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Discussion Paper 15 (1987) - Artificial Conception: In Vitro Fertilization

8. Research, Experimentation and IVF

History of this Reference (Digest)

I. STATUS OF THE OVUM FERTILIZED IN VITRO

A. Background

8.1 The regulation of research and experimentation on IVF fertilized ova has sparked public debate the world over. It is not an overstatement to say that the IVF debate today is, for all practical purposes, a debate about research. In this Chapter we use the word “research” because of its substantial definitional overlap with the word “experimentation” to cover the activities also comprehended by “experimentation”.

8.2 As we shall show in this Chapter, there is reason for the opinion that resolution of the research issue will either allow the continuation of the practice of IVF or bring about its cessation. Accepting that the future resolution of that issue should not necessarily be determined by what has happened in the past, we believe that it should not be forgotten that IVF as practised today was developed following extensive research and experimentation on human gametes and fertilized human ova and could not have been developed otherwise. This fact is significant for any decision that accepts the IVF procedure but requires prohibition of IVF research.

8.3 At the heart of any decision regarding the acceptability of IVF research is the question of the moral, as opposed to the legal status of the IVF embryo. A leading United States authority on ttie issues posed by IVF has written that there is a general tendency “to apply one’s views about the fetus and abortion almost automatically to the preimplantation embryo”.¹ The fact is that the ovum fertilized in vitro, while outside the human body, differs profoundly from the nattirally-fertilized ovum or conceptus both in the treatment which it must receive for development and in its potential for development.

B. Anatomical and Physiological Characteristics

8.4 The IVF procedure involves the insemination of an ovum by sperm in a laboratory dish. Fertilization of the ovum is a gradual process which begins with contact between sperm and ovum. A single sperm will penetrate the ovum during the next few hours and, within three to 10 hours from first contact, male and female “pronuclei” will form in the centre. The complete union or fusion of the pronuclei, that is, the indissoluble mingling of the chromosomes of the two partners, will be complete between 22 and 30 hours from commencement of the process.² The fertilized ovum is called a “zygote”, and is only one cell. The zygote begins to divide, or “cleave”, first into two cells (24 to 36 hours), then four (40 to 50 hours), then eight and so on, so that 50 to 78 hours af ter insemination, it consists of a cluster of about eight cells. It is around this point that the IVF embryo is normally transferred to a woman’ s uterus. It is not visible to the naked eye.

8.5 In the uterus (or in vivo), the cell cluster continues to divide until it consists of considerably more than eight cells. At this stage of its development, typically three or four days after fertilization, it is called a “morula” from the Latin for “mulberry”, which it resembles. Cell division continues and a cavity begins to form within the conceptus. The cavity fills with fluid and finally forms a single large space. At this point the morula is called a “blastocyst”, and consists of an outer cell layer (trophectoderm) which gives rise to the “trophoblast” and an inner cell mass which may subsequently give rise to placental membranes and the embryo, properly so-called.³

8.6 The blastocyst normally floats free in the uterus for a few days before “implantation”, that is, before attaching itself to the endometrium or lining of the uterus. Implantation of the blastocyst into the maternal cells of the endometrium marks the beginning of recognisable pregnancy.⁴ The process of implantation is normally completed towards the end of the second week following fertilization, that is six to 12 days after ovulation.

8.7 Until this stage the outer cell layer has played the major role in the developmental process. The inner cell mass has developed into “endoderm” and “ectoderm.” However, once implantation is complete the endoderm and ectoderm reorganize into what is termed the embryonic disc.⁵ The third post-fertilization week is characterized by the formation of a ridge of cells along the embryonic disc. This is the “primitive streak”, the “first true rudiment of the embryo”⁶ along which all the tissues and organs of the embryo will develop.⁷ It has been said that:

... biologic individuality emerges only after implantation and the emergence of the embryonic axis [primitive streak]. Prior to that time, several or no embryos might emerge from the developing fertilized egg.

⁸

Traditionally the use of the word “embryo” to describe the developing human zygote or conceptus is not used until after the embryonic disc forms at the end of the second week following ovulation.⁹

8.8 By the end of the fourth week the rudiments of all major organs are present and cardiovascular circulation has begun. By the eighth week, an anatomically recognizable human miniature exists, displaying very primitive neuromuscular function, but still extremely immature by all structural and functional criteria. From this point until birth, the developing human life is called a fetus. The higher parts of the brain do not show any electrical activity or nerve cell connections until 12 weeks after fertilization.¹⁰ Viability of a fetus, or its ability to exist independently of its mother, is usually calculated from the beginning of the twenty-sixth week following fertilization, although fetuses as young as 20 weeks have been known to survive. Birth usually occurs in the thirty-eighth week following fertilization.

8.9 Prior to implantation, the conceptus lacks even the rudimentary structures of a nervous system. It has no capacity to think or feel. It is not yet individual (see para 8.7). It follows that the proposition that the pre-implantation conceptus should be accorded all or some measure of the respect that we accord to human persons, must be based upon considerations other than biological status.

C. Legal and Moral Status of the IVF Embryo

8.10 In law, neither the embryo nor the fetus is a person (see para 3.8). The issue for present purposes is whether the IVF fertilized ovum should be so classified in relation to IVF research. Basically, there are three lines of thought on this matter. The first is that from the “moment” of fertilization the IVF conceptus is a human person or has the capacity to become a person and therefore should be accorded all the rights attaching to “personhood”. Advocates of this line would oppose any action prior to ET which might “harm” the conceptus including freezing and research. As already mentioned, fertilization itself is not instantaneous but is a process like other features of human life.

8.11 The second view, at the opposite extreme, is that the IVF conceptus prior to ET is nothing more than a collection of human cells and should receive no greater (or less) regard than any other separated human tissue. Research on it would accordingly be subject to no limitations except those applying to medical and scientific research on human tissues.

8.12 A third view is that the IVF conceptus, while not entitled to the same measure of respect as is accorded to a person, should be treated with greater respect than other “extracorporeal” human tissue. The measure of respect which the IVF conceptus would be given would be based not upon its instant biological characteristics, but upon its capacity or potential for development into a person (given certain conditions and events). The ultimate successful development of the IVF conceptus, is to become a human person. As one commentator has noted, it may be accorded respect in order to symbolize respect for human life generally:

Such symbolizing is an essential part of any human community, and helps constitute and identify the community’s values.

¹¹

8.13 This view has been widely adopted by official Inquiries. For example, the Ethics Advisory Board of the United States Department of Health, Education and Welfare in its comprehensive 1979 report used the following widely-quoted words:

... the human embryo is entitled to profound respect; but this respect does not necessarily encompass the full legal moral rights attributed to persons.

¹²

Its recommendations were unanimous, and favoured the conduct of properly-conducted research on the IVF embryo. The United Kingdom Committee recommended that the human embryo should be afforded “some protection”,¹³ though not “necessarily” the full protection accorded a living child or adult. The majority of that Committee also favoured properly-conducted research on the IVF conceptus.

8.14 The difficulty is in deciding how far the measure of respect to be accorded the IVF conceptus should extend. An illustration of the conflict generated by this question may be found in the opposing views of members of a recent Australian Inquiry into the issue, undertaken by the Senate Select Committee on the Human Embryo Experimentation Bill 1985. The Committee did not assert that the IVF conceptus is a human person. However, a majority of the committee in effect did so by recommending that, in relation to research, it should be treated as though it were a living person.¹⁴ The basis for recommending this degree of respect was said to be found in its “orientation to the future.”¹⁵ is In the words of the majority:

If, as is the view of the [majority of] the Committee, the embryo may be properly described as genetically new human life organised as a distinct entity oriented towards future development, then the stance and behaviour proper to adopt towards it would include not frustrating a process which commands respect because its thrust is towards the further development of a biologically individuated member of the human species.

¹⁶

The majority held that fertilization and birth are the critical “marker events” in the development of a conceptus, and from the time of fertilization until birth there should be no “frustration” of its development. A minority report which strongly disagreed with the majority report was published by two of the female members.

II. RESEARCH¹⁷ ON HUMAN SUBJECTS AND THE IVF EMBRYO

A. Purpose and Justification

8.15 The acquisition of knowledge by planned scientific research and experimentation is as old as the practice of medicine.¹⁸ Medicine cannot develop, and knowledge cannot be systematically acquired, without research. One eminent American writer wrote that “all serious therapy is experimental”,¹⁹ and it is no more than trite to say that medicine and research go hand in hand.

8.16 In its 1982 report Ethics in Medical Research the NHMRC included a background paper on IVF and ET which made the following significant observations on IVF research:

Research with sperm, ova and fertilized ova has been, and remains, inseparable from the development of safe and effective IVF and ET.
It is also clear that as part of this research important scientific information concerning human reproductive biology might legitimately be sought.
It is clear that uninhibited research on human sperm, ova, embryos and embryonic tissues is ethically unacceptable; not everything that can be done should be done.²⁰

8.17 The NHMRC principles regulating IVF practice and associated research reflect these comments which acknowledge that IVF itself became a successful procedure as the direct result of research and experimentation involving the fertilization of human ova by human sperm. This, of necessity, involved failure as well as success, and the discard of much human tissue including fertilized ova. Principle 5 of the NHMRC rules on IVF research repeats almost word for word the contents of (1) and (2) in paragraph 8.16 above. The effect of the principle is that such research may be ethically performed in Australia, subject to a stated limitation of time:

.... continuation of embryonic development in vitro beyond the stage at which implantation would normally occur is not acceptable.

8.18 As a matter of normal scientific practice, research on humans is preceded by laboratory experiments and experiments on animals. The general NHMRC Statement on Human Experimentation provides in paragraph (4):

The research protocol should ... wherever possible be based on prior laboratory and animal experiments.

8.19 Pursuant to official NHMRC national guidelines, an Australia-wide network of institutional ethics committees (IECs) has existed for some years for the purpose of the proper supervision of research on human subjects. Ethics committees operate in every institution in Australia that conducts research on humans. Their composition and functions, including record keeping, are governed by a separate set of NHMRC principles.²¹ The NHMRC has, with the assistance of state and territorial departments of health, identified all such institutions and monitors their operations.²² Additionally in 1985 the MREC audited all IVF clinics operating in Australia for compliance both with the IVF national guidelines and those relating to IECs and has published a report of its findings.²³ The likelihood of “uninhibited” IVF research of any significance taking place in Australia unnoticed, is, in our opinion, not high.

8.20 As far as serious IVF research is concerned, its aims and potential benefits are both specific and general. It offers, in the opinion of many, great improvement in individual health and the health of the entire community, for example -

the eradication of disease, abnormality, pain and suffering in female patients and children born with disease or defects;
study of very early human development which could lead to detection of the causes of congenital abnormalities and inherited disease, and development of treatments;
improvement in the practice and success of IVF and thus the possibility of direct benefit to a large segment of the population. As mentioned earlier, 10 to 15 per cent of couples of childbearing age are afflicted with infertility;
alleviation or eradication of infertility and knowledge of the causes of infertility;
improvement in knowledge of human conception;
possibility of improved methods of contraception with a consequent likely reduction in the number of abortions;
greater knowledge of embryo development and the reasons for interference with normal development by environmental and genetic factors; and
improvement in public health that must flow from increased information about human life at its earliest stages. Many believe that this line of research could also lead to radical improvement in the detection and treatment of cancer.

8.21 We believe that properly-conducted medical research should in principle be allowed to take place unless there is compelling reason to the contrary. In support of our position, we cite two documents. The first is the Declaration of Helsinki where it said:

Medical progress is based on research which ultimately must rest in part on experimentation involving human subjects.

The second is the evidence given to the Senate Select Committee by the MREC and its chairman. Para 2.1.4 of the written submission of the MREC said:

We question whether it would be ethically acceptable for the practice of IVF to continue if research critical for its improvement was made unlawful.

²⁴

In the course of his evidence the chairman of the MREC said, after citing the words just quoted:

I do not know that many responsible doctors would be willing to practise any branch of medicine in a field in which critical research was inhibited legally.

²⁵

Evidence of this kind, supplemented by positive statements to the same effect given to the Select Committee by numbers of leading IVF practitioners and scientists²⁶ justifies the conclusion that legislative prohibition of important IVF research may bring to an end IVF as a part of medical practice.²⁷

B. International and National Regulation of Research on Humans

8.22 In Australia and in other Western societies research on human subjects takes place within the confines of the law and normally within clear, publicly-recognised guidelines. The well known Declaration of Helsinki, adopted by the World Medical Assembly in 1986, contains principles to guide research workers and others concerned with research on human subjects. The principles address a variety of significant elements, including the skill and competence of the researcher, the balance of risks and benefits of research and the need for comprehending consent of (or on behalf of) the research subject. The Declaration refers to non-therapeutic Biomedical Research Subjects (non-clinical Biomedical Research) and says at paragraph 1:

In the purely scientific application of medical research carried out on a human being, it is the duty of the doctor to remain the protector of the life and health of that person on whom biomedical research is being carried out.

The Declaration of Helsinki is concerned with research on human persons capable of giving consent or for whom consent may be justifiably given. It is not concerned with research on embryos or IVF conceptuses prior to ET.

8.23 At the national level, the NHMRC produced in 1982 an official regulatory code of principles for IVF practice and associated research. It is one of a series of sets of principles published by the NHMRC inspired by the Declaration of Helsinki. One set of the NHMRC principles requires the establishment of an institutional ethics committee (IEC) in every Australian institution in which human research is undertaken (see para 8.19). These IECs are required to consider the ethical implications of all proposed research projects, to keep progress under surveillance and to maintain a register.²⁸ The IVF code of the NHMRC links the principles that govern IECs with the general NHMRC statement of principles that govern human research, by declaring that although IVF is an established practice, it contains an experimental component, thus falling both within the ambit of the general statement of principles mentioned and also under the jurisdictions of IECS.

C. Some Official Inquiries and Research on IVF

1. National Health and Medical Research Council

8.24 The NHMRC national principles regulating the practice of IVF and ET have already been referred to in paragraphs 3.12, 8.16 to 8.19 and 8.23. The principle relating to research provides:

Research with sperm, ova or fertilized ova has been and remains inseparable from the development of safe and effective IVF and ET... However continuation of embryonic development in vitro beyond the stage at which implantation would normally occur is not acceptable.

²⁹

2. The Victorian Inquiry

8.25 The Victorian Committee in its final report in 1984, recommended by a majority that embryo research should be permitted provided that the embryo is not allowed to develop beyond the stage of implantation, set at 14 days after fertilization. However, unlike the United Kingdom Committee the majority further recommended that research should be limited to the excess or “spare” embryos produced by patients in an IVF program³⁰ and that IVF conceptuses should not be created expressly for the purpose of research. Considerations of morality were uppermost in this decision:

... this individual and genetically unique human entity may not be formed solely and from the outset to be used as a means for any other human purpose, however laudable. Where the formation occurs in the course of an IVF procedure for the treatment of infertility, the reasons which lead to the embryo’s existence are not “means to an end.”

³¹

The Committee further recommended that research on human embryos be subject to regular scrutiny by the Health Commission. The recommendations of the majority have been reflected in the legislation enacted in Victoria in November 1984. That legislation provides a regime, now in force in Victoria, under which “spare embryos” may be the subject of research. This matter is discussed further in paragraphs 8.36 and 8.45 to 8.48.

3. The United Kingdom Report

8.26 The United Kingdom Committee gave careful consideration to the use of human embryos for scientific research. The majority decided that research on IVF fertilized ova should be permitted, subject to licensing, up to the end of the fourteenth day after fertilization. Beyond that time, research on the IVF embryo should constitute a criminal offence. The time limit was chosen as being just before the time of the formation of the primitive streak.³²

8.27 Members of the Inquiry were divided on the question whether research should be permitted on ova fertilized in vitro specifically for the purpose of research. The majority recommended that research should be permitted in such a case on the basis that:

... if research on ... embryos is to be permitted at all, it makes no difference whether these embryos happen to be available or were brought into existence for the sake of research. In neither case would these embryos have a potential for life because in neither case were they to be transferred to a uterus.

³³

It was further decided that no fertilized ovum which had been used for research should be transferred to a woman.³⁴

4. The United Kingdom - Voluntary Licensing Authority (VLA)

8.28 A significant consequence of the United Kingdom Report was the establishment in 1985 of the Voluntary Licensing Authority (VLA) which is described in paragraph 9. 13 below. The VLA exercises supervision over IVF research in the United Kingdom and provides details of research projects in its annual reports.

5. The Ontario Report

8.29 The Ontario Law Reform Commission, when considering the question of IVF research, proceeded from the assumption that “embryonic research is necessary for human welfare, not simply for the development and refinement of the IVF procedure itself”.³⁵ As a result, its recommendations began with a proposal that research and experimentation on fertilized ova be permitted³⁶ and subsequent recommendations addressed the practical aspects of a system of control or regulation of research. Regulation was to be achieved by restricting research on pre-implantation conceptuses to research centres approved by the Ministry of Health. A research centre would only be eligible for approval if it had established an ethical review committee for the internal screening of research projects.³⁷

8.30 However, the Commission also expressed an opinion on the subject of the transfer of pre-implantation embryos which have been subjected to research, in the following words:

... an embryo that has been the subject of experimentation that has no direct therapeutic purpose in relation to the ovum should not be transferred to a woman.

³⁸

On the subject of an embryo that has been the subject of therapeutic measures, the Commission was divided.

6. The Australian Senate Select Committee Inquiry

8.31 In April 1985, a private member’s bill was introduced into the Australian Senate. That bill, entitled the Human Embryo Experimentation Bill, provides for the prohibition of experimenting (as defined by the bill) “in relation to the IVF conceptus prior to implantation in the womb of a woman”. Its further consideration was deferred pending the report of a Senate Select Committee already referred to in paragraph 8.14. Throughout 1986 the Select Committee conducted hearings in a number of Australian capital cities.

8.32 The Committee reported in September 1986. Two of the seven members published a strong dissenting report. Senator Harradine, who was the proponent of the bill and a member of the committee, signed the majority report but also published a “Qualifying Statement”. The majority drew a distinction between therapeutic and non-therapeutic experimentation, and recommended prohibition of “destructive non-therapeutic experimentation” defined as:

... experiments [that] are, in the present state of knowledge, so invasive as to inevitably cause the destruction of the subject of the experiment.

³⁹

If given effect, the recommendations would, we believe, prevent research on IVF conceptuses of the kind described in paragraph 8.20 and may have other consequences as referred to in paragraph 8.21.

8.33 The crucial conclusion of the committee’s majority was that an Australia-wide statutory prohibition of most research on IVF “embryos” specialty defined by the majority) should he introduced with criminal penalties.⁴⁰ The foundation of this conclusion, and of the majority’s entire report⁴¹ is the special definition of “embryos”:

... the embryo may be property described as genetically new human life organised as a distinct entity oriented towards further development.

⁴²

The majority emphasises the importance to its report of its own definition by “adopting the usage ‘embryo’ to describe the fertilized ovum and succeeding stages up to the observation of human form”.⁴³ This statement followed a lengthy physiological discussion of the processes of fertilization and a careful analysis of the use and meaning of the word “embryo”.⁴⁴ It is, however, significant that nowhere in the discussion and analysis is there any reference to the differences between an ovum fertilized by the IVF process and one fertilized by sexual intercourse, although the differences are obliquely referred to at the end of the majority’s report.⁴⁵ We discuss these differences later in this Chapter.

8.34 Having defined “embryo” as described above the majority report then concluded without further analysis or argument, that

... the stance and behaviour proper to adopt towards it would include not frustrating a process which commands respect because its thrust is towards the further development of a biologically individuated member of the human species.

⁴⁶

We believe that this conclusion may be property described as a “value judgment” or a “moral judgment”.

8.35 For reasons which we now set out below, we are of the opinion that the majority report’s definition of “embryo” is defective because at the least it is ambiguous.

8.36 The majority state in their paragraph 2.21 that their usage of the word “embryo” is meant to refer to, or “speak of genetically new human life organised as a distinct entity oriented towards further development”. They also state in paragraph 2.21 that they use the word “‘embryo’ to describe the fertilised ovum and succeeding stages up to the observation of human form”.

The Commission has been advised that the phrase “genetically new human life” accurately describes the ripening ovum of every human female of childbearing age at the time of meiosis during her menstrual cycle.⁴⁷ Meiosis is a biological event when the ripening ovum sheds 23 of its 46 chromosomes in natural preparation for the possibility of fertilization. The ovum, by this natural process becomes not only a unique human cell but reorganises itself genetically and acquires a gene structure that is not the same as that of the other cells of the woman in whose body it occurs. The gene structure of the ovum is a “mix” of the male and female genes that make up the woman’s body, and the cell at that point is unique.⁴⁸ Its uniqueness is further illustrated by the fact that its gene structure is also different from that of every other ovum or oocyte in the woman’s body. The procedure of parthenogenesis can be and has been applied to human ova, causing them to develop without the use of sperm at all, in the same way as the fertilized ovum, up to the 8-cell stage at least.⁴⁹

We are not here concerned with the morality or ethics of parthenogenesis. Our concern is to demonstrate that other living human tissue than the fertilized human egg answers the description “genetically new human life organised as a distinct entity oriented towards further development”. It follows that an unfertilized human ovum that has been stimulated parthenogenetically is also covered precisely by the majority report’s definition of embryo. However, such an ovum is neither an embryo nor a fertilized ovum in any normally understood sense. Indeed, the majority report cites with approval statements that reject the suggestion that either ovum or sperm should be in any way equated with an embryo.⁵⁰ We are further advised that, conversely, there are human tissues that answer the majority’s definition of “embryo” but can never become an embryo (in the normal, medical sense), fetus or human person.⁵¹ For example, tissues, described scientifically as embryonic stem cells and terato-carcinoma cells, are developed in laboratories and are used for research. Their further development involves a disorganised differentiation into types of human somatic cells such as teeth, muscle and skin, but cannot form a human person. However, they answer the description “genetically new human life organised as a distinct entity oriented towards further development”.

III. A SUMMARY OF THE DEBATE ON IVF RESEARCH AND SOME TENTATIVE CONCLUSIONS

A. Arguments for Restriction of Research

8.37 Apart from the theological or moral propositions of religious faiths and denominations there have been two major arguments put forward to justify direct official restriction or prohibition of research on the IVF embryo. One is that the IVF embryo, from completion of fertilization, should be accorded by society status (often referred to as moral status) as a human person or a potential human person together with an entitlement to extensive protection. The basic proposition is that the human ovum, upon fertilization, is not only unique but different from other live human tissues because it has the capacity or potential to become a human person. Such uniqueness and capacity (or potential) are said to confer the moral status mentioned, which in turn is said to oblige society to extend protection of such a kind that the IVF fertilized ovum’s potential to develop into a human person cannot or should not, be thwarted for any reason. We call this the capacity argument” or “potential argument.”

8.38 The second argument is that the purposeful fertilization of human ova solely for research is repugnant or wrong and should be prohibited. However, if “spare,” “unwanted” or “supernumerary” fertilized ova should result at some stage from normal IVF procedures, they may be used, under strict controls, for research. We call this the “spare embryo” argument. We add that we are not aware of any argument or proposition ever having been put that research aimed to benefit a particular IVF embryo, should be prohibited or restricted, although some persons hold the opinion that the procedure of IVF itself is not acceptable.⁵²

B. The “Capacity” or “Potential” Argument

8.39 It follows from this argument that any research on an IVF conceptus not directly aimed to benefit that conceptus must be prohibited. The reason is that the “capacity” of the embryo to become a person is said to entitle it to be given the opportunity so to develop. Therefore it is not licit morally or ethically to conduct research that might frustrate that development. The distinction drawn between “spare” embryos and others is neither relevant nor acceptable on this approach.

8.40 Prohibited research would include all research on the IVF fertilized ovum directed to the alleviation or eradication of human infertility and thus to the birth of children who would not otherwise be born, to the improvement of the procedures of artificial conception, to the acquisition of knowledge of the reasons for infertility or of embryonic abnormality and to the other aims and benefits referred to in paragraph 8.20.

8.41 We believe the “capacity” argument to be fallacious. Its basis is extensively articulated in paragraphs 2. 17 and 2.18 of the Senate Select Committee majority report, which include the following quotations, cited by the majority with approval:

“From the time of fertilisation onwards the embryo has the for further development as an individual human being provided this is not interrupted by natural intervention such as spontaneous abortion, a major complication of pregnancy or interruption of the pregnancy by artificial means which threatens the well-being of the fetus” (Submission of Dr. John Kerin)⁵³; and
“Now when [fertilization] has taken place... a whole set of very remarkable has been established. Allowing for the normal availability of nourishment and a non-hostile environment, that [embryo] already has the capacity for directing its development in such a way that a brain is developed suitable for all those activities which we saw to be characteristic of human beings ... The capacities for those activities already exist in the genetic material of the embroil (Submission of St Vincents Bioethics Centre).⁵⁴

8.42 The foregoing quoted statements put the “capacity” proposition clearly. The argument invariably rests upon characteristics of the naturally-conceived embryo and implies or leaves it to the reader to accept that the IVF fertilized ovum possesses identical characteristics.

8.43 The fallacy is that the “capacity” argument ignores a fact that makes an ovum fertilized in vitro different from one that is naturally fertilized. Not only does the IVF embryo not possess the same characteristics as the naturally-conceived embryo, it exhibits a difference that in our view nullifies the argument itself .

8.44 The truth is that the IVF embryo does not have the capacities described in both quotes above. It does not have those capacities because it is produced or “created” outside the human body. It could be said that a number of the conditions that both quotes lay down for the development of their stated “capacities” are inapplicable or inappropriate to the IVF embryo, and as well it could be said that even if every condition were complied with, the IVF embryo will still lack the alleged “capacity” to become a person. The submissions quoted above in paragraph 8.41 say that the capacity for development into a human person depends on conditions, as follows:

“Provided this is not interrupted by natural intervention such as spontaneous abortion, a major complication of pregnancy or interruption of the pregnancy ...” (Kerin); and
“Allowing for the normal availability of nourishment and a non-hostile environment, that [embryo] already has the capacity ... (St Vincents Bioethics Centre).

None of the Kerin conditions have application to the IVF embryo prior to ET, which is the relevant period for the purposes of research under this discussion, because it is outside the human body. As to the St Vincents Bioethics Centre conditions, even if they were present or complied with, the IVF embryo could never become a human person. If given nourishment, the best available environment and no interference to impede its development, it will still wither and perish within a few days. On the other hand, the naturally-conceived embryo will develop into a human person if the conditions prescribed in both quoted propositions above and by the “capacity” argument are fulfilled.

8.45 If an ovum fertilized in vitro is to become a human person it must undergo a process not applicable or relevant to one that is naturally fertilized, namely transfer or placement in the uterus of a woman. In our society and, in our view, in Western societies generally, a further condition applies, namely that the recipient woman must willingly receive the embryo into tier body. Unless these two requirements are fulfilled, the IVF embryo will develop in its laboratory dish for a few days and then perish. Freezing is no “solution” because it merely postpones the inevitable. Further, we would reject the suggestion that a duty or obligation rests upon any woman (whoever it may be) to receive the IVF embryo into her body. Stich an assertion involves the creation of a new moral or ethical rule or, at the least, a debatable value judgment. In our opinion, the IVF embryo must be considered as it is. If it can be “produced” in the first place, its status must be determined on its own characteristics, not on the characteristics of a different kind of “embryo.”

8.46 The “capacity” argument fails on the ground that it bases its conclusions on an incorrect assertion or imputation, namely that at fertilization the characteristics of the IVF embryo are the same as those of the naturally-conceived embryo. It is also arguable that it fails on a second ground, namely that it assumes or suggests that the capacity of an embryo to become a human person (if it surmounts or survives the stated obstacles and threatening circumstances) of itself imposes a moral duty upon all other persons not to impede or frustrate the process for any reason at all. This is neither demonstrable nor capable of proof. It is a proposition.⁵⁵ In our view, even if the IVF embryo is considered to have the “capacity” to become a human person, it does not follow that it should be accorded the same treatment or “respect” as a human person nor that it should have immunities or entitlements of the degree suggested. The respect given to it at completion of fertilization could, justifiably, be less than at later stages (but it would be respect nonetheless) and could increase as the embryo develops. The moral and theological Judaeo-Christian tradition, according to some moral theologians, also says precisely that.⁵⁶ It is also the effect of a crucial conclusion of the United States Ethics Advisory Board.⁵⁷

C. The “Spare Embryo” Argument

8.47 This argument is not related to the “capacity” argument. It is not based on a moral duty that derives from the status (“capacity”) of the embryo. It is based to some extent on practical considerations, namely that there I will not be many “spare” embryos and that research on “spare” embryos is therefore not likely to be extensive, or to be a “floodgate” or a “slippery slope”. Some who favour this argument say that they see a moral distinction between research on embryos available “by chance” and research on those produced deliberately for that purpose. Others have seen a justification arising out of the philosophical proposition that an act may be permissible if it occurs as a by-product of a separate well-intended act, even though it would not be permissible if done for its own sake.⁵⁸

8.48 The “spare embryo” argument has also been based upon the belief that if IVF embryos are permitted to be “deliberately produced” for research, there will be unacceptably large numbers produced, and a likelihood of excess and abuse on the part of scientists. The argument demands regulation of research by reference to an “intention”.⁵⁹ The intention of all parties to the IVF process must be confined to fertilization of ova solely for reproductive purposes. If (for unforeseen reasons) not all the IVF embryos are needed or used for reproductive purposes they may be classified as “spare” and used for research.

8.49 Such an argument cannot, we believe, rest on a moral rule that gives a special status to embryos, because it will allow research on some IVF embryos and not on others. Obviously this can have nothing to do with the “capacity” or “potential” of an embryo (unless restricted to proven defective embryos). We find it difficult to accept for a number of reasons:

to the extent that moral or philosophical justification has been put forward for the “spare” embryo argument, we believe it to be unpersuasive as well as difficult, if not impossible, to police;
it can be readily circumvented by concealing or blurring the “intention”; and
it is arguably inconsistent for two reasons. The first is that it would allow research on existing (already produced) embryos but would prevent important research that requires the commencement and development of the IVF process. The second is that it would allow research on some embryos but not on others of the same kind, depending on the intention of the persons who produced them.

8.50 We observe that rejection of research on “spare embryos” was one of only two subjects on which all members of the Senate Select Committee were unanimously agreed. The other was the rejection of the Human Embryo Experimentation Bill 1985. Apart from a majority of the Victorian Committee in 1984 (five to four), no Australian official Inquiry, nor the Warnock Committee, nor the Ontario Report has favoured the “spare embryo” argument. It is, however, to be observed that the “spare embryo” concept has been entrenched in the Victorian statute.⁶⁰

D. Our conclusion on the debate

8.51 It can be seen that we have found ourselves unable to accept that either the “capacity” argument or the “spare embryo” argument provides persuasive reason to restrict or prohibit research on the IVF embryo entirely or substantially. We should add that we also do not accept the pivotal recommendation of the majority report of the Senate Select Committee (see its para 3.7) because that report relies to a large extent on the “capacity argument” and also because of our opinion that that recommendation is based on a definition of “embryo” which, for reasons given above, is defective, being at the least, ambiguous.

IV. THE DIFFICULTIES OF REGULATION

8.52 We are at the same time very much aware of the extraordinary difficulties in grappling with the regulation of IVF and its associated research. In order to indicate that our awareness of the difficulties mentioned is shared by others, we now quote from two recent publications from France and the United Kingdom respectively. The French National Consultative Ethics Committee for the Life Sciences and Health in a report published for consideration in the context of its international roundtable held in Paris on the 15th December 1986 wrote:

Some people object to the very principle of any research on the embryo, because of the respect which they bear for the person which they recognise in it. The embryo consequently cannot be subjected to experiments leading to treating it as an object.

Others, who do not reject the principle of research nevertheless diverge on the analysis of the aims pursued, of the means which it uses, on the interest or usefulness which it offers and of the limits which should be imposed thereon.

Research on the human embryo is however today a reality which cannot be ignored and which must be brought under regulation.

Despite the opposition of some of its members, the Committee thinks that it is not possible a priori to exclude all research on the embryo in vitro, or to prohibit the donation of supernumerary embryos for this purpose.

However the Committee thinks that research, because it concerns the embryo, a potential person, and because of its consequences, must imperatively be subjected to rules and must come under a social control by organisations whose composition reflects different schools of thought.

These rules and these controls are required for mastering the power of science on the genesis of human life and for requiring those who are led to use such research to give an account of the use of their power.

The contents of the rules must take into consideration not only the requirements of fundamental ethics but also the contradictions, the risks and the uncertainties of research on the human embryo, as well as the advantages which may be reasonably be expected there from:

- contradiction for example between the legitimity of research relating to the well-being of the child to be born and the need to experiment before on the human embryo ...

⁶¹

8.53 The second publication is a Consultation Paper presented to the United Kingdom parliament in December 1986 and entitled Legislation on Human Infertility Services and Embryo Research, which put to the United Kingdom public for further consideration a number of issues raised by the Warnock Report in mid 1984. On the subject of research on the IVF embryo it says:

The majority view of the Warnock Committee was that research should be permitted in certain circumstances and within carefully defined controls. They recommended that:

a. the embryo of the human species should be afforded some protection in law:

b. any unauthorised use of an in vitro embryo should in itself constitute a criminal

offence:

c. the Statutory Licensing Authority should license research conducted on human embryos in vitro

d. research might be carried out on any embryo resulting from IVF, whatever its provenance, up to the end of the 14th day after fertilisation but subject to all other restrictions as may be imposed by the licensing body.

The Warnock Committee’s report highlights the diversity of views about human embryo research Two of the three expressions of dissent in the report were about this subject. Three members of the Committee recommended that no experimentation should be permitted because of the potential of the embryo to become a human person. Four other members of the Committee drew a distinction between the use of “spare” embryos produced during attempts at IVF, for research and the deliberate creation of embryos perhaps from donor gametes, purely for the purpose of research. That group thought that the former was acceptable but not the latter.

Those who favoured the continuation of controlled research involving human embryos have suggested that the continuation of this research is very important because it offers a number of benefits which could not be obtained in any other way ...

Those who are opposed to any research involving human embryos argue that embryos from the point of conception have the same human status as that of a child or an adult...The embryo should be seen as fully human because of its potential for human life ...

⁶²

V. TIME LIMITS ON RESEARCH

8.54 Reference should be made to the matter of time limits upon research on ova fertilized by IVF. The United Kingdom Report favoured a time limit of 14 days after fertilization. The Victorian Committee favoured the same time limit. The NHMRC principle on research states that “continuation of embryonic development in vitro beyond the stage at which implantation would normally occur is not acceptable”.

8.55 Our inquiries indicate that the 14 day limits were intended to relate to the latest time for implantation of the conceptus in the uterine lining. There may be little logic in the selection of “implantation” as a reference point, particularly as a conceptus that has been the subject of research will almost certainly not be transferred to a woman. On the other hand there is an arguable case to justify such a time limit.

8.56 We believe that these recommendations of time limits reflect a judgment of community feeling. They involve a recognition that there are grounds for preventing the “uninhibited research” rejected by the NHMRC⁶³ and a belief that the community would not tolerate at present the growth of conceptuses and embryos in laboratories for periods beyond the time when they could be feasibly transferred to a human uterus.

8.57 We therefore pose the question whether, if research on the IVF fertilized ovum is to continue, a time limit should be set on its permissible development while it is outside the human body? The answer, in our opinion, should involve an assessment of what a reasonable person would think: what would be the upper limit for research acceptable to persons of good conscience? We believe that a time limit should be set for research and that time limit should relate to implantation, whether it is described by reference to implantation or whether it is a specific period such as 14 days. We consider that the community would tolerate properly-conducted research on the IVF fertilized ovum within such a limit, provided that it could be confident that other reasonable constraints and procedures would also exist by way of accountability, supervision and record-keeping. It may be that in the future the time limit would be extended, for example from the time of implantation to the stage before development of sentience. Such extension would be related to community opinion and acceptance at the time.

VI. TENTATIVE CONCLUSIONS

8.58 Our conclusions on the subject of IVF research at the present time may be summarised as follows:

We are persuaded that the public interest requires that medical research in general and in relation to IVF in particular should take place under reasonable conditions that will balance freedom against regulation and accountability.
We recognise the deep division of opinion in the community concerning IVF research evidenced both by public comment and by the reports of significant Official Inquiries.
We agree with the French National Consultative Ethics Committee that it is not possible (nor in our view justifiable) “to exclude all research on the embryo in vitro”.
We agree that the ovum fertilized in vitro should be afforded protection, and in this regard we bear in mind the opinion of the United States Ethics Advisory Board and the NHMRC that it is entitled to respect but not necessarily the same respect that is due to a person.
We believe that such respect may be justifiably underwritten by legislation.
We are not persuaded by the proposition that research should be substantially or wholly prohibited by legislation because of the moral status of the IVF fertilized ovum. Our reason is that no argument that we have seen in support of the proposition can be sustained without resort to moral or theological assumptions that are subject to genuine debate and opposition in the community.
We do not accept the proposition that research on “spare” IVF fertilized ova may be permitted while research on other IVF fertilized ova should be prohibited.
In our opinion, properly-conducted research on ova fertilized in vitro may be conducted prior to ET under conditions that include, but are not necessarily restricted to, the following:

(i) Registration or licensing of the research institution

(ii) An overall time limit fixed by reference to implantation

(iii) Reasonable review or supervision

(iv) Record keeping

(v) Accountability through a reporting process

(vi) Reasonable limits on the purpose of the research, for example the alleviation of infertility, the alleviation or eradication of disease and abnormality at birth and the acquisition of knowledge for the relief of human suffering that cannot feasibly be obtained otherwise.

VII. ISSUES FOR REFORM

1. Should research on the human ovum fertilized in vitro be legally regulated?
2. If so, how should such regulation be implemented?
3. Alternatively, should such research be legally prohibited?
4. Should it be permissible to fertilize the human ovum in vitro solely for the purpose of research?
5. Should it be permissible to transfer to a woman a fertilized ovum that has been the subject of research?
6. Should a time limit be placed on the permissible development of the ovum fertilized in vitro while it is outside the human body?

Footnotes

1. J A Robertson “Embryos, Families and Procreative Liberty: The Legal Structure of the New Reproduction” (1986) 59(5) Southern California Law Review 942 at 971.

2. Information supplied by Dr Alan Trounson and Dr Ismail Kola, respectively Director and Research Fellow of the Centre for Early Human Development, Monash University, Melbourne on 9 June 1987 in personal discussion with the Commissioner-in-charge.

3. K L Moore The Developing Human (3rd ed 1982) at 33.

4. Note 1 at 969.

5. Note 2 above.

6. Note 1 at 969. The endoderm and ectoderm also produce extraembryonic tissue, such as the yolk sac.

7. Note 3 at 53.

8. Note 1 at 969 note 92.

9. Note 2 above; See also R O’Rahilly Developmental Stages in Human Embryos, Part A, Embryos of the first 3 weeks.

10. Note 1 at 969.

11. Id at 975.

12. Ethics Advisory Board Department of Health, Education and Welfare HEW Support of Research Involving Human In Vitro Fertilization and Embryo Transfer (4 May 1979) at 101.

13. United Kingdom Report at para 11.17.

14. Senate Select Committee Report at paras 3.22, 3.23, 3.24.

15. Id at xiii and para 3.6.

16. Id at para 3.7.

17. For the purposes of this discussion we make no distinction between research and experimentation. Although distinctions can be drawn between the two, they overlap substantially, as study of the dictionary will confirm. In our view, discussion of research and experimentation in relation to IVF can only be aided by using the words interchangeably.

18. Russell Scott “Test Tube Babies, Experimental Medicine and Allied Problems” (1984) 58 Australian Law Journal 405.

19. P A Freund (ed) Experimentation with Human Subjects (1972) xii.

20. NHMRC Ethics in Medical Research (1983) at 27, 31 and 36.

21. Id, Supplementary note 1 at 19.

22. MREC Workshops on the constitution and functions of Institutional Ethics Committees in Australia 1984-1985 (November 1985).

23. IVF Audit Report.

24. Senate Select Committee on Human Embryo Experimentation Bill 1985 Hansard Report of Evidence (26 February 1986) at 303.

25. Id at 377.

26. See eg the Submission of Mr W I H Johnston, note 24 at 555 and his oral evidence at 661.

27. See para 8. 1 5 above ; also note 20, Supplementary Note 4, principle (5) at 20.

28. Note 20 at 19-20.

29. Id at 27.

30. Victorian Report (1984) at para 3.26.

31. Id at para 3.27.

32. Note 13 at paras 11.19-11.21.

33. Id at para 11.28.

34. Id at para 11.10.

35. Ontario Report vot II at 208.

36. Id at 209.

37. Id at 212.

38. Id at 213.

39. Note 14 at para 2.31.

40. Id at xiv - xv, conclusions 8, 15 and 17.

41. Id at paras 3.6, 3.7, 3.21 and 3.22.

42. Id at para 3.7.

43. Id at para 2.21.

44. Id at paras 2.2-2.20.

45. Id at para 5.14.

46. Id at para 3.7.

47. Note 2 above.

48. Ibid.

49. Ibid; see also R R Angell, R J Aitken, P F A Van Look, M A Lumsden, A A Templeton “Chromosome abnormalities in human embryos after IVF” (1983) Nature Vol 303 at 336-338. A Laws-King, A Trounson, H Sathananthan, I Kola “Fertilization of Human Eggs by Micromanipulation of a Single Spermatozoon under the zona pellucidall (1987) Fertility and Sterility (in press).

50. Note 14 at para 3.6.

51. Note 2 above.

52. See paras 4. S and 4. 6 above: according to eight sep arate Morgan Gallup polls, three quarters of the Australian population approve of IVF as a treatment for infertile couples.

53. Note 14 at para 2.17.

54. Id at para 2.18.

55. Congregation for the Doctrine of the Faith, Instruction on Respect tor Human Life in its Origin and on the Dignity of Procreation (Vatican City, 1987); see also para 8.34.

56. See eg P Badham “Christian Belief and the Ethics of In-Vitro Fertilization and Abortion” (1987) 6(2) Bioethics News 7; G R Dunstan “The moral status of the human embryo: a tradition recalled” (1984) 1 Journal of Medical Ethics 38.

57. Note 12 at 101.

58. Note 13 at 11.27.

59. Infertility (Medical Procedures) Act 1984 (Vic) s6.

60. Ibid.

61. French National Consultative Ethics Committee Report Relative to Research Work on Human Embryos In Vitro and Use Thereof For Medical and Scientific Purposes (December 1986) at 15-l6.

62. Department of Health and Social Security Legislation on Human Infertility Services and Embryo Research (HMSO Cmnd 46, London 1986) at paras 46, 47, 48 and 52.

63. Note 20 at 31.

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