1. We dissent from the majority recommendations relating to research on the fertilised ovum in vitro (hereafter referred to as the embryo) because they do not in our view go far enough to protect the embryo and the values it symbolises. In addition to the specific recommendations on the topic in the report we recommend that:-

1. "Destructive non-therapeutic experimentation" on an embryo should be prohibited; and

2. The creation of an embryo for the purpose of research or experimentation on it should be prohibited.

2. Each of the two principal recommendations is derived from our belief that the fertilised ovum is biologically a unique living entity with potential to grow into a human person. For that reason it is, we believe, morally entitled to such a degree of respect that protection in the form of the recommended prohibitions is appropriate. Our reasons are given below. As will be apparent from the form of the first of our recommendations we have drawn substantially upon the report of the majority of the Senate Select Committee on the Human Embryo Experimentation Bill 1985 (the Tate Committee) Human Embryo Experimentation in Australia (1986) (hereafter called "the Tate Report"). We specifically adopt the following passage from that Report:

"Whilst it may not be possible to achieve agreement, either among scientists or others, on the complete set of attributes of this entity formed from the fusion of sperm and ovum, it may be of assistance to establish those attributes for which there is general agreement; that is, to achieve a minimum description of it. Two universally accepted attributes are that the fertilised ovum has 'life' and that it is genetically human (ie it is composed of genetic material entirely from the species Homo sapiens). It is also generally agreed that if is an entity a centrally organised unit which has a purposeful independent function as opposed to an organ or tissues). It also has developmental potential (whether that may progress to little more than cleavage, or to birth and on to subsequent adulthood). The latter attribute is of great significance." (Para 2.6)

See also the evidence of Dr Kerin set out in para 2.17 of that Report.

3. It is our understanding that there is universal support for the proposition that the embryo is entitled to respect that reflects these biological facts. Disagreement centres upon the level of that respect; whether it has any different application before the period in which the embryo is capable of implantation (generally accepted as 14 days from fertilisation); whether decisions about the "fate" of particular embryos are to be made by the donors of the gametes, by ethics committees, or by society generally and universally; and about the means of enforcing such decisions.

4. In our judgment the appropriate level of respect to be afforded to the fertilised ovum requires that it should not be regarded as an object to be created or to be used for research as an end in itself. In one sense this is but to restate the two recommended prohibitions in an alternative form. This method of expressing this principle which we shall seek to support below draws attention to the fact that the embryo has in our view in this regard the same attributes as a living person. It attracts these particular attributes and as a result qualifies for recognition of the rights which form part of these attributes. (The nature and level of legal recognition of these attributes is a separate issue dealt with later.) The conclusion in this paragraph is a moral judgment not a scientific fact. We seek to defend it on ethical grounds and it may be disputed on ethical (but not exclusively scientific) grounds.

5. We do not assert that the embryo is n person with all of the legal or moral rights of a person. To say that would be to contradict the reasoning of a virtually unbroken tradition of Western moral philosophy, canon law (until changed in the Catholic Church as late as 1869) and English common law that held the termination of fetal life that was not formats (recognisably human) did not constitute homicide (see P Badham, "Christian Belief and the Ethics of In-Vitro Fertilization and Abortion" (1987) 6 Bioethics News p7). This same tradition condemned abortion, with varying degrees of opprobrium, depending on the stage of development of the foetus. But it did not, so far as we are aware, ever treat the embryo or "unformed" foetus as an object to be baptised or, if expelled by natural or procured abortion, afforded any form of burial rite.

6. The rights of a living person not to be treated as a mere object for research are stated categorically and authoritatively in the introduction to the 1964 Declaration of Helsinki:

“In the field of biomedical research a fundamental distinction must be recognized between medical research in which the aim is essentially diagnostic or therapeutic for a patient, and medical research, the essential object of which is purely scientific and without direct diagnostic or therapeutic value to the person subjected to the research.”

Section 3 of that Declaration, dealing with non-therapeutic clinical research, states that "in the purely scientific application of clinical 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 clinical research is being carried out." Whilst the Helsinki Declaration was obviously intended to deal with biomedical research on living human beings we consider it should be applied to the fertilised ovum for reasons set out below.

7. The starting point in our reasoning why the embryo attracts these attributes is its biological nature summarised in para 2 above. These scientifically ascertainable facts represent a recent confirmation of something that was simply asserted in former times or even denied by the majority of moral philosophers who contended that "quickening" occurred well after fertilisation. In this sense science has created or presented material calling for a moral judgment in the light of new facts. It is also science that has brought us IVF itself ,with its capacity to "create" and sustain extra-corporeally a living entity that may grow to a human person after transfer. It is only in the last decade that anyone could examine with a microscope the cells constituting the early embryo and discern and track their development.

8. A further analysis of the debate around the status of the embryo in respect of its "personhood" or the attribute of "life" given it by the Tate Report, is offered by Daine Mary Warnock. ("In Vitro Fertilization: the Ethical Issues (11)", in the Philosophical Quarterly, Vol 33 No 132). She believes it may be preferable to identify the principles rather than the "rights" associated with a person, or the characteristics of those on whom they are to be conferred. The suggestion she poses is that the object about which treatment is being considered should be perceived as a "human being" rather than whether or not "it" is a person. "Human" is a biological term and simply distinguishes human from other animals. She suggests that "we being human... there are ways of treating our fellow humans that are right and ways that are wrong." This in itself "is a moral principle, the very principle, in fact upon which the demand/or rights depends". We believe it is Warnock's suggestion that this principle which reflects our humanity directs us to regard fellow members of our species as in a special relation to ourselves. There is an acceptance that there are problems with such a principle. It will not cover, for example the treatment of all embryos; some will be aborted spontaneously, others will live and die without any awareness of their existence. "Nevertheless however far from full humanity a foetus may be, we would do well to remember that it is a human foetus" she writes.

9. Having decided that the embryo is sufficiently, human to warrant protection, Warnock analyses the philosophical positions of Utilitarianism and what she terms strict Utilitarianism. She identifies the position of people who cannot support these approaches because of their moral beliefs and feelings. She places the emphasis on the fact that it may particularly be their feelings or sentiments which can have a central influence on their moral decision making. In discussing a woman's views on what should be done with say her spare embryos, whether this be consent for experimentation or not, "the matter turns not on her reasons, but her feelings". Warnock quotes Hume who has said that morality is "more properly felt than judged of". Finally she goes on to express her strong view that the essence of morality can be the existence of a set of not necessarily coherent or unified principles, which constitute barriers against what is felt to be wrong doing. She suggests that often members of committees and other organizational enquiries find it difficult to believe anything but that a moral judgment should be rational or else based on religious dogma.

10. Most official inquiries (and this report is no exception) recognise those attributes in the recommendation that at the very least non-therapeutic research and experimentation on the embryo in vitro should cease after the 14 day period. There are many reasons why it is generally seen as immoral to develop the embryo beyond or significantly beyond the 14 day period in order to produce a medium for research which is intended to be discarded once the research goal has been achieved. Some of these reasons are basic attitudes of personal revulsion which may or may not reflect moral judgments but which are generally seen to be valid nevertheless. Other reasons are given which are more obviously within the realm of moral discourse and cover a range of deontological and teleological stances. These appear to have nothing to do with the sentience of the embryo because those that hold them seem generally to accept that brain activity does not commence until 10-12 weeks after fertilisation. Some of these attitudes proceed from concern not to harm or abuse the entity itself ; others add that disrespect for this form of life may lead to disrespect for other and more developed forms of human life including living persons. Not everyone holds these views (see Fortin, "Legal Protection for the Unborn Child" (1988) 51 Mod L 54) , but they are so widely accepted that they require no further elaboration or justification in this dissent.

11. These views about the more developed embryo and the foetus are important because they are the starting point from which debate must be joined concerning the attributes of the embryo during its first 14 days of existence. We call this the early embryo, without (we hope) thereby prejudging or slanting the debate. Why then should the respect which society is generally prepared to afford to the embryo after 14 days from fertilisation not be afforded for this earlier period?

12. The main justifications currently advanced for distinguishing the early embryo and (subject to specific approval by an appropriate authority) permitting destructive non-therapeutic research on it appear to be threefold:-

(a) The interests of humanity in the increase of scientific and medical knowledge justifies using the early embryo as a vehicle for non-therapeutic research;

(b) The process of implantation which the 14 day period conventionally represents is biologically a marker event of such significance that it is not possible to project the moral concern to protect the embryo back earlier than that event;

(c) The IVF embryo does not have the capacity to develop into a living human being because it requires implantation into a uterus and this in turn necessitates the willing consent of the recipient woman.

13. We do not consider any of these propositions to be sound as a justification for drawing the line of protection at the 14 day old embryo.

14.(a) The needs of humanity. It is an historical fact that IVF would not have developed so rapidly to its present stage had such research been prohibited as we would now seek to do. It may be conceded that the prohibition will impede some (but not all) further research into the causes and treatment of infertility and congenital disease as well as the other areas of medicine for which society screams for a cure. As Professor Robertson has put it, "restrictions on embryo research thus carry a price-tag in terms of foregone knowledge which could improve the lives of persons in important ways" ("Embryo & Research (1986) 24 U W Ont LR p17). But the same can be said for non-therapeutic research on the embryo after 14 days, on the foetus, on the neonate, on the healthy adult and the aged person who is about to die from a terminal illness. Yet we are not prepared to allow any of these to be laboratories for destructive non-therapeutic experimentation. The reason is simply stated in the maxim that "the end does not justify the means". We see no reason why the early embryo should be treated any differently, although this involves the need to meet other arguments to which we shall turn shortly. The facts that the early embryo in vitro has been "created" by "artificial conception" and that it is accessible simply because it is not in utero do not appear to create appropriate grounds for being prepared to do something with it that most would refuse to do were it in utero. (We do not say that the maxim about the end not justifying the means has no exceptions, but we cannot conceive of any in this area. To those who ask if we would change our minds if science could guarantee that our view was preventing the immediate discovery of the cure for cancer, we can only say that we are unsure what our response would there be. We are however presently satisfied in point of fact that no-one can guarantee that any specific beneficial advance that cannot be procured by alternative means would occur from permitting destructive non-therapeutic experimentation that is so beneficial and so imminent that this can be justified on any form of utilitarian analysis.)

15. In the case of living human beings, a decision to protect from destructive non-therapeutic experimentation affirms an important value about the meaning of their life itself. Although each such person is one out of billions, he or she is unique and entitled to have that uniqueness affirmed by such an appropriate moral and legal right. We would base such a view partly upon moral premises derived from theological grounds. Others would reach an identical ethical position from different moral premises, some of which we would doubtless also share. Dispute centres upon the conclusions one draws from these and other premises and the question of their application to the early embryo.

16.(b) Implantation as a significant marker event. As to this ground for distinguishing the early embryo we adopt the Arguments of the majority of the Senate Select Committee in paras 3.8 - 3.24 of the Tate Report. The competing scientific and moral arguments are there summarised and reasons given for the Committee's conclusion that it was not persuaded of the inherent ethical validity of the marker event. We wish to add simply that we find great difficulty in understanding how the existence of the so-called marker event that others perceive to exist at 14 days becomes the basis for their virtually unanimous consensus for drawing the line against destructive research at 14 days. In other words, the capacity to implant which is achieved at about 14 days' development does not itself explain why that point is chosen as the limit of a particular type of research.

17.(c) The IVF embryo's incapacity to develop without a willing Recipient. As to this ground for distinguishing the early embryo, we refer to the discussion concerning the "capacity" or potential" argument in para 8.39 - 8.46 of this Commission's Discussion Paper In Vitro Fertilization (DP 15, 1987). The Commission there tentatively advanced its reasons why it rejected the "capacity" or "potential" argument which was advanced by the majority of the Senate Select Committee, and why it supported what we have termed (in para 12) the third main justification currently advanced for distinguishing the early embryo. This Commission's reasoning was strongly attacked in a number of submissions made in response to the Discussion Paper. On consideration of these submissions we have reached the view that the tentative conclusions in the Discussion Paper in which we participated cannot be supported. There is in our view no essential difference in this regard between the early embryo on the one hand and the more advanced embryo or the new-born child on the other. All are entirely dependent upon external human assistance for both life and development.

18. In any event, while it may be morally permissible for that assistance to be withdrawn in some cases (eg, arguably extraordinary means of life support for seriously incapacitated neonates), it does not follow even there that destructive non-therapeutic experimentation is justified. In all cases involving persons, including the seriously incapacitated neonate, it is generally considered wrong to treat the person as an object for destructive research that has no therapeutic purpose. As far as we are aware the protection which law and morality affords to any of these persons does not depend upon their capacity to feel pain or their ability to survive and develop. It would generally be regarded as quite wrong for a dying acephalous child to be subjected to such experimentation. Equally, most persons would unhesitatingly deny the right to conduct non-therapeutic experimentation upon an accident victim who has suffered irreversible brain-damage and is permanently comatose (often spoken of as "reduced to a vegetable"). If one accepts the description of the early embryo summarised in para 2 above and the conclusion that nothing occurs at about the 14 day period that represents a significant marker event then we see no logical ground for distinguishing the position of the early embryo from the later embryo, the foetus or the living person so far as concerns external dependency as the basis for a moral decision about research. Indeed the early embryo may have greater "potential" than the accident victim referred to above (cf Michael A Jones, "Research on Human Embryo: The Ethics of Pragmatism" (1985) Professional Negligence p21).

19. In stating these views we are obviously rejecting the arguments of Senators Crowley and Zakharov of the Senate Select Committee in para D40 of their dissenting report. They reason that since the developmental potential of what we have described as the early embryo is dependent on decisions made about it, ie for a woman to decide to accept the embryo into her uterus, then it follows that the decision-maker can determine for the embryo prior to implantation. Those same Senators also supported this view by arguing, as did the majority of the Tate Committee, that no woman should be compelled to have an embryo transferred to her uterus (see esp paras D31-D35). The difficulty is that a right to consent to destructive non-therapeutic research simply does not follow from these premises. Together with the other members of the New South Wales Law Reform Commission on the Artificial Conception Division (see para 5.44 of report), we accept that no woman can be compelled to have a fertilised ovum implanted in her uterus; and that in consequence the effective decision as to the fate of the embryo can and will be made in the usual case by the woman who provided the ovum. But this is simply to recognise the reality of the woman's position and the practical limitations of legal control (cf Re F (in utero) [1988] 2 All ER 193) if not indeed (as many would claim) the moral right to assert her personal liberty regardless of the apparent state of health of the embryo or her prior decision in the matter. if that leaves to those having the custody of the embryo the effective choice of freezing or destroying the embryo, that is the incidental effect of the woman's decision. The law cannot and (most would argue) should not compel the woman or some surrogate to maximise the embryo's chance of development and survival at the expense of the woman's liberty. Be that as it may, it simply does not follow that the woman or any other person involved in the creation of the fertilised ovum has the right to decide what forms of experimentation are appropriate for the early embryo, other than to prevent certain types of experimentation The question is not "who shall decide", but "who shall decide what?". We come back to the position that the early embryo is in this regard more than just a part or extension of the woman's body.

20. In any event it seems to us that even if the ovum provider and/or the man whose sperm fertilised the ovum may exercise "guardianship" or other types of control over the early embryo, such rights would seem logically to cease at the time when those gamete- providers cease to have any particular interest in the welfare of the embryo as such. To authorise the use of the embryo as an object for destructive non-therapeutic research has clearly passed to this stage. Personal consent, and a fortiori the proxy consent of a guardian does not under current law justify maiming without justification (Attorney General's Reference (No 6 of 1980) [1981] 1 QB 715); or the transplantation of non-regenerative tissue of a minor (Human Tissue Act 1983, s8).

21. We wish to stress however that we give no support to those who would in the matter of experimentation or research, seek to give to the early embryo a greater level of respect than that which they afford to a living person. Subject to the resolution of issues about the "guardianship" of the embryo in vitro for the purpose of giving appropriate consents, there is in our minds no reason why that embryo should not be subject to therapeutic research which may obviously (but incidentally) lead to the advancement of medical science or which carries a risk of harm which happens to eventuate. For this reason we would reject s14(2)(b) of the Reproductive Technology Act 1987 (SA) as an appropriate model. To prohibit, as it does, research "that may be detrimental to an embryo" (emphasis added) is to elevate the embryo to a status greater than that afforded to living human beings. All research and life generally involve elements of risk. Medical ethics frequently addresses the issues of what regard should be given to the possible risks inherent in a medical procedure or form of medical research and it does so in a comparatively uncontroversial way (eg, NH & MRC Statement on Human Experimentation, supplementary note 2, clause AS). There is indeed widespread support for the ethical validity of non-therapeutic research on children subject to strict limits, including (obviously) minimal risk to the subject (see G Dworkin, "Law and medical experimentation: Of embryos, children and others with limited legal capacity" (1987) 13 Mon ULR 189 esp at pp198, 202, 205). As we shall we hope make plain in our later discussion about the definition of the concept of destructive non-therapeutic experimentation we are concerned only to prevent experimentation which has no purpose of conferring any benefit on the embryo concerned. We note that the 1987 Instruction of the Catholic Church which some would oppose for its "conservative" view in other respects supports this approach (see below para 29).

22. We have, we trust, made plain that our recommendations thus far are based on a judgment which stems from a scientific fact but is essentially an ethical one. The question then arises as to how we justify the recommendation that the two prohibitions should be universal rules. Many highly respected persons and groups argue that decisions as to the type of experiments to which the early embryo may be subjected are matters for individual judgment. Included amongst them are the NH & MRC and the majority of this Commission with whose views on this point we regretfully dissent. They argue that there are many people in the community who do not have a moral objection to what we have termed destructive non-therapeutic experimentation provided that there are appropriate safeguards. These safeguards are said to include the consent of the gamete-providers, the prior approval of an institutional ethics committee and the approval of some established body such as the New South Wales Biomedical Council proposed in Recommendation 1 of this report. Those who hold this view argue (correctly) that the onus rests upon people like ourselves who would seek to deny the liberty of those in control of the early embryo to do with it that which they believe to be morally just and which has the consent of the appropriate persons or bodies whom the law currently deems authorised to give such consent. It is obvious that one is immediately thrown into the area of controversy as to the respective roles of law and morality. The famous Hart-Devlin debate discussed these issues and they recur repeatedly in modern pluralist societies.

23. Those who say that their view of morality should be backed up by legal sanctions and those that deny this in a particular or general context are in turn debating moral propositions on which minds will legitimately differ. While the latter group stress the importance of freedom, that premise and the conclusions drawn from it are matters of moral judgment. of course the mere fact that something is widely or even universally seen to be wrong does not in itself justify legal regulation. Professor Charlesworth has reminded us that, "we must... not expect the law to be the agency by which a common morality should be enforced in the community. Equally, we must resist the idea that if the law is silent on a particular issue, that it is condoning a line of action or conniving in it". ("New Ways of Life & Death" (1984) 61 Current Affairs Bulletin 4 at p20.) To the extent that opinions differ as to the correctness of the conduct, the law should be increasingly hesitant to intrude.

24. Nevertheless the law can and does daily intrude into what may be said to be matters of morality although they are usually described these days as political or social decisions. A clear example is the use of the law to protect the environment, something that was virtually unheard of until this century but now has wide but not universal acceptance at least in matters of detail. Issues of protection of the early embryo and the values it represents cannot be swept into a separate compartment marked "private morality - no regulation" simply because this is an area of difficulty and present controversy.

25. It is, we suggest, reasonable to take as a starting point that the law should not be used as a mechanism to control conduct which some regard to be proper and others improper unless at the very least:-

1. those seeking to convert their moral judgment into legal prohibition have a clear and ethically reasonable conviction that the conduct sought to be proscribed is harmful and wrong;

2. the conduct to be proscribed is capable of clear description;

3. prohibition would not be counterproductive, eg because the law would be brought into disrepute when judges and jurors effectively declined to enforce a particular criminal law; and

4. there is some likelihood that the conduct to be proscribed would take place in the absence of the proscription.

26. We stress that the four criteria mentioned in the previous paragraph are but prerequisites to possible legal intervention. They are we believe satisfied in the present case. The threshhold is crossed, certainly with respect to specific non-criminal sanctions for breach (see below, para 29). It is, furthermore, appropriate that the law should seek to prevent the two types of conduct to which we have referred. Compendiously but briefly our reasons for these conclusions are:-

(a) There is widespread concern that medical science should be regulated to some degree in this field. To our understanding Most scientists themselves seek to have some limits prescribed if only to ensure they may work within those limits without undue criticism.

(b) Making due allowance for the beneficial work of experimental scientists and the possibilities which research offers in this field, the level of sensitivity which many people in society have about this particular issue suggests a need for caution.

(c) The biological evidence now available in relation to the early embryo means that we have the advantage which former generations lacked of knowing as a scientific fact that it is a genetically unique living entity. We have already dwelt upon its other attributes which relevantly call for this level of protection in our view.

(d) In the absence of restraint there is a clear indication that some, and perhaps an increasing volume of, destructive non-therapeutic experimentation on the early embryo will take place. It has occurred, and scientists in this country wish to engage in such types of research under certain conditions.

(e) Many of those who argue for absence of general control (eg, the dissenting senators in the Senate Select Committee) do so for what in our view is an unsound reason. They assert in effect that the justification for their view flows from the decision of persons who in this regard (ie consent to destructive non-therapeutic research) we consider to lack any special interest that would sustain such a decision (see paras 19-20 above). We wish to make plain that we accept that the gamete-providers have an intimate and real concern that sets them apart from the public generally. In this regard their moral opinions are entitled to very special weight. What we are however saying is that their moral judgments must be assessed by the arguments advanced to support them: they do not draw their justification from the simple fact that the judgments are advanced by gamete-providers. Particularly when it is in vitro and about to be subjected to destructive experimentation, the embryo is more than a part or projection of their bodies.

(f) We deal. below (paras 29-35) with the question of definition of the proscribed conduct and the proposed sanctions for its breach.

27. Before we turn to the question of the form of legal sanction which is proposed, we recommend that whatever form of legal underpinning is given to the recommendations made in para 1 there should be a five-year sunset clause. This will ensure that the arguments which would prevail if our recommendations were accepted have to be advanced again after the five-year period if the legal restraints are to be prolonged. Some will construe this as a lack of conviction on our part about the correctness of the recommendations which we make. We, on the other hand, would see it as a recognition of the fact that this is an area of great difficulty and one in which extensive public debate is just beginning. As scientific knowledge develops, so may the arguments for or against change (cf para 7 above). Because as we have already said the onus should be on those who seek to restrict the liberty of others to do that which they may believe to be morally correct there should be no restraint placed in the way of the matter being debated afresh after a reasonable interval. A five-year period would allow the impact of the restraints to be monitored in terms of developments in this State and elsewhere and it would mean that those whose views differ from mine would bear no impediment or stigma for seeking to re-agitate discussion on the topic.

28. On the topic of sanctions the choice is essentially between a criminal prohibition where a penalty flows, and a licensing condition where the consequence of breach is (after an appropriate finding) the loss of licence. It is of course possible to impose both forms of sanction concurrently (cf Reproductive Technology Act 1987 (SA), ss14(4) and is).

29. We recommend that the sanction for breach of the prohibitions referred to in para 1 should not be criminal but should be loss of licence for any participant knowingly involved and for the research establishment itself if the prohibition was breached in circumstances other than on where the management had a reasonable excuse for failing to prevent it. In addition breach should constitute professional misconduct for any person who is in a profession having such a concept. Our reasons for declining to recommend a criminal sanction in lieu or in addition are essentially pragmatic. A criminal sanction would encourage a literal or restrictive as distinct from generous and purposive interpretation of the legislated form of prohibition. It would also inevitably encourage attempts to justify prohibited conduct by an appeal to the moral judgment of the individual jury who would doubtless be given "scientific" evidence about the intended benefit of the proscribed actions. If these things occurred the substantive recommendations we have already made, including that directed at relatively dispassionate review after a decent interval, would risk being undermined at the altar of an individual researcher's possible martyrdom. We note that this non-criminal form of sanction was proposed by several of those who made submissions to the Commission advocating a level of protection for the early embryo equal to or stronger than that embodied in our proposals.

30. If our recommendations are adopted there will be no need to define a period after fertilisation at which any legal restraint is to be lifted, whereas this will be necessary (but not difficult) if the majority recommendations are simply adopted. However, our first major recommendation (see para 1) requires the use of the concept "destructive non-therapeutic experimentation". We believe this term to have sufficient clarity of application that it is appropriate for use as part of a non-criminal prohibition of conduct, although it may be expanded in an appropriate definitional clause.

31. The distinction between therapeutic and non-therapeutic research is well recognised in the field of medical ethics. The clearest illustration of this is in the use of the concept in the Declaration of Helsinki (para 6 above). The National Health & medical Research Council. has formally recognised this Declaration in its published Statement on Human Experimentation and Supplementary Notes. Supplementary Note 2 deals with "Research on Children, the Mentally Ill and those in Dependent Relationships or Comparable Situations" and, in dealing with the ethics of research on children stressed the nee- to determine the acceptability of the risk/benefit relationship of any research study (cl A(3)(ii)). Clause A(5) states:

"Risks of research may be considered in terms of:

(i) therapeutic research (where the procedure may be of some benefit to the child).

In determining whether there is an acceptable relationship between potential benefit and the risk involved, it is essential to weigh the risk of the proposed research against customary therapeutic measures and the natural hazards of the disease or condition.

(ii) non-therapeutic research (where the procedure is of no direct benefit to the child).

The risk to the child should be so minimal as to be little more than the risks run in everyday life.

Risks of research in this context include the risk of causing physical disturbance, discomfort, anxiety, pain or psychological disturbance of the child or the parents rather than the risk of serious harm, which would be unacceptable."

The same distinction is reflected in the 1987 Instruction on Respect for Human Life in its Origin and on the Dignity of Procreation issued on behalf of the Catholic Church by the Sacred Congregation for the Doctrine of the Faith. That stated (in p24):

"One must uphold as licit procedures carried out on the human embryo which respect the life and integrity of the embryo and do not involve disproportionate risks for it but are directed towards its healing, the improvement of its condition of health, or its individual survival."

32. This distinction is also generally recognised by the law: see eg Re D [1976] Fam 185 at 196; Re Eve (1986) 31 DLR (4th) 1 at 34. Recently members of the House of Lords were critical of the usefulness of the distinction in relation to the exercise of the parental jurisdiction of the court to authorise the sterilisation of a severely mentally handicapped ward (Re B [1987] 2 All ER 206 at 213C, 214C, 219C). They stressed, nevertheless, that approval to a medical procedure for a minor or mentally incompetent person would only be given when it was for the benefit of that person. In this field the interests of society generally and of the person's near relations were quite irrelevant (Re B at 214C, 219D; see also Re Eve at 29, 31). "The discretion is to be exercised for the benefit of that person, not for that of others" (Re Eve at 29 per La Forest J).

33. The well known therapeutic/non-therapeutic distinction addresses the question of the overriding intention of the person performing the relevant procedure. It asks whether that was directed to the benefit of the person (or embryo) or at the benefit of others. The fact that healthy development does not occur is not critical (cf the child suffering terminal cancer whose parents consent to some radical treatment with little or no proven chance of success). Nor does a procedure become non-therapeutic simply because it is observed and the results recorded for the benefit of medical science generally.

34. To reduce further the possibility of difficulty in application we propose that "destructive" be added to the prohibited form of procedure. This is intended to add a cumulative requirement in order to underscore that only certain types of non-therapeutic research are to be precluded absolutely (cf para 21) . We would expect that this concept of "destructive" might be further defined by Parliamentary counsel who could draw on statements such as those discussed in para 31.

35. One additional drafting matter is prompted by a comment of the dissenting Senators Crowley and Zakharov ("Tate Report" para D98). This is the desirability of indicating whose intent is relevant in relation to the non-therapeutic destructive procedure. In our view the relevant person is the researcher involved.

36. Finally on matters of definition we record, in relation to our second principal recommendation (para 1 above), that we do not see any real difficulty in creating a civil prohibition of an act done for a particular "purpose". There may be difficulties of proof, but the fact that a person may contemplate a number of possible consequences of an action does not mean that each is necessarily part of his or her "purpose". Where there is a plurality of purposes present, the ulterior purposes will only vitiate the act "if the ulterior purpose is a substantial purpose in the sense that no attempt would have been made to do (the act) if it had not been desired to achieve the unauthorised purpose" (Samrein Pty Ltd v MWSDB (1982) 56 ALJR 679 at 679).

37. Before ending this note of dissent we wish to address briefly what we perceive to he some likely objections that may be raised to our proposals on the matter of research. Without, we hope, falling prey to pretentiousness, may we do it in the form of a short "socratic" dialogue with someone we shall call X:

X: Your proposals would Stop IVF in this State.

KM/EL: No, there are already clinics here and elsewhere which practice IVF without doing any research. Besides, many forms of research would be permitted under my proposals (subject to the other controls recommended in the majority report). A significant one is embryo biopsy which involves the removal and culture of one or two cells from an embryo still in vitro which need not affect the subsequent development of the embryo.

X: Well at least it would be tougher in this State than elsewhere. Don't forget that some scientists believe it is morally wrong to implant IVF embryos unless particular procedures have been adequately tested and sometimes this means that some embryos have to be used for such testing even if it means that they are thereby destroyed. Your proposals will either force our scientists to do their research in a less restrictive jurisdiction; or (worse still) cash in on the research of others elsewhere. You are just pushing the moral issue outside this State.

KM/EL: If that is the consequence of our legislators adopting our proposals so be it. But what you are really saying amounts no more than to recognise that we are proposing a universal norm for this State which we both know will not please those who wish to disregard it even for the highest motives. Like individuals, no society can abdicate its own moral or legal responsibility because others see things differently or are not prepared to give effect to the views they in fact hold. The point about the morality of using the research data of others overseas who are not subject to similar constraints is a difficult one. It has surfaced recently in the United States involving proposals to use apparently significant scientific data recorded in the course of inhuman experiments by Nazis upon human subjects.

X: All this talk about "morals". I just want to allow those scientists or couples who see nothing inherently wrong with any type of research to do what they wish to do. You are trying to stop the development of knowledge by making moral judgments.

KM/EL: But can't you see we are all making ethical or moral judgments. The protection which we choose to give or withhold from the early embryo necessarily involves the making of moral judgments. We may argue about our premises and about the conclusions we draw from them for that is the nature of ethical discourse. Those who assert the liberty of the gamete-donors or the scientists to decide what they think is right and themselves making judgments. It is often they who appear unwilling to argue the reasons why the premises lead to permitting all forms of research (subject to individual restraints). Similarly, the pluralism of Australian society cautions one to be restrained but it does not paralyse action. We happen to believe that we don't solve an immense ethical problem by passing ii to others to decide.

X: It worries me that you want to give such a level of protection to what you term the early embryo, but what are really clusters of up to a few dozen undifferentiated cells. The Economist summarised what we are talking about as follows (15 November 1986): "There is no distinguishing between cells which might much later become part of a foetus - or two foetuses - and those which may become a placenta, an umbilical cord or other extra-embryonic matter. Indeed, the cells may become a cancerous mole which could kill a mother if it was in her womb. But the likeliest fate for such a cluster of cells if it is in its natural environment, a womb - is destruction. Most early embryos (at least 60%) fail to implant themselves in the wall of the womb and are lost before anybody knew they were there".

KM/EL: We don't dispute those facts, but to us they miss the point. Don't forget that we are only against destructive non-therapeutic research and the creation of embryos for thepurpose of research. If you accept the proposition that the embryo is human life which (given ideal circumstances) can develop into a living human person we draw the Line (for reasons already given) at using that embryo for ends which have nothing to do with its own individual welfare.

X: Well society will look rather silly if it legally condones the therapeutic abortion of the fully developed foetus (eg at 8 weeks) and the destruction of the in vitro embryo after 14 days but balks at using your early embryo for research which may lead to significant advances.

KM/EL: Those who take an absolutist or near-absolutist view on the abortion debate would agree. But again, we say we are dealing with different things. Whatever be the moral rights and wrongs about a decision to abort therapeutically where there is no real risk to the mother (however defined) the fact is that there are significant legal difficulties in the enforcement of any abortion prohibition. The evidentiary problems and the unwillingness of juries to convict coupled with the risks to health of mothers if they are driven by law to disreputable and unqualified abortionists are factors which are totally removed from the present issue. The law cannot effectively require any woman to become an unwilling life support system for an ovum fertilised in vitro, even if it were morally right to contemplate doing so in any circumstances. For these reasons the embryo's and the foetus's viability and potentiality can in fact be frustrated by circumstances external to it. But this does not address what we perceive to be the issue, which is the appropriateness of using that entity for research purposes that have nothing to do with its own welfare and which are necessarily destructive of it. If the debate really were about abortion we would be finding people willing to contemplate destructive or even non-therapeutic research well beyond the 14 day limit which is widely acknowledged today. We know that there are many who seem to take a strong stance for or against destructive non-therapeutic research depending on their attitudes to the abortion issue, but we don't. The dangers of confusing the two are fully discussed by Professor Robertson in his article "Extracorporeal Embryos and the Abortion Debate" (1986) 2 Journal of Contemporary Health Law & Policy 53.