrogacy involved the surrogate mother as a mere "carrier" of the child then. the resulting zygote is then implanted into the uterus of a surrogate mother. a mother of a child was "the one from whose womb the child came"[19] and traditionally.[17] 4. she should not be allowed to back off from her promise when the baby is later born. After all. The Problems with Surrogacy The problem with surrogacy is not because it is an unnatural way of getting a child.was born via a living incubator. this was an unshakeable presumption. then an ova from a donor would have to be used. she will be expected to carry the child to term and upon safely delivering the child. . This brings us to the moral and ethical discussion of surrogacy arrangements. Should such contracts be enforceable to begin with? And so the proponents of surrogacy submits that there is an eminent need to construe the intention of the parties from the contract. the child is expected to be handed over to the commissioning parents for adoption. after all helping an unfortunate couple and not causing any difficulty to anyone but herself. The surrogate who carried him would definitely be his "natural" mother if she supplied the ova and carried him to term. Once born. if the commissioning mother is not able to provide her ova and neither does she want the surrogate to use hers. in that the surrogate mother will agree that for an agreed sum.[22] She is. if a man could sell his sperm. not only will the child end up having three potential "mothers" but also two potential "fathers" as well! In order to "solve" this confusion. she must agree to surrender not only the custody of the child to the commissioning parents for them to care and nurture. why should a woman be stopped from using her reproductive organs for a certain payment. And so arises the notion of womb leasing and baby selling. the "genetic" mother would also be in the picture. Therefore. In such a circumstance. traditionally. A child born a result of a surrogacy arrangement could in fact have up to three "mothers" in certain instances. in extreme cases. but also relinquish all her parental rights over the child. Thus. The surrogate mother was not forced to do anything that she did not want. and so the child now has two mothers.[20] Surrogacy makes things somewhat complicated. The third type of surrogacy may be achieved when the commissioning parents obtain sperm and ova from donors and after fertilization is achieved. and matters would worsen if even the sperm was taken from a donor to be fused with the donated ova. which they had signed. Then the issue of legality and enforceability of the contract would also arise. As Andrea Stumpf puts it. One such issue usually arises in cases where the surrogate mother refuses to honour her part of the bargain and does not want to part with the child after she delivers the child. Some feminists even argue that a woman should be allowed to do whatever she wishes with her body. the term 'in vitro fertilization surrogacy'[16] is also used to describe this type of surrogacy.

The law with regards to surrogacy in the United States began to develop when the case of Baby M[26] was brought to court. However. Judicial decisions from the US courts tend to take the position of considering the best interest of the child resulting from a surrogacy arrangement rather delve into the moral and ethical status of the act.[23] Objections towards surrogacy have similar under tones of the objection towards prostitution. he is already the subject of a legal dispute and should he be unfortunate enough to find out later in his life that the person who had carried him had done so for purely economic reasons would certainly blight his future. Due to the ethical and moral issues involved in surrogacy arrangements. It has been suggested that where the baby is born less than perfect. surrogacy should be allowed if purely done for altruistic reasons.Those against surrogacy arrangements claim that surrogacy is in fact a form of exploitation of women. Therefore. This is noticeable in the UK where commercial surrogacy has been declared illegal but surrogacy is still allowed if it is not done for commercial purposes. It would also leave a very unhealthy impact on the resulting child. In that case.[27] This set the judicial tendency in US courts whereby. some countries like the United States and the United Kingdom has seen it fit to consider surrogacy as a valid form of treatment for infertile couples but such arrangements are subjected to certain rules and regulations. as he did not fulfill the determined specifications. then there can be no denying that surrogacy arrangements are nothing more than contracts for the hiring of a womb and for the purchase of the resulting child. the Supreme Court of New Jersey had invalidated the surrogacy agreement and had held that the best interest of the child was best served if placed in the . the Court decided that although the contract must be considered unenforceable. there is a middle view that opines that altruistic reasons for surrogacy should be allowed to help alleviate the sufferings of childlessness for some couples. The Warnock Committee for example strongly condemned surrogacy for financial profit and treat her uterus as the mere incubator for someone else's child. especially if it has a commercial motivation. although the surrogacy agreement in itself is considered as void and unenforceable. in extreme circumstances. 5. In that case. with a defect and the commissioning parents refuses to accept him and neither does the surrogate? If precedence is to be taken from the StiversMallahof case.[24] The ethical debate on surrogacy intensifies when something goes wrong with the pregnancy. many still frown upon surrogacy. the parties should go back to the terms of a contract. Once born. [25] There has also been suggestions that should the surrogate mother not want the care and responsibility of the baby. she should be allowed to offer it for adoption as she did not have the intention to keep in the beginning anyway. As in defective goods. A number of the decisions tend to point to a pattern of recognizing the rights of the commissioning parents over and above of the surrogate mother. The case of Baby M for example reflected this attitude. Whatever the justification. Legal Position in the United States. according to them. similarly a defective baby would have to be kept by the surrogate. regardless of her participation in the surrogacy arrangement. What happens if the baby is born. the custody of the child will usually be awarded to the commissioning parent and not the surrogate. it was in the best interest of the child that the baby be given to the Commissioning father and not the surrogate mother.

To further illustrate the nonchalant attitude towards the plight of the surrogates and the general willingness to accept surrogacy arrangements as a valid subject matter for commercial transaction and the baby as made to order goods. In the 1993 case of Johnson v Calvert[29] . While in the hospital. the baby developed strep infection and it was reported the Mr. the child was treated like defective merchandise that did not fit the specification for the good.[31] Both parties rejected the unfortunate baby and announced that it would be put up for adoption. Wilentz C.J.[32] Treatment to the baby was however given at the initiative of the hospital after obtaining the necessary court order." The Court mentioned that in this case proof of giving birth is not the only way of determining the natural mother of a child. a baby boy was born with mental retardation . New York had contracted with Mrs. the Court held that the woman who "intended to bring about the birth of the child that she intended to raise as her own is the natural mother under Californian law. the surrogate is even more unfortunate. Judy Stivers to have her artificially inseminated with his sperm and the child to be delivered to him after it was born. the Court gave due recognition to the woman who donated her ovum thus proving that she had a genetic relationship with the child although not giving birth to the baby. Alexander Malahoff of Queens. This is aptly considered by one surrogate who commented that surrogacy "is transferring the pain from one woman to another. The court even suggested that the surrogate mother cannot be considered to have given full informed consent before she delivers as at that time the feelings which developed between her and the baby had yet to be formed. could therefore be replaceable. The decision in Baby M was however greatly criticized as being callous and unfeeling towards the surrogate mother. If she still decides to continue with the surrogacy agreement. it would be interesting to look into the Stivers-Mallahoff case. they merely restored her parental rights but not the custody of the child. it was held that when two women contest for the custody of a child resulting from a surrogacy arrangement.[30] In that case. nevertheless conveniently awarded custody of the child to the commissioning parents instead of the surrogate mother. who had commissioned for the pregnancy had instructed the hospital not to treat the baby. Although the Court acknowledged that the consent given by the surrogate mother at the time of entering into the contract could not have been full and informed consent. It was further contended by the Stivers that not only did Malahoff refuse to pay them. Mallahoff.custody of the commissioning father. Instead. As such. for a surrogacy contract to be binding on her. . from a woman who is in pain from her infertility to a woman who has given up her baby".[28] In cases of in vitro fertilization surrogacy or partial surrogacy. but he had also asked Mrs. Mr. Although the intention of the Court for awarding the custody of the baby to the commissioning parents is to deter women intending to venture into such commercial transactions from doing so. in that case while holding that surrogacy contracts are invalid and unenforceable due to the lack of informed consent on the part of the surrogate mother. Stivers to "start over and make a new one for him". In January 1983. her consent to part with the baby must be considered only after the baby has been born and she has had time to consider her feelings towards the baby thereafter.[33] Clearly. only then can the agreement be enforced against her. the end result is severe injustice caused to the surrogate mother.

As a result of the laxity of treatment towards the commissioning parents and the surrogate mother. Thus this is the direct opposite of the legal situation in the US. the child remains to be perceived as the subject matter of the contract. tries to regulate altruistic surrogacy whereby section 30 of the Act provides the procedure to be taken by the commissioning parents in order to ensure that the resulting child is legally placed with them in after he is born. The effect of considering a contract as void is that the court will take the position as if the contract had never happened. the legal position in America on surrogacy is largely dependent on the states. Some states have enacted specific legislations making commercial surrogacy unenforceable for example Indiana. and Utah[35] whilst other states such as New Jersey tend to rely on existing legislations which govern the adoption cases. What about the child? The resulting child will be regarded as the child of the surrogate and she will be entitled to keep it. the commissioning parents will not get their baby and the surrogate will not get her payment. the Surrogacy Arrangements Act was enacted and later on in 1990.Regardless of the outcome of the case. In 1985. the issue to be pointed out here is that if the practice of surrogacy was to be accepted as a form of treatment for infertility. as in the risk of surrogate mothers changing their minds when the child is born. However. which recruit surrogate mothers. Although the intention of the legislation is to curb surrogacy arrangements. her husband or partner will be treated as the father. To date there is no federal legislation in America governing surrogacy arrangements and not all states have specific legislations governing surrogacy arrangements. Concentration is given to the suffering of individual couples without considering the horrendous consequences to other parties such as the surrogate herself and even worse to an unfortunate child such as the Stivers baby as mentioned above. it only awards criminal punishment to agencies or middlemen who take profit from the surrogacy transactions. this is just a risk that the contracting parties would have to take. will not be punishable for any offence. the child must first be registered as the child of the surrogate mother and.[34] The callousness present in this line of thinking permeates similar individualistic approaches to concepts of reproductive rights. The Surrogacy Arrangements Act 1985 for example is directed towards commercial agencies. The surrogate mother and the commissioning parents however. . Kentucky. Commercial surrogacy has also been declared as unlawful under the Surrogacy Arrangements Act. Louisiana. One example of such laws is the prohibition of baby selling in adoption cases and the best interest of the child when deciding to award custody. 6. the leniency given to the commissioning parents and the surrogate is a matter to be criticized. Legal Position in United Kingdom Initial reaction to surrogacy happened in 1978 when the case of Av C was brought to court. No similar laws exist in the US. after the Baby Cotton case. legislation only came into being approximately ten years later. Thus. Michigan. It is submitted that in order to ensure that childless couples do not resort to this practice some form of deterrence must be provided and punitive punishment could be one way of doing so. As a result. no matter how far the denial goes. the Human Fertilization and Embryology Act came into being. if she is married. Nebraska. non-commercial surrogacy is still being practiced in the UK. Both these legislations make surrogacy arrangements illegal and any such contracts are considered as void. However. Accordingly. According to some American writers.[36] The Human Fertilization and Embryology Act 1990 in turn. 1985.

The Malaysian Position The Malaysian legal scenario is a unique blend of Islamic laws and civil laws. the child may be supplied with information enabling him or her to obtain information pertaining to their history. Although governed by one system of justice whereby parliamentary legislations generally apply to all citizens. legislation with regards to family matters are divided into Islamic laws and civil laws. not possible to "pretend" that the resulting child is the "natural" child of the commissioning parents. under the Malaysian law could have two possible statuses. The records will stand and at the age of eighteen. Under the civil laws. a child brought about by a surrogacy arrangement would." . `child' has the meaning of `child of the marriage' as defined in Section 2 who is under the age of eighteen years. Firstly." For non-Muslims. which applies to both Muslims and nonMuslims. which houses a majority of Muslims as well as Chinese. 7. The section provides: "The fact that any person who is born during the continuance of a valid marriage between his mother and any man. or within 280 days after its dissolution. 1990. then she will be considered as the mother of the child and her husband would be considered as the father. 1976. In fact. which directly governs either the act of surrogacy or the status of a child resulting from such an arrangement. the Registrar General will make a separate Parental Order Register registering the child and crossreferencing to the entry in the existing Register of Births. The relevant legislation which governs family matters amongst the non-Muslim population in Malaysia is the Law Reform (Marriage and Divorce) Act 0f 1976 whilst the Muslims are bound by the Shari`ah law either those which had been legislated or not. perhaps Section 112 of the Evidence Act 1950. 87 of the Law Reform (Marriage and Divorce Act. the mother remaining unmarried shall be conclusive proof that he is the legitimate son of that man. But before looking into the provisions of the Law Reform (Marriage and Divorce) Act.Once this has been done and once a parental order has been granted to the commissioning parents under section 30 of the Human Fertilization and Embryology Act. there are no legislations. the commissioning father has no legal backing since only the husband of the surrogate may disavow any the legitimacy of the resulting child to himself by proving that he and his wife "had no access to each other at any time when he (the child) could have been begotten. could better elucidate to us the possible status of surrogacy in Malaysia. if the surrogate mother is a married woman. Indians and other ethnic cultures. 1976 which provides: "In this Part." The application of this section would pose a problem to the legitimacy of a child born out of surrogacy arrangements since recognition is only given to the husband of the surrogate and not to the man commissioning the pregnancy and far less recognition is given to his wife. unless it can be shown that the parties to the marriage had no access to each other at any time when he could have been begotten.[38] This is largely influenced by the make up of the country.[37] It is therefore. This possibility is also supported by s. wherever the context requires.

could it be done? This too might not work to his advantage as it could contravene section 24(e) of the Contracts Act.112 of the Evidence Act 1950 and the above cited section would seem to imply that should the surrogate mother change her mind and decide to keep the child for herself.[39] However. The present legislations are still very basic in nature and does not even begin to address the complex problems that involve any third parties in the reproductive process. to date there has been no legal claims made for surrogacy arrangements or any other orders pertaining to third party involvement in the reproductive process in Malaysia. again. Malaysians are very careful when seeking the various forms of assisted reproductive treatment available to them. but the law does recognize him as the child's natural father. they are prohibited from falsifying registration and registering the child as their own as this would be in direct contravention with section 466 of the Penal Code which makes forging a register of Birth as a crime which is punishable with a maximum of seven years imprisonment and fine. The commissioning father will not be recognized in law as the legitimate father of the child. she would be able to do so as the present situation would give her ample recognition and protection over her rights on the resulting child. and then the commissioning parents could adopt the child as their own. Every agreement of which the object or consideration is unlawful is void. if compared to the US and UK situations. the notion of surrogacy has not yet found its place in the Malaysian society. It is submitted that this is the main reason for such a laid back attitude of the Malaysian legislators to the possible perils of the new reproductive revolution to Malaysians. Due to her unmarried status. Should the commissioning father wish to claim his rights under the law of contract. Nevertheless.[40] True. which is later to be carried by the wife. For many Malaysians third party involvement in the reproductive process is not an acceptable form of treatment for cases of infertility. Nevertheless. The remaining issue that arises is the legality of the contract of surrogacy. 1950 which reads: "The consideration or object of an agreement is lawful unless -« (e) The court regards it as immoral or opposed to public policy«to be unlawful. the commissioning father would not be able to obtain custody or guardianship over the child. In the case of surrogacy it is even more unsettled as it seems to involve an intricate web of legal issues. it can be seen that the legal position of surrogacy in Malaysia is still rather murky. there is a possibility that the commissioning father could go around this section as the Malaysian Courts have been rather unsure in their determination of what amounts to immoral acts and acts which is opposed to public policy. In a society where importance is placed on marital relationships and on the traditional concepts of the family. the resulting child would most definitely under Malaysian law be an illegitimate child. As such. Assisted reproductive techniques which help married couples obtain their dream of having a child must still be restricted to that which involves sperm taken from the husband and ova taken from the wife. The second possibility would arise in a situation where the surrogate was an unmarried woman.The position of s." Nevertheless. should the surrogate mother have no qualms about giving up the child. Fortunately. The maintenance of .

Provisions on maintenance (nafkah) of the children. But human kind must be careful in using that technology. which is the central figure and source of strength of its system.e. In view of the above legal setting. to the other contracting party as well as to the society at large. primarily in this case. Procreation within a valid marriage and which results in legitimate children and further includes other legal consequences. it will not always achieve justice. 8. As Afzalur Rahman aptly puts it: "Islam allows neither unrestricted freedom to damage the interest of the community or the individual.[42] The main reason for such a moralistic approach to intimate sexual relations is to ensure the protection of the five essential values in a man's life.religious beliefs and a strong sense of respect to rich Asian cultures is a strong influence to reproductive choices in Malaysia. but one to be careful with."[45] 9. Status of Surrogacy in Islam In Islam. as it could very well lead to the very destruction of humanity. the reason being that the manifestation of the Allah's compassion to human kind begins while he is still in the dark recesses of his mother's womb. naturally arises out of kinship. Aside from that. such freedom must be coupled with responsibility. Take the legal position of the United States for example. Perhaps. nevertheless. It aims at facilitating human life and as for medical technology.[44] When a child is born within a valid marriage the aurah and prohibited degrees of marriage is also determined by the Shariah. i. nor does it recommend totalitarian regimentation so as to destroy the personality of the individual. Not only is surrogacy prohibited under the Islamic family laws. as a consequence of such regulations. the womb is known as "Rahim" a word that is also used to describe one of the attributes of Allah s. but it could also cause chaos to the determination of rights and responsibilities under Islamic laws. which have not yet been eroded. The discussion of the position of surrogacy must begin with a discussion of procreation in Islam. him being the Most Compassionate. Although many aspects of the Western thought have evaded the Malaysian attitudes and thinking. rights of inheritance too involve a child being born within a valid marriage. neither would surrogacy be allowed under Islamic laws of contract. Man made laws can try to regulate human actions. there remains a significant part. surrogacy arrangements would not only up heave the very notion of family relations. which maintains the respect for religion and preservation of Asian values. it is designed to help alleviate the suffering of mankind as far as possible. Conclusion Technology is a tool.[43] The right of custody (hadhanah) also arises out of such legitimate relations.w. It must be mentioned on the outset that procreation is only allowed within a legally binding marriage. Whilst the Islamic economic system allows individual freedom in forming commercial transactions.[41] It is rather interesting that the same name is given to the womb. his faith and progeny. although the surrogacy .t.

It seems one way of "punishing" the surrogate mother for having the audacity of agreeing with such a transaction. In fact. the surrogate will not be able to make any claims against the commissioning parents. as what had happened in the Stivers-Mallahof case. Surrogacy would give them an opportunity to get a baby without any pain and it's done for free! Since surrogacy arrangements are held as void and unenforceable. the surrogate gets the same thing. This is not a novel idea. advertising and marketing. which violate this basic nature. Any acts. The reason being that firstly. which means that it is nontransferrable and non-saleable. . There are certain things in life. legal or illegal.[46] According to Radin: "Market-inalienability often expresses an aspiration for noncommodification. as Alta Charo puts it be it with a contract. the fact that judges in the Baby M and Johnson v Calvert's case clearly point that the custody of the child be given to the commissioning father. speculation and valuation in terms of opportunity cost of production. Such decisions fail miserably in stopping surrogacy arrangements. will sooner or later result in the psychological disturbance on both the mother and the child.contracts have been considered as illegal and unenforceable. there must be certain matters. brokerage and arbitrage."[47] Some examples of subject matters where commodification is contested includes. infants and children. no baby. market trading is a disallowed form of social organization and allocation. fetal gestational services. By making something non-saleable we proclaim that it should not be conceived or treated as a commodity. Whatever the argument. Allow me to repeat myself. sexual services are some examples. Such an approach seems to be rather unfair to the surrogate mother and there has been a recent move in the UK to allow a determined amount of payment to be made to the surrogate mother for all the sacrifices that she has made to the commissioning parents. However. use of the uterus and sexual services. blood. where matters of kinship have no legal significance. This clearly causes an injustice to the surrogate mother who later decides that she cannot part with the child that she has carried for nine months and risked her life to deliver. there are some things that should not be made the subject matters of commercial agreements. Perhaps there must be a limit to human autonomy. After all why shouldn't a woman decide what she wants to do with her body. I would like to take this a bit further by asserting that while some of these subject matters such as blood and human organs are non-saleable. surrogacy does not seem too problematic on the outset. The nature of a mother is to carry her child and care for it once it is born. especially if it is to help another "suffering sister"? It may be acceptable in the West. which are inalienable. with payment. to allow the sale or even transfer of this subject matter would go against the nature of human being. they may however be transferable as gifts. without payment. the fact that surrogacy arrangements are nothing more than a contract for the sale of a baby becomes evident if and when the baby is born with a defect. which are both non-saleable and non-transferable such as infants and children. We place that thing beyond supply and demand pricing. human organs. it further promotes the practice amongst childless couples.[48] For surrogacy arrangements with an altruistic incentive. When something is non-commodifiable. stockpiling. There must be a limit to a person's right to do anything that he wishes with his body. without a contract.

aurah and many other rights and responsibilities are determined by kinship (nasab). Islam views it in a totally different light. As the judge in Baby M's case rightly puts it. Any human intervention in this fitrah will cause a disruption in all the above matters and would cause serious injustice to those involved in the surrogacy arrangement. The basic ethical belief that there are certain things that should not be bought and sold should be adhered to. who too want a taste of normal family life. where there is a market there will always be middlemen who are in search of free lunches along the way. For the most part. between consenting adults cannot be acceptable in Islam because it will affect the lives of not only the contracting parties. there are also the lesbians and homosexuals. However. Surrogacy. as long as he does not hurt any other member of the society. Whilst the West is seen to inject the idea of individual freedom with fundamental rights. And as proven in many of the surrogacy cases. It protects humans from degradation and lies in the core of human dignity. A busy career woman could choose to hire a surrogate to carry her child for her. "Not everything in life can be bought". Admittedly. If markets were open to human organs. Sooner or later each individual will have one excuse or the other for having resort to surrogacy. human babies and human wombs.This explains the difference in approach taken by Islam. In Islam. much of the assisted reproductive technologies manage to help alleviate the sufferings of most of these couples.[50] Then. This too is where there is a wide difference between the laws in US and UK. Once allowed there will be a clamour from all quarters to justify their need for surrogacy. there must be a limit to the purchasing power of the rich. rights of inheritance. And of course there is the issue of using a person's body as and when he pleases. A lonely single woman would want to have a child to look after her in old age. Whatever the motivation. UK legislation seems to have settled that by making it a criminal offence to surrogacy agencies to make profits out of surrogacy arrangements. Surrogacy is not permitted. Which brings us to the issue of market inalienability. Any couple struggling with such a plight should be sympathized and should try to the best of their abilities to over come their problems. the world would go back to a more gruesome form of slavery where the rich could easily enslave the poor for the use of their human organs. what more if a child discovers that he was conceived by a woman with the sole intention of being given up to another couple. be it monetary or altruistic. but it is more because of the effect that it will leave on the family involved in the act. they should not allow their plight . The problem however remains in the US. maintenance (nafkah). will cause undue confusion to the child. rights are coupled with responsibilities and the collective rights of the society (maslahah al-ummah) must always be given priority over individual rights. but also the child and if allowed to be practiced. the practice of surrogacy has a very real potential of being a threat to society. determination of the status of prohibited degrees of marriage. Any violations to the laws will be punishable in this world or the hereafter. Although no empirical data is available to date as to the effect of surrogacy on the child[49] . In Islam. not merely because of the ethical roller coaster that it causes. if it has not already been so. The way in which this is to be done has been clearly mentioned in the Qur'an and the Sunnah. infertility is a most unfortunate malady. it is submitted that if the knowledge of being an adopted child in itself can cause undue psychological hardship on a child. human blood. Certainly. especially the resulting child. even if viewed as a private affair.

p. [3] The sub section provides. i. Islam allows its believers to try their best to their abilities to find cures for diseases and He has in fact promised that for every disease there is a cure. Whoever honours it (by maintaining the links established with the womb) I shall homour him and whoever violates it (by severing the links established with the womb) I shall disown him. in the Hereafter. it violates the fitrah. which tend to prejudice the rights of others. who are bound by holy matrimony. it will be nothing more than a transaction of womb hiring and baby selling. the rights of the surrogate and the resulting child are made subordinate to that of the commissioning parents. There must be limits to human action. A Collection of Agreed Upon Hadith From al-Bukhari and Muslim. Chapter 26. if not in this world. Allah s.50 [2] Hadith of the Holy Prophet Muhammad s. 232.w.e. If payment is awarded to the surrogacy. For Muslims. I created the womb and named it with the deravative of My name. It would violate the nature of mankind if a practice such as surrogacy were to made available commercial or other wise. are strictly prohibited in Islam. the family is regarded as a basic social unit which constitutes at least two people. to try and grapple the best way to justify and allow an unnatural act to result in a "natural" child. whereas. Al-Lu'lu' wal Marjan. [4] This is evident from the wording of Section 27. many Western societies have come to accept cohabitation outside marriage and this has forced the laws in ." For the Muslims. [1] Surah al-Shura (42) : 49 . 1995.w. much more complicated for those who choose. and acts. Nevertheless. After all. "I am Allah and I am the Most Merciful. Any children born as a result of the marriage will also be included as part of the family..to overshadow the very basic tenets of humanity. there must be a limit to every act. 28 and 30 of the Human Fertilisation and Embryology Act 1990. Traditionally. Khan. if it was done for altruistic reasons. It is however. However. because to every action there is an opposite reaction. it might not be easy but guidance is clear . ³ A woman shall not be provided with treatment services unless account has been taken of the welfare of any child who may be born as a result of the treatment (including the need of that child for a father).t has long reminded us of the need to maintain the ties created by the womb. narrated by al-Bukhari & Muslim.a. Allah has created every being in its own fitrah and He has ordained that no change should there be in that fitrah. which Allah has already set and would not be allowed. the sacredness of the human body. Muhammad M (Trans). Dar-us-Salam Publications:Riyadh. and of any other child who may be affected by the birth. Surrogacy is one such instance where.

yahoo. USA for example revealed that all the 26 couples interviewed were from ³very happy families´. Assumption that married couples are usually parties seeking a surrogacy arrangement can also be seen in the way certain legislations are worded.: London. & Tingle. p. Oxford : Blackwell Publishers. West Publishing Co. The Mother Machine. there is also indication that most surrogacy agencies in the United States for example.308 ? 317 at p. 10. 27 : 3. p. Doheny. 601. (2nd Ed). Kathleen.´ (1988-89) Journal of Family Law University of Louisville School of Law. 396. as in every pregnancy. 217. K. (1998) Sourcebook on Medical Law. Ilmiah Publishers : Kuala Lumpur. A Question of Life. 30 of the Human Fertilisation and Embryology Act 1990 clearly makes provisions for situations involving a µhusband' and his µwife' when dealing with matters arising out of surrogacy arrangements.587 at p. Thus it would seem rather selfish for a woman to save herself from the danger but at the same time expects another woman to do it for her in return for a price. Ninth Edition. For further reading on this topic see Kamali. See In The Matter of Baby M (1988) 109 N. Christine B. intellect. Johnson. Jost & Schwatrz. [8] A study done by Dr. lineage and property. for every woman. Warnock.´ 4 (1990) International Journal of Law and Family. [12] Corea. Long Beach. Gena. p. (1999) The Dignity of Man : The Islamic Perspective. 16. This risk is a recognised risk. Also see commentaries of certain writers on this issue Russell. M. 1998. life. G. See for example. [6] The contract is usually between the commissioning father and the surrogate mother although this may not always be the case.these countries to adapt to this change in social behaviour by giving some form of recognition to extra-marital unions in order to protect the ³spouses´ or children resulting from these cohabitation in the event the unions come to an end due to separation or death. See Corea. 213. 537 A. Aside from that the judicial decisions in surrogacy cases suggest that in the best interest of the child. Butterworths : London.news. Mohammad Hashim. Reuters. 309...: London. G. and Davies. [10] Ibid. Irma. Available at : [http://story. Bromley's Family Law. [9] Stauch. See MacPhee. The same suggestions have also been made by Gena Corea. p. make it a policy that treatment will only be available to married couples. ³ Within The Best Interest Of The Child : The Factor Of Parental Status in Custody Disputes Arising From Surrogacy Contracts. N. 4th April 2002.J. 216 . p. (1985) The Mother Machine. David & Forest. (1985) The Mother Machine. p. See Furrow.2d 1227. Mary. 974. [7] Definition given by the Warnock Committee. (1991) Health Law ? Cases & Materials. 390. there is some degree of danger expected. 1. See Lowe. Kathy. the parental status commissioning parties must be taken into consideration. p. Minnesota. [5] These values include the protection of faith. [11] The writer is rather sceptical about this reason. ³Surrogacy : Programme Comparisons And Policy Considerations.com/news?tmpl=story&u=/nm/20020424/hl_nm/women_children_1 ]. p. p. S. The Women's Press Ltd. K. Aside from that. ³ Most Surrogate Moms Fit For The Job : Study´ . Cavendish Publishing Ltd. Kleinpeter from California State University. Wheat. 1985.

p. p. Through what is known as nuclear transfer technology.´ The Yale Law Journal. 4th 84 where in that case the surrogate mother tried to keep the resulting child but failed as the Court in decided that the woman who intended to bring about the pregnancy would be considered as the natural mother under Californian law. The view mentioned here is one that is brought by the more liberal set of feminists. April 1. 2000(On Line Serial) Available at : [ http://www. 2002.´ (1989) 5 Journal of Contemporary Health Law and Policy. 213. 23. [16] Brinsden.D. [15] Corea.[13] Cloning is a procedure which is different from the normal assisted reproductive techniques. TIME. You're History. 20 and Hassan. the sheep was created. ³ An Essay on Surrogacy and Feminist Thought. there are scientists who insist on continuing with this intention.p. ³Kontroversi Pengklonan Manusia´.´ (1988) 16 Law. Najibah. ³ Redefining Mother : A Legal Matrix for New Reproductive Technologies. Sinauer Assoc. p. Publihers & Willard Grant Press : Boston. 32. [21] Posner. . Times Special Report on Cloning. 1998.findarticles. Cloning techniques have improved since then and are more efficient than when it was first introduced. TIME. Charles. Richard A. August 3. See promises made by some scientists to produce live human clones by the end of 2002. M. there will be normal cell division as if there was fertilization of an egg by a sperm. (1983) Life. p. See also Bernsteins. Dolly. thus making cloning as a possible assisted reproductive technology in the future to be quite possible. (1986) 96 : 167.´ (2000) British Medical Journal. Aaron. ³ The Ethics and Economics of Enforcing Contracts Of Surrogate Motherhood. See for example the cloning of mice by Lemonick. More often than not cloning is associated with how Dolly.com/cf_0/m0999/7239_320/61932188/print. p. Inc. August 14. G. 187.p.p. Zitner. p. [20] Ibid. 81. For further reading on the cloning process see Purves & Orion. Once the enucleated ova has fused with the cell. Whilst another set believes that surrogacy is a clear form of exploitation of women. Cloning Controversy. It ia in fact an asexual form of reproduction which does not involve the use of a male sperm. a somatic cell is taken from any part of the body which will then be fused with an enucleated ova by administering determined amounts of electric pulse. Madeleine. 1997 and Nash. ³ Treatment by in vitro fertilization with surrogacy : experience of one British Centre. The Star. For an interesting account of these differences see Mahoney.jhtml ] ( 21/5/2002) [17] See for example the case of Johnson v Calvert (1993) 5 Cal. Mingguan Malaysia.350. Medicine & Healthcare. [14] Despite worldwide objections to reproductive cloning. [22] Feminists are faced with a difficult position in determining the status of surrogacy contracts. Joan. The Mother Machine. [18] Basically all types of assisted reproductive techniques are unnatural ways of achieving pregnancy. (1982) Biology: The Study of Life. 542. March 10. The Science of Biology. April 14. Harcourt Brace Jovanivich Inc : New York. Peter. 2001. For an interesting account of how she was created see Krauthammer. 42. [19] See her article entitled. The Age of Cloning of the same issue.

Yale University Press : New Haven.2d 1227. Sheila. p. ³ United States : Surrogacy´ as edited in Mc Lean. Aldershot.´ p. Apparently. p. [31] This was indicated from the baby's small head. 231. the commissioning parents must still be responsible for payment of the agreed amount to the surrogate. 227. See. [28] As cited in MacPhee & Forest.´ p. 537 A. ³ The Ethics and Economics of Enforcing Contracts of Surrogate Motherhood. R Alta. Dartmouth Publishing Co. she had not done so just before the treatment was carried out on her. 204 [35] Charo. The Mother Machine. as the whole set up was initiated by them.´p. [24] Posner. ³ Redifining Mother´. Stumpf. . 396. Malahoff was proven not to be the genetic father of the child. Blackstone Press Ltd. (1992) Law Reform and Human Reproduction. 2001. 219. R. See Stumpf. R. 4th 84 [30] See Corea. Dartmouth : Aldershot. But the Commissioning parents cannot claim for damages from the surrogate as pregnancy is not a situation which is totally controllable by her. Ahmad. Gower Publishing Co.G and Morgan. 97. [26] In The Matter of Baby M (1988) 109 N. 219 and Shaler. 200. [29] (1993) 5 Cal. [33] Ibid [34] The case then took an unexpected turn when Mr. : Alderhshot.p . The Stivers then decided to keep the child. see Ibrahim. ³ Surrogacy : Programme Comparisons And Policy Implications. p. p. Regulating the Reproductive Revolution.A. p.J. (1992) ³ United States : Surrogacy´ in Shiela Mc Lean's Law Reform and Human Reproduction. : London. [27] See the judgement of J. ltd. Human fertilisation and Embryology. Carmel. (1989) Birth Power ? The Case For Surrogacy. Family Law in Malaysia. ³ Redefining Mother. p. Micheal. (1989) ³ Is Surrogacy Exploitative?´ in Shiela Mc Lean's Legal Issues in Human Reproduction. Malayan Law Journal : Kuala Lumpur. who also commented that if state laws prohibit monetary inducement to adoption then similar prohibitions would make paid surrogacy illegal. [32] Corea. The Mother Machine.[23] Freeman. [36] See section 2(1) and (4) of the 1985 Act. 24. although abstaining fro having sexual intercourse with her husband after the treatment. 166. Gena.p. See comments on this issue Charo.. 308. 204. 1997. [38] For further comprehensive reading on the family laws in Malaysia. [25] Some writers have suggested that although the child will remain with the surrogate. [37] Lee. D.

1856. A. the UK government launched a study to look into the potential health problems faced by the 68. [45] Rahman. Darul Ilm Lil Malayin : Beirut. 18.com/cf_0/m0999/7239_320/61932188/print . M. the only difference is in the degree of the reaction given by the mothers.444-448. ³ Market-Inalienability´.The Sun. [44] See Surah An-Nisa' (4) : 7. ³ UK to track health of IVF children´. 1849. Afzalur. See Connor.000 children conceived as a result of fertility treatment since the first test-tube baby was born in 1978.p. 1998. [43] See Surah Al-Talaq (65) : 7. ³ Treatment by in vitro fertilisation with surrogacy : experience of one British Centre.Butterworths : Singapore. For example. ( 1981) Quranic Sciences. 23 October 2002. For further reading see Radin. 100 : 8.´ (2000) British Medical Journal. [48] Tests have shown that the surrogate mother is affected by the separation. [40] For a more detailed reading on the concept of immorality and public policy under and its application under Malaysian laws.J. Fifoot and Furmstone's Law of Contract. . Cloning by way of nuclear transfer technology offers this possibility which in turn has it own set of legal and ethical issues that need to be discussed elsewhere. according to Radin. [42] This is clear from the prohibitions of having sexual inter course outside of marriage and extra-marital affairs. Rohi. inalienability can sometimes mean things which are non-transferable but there are time when it can come to mean things which are transferable but only non-saleable. Steve. [41] Baalbaki. The Muslim School Trusts : London. p. See Brinsden. p.findarticles.´ (1987) Harvard Law Review. "father" in relation to an illegitimate child means the natural father. p. [50] There is however a new possibility for single women to have children without having to depend on men. [47] Radin.[39] See section 2 of Adoption Act 1952 (Revised 1981. This would include those born from surrogacy arrangements. Chesire. [46] Some writers have however differentiated the two.jhtml] [49] Recently. see. (1996) Al-Mawrid. Boon Leong.P. ³ Market-Inalienability. See Surah Al-Isra' (17) : 32 and Surah Al-Nur (24) : 2.159. p. Available : [ http://www.

. Daripada seorang kanak-kanak dengan keizinan ibu bapanya dan prosedurnya tidak mengakibatkan mudarat. 5. kebijaksanaan. saintifik dan dikendalikan oleh penyelidik yang benar-benar mempunyai kemahiran. Harus melakukan penyelidikan ke atas pra-embrio untuk mengetahui penyakit genetik bagi pasangan suami isteri yang berisiko tinggi dan hanya embrio yang dikenalpasti bebas dari penyakit sahaja boleh ditanam dalam rahim ibunya dalam tempoh perkahwinan yang sah. Rawatan kejuruteraan genetik ke atas pra-embrio yang melibatkan pengubahsuaian sifat semulajadi seperti rambut. Praembrio hasil penyelidikan ini. tidak boleh sama sekali ditanam dalam rahim isteri atau mana-mana wanita yang lain. pemilihan jantina diharuskan sekiranya faktor jantina menatijahkan suatu penyakit genetik yang serius yang boleh membawa kematian. warna rambut.HUKUM PENGKLONAN TERAPEUTIK DAN PENYELIDIKAN SEL STEM (STEM CELL) y Sosial/Syariah Keputusan: 1. Penyelidikan hendaklah dijalankan secara sah dan proposal penyelidikan mestilah jelas. 4. 3. Pengklonan terapeutik untuk tujuan rawatan perubatan seperti mencipta sel-sel tertentu atau menggantikan organ yang telah rosak dengan mengambil kira langkah-langkah sempadan yang dibenarkan oleh syara' adalah diharuskan. Harus menggunakan embrio yang disimpan beku atau lebihan embrio dari proses persenyawaan di luar rahim (IVF) untuk tujuan penyelidikan dengan syarat mendapat persetujuan pasangan suami isteri yang menerima rawatan dan kajian tersebut dilakukan sebelum mencapai tahap "alaqah"(blastocyst). Sebarang penyelidikan yang berunsurkan komersial atau yang tiada kaitan dengan kesihatan ibu atau janin adalah tidak dibenarkan. Sel stem daripada sumber-sumber berikut adalah harus digunakan untuk tujuan rawatan perubatan dan kaji selidik: a. 6. Penyelidikan ke atas pra-embrio selain dari untuk tujuan terapeutik hendaklah mendapat kebenaran daripada pasangan suami isteri. amanah serta bertanggungjawab. 2. Daripada seorang dewasa (sel stem dewasa) dengan izin dan prosedurnya tidak mengakibatkan mudarat. ketinggian dan sebagainya termasuk memilih jantina adalah haram. 7. Bagaimanapun. b.

AGM.500-2. P. Daripada janin yang gugur secara spontan atau keguguran akibat daripada rawatan perubatan yang dibenarkan syara' dengan syarat mendapat keizinan ibu bapanya. Status Penwartaan: Diwartakan Nombor Rujukan: [Mufti.c. 13. Daripada uri dan darah tali pusat bayi dengan keizinan ibu bapanya. PU.Sel.0 Akta/Enakmen: Sel.Sel.U. bukan janin yang digugurkan secara sengaja atau digugurkan tanpa sebab-sebab perubatan yang dibenarkan oleh syara'. d. Sel stem daripada embrio yang dihasilkan secara sengaja (created embryo) dengan teknologi Somatic Cell Nuclear Transfer ( SCNT ) adalah tidak dibenarkan berdasarkan kaedah saddul zaraie" iaitu menutup pintu keburukan. . Daripada lebihan embrio (excess embryos) yang disimpan beku daripada teknologi bantuan kesuburan IVF dengan syarat mendapat keizinan daripada ibu bapanya. e.

Sign up to vote on this title
UsefulNot useful