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Submission from CMF to the Department of Health in response to 'Human Bodies, Human Choices - The Law on Human Organs and Tissue in England and Wales'

Published: 14th October 2002

Introduction

Christian Medical Fellowship (CMF) is interdenominational and has as members over 4,500 doctors throughout the United Kingdom and Ireland who are Christians and who desire their professional and personal lives to be governed by the Christian faith as revealed in the Bible. We have members in all branches of the profession, and through the International Christian Medical and Dental Association are linked with like-minded colleagues in more than 90 other countries.

We regularly make submissions on a whole range of ethical matters to Governmental and other bodies, and welcome this opportunity to comment on 'Human Bodies, Human Choices - the law on human organs and tissue in England and Wales'.

Past submissions are available on our website at www.cmf.org.uk/publicpolicy/submissions/

Our ethical code is based on the Judeo-Christian ethic as revealed in the Bible; and is broadly in conformity with historical ethical codes such as the Hippocratic Oath, Declaration of Geneva (1948) and International Code of Medical Ethics (1949).

Principles from our ethical code relevant to this debate include:

  1. We acknowledge that God is the Creator, the Sustainer and the Lord of all life. All human life, is made in the image of God, belongs to God and should be treated with the utmost respect from its beginning to its end, including the unborn, the helpless, the handicapped and those advanced in age.
  2. We are accountable to God in all we do and, therefore, we endeavour to conduct our private and professional lives in accordance with the standards of Christ, in loving and serving others sacrificially.
  3. The social structures of society, including state and family, are divinely instituted in order to uphold the protection of the vulnerable, the care of children, the security of the family and the stability of society.
  4. Each patient must be served according to his need, using only those drugs and procedures that we believe will be of benefit to him. This means that health professionals must subordinate personal gain to the interest of the patient and decline to take part in collective action that would harm him.
  5. Patients' privacy, opinions and personal feelings must be safeguarded, and they must be told the truth about their diagnosis, prognosis and treatment, as far as they are able and willing to accept it, so as to ensure as far as possible fully informed consent.
  6. We aim to work constructively with colleagues in scientific research and in training doctors, nurses and paramedical workers, for the benefit of individual patients and the advance of health care throughout the world.

We have not answered all questions posed in the review, and for some sections (especially 3, 15-17) have added a lengthy preamble to our responses. We are concerned that the scope of this review extends far beyond the consideration of the handling of organs and tissues resulting from the Alder Hey enquiry, and are especially concerned that the issues of transplantation, fetal tissue and stem cells have been incorporated in this enquiry rather than being treated separately. The latter approach would have provided much more time for a proper consultation. As it is the title of the report gives no indication that such important matters were to be included. This leaves the impression that the department is appearing to want to 'smuggle some things through' on the back of another consultation rather than giving them the time and effort they deserve. With such an important review we would have wanted to consult more widely on specific sections than time has permitted.

However, this being said, we do wish the department all the best in their deliberations.

Preliminary points

  1. We endorse the respectful use of human remains for medical education, research and transplantation provided that appropriate procedures regarding consent and treatment of the remains are followed. The retention of human tissue and organs following autopsies is a valuable medical practice for ensuring correct diagnoses, the continued education of medical staff and students, and for research. Access to archives of human organs enables review of past cases as new ones arise, which leads to improvements in our knowledge of disease processes. Examples of this can be seen with the management of congenital heart disease, and our understanding of dementia.

    2. It is therefore necessary that a coherent approach is developed for this practice, and we are pleased that the Department of Health is giving this matter such careful consideration. The shift in emphasis from 'retention' to 'donation' is a welcome one. This will, however, require an increased openness on behalf of practitioners and more complete education of the public regarding this aspect of medical practice.

    3. While this is welcome, the capacities of an already over-stretched national health service will be a limiting factor on how well this can be achieved. Following the Alder Hey and Bristol enquiries it is crucial that a relationship of trust is fostered between doctors and the public. The 'informed consent' procedure may only be capable of achieving this where it is managed properly, with sufficient time to discuss the relevant issues with patients and address their concerns. When this time is lacking there is a danger that 'consent' will become merely a mechanism to protect doctors, rather than to respect and reassure patients and relatives.

    4. Similarly the fact remains that not all patients/public want 'full' information, especially in situations of distress or recent bereavement. For example, unless relatives are expressly requesting it, it is not appropriate to give a full description of what physically happens during an autopsy; and most will be content with knowing that an experienced and trustworthy professional will carry out an examination of the body (including retention and microscopic examination of organs and tissues where necessary) once they are satisfied that the purpose for doing it is justified.

    5. We worry that rapid drafting of laws and amendments may lead to unmanageable outcomes, and prefer guidelines that can be modified with practice. We need a Human Tissue Authority to oversee research and ethical aspects of tissue archives (and that includes material from surgical operations - another area of historical ignorance). But the autopsy will continue to be a fundamental part of clinical governance and medical education.

    6. The granting of guardianship to parents is on the assumption that they will be acting in the best interests of their human offspring (including children, fetuses and embryos). It is never in the best interests of human beings to be killed, and so parents who either authorise or willingly comply with the destruction of their offspring, for whatever reason, have ceased to protect their offspring or to act in their best interests, and are thereby not acting as guardians. We relinquish our right to donate tissue from our own offspring, if we have deliberately conspire in harming them.

Section 3 - Present Legal Framework

A Christian perspective on death and the body

It is important that the beliefs of individuals involved in any given situation are respected and given proper consideration. England is an increasingly multi-cultural society, and there will be great variance in the attitudes that people have towards death and the dead body.

But we are also concerned that Christian attitudes to the body and to death are not sidelined in the desire to respect other traditions and in particular a materialist view. In fact we believe that the materialist view, which equates the person with the body, is a big part of the problem that led to some of the public outrage expressed at the Alder Hey 'scandal'.

Christianity has a high view of the body. The 'English Hippocrates', Thomas Sydenham, in his advice to his students, as published in 'Medical observations concerning the History and Cure of Acute Diseases' in 1688, crystallises what should be doctors' attitudes to living human beings: 'Whoever applies himself to medicine should seriously weigh the following considerations...he must remember that it is no mean or ignoble creature that he deals with. We may ascertain the worth of the human race since for its sake God's only begotten Son became man and thereby ennobled the nature that he took upon him.'

The Bible tells us that the human body is material - made from 'the dust of the ground', but also made a living being by 'the breath of God'.(Genesis 2:7) It is a 'tent', or 'clothes' ( 2 Corinthians 5:1-5), allowing expression of the real person who is 'at home' in the body, then absent from it after death (Philippians 1:22-24). It is mortal and will decay. The overall picture is one where both the limitations of the physical body (mortality, decay and disintegration) and also its uniqueness and value are recognised. Above all else it is clear that after death, the body is only a shell.The body, although a priceless and unique masterpiece, is not the totality of the person. Rather it is a dying seed, a mere foretaste of the resurrected body (1 Corinthians 15:35-58; 2 Corinthians 5:1-10) the person could enjoy for eternity through the grace and power of God. The destiny of the person is elsewhere; either to be with Christ, clothed with a resurrected body like his or to face eternal separation from God.So from a Christian perspective, although death is not the end of existence, dead bodies and body parts are not to be equated with the person. Rather, the person has 'moved on'. This has implications for Christian beliefs about the way the body should be treated after death.However, this does not mean that dead bodies should not be treated with respect. There are biblical examples of careful and loving treatment of the body after death (the burial of Sarah, Abraham, and other Patriarchs), and even of embalming (Jacob and Joseph - and this, of course, would have involved removal of the viscera). Jesus' own body was treated with care and respect by two secret disciples.

3A. No

3B. No comment

Section 4 - Scope of the Review

4A. Yes. It is a fundamental principle to distinguish between an image of a thing and the thing itself. Photographs and other images of organs and tissue should continue to be treated as forms of personal health information rather than being bought specifically into the ambit of the law on organs and tissue.

Section 5 - Defining Organs and Tissue

5A. The terms 'organ' and 'tissues' are preferable to 'materials' and we are happy with the definitions for 'organ' as defined in the Human Organ Transplants Act 1989 5.3. The Concise Collins Dictionary definition of 'tissue' given in 5.3 could be similarly adapted: 'any part of the human body consisting of a large number of cells having similar structure and function'.

It is important to maintain the distinction between 'organ' and 'tissues' whilst allowing for the fact that is there is some blurring of distinction, and that some 'tissue blocks', whilst not constituting whole organs, do contain different types of tissues. We agree that the fundamental issue is that whatever is retained is subject to valid consent or other legal authority.

It is essential that the public are made aware of the differences so that they feel fully informed of the principles and so that the unfortunate instances at Alder Hey of whole organs being retained under the definition of 'tissue' do not recur.

5B. Yes, distinctions should be drawn between 'discarded human tissue' and other types of tissue, and the definitions given here in 5.8 are helpful. The term 'discarded human tissue' is a suitable term to use in legislation provided that it is adequately defined. It is preferable to 'discarded human material'.

Section 6 - Principles of Consent

6A. We agree that legislation should provide for a code of practice on families and post mortems, but that this should be broad, flexible and emphasise the importance of openness and trust in the doctor-patient relationship.

6B. For the purposes of post-mortem, forms of consent other than written consent should be valid. In our technological age, and with the disparate nature of many families, the use of telephone or email may prove useful to obtain consent, followed up by paperwork. Stricter requirements may be desirable for organ retention.

Section 7 - Who would give consent?

7A. Yes. The immediate amendment to the Human Tissue Act 1961 recommended by the CMO is wise in light of recent events involving retention of children's organs. However, the difficulty of how parental consent should be attained remains. Many parents from the Alder Hey 'scandal' reinforce that they would have consented to the retention of their child's organs had they been asked. But the trauma of a child's death means that 'obtaining consent' must be done at the worst possible time. Doctors may often wish to limit the information given to the bereaved in order not to aggravate their grief.

7B. Retention of adult organs should be based upon prior consent by the deceased individual. However, the next of kin should be consulted in this decision. If they knew that the person was pro-donation of organs for research/transplantation but never recorded this intention, that should be taken into account.

7C. Yes.

7D. Yes.

7E. 'Next of kin' is a useful term for describing the person closest to the deceased by either blood or marriage (or adoption) in the accepted familial hierarchy.

7F.
People should be encouraged to specify their 'next of kin' (including spouse, partner or friend) and that person should be given the primary role. This would enable relationships other than legal marriage and blood to be recognised. Without such specification the accepted hierarchy should be used (as for purposes of inheritance where there is no will).

7G. No.

7H. This should be based on previously expressed preference by the deceased; or by the usual criteria applying in establishing inheritance.

7I-J.See 7F above. On the basis of patients' expressed desires and preference.

7K. Yes, any decision should preferably be made with the consent of both parents, except in the case where only one has legal custody.

7M. 'Custodian' is a preferable term - if this designates the person with responsibility to authorise removal of organs, and ultimately the burial/cremation of the remains. Such a custodian would retain responsibility for the body even though it remains on NHS property (7.18). The manager of the hospital/institution should only be vested with custodial rights where there is no next of kin or other designated person. Under such circumstances their duty would be to treat the body with respect, in accordance with the expressed wishes of the deceased.

7N. Yes.

7O. Yes.

7P. Yes. Ownership of a body is quite different from the responsibility to ensure that the wishes of the deceased, or in the case of lack of capacity, the guardian, are carried out.

Section 8 - Defining Consent

8A,8B. The current legal understanding of consent is that it must be competent, informed and voluntary. This is an acceptable term for the permission necessary for post mortem and organ retention purposes. Where an adult has the opportunity to give consent themselves to organ retention/donation after their death, this should be sought and respected. Where an adult has not expressed any clear prior wish, the retention of organs should only be considered where there is a clearly defined purpose for taking 'material' from this specific person/dead body. If there is reason, then the opinion of the next of kin may be sought - carefully, and without any persuasion - in order to ascertain whether the dead person had any particular views on organ donation/retention. The consent of the next of kin may be sufficient to warrant retention/donation in such circumstances.

8C. Not applicable.

Section 9 - What is removed and why?

9A. Fetal tissue from terminations and stem cells from embryos should be excluded from this new legislation on the basis that:
a. informed consent cannot be obtained, or presumed
b. the parents have abrogated responsibility to act as guardians, and hence being able to consent or act in the best interests of their offspring
c. the retention of the tissue cannot be in the interests of the individuals concerned. (see sections 15 and 17)

9B. Yes.

9C. No.

9D. Yes.

9E. Yes; as long as general consent for the further use of removed tissues is obtained as part of the consent for removal.

9F. Not applicable.

9G. Yes; provided that there is an opportunity to 'opt out' and that general consent is obtained and it is explained that this may happen.

9H. Yes.

9I. Yes. The present principle in existing justice legislation should be upheld, but should be used only as a last resort when consent cannot be obtained and justice would not be served without tissue being examined.

9J. Yes. But human bodies or their parts should only be displayed for non-clinical and non-scientific uses with the proper consent of the individuals involved; and for purposes of education, not entertainment, and only when illustrations, photographs and models would not fulfil the role. The display of human remains from other cultures is unacceptable if done without prior permission or in a way which would be unacceptable either for our own citizens or in the place of origin.

9K. Yes.

Section 10 - Training edcuation and research

No specific comment. See item 1 under '2.Preliminary' points above.

Section 11 - Oversight and Compliance

We agree that we need a Human Tissue Authority to oversee research and ethical aspects of tissue archives (and that includes material from surgical operations - another area of historical ignorance).

11A. Yes.

11B. Yes.

11C. Yes, although we are concerned that rapid drafting of laws and amendments may lead to unmanageable outcomes, and would prefer guidelines that can be modified with practice.

11D,E. No comment

Section 12 - Penalties for non-compliance

We agree with the principle of penalties or non-compliance but will not be commenting on specific details.

Section 13 - Transplantation from people who have died

13A. Medical progress has already shown that definitions of death can 'shift' with improvements in technology helping us more accurately define the boundary. This points to a set of guidelines and a code of practice being preferable to inflexible statutory definitions.

13B. The 1998 definition is suitable provided that the word 'irreversible' is taken with full force. Cases of 'misdiagnosed' death with individuals that doctors recommended 'turning off' who later made a recovery highlight the wariness that should be employed about making hasty decisions. The danger is that the need for organs may promote such hasty diagnoses, particularly when teamed with the expense of caring for such vegetative patients and the limitations of resources.

13C. Yes.

13D. Only if there is a high likelihood that the views of the patient from those close to him will be known within a very short space of time, and that a series of steps to establish this is clear.

13E. Yes.

13G. There should be a statutory requirement for a code of practice, but not a statutory code of practice.

13H. No, except in cases where it was necessary to establish the real wishes of the patient from relatives.

13I. Any of these methods would be acceptable as long as it was clear that the decision was made with fully informed consent.

13J. No. It is far more preferable to encourage people to signal their intention about this before death.

13K. The same rules of consent for minors as with other surgical interventions should operate; with the parents retaining the right to withhold consent if they believe it to be in the best interests of the child.

13L. No, see 13J above.

13M. No, unless the deceased had signalled a clear intention before death to that effect when having capacity.

13N. Not applicable.

13O. Not applicable.

13P. No. An arbitration procedure would be counterproductive and inappropriate in the acute bereavement situation.

13Q. Yes.

13R. No.

13S. Not applicable.

13U. No, in keeping with an unconditional gift, the transplanted organ is now considered as part of the recipient's, and not the donor's, body.

13V. Yes. This is vital for the protection of vulnerable people and to promote equality in this area. Additionally, if the aim is to promote 'donation' rather than 'retention', how will commercialisation help this?

13X. No, provided that this has been determined by others qualified for the task.

13Y.
No.

Section 14 - Transplantation from living donors

14A,B. Procedures that carry greater risk (eg. lung or liver lobe removal may be 1/100, whereas kidney is between 1/3,000 - 1/6,000) should be subject to greater scrutiny. Levels of harm need to given a 'cut off' point to define high risk categories which would then be given much stricter control in terms of who can donate, consent required, procedure, second opinions etc.

14F,G. The distinction between genetic and non-genetic relationships may be a false one in some cases. The genetic link and associated family may actually place greater pressure on an individual to donate when actually there is less altruisic motivation than exists in certain non-genetic relationships. Perhaps then it is better if all live donations are subject to the same scrutiny to ensure the donor's action is fully voluntary. The extent of scrutiny would be better governed by the risks associated with the procedure rather than genetic relationship.

However, it is also necessary to protect against donors offering their organs for reasons other than altruistic motivation - as this could lead to a commercial undercurrent. For this reason it may be wise to limit live donations to where there is a well-established link between donor and recipient, be it social, marital, genetic, or familial.

14H. A blanket prohibition on transplantation from incapacitated adults would not allow for the rare cases where it may actually be appropriate. In general there should be an acceptance that it will not be allowed, but in an exceptional case the courts may decide to authorise it on the basis of 'ethical, social and moral considerations' that are part of a person's best interests. Perhaps specific criteria for the exceptional cases can be laid down so that practitioners know when it is worth bringing a case before the courts?

14J,K. The ECHR & Biomedicine guidelines for regenerative tissue donations may be useful here, though the addition of an close and active/current relationship between the donor and recipient should also be stipulated.

14R. Yes.

14X. No. See section 16.

Section 15 - Fetal Tissue

Preamble

We have to consider the ethics of two distinct areas in the use of fetal tissue. The first is where the relevant tissue is extracted from a recently aborted fetus and used more or less immediately for transplantation into the recipient. The second is where cells from an aborted fetus are harvested and grown in tissue culture. At some subsequent time, which may be many years in theory, these cells are then used for transplantation. This latter situation is synonymous with the use of stem cells from embryos and, by implication, is dealt with in section 17 (see below)

We accept that the use of tissue from spontaneous abortions is ethically acceptable. However, research already carried out shows that this is not a practical option for several reasons. In spontaneous miscarriages the fetus often dies some time prior to expulsion, so the tissues will not be viable. In spontaneous abortions there is a higher incidence of chromosomal and genetic abnormalities, especially those in early pregnancy. There is also a major problem of bacterial contamination during natural delivery. Even if an individual was willing to try and carry out research to overcome these problems it would be surprising, in the current environment, if funding could be found to support such research which in scientific terms would be less likely to achieve results compared with the use of surgical abortions. So we have to consider the use of surgical/medical abortions.

The most common argument in favour of the direct use of fetal tissue, is that the baby will be aborted in any case, therefore why not make use of the tissue and at least gain some benefit from this unethical act. Furthermore, some argue that the doctors involved in the transplantation are not those who are responsible for the abortion and therefore are free of any moral responsibility for that act. In addition it is further argued that the aborted baby is already dead, and therefore the ethical principles which govern cadaveric organ transplantation apply. The government commissioned the Polkinghorne report which reported in 1989 and established a Code of Practice for the use of fetal tissue.

Let us now consider the argument that the doctor involved in the transplantation has nothing to do with the abortion. Polkinghorne stated that the decision for abortion must be separate from the decision for the use of the aborted fetal tissue. However, the reality is that tissue for transplantation must be viable and in as fresh a state as possible. References that discuss the collection of fetal tissue discuss the modification of the abortion procedure so as to maximise tissue preservation. For instance, in early abortions a low suction pressure is used and the abortion cannula is inserted under ultrasound control so that the fetus can be 'selected' - which in some cases led to extraction of an intact fetus. The doctor accepting the fetus would be in the room immediately adjacent to the theatre where the abortion was taking place and would be receiving the tissue virtually immediately. In the pilot series of fetal brain transplantation both donor (mother) and recipient were screened for a range of possible infections, including HIV and so it is difficult to argue that there is not co-ordination between the two groups of doctors. And so from a moral perspective we cannot see how it can be argued that the transplantation doctor is not an integral part of the abortion process.

Currently, and rightly so, consent is required for organ transplantation. This is normally obtained from the relatives although it might be valid to argue that a person carrying a donor card has already given permission, and that wish should be respected. But whichever way you look at this topic, there is a common consensus that consent must be given. The fetus is obviously unable to give prior consent, and so people look to the woman for her consent. This immediately raises several problems. The voluntary predetermined death of the fetus is in no way comparable to the death of an accident victim whose organs may be suitable for transplantation. No person, and especially the mother, has the authority to end the life of her unborn child. We therefore find it perverse that she should then be asked to give consent, on behalf of her unwanted unborn child, for its tissues to be used for transplantation.

There is also a further issue here. A study of women's views showed that overall 12% (and 17% of those who would consider abortion if they were pregnant) of women would be more willing to have an abortion if they could donate tissue for fetal transplantation. This indicates, as many have argued, that fetal transplantation would be used, at least in part, to justify the abortion.

It is a cardinal principle of moral theology that it is not permissible to perform an evil act so that good may come of it (Romans 3:8). The end does not justify the means. We believe, as argued above, that by implication many would attempt to minimise the evil of the abortion because of the good that may come about as a result of the use of fetal tissue.

So our starting point is that abortion itself is an unethical act which is contrary to the Judeo-Christian ethic and all historical ethical codes including the Hippocratic Oath, Declaration of Geneva(1948) and International Code of Medical Ethics (1949). It cannot be sanitised or justified by the argument that the tissues of the aborted fetus can be used for a good purpose.

15A. Termination of pregnancy is ethically unacceptable. It is equally unacceptable to modify the termination procedure to enable more effective 'harvesting' of fetal tissue even if the procedure poses the same, or less risk to the woman, or if the modification is approved by a research ethics committee, or if the woman consents.

15B. Parental consent is based on the principle that the parent in giving consent is acting in the best interests of her offspring. But it is never in the best interests of any human being to be killed and she has already made a decision to end her fetus' life. So it is perverse to suggest that she can then consent to the use of the fetal tissue. By ceasing to act in the interests of her offspring she has morally abrogated parental responsibility and hence the right to consent. As termination in itself is not a morally acceptable procedure, altering termination procedure so as to facilitate the retrieval of viable fetal tissue makes the procedure worse rather than better (as it reduces the fetus to the status of property).

15C. Termination is not a moral procedure and to use the fetus or fetal tissue subsequently for research or therapy is equally unacceptable.

15D. Anyone giving consent to the destruction of another human being, whether genetically related or not, has abrogated the responsibility of protecting that individual from harm and thereby the right to consent.

15E. This approach treats the fetus and its tissue as property. Again, no human being should ever become the subject of any procedure that might conceivably harm it without its consent, unless, in the case of incapacity, the parent or guardian, considering only the best interests of that individual should consent to the procedure for the good of that individual. Termination is always carried out in the interests of some individual other than the fetus. For the reasons given above in practice it is impossible to separate the act of termination from the act of harvesting tissue.

15F. Although it might be argued that an intermediary body could ensure 'clear separation of the supply of fetal tissue from those who use it', there can never for practical purposes be a clear separation of termination and 'harvest', nor of supply and use, for reasons outlined above and because of the desire to use 'fresh material' for research . It is impossible to eliminate complicity.

15G. The fetus and fetal tissue are not property and should not be the subject of property rights.

15H. Fetal tissue from terminations should not be used for research or therapy.

15I. A provision for conscientious objection is essential to ensure that doctors and other health professionals who wish to abide by the Hippocratic Oath and Declaration of Geneva should not be discriminated against or stigmatised.

15J-K. The dead bodies of fetuses, whether the product of termination or miscarriage, and regardless of the wishes of the parents, should be treated with the same respect and procedure as the bodies of any other human beings. And in keeping with the general spirit of this review, every human being is to be treated after death with the utmost respect.

Section 16 - Issues concerning Gametes

Preamble

There are circumstances where a person without capacity may be in a situation where their future fertility may be jeopardised (for example in receiving chemotherapy or radiotherapy). In these circumstances the person with parental responsibility may give permission for gametes to be stored for future use in reproduction by that person, should they gain capacity. Our view is that marriage is the proper context for reproduction and so we have grave reservations about storage of gametes beyond death (because marriage ends at death) or gamete donation (because it violates the marriage bond).

16A. We are happy with the Human Fertilisation and Embryology Authority's definition of gamete (16.2).

16B. The HFEA should have the power to waive the requirement for personal consent to the storage of gametes for the duration of a child's incapacity, in circumstances where their future fertility may be jeopardised, provided that the person with parental responsibility gives permission.

16C. The consent of the person(s) with parental responsibility only should be required.

16D. If a child has reached the age of 18, but not attained capacity, the courts should have a power to the continued storage of gametes provided there is a reasonable possibility the person will attain capacity in the future, and provided the gametes are stored for the use of that individual alone.

16E.
The gametes of individuals without capacity should not be stored in any circumstances beyond the death of the individual, nor donated for research, or for use in assisted reproduction by any other individual.

16F. No (see 16E)

16G. The gametes should be destroyed at the child's death.

16H. We are broadly happy with the principles outlined in the conclusions reached by Professor McLean (as stated in 16.17). It is essential that the gametes are used in the future only in line with the intentions of that individual and in accordance with their best interests provided that individual is alive and that the gametes are not used for research or in assisted reproduction by any other person other than the person's spouse.

16I. Not applicable.

16J. No, provided that individual has made their intentions clear during the previous period of capacity.

16K. The courts should be able to authorise the removal of gametes from a person with previous capacity only in circumstances where that individual is judged as likely to have consented to such a procedure for purposes of reproduction and where the illness, accident or treatment necessary to preserve the life of the individual may put that person's fertility at risk

16L. The gametes of individuals without capacity should not be stored in any circumstances beyond the death of the individual, nor donated for research, nor used in assisted reproduction by any other individual. They should be disposed of.

16M. The gametes should be destroyed at the person's death.

Section 17 - Cell Lines and Stem Cells

Preamble

We have consistently opposed the harvesting of embryos (cloned or otherwise) for stem cells and believe that the government move to legalise embryonic stem cell cloning was both irresponsible and unnecessary.

Like most critics of the House of Lords Select Committee on Stem Cell Research we were deeply concerned both about human embryos being used as a means to an end and also about slippery slopes to reproductive cloning. We were equally concerned that motives of prestige and profit, rather than sound ethics and good science, precipitated legal change before ethically acceptable alternatives for tissue repair had been properly researched.

The Donaldson Report's recommendations, endorsed by the government were based on an overly pessimistic belief in the capacity of adult stem cells to produce new treatments for debilitating degenerative diseases like Parkinson's and diabetes. Subsequent research has demonstrated adult stem cells remarkable versatility, and this approach has major advantages, given our extensive clinical experience in obtaining, purifying and transplanting adult stem cells, for example in the treatment of leukaemia.

The Human Fertilisation and Embryology Act recognises that human embryos have special status and deserve legal protection. Furthermore the Human Fertilisation and Embryology Authority has an obligation to determine that any research involving embryos is both necessary and desirable, and that all alternative pathways have been fully explored through prior research or work with animals. This has not been done.

We believe it is therefore grossly irresponsible (17.18) to assert that 'the removal of stem cells from an embryo for research purposes is beyond the scope of this review' because it has already been asserted elsewhere (17.7) that the purpose of ethical review 'is to protect the dignity, rights, safety and well-being of all actual and potential research participants'. To turn a blind eye to the means by which tissue for research is obtained is therefore hypocritical.

When the harvesting of stem cells to be used in research results in the destruction of those subjects donating the cells (as it quite clearly does with embryos and fetuses), these principles are clearly violated. The Declaration of Helsinki (1975) says that in biomedical research 'the interest of science and society should never take precedence over considerations related to the well-being of the subject'.

The Nazis' experiments on human subjects have been well-publicised: Hallervorden's collection of brains for his neuropathological collection; radiation and castration for sterilisation; intravenous phenol, gasoline and cyanide; hypothermia and haemorrhage studies. It was these that prompted the drafting of the Nuremberg code in 1947, making informed consent an absolute requirement for research. There is little difference between Hallervorden's use of Jewish brains and the contemporary use of embryonic and fetal tissue, apart from the age of the subjects. In both cases research interests ride roughshod over consent. In fact, the harvesting or embryonic tissue is arguably worse, because the embryos concerned are destroyed for the explicit purpose of providing tissue (ie they are cannibalised); whereas the subjects who provided the tissue Hallervorden used in research were utilised after they had been killed for other reasons.

There is therefore a fundamental inconsistency in this review in that it applies different rules to adult and fetal/embryo subjects.

Our answers to the following are with the above provisos.

17A-C We agree that cell lines (excluding stem cells) are valuable and essential tools in both medical diagnosis an a wide range of research. We also believe that such research should be under ethical review to ensure that proper informed consent is obtained and that the dignity, rights, safety and well-being of all actual and potential research participants are protected.

17D.
Provided that stem cells derived by unethical means are not used in research (in particular any processes that result in harm to or destruction of the individual who donated the tissue), stem cell research should be subject to the same ethical review as that applying to other human cell lines.

17E. Not applicable

17F. We agree that consenting donors whose tissues are used to develop cell lines for tissue engineered products should be asked to give up all profit rights to that tissue, such that they could not benefit from any profit that may accrue from such developments. It is essential therefore that such tissue be donated and not sold. But there should also be provision for donors to 'restrict' the purpose for which such tissue could be used to ensure that individual research projects are of real value in diagnosing real illness and treating real disease; rather than being driven by profit into developing unethical diagnostic tests (for example those used to identify abnormal individuals as a precursor to destroying them especially at fetus and embryo stage) or 'treatments' for 'conditions' that are not diseases. All commercial companies doing research in this area need to be under ethical review also.

17G. Not applicable

For further information:

Steven Fouch (CMF Head of Communications) 020 7234 9668

Media Enquiries:

Alistair Thompson on 07970 162 225

About CMF:

Christian Medical Fellowship (CMF) was founded in 1949 and is an interdenominational organisation with over 5,000 doctors, 900medical and nursing students and 300 nurses and midwives as members in all branches of medicine, nursing and midwifery. A registered charity, it is linked to over 100 similar bodies in other countries throughout the world.

CMF exists to unite Christian healthcare professionals to pursue the highest ethical standards in Christian and professional life and to increase faith in Christ and acceptance of his ethical teaching.

Christian Medical Fellowship:
uniting & equipping Christian doctors & nurses
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