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Response to Human Bodies, Human Choices (2002)


A response by the Linacre Centre to a Government consultation.



[2002]

The Linacre Centre for Healthcare Ethics is a research institute whose Trustees are the Catholic Archbishops of England and Wales. We publish material, run conferences and provide speakers on a range of topics in healthcare and biomedical research. We also provide advice and information to individual health practitioners and scientists on ethical aspects of their work.

We welcome the opportunity to respond to the Consultation Report Human Bodies, Human Choices. In so doing, we would emphasize that what we say does not rely on premises held by Catholics only. On the contrary, the arguments we present are potentially acceptable to those of other faiths, and of no faith. We should also note that much of what we say goes beyond the current teaching of the Church, both because it concerns scientific questions outside the Church's competence (for example, the diagnosis, as opposed to the definition of death), and because this is an area in which Church teaching is still in the process of formation.

The Church endorses the respectful use of human remains for medical education, research and transplantation, given the consent of the donor or his/her legitimate representative and proper treatment of the donated tissue. This teaching has been explicitly affirmed in strong positive terms by Pope John Paul II.2 In the case of taking organs from a live donor, the Church requires, in addition to consent from the donor, that removing the organ not bring about his or her death or disabling mutilation. The Church has not taken a definitive position on neurological criteria for the determination of death, but has tended to accept their use in practice. What has been made very clear is that death must be defined by reference to the life of the body as a whole and not only by reference to mental (in)capacity.

Brain death

The Linacre Centre's own view is that `brain death' protocols are insufficient for establishing the death of the body: we have become increasingly convinced by evidence suggesting that integrated bodily activity can continue after `brain death' has been diagnosed. There have been documented cases of `brain dead' patients maintaining bodily functions for months or even years: pregnant women have gone through pregnancy, children have grown up and passed through puberty, etc. 3 Moreover, it is well-known to transplant teams that heartbeating donors move when organs are taken, unless they are paralysed by drugs, and that their blood pressure goes up when the incision is made. It is worth noting that some anaesthetists recommend that the supposed `cadaver' be anaesthetised when his/her organs are retrieved. Most organ donors are unaware that their hearts may be beating when their organs are taken, and that they may be pink, warm, able to heal wounds, fight infections, respond to stimuli, etc.

We would urge that while the adequacy of brain-related criteria for diagnosing death is fully and fairly investigated, the retrieval of organs from heartbeating donors should be put on hold. Donations from non-heartbeating donors - perhaps after organs have been cooled to preserve them - could continue while this investigation was carried out. At the very least, those who wish to donate their organs should be given the option of being non-heartbeating donors only, and should be fully informed of the state their bodies will be in when their organs are retrieved. Such information requires a proper interview with a medical practitioner who can explain current controversies: simply signing a donor card in no way indicates that the prospective donor understands what organ donation will involve.

Consent

In view of the uncertainties surrounding diagnosis of death, it is all the more important that an `opt out' system of organ donation be firmly excluded. We welcome the emphasis placed on consent in Human Bodies, Human Choices. Explicit consent by the donor, in addition to consent (or non-objection) by relatives is needed both to safeguard respect for the body, and to protect the interests of the donor in avoiding premature retrieval of organs. We would urge that even if the donor had given fully informed consent to organ donation, objections raised by relatives should be seen as overriding. This is particularly the case with retrieval of organs from heartbeating donors, which can be most distressing for relatives who believe - not without evidence - that their loved one may still be alive.

In the case of non-heartbeating cadavers, we would require consent from the donor him/herself, while relatives should be kept informed and could veto the procedure if they raise strong objections. In the case of children, however, parental consent should be both necessary and sufficient for the retrieval of organs from a non-heartbeating cadaver. Parental consent should also be necessary and sufficient in the case of stillbirth or miscarriage, at whatever stage of pregnancy. Wherever practicable the consent of both parents should be obtained, as generally both will have a legitimate concern for the child, though this will depend on the circumstances of the relationship, contact and custody. However, the deliberate termination of pregnancy and the destruction of human embryos are serious acts of injustice against the child in which the parent or parents are complicit. The use of the body of a child whose life is taken in this way adds insult to injury and is wholly unacceptable.

Apart from the cases of abortion and embryo destruction, where those complicit may not consent to the use of cells or tissue, we would distinguish between retention or use of small tissue samples (for which the relatives' consent need not be obtained) and retention or use of organs and large body parts (for which relatives' consent or non-objection should be essential). Given that the symbolic significance of small body parts is less than that of large body parts, it seems reasonable to distinguish between the two in terms of the requirement for consent. Again, in the case of hospital post mortems, although relatives should be informed where possible, we do not believe that explicit consent by relatives, or by the deceased, should be required. If strong objections are raised by relatives, however, or have been raised by the deceased while he or she was alive, these could well be overriding, depending on the urgency of the need to establish the cause of death.

Finally, on the question of live donation, we would urge that cells or tissue not be taken from children or incapacitated adults outside the context of their own medical care. The sole exception to this should be a case where regenerable tissue is removed, with court permission, for the benefit of another person in whose health the donor has a strong interest (normally, a close family member). It is essential to draw a firm line to protect the interests of vulnerable people who could easily be exploited as a source of tissue for transplantation or research.

Answers to Consultation Questions

5A. What wording should be used in legislation to describe `organs' and `tissue'? Are `human tissue' and/or `human materials' suitable collective terms?

5A. `Human tissue' seems an acceptable term but `human material' is too reductive.

5B. Should distinctions be drawn between `discarded' human tissue and other types of human tissue? If so, are `discarded human tissue' and/or `discarded human material' suitable terms to use in legislation?

5B. There is a useful distinction here, but the major distinction is between whole bodies, organs, limbs and significant masses of flesh on the one hand, and small tissue samples, blood, DNA etc., on the other. Again, we would prefer the word `tissue' to the word `material'.

6B. Are there any circumstances in which consent to a hospital post mortem or to the retention or use of organs or tissue may be given other than in writing? If so, should any safeguards or special procedures be applied? Are there alternative forms of consent that may be acceptable?

6B. Written permission, in the context of an interview with a doctor who explains the facts, should be required in the case of donation of tissue or organs for transplantation (see 13I). This is necessary to protect the donor's interests, particularly in view of controversies over the diagnosis of death. However, oral permission before witnesses could be sufficient for consent to a hospital post mortem or the retention of organs or tissue for use in education or research. We would, however, exempt the case of gametes or precursors to gametes: for this, written permission from the donor or his or her parents or next of kin should be required. Such research should not under any circumstances involve fertilisation or similar procedures (for example, cloning or parthenogenesis). Such procedures are incompatible with respect for human fertility, and for the lives they may create.

7A. Should legislation provide that the consent of those with parental responsibility must be obtained for the retention or use of organs or tissue from a post mortem examination on a child beyond, if relevant, the time necessary to establish the cause of death?

7A. Yes in the case of organs or large body parts or gametes or their precursors (but see 9B). The retention of organs without parental consent was the abuse that provoked this review. In the case of small tissue samples not involving gametes or precursors to gametes, we would accept such use without explicit consent from the parents, although the parents should be informed that such use is intended. If the parents have serious objections to the use of small tissue samples, their objections should sometimes override those at stake in the proposed research.

7B. Should there be a similar provision requiring the consent of relatives or `next of kin' (see paragraphs 7.8-11) for the retention or use of organs or tissue from a post mortem on an adult?

7B. Again, we would distinguish here between the retention/use of organs or large body parts such as limbs after a post mortem and the retention/use of small tissue samples. In the case of organs or large body parts, the next of kin must give consent, and strong objections on the part of close relatives should be overriding. In the case of small tissue samples, the next of kin should be informed where possible; however, his or her objections would not necessarily override the interests of researchers. In neither case should organs or tissue be retained or used if the deceased expressly objected, except in the case of a medical emergency (for example, the control of an epidemic).

7C. Should legislation specify that consent must be obtained if tissue is removed:

* for any purpose other than the clinical care of the patient; or
* in excess of that required for clinical use?

7C. If the patient is competent, consent should be obtained from the patient in either case. If the patient is a child or is mentally incapacitated, tissue should not be removed outside the context of the patient's medical care.

If, however, tissue is taken from a child or mentally incapacitated person, we would accept taking a small quantity of extra tissue from the same body part for use in research, with the consent of the parents or next of kin. If the parents or next of kin cannot be contacted, extra tissue should not be taken for research.

7D. Should consent be required to retain or use tissue removed in these circumstances?

7D. If small tissue samples have already been removed (for example, some years ago when consent requirements were less stringent) and it is not practicable to obtain consent from the patient, then such small samples could be retained or used in teaching or research if there is sufficient need.

7E. Is `next of kin' a satisfactory term to describe the person or person (s) closest to someone who has died?

7E. This is an arbitrary term but is well established and therefore useful.

7F. If so, does this term need to be defined in legislation in this area? If so, what should that definition be?

7F. People should be encouraged to specify `next of kin', including spouse or close friend, and the most recent such specification should be given a primary role. Where no next of kin has been specified it would clarify matters if relationships were legally set down in order of importance.

7G. Is it ever ethical to allow a hospital post mortem examination if no consent from the deceased has been given and no surviving relative or other person close to the patient can be traced?

7G. Yes. However, in this case organs and large body parts should not be retained and used in subsequent research.

7K. Should parents have equal rights to be consulted about what happens to their child's body? Are there circumstances in which the mother's request should prevail: for example if her own health or future reproductive choices are involved?

7K. Either parent should have the right to request a post mortem to resolve the cause of death. If both parents are contactable, the consent of both should be required for retention of organs or use of organs or tissue in research or transplantation. However, where it is proposed to use small tissue samples in research, as opposed to organs or large masses of tissue, the consent of one parent could suffice, providing he or she had custody of the child. There should be some form of arbitration in cases of dispute over funeral arrangements. One parent should not be arbitrarily excluded from the decision-making process.

7P. Should legislation specify that there are no property rights in a dead body or its parts, as such?

7P. Yes. This is a fundamental element in the Christian and common Western understanding of human remains, and is well worth enshrining in law.

8A. Are there any circumstances in which it would be acceptable to carry out a post mortem examination (other than one arranged by a coroner), or to retain or use organs or tissue, without consent having been obtained as part of a fully informed process? Are there better ways of approaching cases in which relatives would prefer not to know the details of what a post mortem involves?

8A. Carrying out a post mortem and retaining or using small tissue samples should be distinguished from retaining organs, limbs or large parts or using whole bodies for research or transplantation or display.

In the case of hospital post mortems, relatives should be informed, where possible, of the hospital's intention; if they then register a serious objection, this may be decisive, depending on the need for the post mortem. Information could be given in general terms, and further information offered, but not forced on relatives who would prefer not to know the details. A similar approach should be taken to retention and use in research or teaching of small tissue samples. Consent of the donor should not be required in the case of post mortems or retention or use of small parts. However, an express objection by the donor before death should be given due weight (in the case of research, as opposed to a post mortem, such an objection would normally be overriding).

In the case of taking or using organs, limbs, large parts or whole bodies outside the context of a post mortem, prior consent of the donor (or, in the case of children, of the parents) should be required. In any case, the next of kin should be informed, and if he or she, or some other close relative, has a serious objection this should be decisive.

Explicit consent should be obtained from the next of kin for the retention and use of gametes or their precursors. Such consent should not be sought for use involving fertilisation or similar procedures, as such use is incompatible with respect for the fertility of the deceased, and for the lives of those created from his or her gametes. If, however, such use is planned, both the next of kin and other relatives should have an absolute power of veto.

8B. Should legislation use the term, `consent', to denote the necessary permission given to carry out a post mortem or to retain or use organs or tissue? If so, should it be defined and, if so, how?

8B. Legislation need not use the word consent, but may use the word authorisation, in the case of post mortems and retention or use of small samples of tissue (excluding germ-line cells) in research. However, outside the context of post mortems and the use of small tissue samples in research the term consent should be used, and should relate to the consent of the donor him or herself (except for the case of children, where it should relate to the consent of the parents).

9A. Should any human tissue or material, other than `discarded' tissue (see paragraphs 5.8-10) and that within the scope of the Human Fertilisation and Embryology Act (see paragraph 4.12), be excluded from new legislation; and if so on what basis?

9A. Some tissue should be treated separately in new legislation, rather than being excluded from it. For example, small tissue samples (perhaps defined by a maximum weight) and slides should be distinguished from organs and limbs. (Organs that have been fixed to make tissue blocks should, however, be treated as organs.) Precursors to gametes should be subject to special consent requirements, and research on them should not involve fertilisation or similar procedures.

9B. Should consent explicitly be sought for the retention, use or disposal of organs or tissue once the coroner's legitimate interest in them has ceased?

9B. In the case of organs and large body parts, consent should be sought from the next of kin for retention, use or disposal. However, pathologists should be permitted to retain samples for sufficient time to check their diagnosis at the microscopic level, even if the cause of death has already been determined at the macroscopic level to the satisfaction of the coroner. Such checks are necessary if pathologists are to be able to rely on their own macroscopic examinations. In the case of small tissue samples, formal consent to retention or use need not be obtained, though an express objection by relatives or the deceased would normally be binding.

9C. Should an exception be made for organ or tissue blocks or slides following sudden infant death and/or in other circumstances?

9C. Slides should be treated differently from organs and/or blocks involving significant body parts (see 9A). However, the latter may be kept with permission from both parents.

9E. Is it acceptable for tissue samples taken from living patients to be used for quality assurance and audit purposes without seeking specific consent, provided that patients are aware that tissue may be used in this way?

9E. Yes.

9F. What should happen if the reliability of a test cannot be guaranteed without testing its quality and yet a patient objects to his or her tissue being used in this way?

9F. This should be explained to the patient and made a requirement for taking the test.

9G. Is it acceptable for unlinked and anonymised tissue samples to be used for properly approved public health surveillance programmes provided that the public are made aware that tissue may be used in this way? If not, what alternative arrangements would be acceptable?

9G. Yes.

9H. Should patients be able to opt out of their tissue being used in public health surveys employing the unlinked anonymous techniques?

9H. Yes, but they should do so formally in writing.

9I. Should new legislation or regulation contain any specific provisions relating to the taking, retention and use of human bodies or parts by (or on behalf of) the coroner or the police for the purposes of:

* identifying a dead person; or
* the investigation of crime?

If so, for what reasons and to what effect?

9I. Only as exceptions to the rules on donation.

9J. Should new legislation or regulation contain any specific provisions relating to the donation, retention, preparation or use of human bodies or parts for artistic, display and/or other non-clinical or non-scientific uses? If so, for what reason and to what effect?

9J. Yes, this is a major concern. Irrespective of whether consent has been obtained from the deceased, certain forms of display of human remains are morally offensive. Questions of public decency need to be addressed and, if necessary, settled by appeal to a court. For example, it could reasonably be held that display of covered, long-dead human bodies in museums (for example mummies) was acceptable, but that display of visible, recently-alive human bodies (as in the `Body Worlds' exhibition currently showing in London) was unacceptable. Where the display of recently-alive human bodies is at issue, relatives should, at very least, be allowed the power of veto.

9K. Are `disposal' or `respectful disposal' in relation to a body or parts suitable terms to use in future legislation or guidance? If not, what alternative terms are preferable?

9K. The term disposal should not be used without the adjective respectful: `respectful disposal' should be used as a single term.

10A. Subject to proper consent being given to particular uses of bodies or parts, organs or tissue, should the present distinctions between uses under the Anatomy Act and Human Tissue Act be removed or rationalised; and, if so, to what effect?

10A. The distinctions between the two Acts should be rationalised to allow more flexibility about use of tissue and to extend the same concerns about consent to all tissue donation (with the exception of small samples taken for research purposes with due authorisation).

10B. Should any particular method(s) of preserving retained organs or parts be permitted to alter their legal status? If so, in what way and to what extent?

10B. A slide taken from a block should not count as an organ, but an organ kept intact should not change its legal status.

13A. Should revised legislation include a statutory definition of death and what would be the advantages or disadvantages of including such a definition?

13A. Yes, a definition would be useful, as there is philosophical controversy concerning the criteria adopted by different countries and concern about the possible extension of notions of brain death to cover other states (e.g. persistent unconsciousness). Such a definition should clarify certain essential features of death, but not lay down specific criteria for clinical diagnosis. It would be a disadvantage if the definition chosen were too closely linked to current medical opinion (or current mainstream medical opinion) or if it were otherwise badly formulated.

13B. If a definition is to be included, is the 1998 definition at paragraph 13.5 suitable? If not, how should death be defined?

13B. The definition given in paragraph 13.5 is inadequate and inaccurate. There seems no obvious reason to isolate capacity to breathe from physiological respiration, blood flow, heartbeat, body heat, response to external stimuli and other aspects of the life of the human body. If it is thought proper to make a separation between mental and physical aspects of death, then the physical aspect should be defined more broadly. Brain related criteria for diagnosing death would only be acceptable if they gave conclusive evidence for the death of the body as a living whole. If there is conflicting evidence of self-integration from other bodily signs, such evidence should also be considered. The human being is a living organism, and death is the loss of the life of that organism. The following is an alternative suggestion for the definition of death:

The irreversible loss of the capacity of the body to function as an integrated whole, including the irreversible loss of the capacity for consciousness/sentience.

In fact, the second part of this definition is not strictly necessary, as the capacity for consciousness is merely one sub-category of the capacity for bodily self-integration.

The definition of death should not make reference to the brain or any other organ. It would be the function of medical science to determine what is necessary for the organic functioning of the body as a whole. Breathing and consciousness are not the only marks of human life. Moreover, apnoea testing, which would be necessary to satisfy the criterion of cessation of breathing capacity, may cause brain damage to a living patient, and should therefore be avoided.

13C. Should new legislation include a power to require compliance with the current code of practice for establishing death by brain stem criteria?

13C. New legislation could include a power to conform to a code of practice for determining death, but this code must itself be subject to regular review and, in particular, to criticism from dissenting physicians, including physicians from other nations who follow other systems. We recommend a thorough investigation of the adequacy of current brain-stem related criteria, during which time the retrieval of organs from heartbeating donors should be suspended.

13D. Should new legislation make it lawful to take steps, after death has been pronounced, to preserve the function of an organ with a view to donation if the views of the person and/or those close to him or her are not immediately known?

13D. Yes. The steps necessary to preserve the life of the organ do not disfigure the corpse and have the great advantage of allowing a donation to occur, if it is discovered that the person is a registered donor. This practice widens the number of potential donors and also avoids the concerns which some rightly feel about current brain related criteria for diagnosing death. However, it is important not to intervene prematurely on a non-heartbeating patient: a minimum of 10 minutes should elapse from the time between when the heart has ceased to beat and the time when the organs are treated to preserve them.

13E. In such cases, would pronouncement of death by a doctor of suitable seniority who is independent of the transplant team be acceptable?

13E. Yes, but proper criteria should be set out for such cases (see 13D).

13F. What other safeguards, if any, are required for `non-heartbeating' donors and those close to them?

13F. Criteria should be laid down for diagnosis of death. Also, a reasonable interval and separation should be observed in treatment (see 13D). Respiration should not be withdrawn in the theatre where organs are to be retrieved, and treatment should not be given before death with a view to preserving organs in death (including elective ventilation and preparation for theatre).

13G. Should there be a code of practice (statutory or otherwise) for the establishment of death after breathing and circulation have ceased?

13G. Yes.

13H. If a person has expressed the wish to donate organs after death, should those close to him or her have any influence in determining whether those wishes should be acted upon?

13H. Yes. Relatives should be kept informed, and objections on their part should be overriding. This is particularly the case with taking organs from heartbeating donors, if this practice is to continue.

13I. If the person's wishes are to be decisive, would it be necessary for these to be expressed by:

* a signed organ donor card;

* registration with the NHS Organ Donor Registry;

* any other acceptable method?

13I. A signed organ donor card is not sufficient evidence that the donor gave informed consent to donation. Most donors are unaware that they may have beating hearts, changing blood pressure and some response to stimuli at the time their organs are removed. Most donors are also unaware that there are real controversies among medical professionals concerning whether brain related criteria are adequate for diagnosis of death.

We would recommend that all prospective donors be interviewed for at least half an hour by a medical practitioner unrelated to the transplant team (for example, a GP), who would be required to explain these facts to him or her. The consent form should give the donor the option of consenting to be a non-heartbeating donor only: we ourselves believe that only non-heartbeating donors should be used at this time. However, if the consent form permitted the donor to opt also for heartbeating donation, the form itself should explain, in simple language, the state in which the donor's body will be when organs are retrieved. It should also state that not all doctors believe brain death to be the death of the body as a whole. The donor should be told that his/her body will be able to move and react to surgery (unless it is paralysed first), and that anaesthetics, though recommended by some anaesthetists, will not necessarily be used.

13J. Should consideration be given to there being a presumption that a deceased person's organs may be used for transplantation unless he or she has indicated that they may not be used in this way? If so, on what basis could this be justified and what safeguards would need to be considered?

13J. Presumed consent is not valid or informed consent and has no place in this context. The body should be treated as a gift, and not a mere resource.

13K. If, by means of an organ donor card or by registration, a person under the age of 18 has expressed a wish to donate organs after death, are there any circumstances in which his or her parents should have a role in deciding whether or not organs are used for transplantation? If so, what are those circumstances?

13K. Persons under eighteen should not be allowed to donate if their parents object; nor should they be allowed, in any case, to be heartbeating donors. Parental objections should be decisive even in the case of those over sixteen or Gillick minors.

13L. Should further consideration be given to arrangements whereby, if a person did not stipulate in his or her lifetime that he did not want his organs to be used for transplantation after death, they could be used for that purpose? If so why; and what safeguards would need to be put in place?

13L. If the deceased did not express a wish to donate then he or she is not a donor but only a thing donated. An express wish to donate should be a pre-requisite for donation for transplantation (and for donation of organs or large body parts for research). The sole exception should be the case of children, for whom parents could give consent in the case of non-heartbeating donors.

13M. Should the removal and use of organs for transplantation without consent from the `next of kin' ever be permissible?

13M. No, especially in the case of heartbeating donors. Even in the case of non-heartbeating donors, if the next of kin or other close relatives object to the harvesting of organs, this should not be carried out.

13O. If the next of kin gives consent for the use of the deceased person's organs in transplantation, should it be possible for the views of another:

* completely to overrule that consent? If so, in what circumstances?
* to be taken into account? If so, by what means?

13O. Consent by the next of kin is insufficient in the absence of consent by the donor him or herself. If a close relative strongly objects, organ harvesting should not proceed, especially in the case of heartbeating donors.

13Q. Should revised legislation make clear that donation from the dead should only be on the basis of an `unconditional gift'?

13Q. Yes. The idea of donation as unconditional gift is essential to the use of human remains in transplantation.

13R. Should additional authorisation for the removal of organs or tissue be required if either:

* the person concerned has expressed the wish to donate in a valid form; or

* the next of kin has given consent to donation for transplantation?

13R. Consent should be required from both the donor and, where applicable, the next of kin. In the case of non-heartbeating donors, this would be sufficient. However, if a close relative raises strong objections, these should be decisive, especially in the case of heartbeating donors.

13T. Are there particular safeguards that should be applied when there is nobody able to give consent to the removal of organs from a potential donor?

13T. If no-one is able to give consent, the organs should not be removed.

13U. Should the family of the original donor have any rights over an organ used in transplantation after the death of the recipient?

13U. No, see 13Q.

13V. Should the prohibition of commercial dealings in organs from living and/or deceased people remain? If not, why?

13V. Yes.

13W. Does section 1 of the Human Organ Transplants Act 1989 (see paragraph 13.37) address the issue adequately? If not, how should it be amended?

13W. This section should be extended so as to cover commercial trafficking in organs and other body parts outside the context of transplantation. Also, payment in kind for organs or other body parts (for example, medical treatment for oneself or a relative) should be included in this section.

13X. Should new legislation include a specific requirement for the relevant practitioner to satisfy him or herself that the donor is dead before removing an organ?

13X. Yes.

13Y. Should revised legislation permit suitably trained and qualified people, acting under the direction of a registered medical practitioner, to remove organs or tissue from deceased donors?

13Y. No. This would be particularly unwise in view of controversies over the adequacy of current tests for diagnosing death.

13Z. Should there be any exceptions to such a provision; and, if so, why?

13Z. No.

14A. Should legislation or regulations specify that procedures for live transplantation that may give rise to concern are subject to suitable scrutiny?

14A Yes.

14C. Views are invited on whether all or particular living transplant procedures should initially be designated as requiring independent oversight. Should there be provision for designating centres as able to carry out particular procedures?

14C. Yes.

14D. Are there any reasons why procedures in which organs and tissues removed for the health benefit of the person concerned and subsequently used in transplantation require special scrutiny?

14D. No, but exchange of money or the equivalent (e.g. free medical treatment) in such contexts should still be an offence.

14F. Should distinctions be made in levels of scrutiny of a procedure on the basis of an existing `relationship' between the donor and recipient? If so, why?

14F. Yes, but only as a preliminary safeguard - as payment is more likely to occur between unrelated donors.

14G. If such distinctions were necessary, on what characteristic(s) should they be based (e.g. genetic relationship, close personal relationship)?

14G. Close genetic or adoptive or marital relationship.

14H. Should the removal of an organ from an incapacitated adult for the purposes of transplantation be prohibited by law?

14H. Yes.

14I . If not, why; and what alternatives (if any) would be suitable?

14I. Incapacitated patients are especially vulnerable, and need stringent protection. While regenerable tissue could be taken from an incapacitated person if this was in his or her social interests (for example, if it would save a brother or sister to whom he or she was attached) the risks and burdens of organ donation are such as to make it unreasonable to impose them without the donor's consent.

14J. Are the safeguards set out by Article 20.2 of the Council of Europe Biomedicine Convention for the donation of regenerative tissue acceptable?

14J. Yes, except that it seems too narrow to limit donation to siblings. An incapacitated person may have an equally strong interest in the continued good health of a parent or close friend, for example.

14K. If not, why; and what alternatives (if any) would be suitable?

14K. See 14J.

14L. Is it acceptable (as provided by the Council of Europe's additional protocol on transplantation) to remove cells from an incapacitated person if that poses a minimal risk and burden to the donor? If not, why?

14L. This is not acceptable unless (a) the cells are being taken to treat someone in whose health the incapacitated person has a compelling interest (such as a close friend or relative) or (b) the cells are being taken for the health benefit of the incapacitated person him or herself. In the first case, a court should be required to give permission for taking the cells. In the second case, it would be permissible, providing the next of kin consented, to take a small amount of extra tissue from the same part for use in transplantation or research.

14M. Are the requirements of Article 20.2 of the Council of Europe Convention (see paragraph 14.21) equally suitable in the case of children unable to consent?

14M. Yes.

14O. Is the exception provision set out in paragraph 14.24 equally suitable in the case of children unable to consent?

14O. Again, we would require that the transplant recipient be a close friend or relative of the donor (see 14L) in whose health the child has a compelling interest.

14P. If not, what safeguards would be suitable?

14P. Tissue should only be taken in the circumstances described in 14L, with the additional proviso that the parents or guardians, as well as the court, should give permission. See also 14R.

14Q. Should the donation of regenerative tissue such as bone marrow from a child unable to consent require prior approval by the courts?

14Q.Yes, for the protection of the donor.

14R. Should there be a legal prohibition on the donation of organs or tissue by a child who is competent to give consent, but refuses to donate?

14R. Yes.

14S. Should a person be permitted to risk the removal of an organ for the benefit of a stranger? What legal, ethical and/or clinical issues would such altruistic donations raise?

14S. Yes. This is a case of heroic generosity which ought to be allowed. Donors should be fully informed of the risks and burdens involved: since they have no compelling personal reason to donate, their willingness may indicate a lack of awareness of these risks and burdens. Care should also be taken to ensure that `altruistic' donors are not taking covert payment from the recipient or his or her family.

14T. If such donations were allowed:

* what kind of safeguards should apply or be available?

* should the anonymity of the donor be maintained in all or some circumstances:

* should any different arrangements apply to `paired' donations (see paragraph 14.34) and, if so, why?

14T. Altruistic donation should not be allowed from those who have dependants, or from those whose ill-health makes the operation high risk. This procedure should be entirely anonymous. The candidate would have to undergo a thorough psychological examination and approval should be sought in each case from the courts. Paired donation should not be allowed, as this is a form of `payment in kind'. However, incompatibility with a close friend or relative who needs an organ could be a legitimate motive for altruistic donation.

14U. Should it be possible for a member of a transplant team to decline to take part in an intervention (removing an organ from an altruistic donor) that he or she considered was not in the best medical interests of the person concerned? If so, should he or she be obliged to refer the person to a team that was willing to perform the procedure?

14U. No health professional should ever be required to provide treatment which, in his or her judgement, is against the patient's medical best interests. Nor should a health professional be required to refer a patient to someone else who would provide such treatment: at most, he or she should be required to inform colleagues or superiors of his or her decision to refuse to be involved.

14V. Are any specific safeguards needed for an altruistic donation of regenerative tissue by a person able to consent? If so, what safeguards and for what reasons?

14V. Only to the extent that the procedure involves significant risks and burdens - in which case, similar safeguards could be provided to those described in 14B.

14W. Should there be any restrictions on the donation of cord blood other than requiring the consent of the mother? If so, what restrictions and for what reasons?

14W. No, this should be regarded as discarded tissue.

14X. If transplantation of reproductive tissue became feasible, should this be permissible and, if so, should it happen only with the informed consent of the donor of the tissue? What additional or alternative safeguards should apply?

14X. This should not be permitted: it is wrong to create a child whose sense of identity will be confused by the deliberate separation of genetic from birth and social parenthood.

15A. Is it acceptable to permit modification to the termination procedure if:

* the procedure poses either the same, or less, risk to the woman; and

* the modification is approved by a research ethics committee; and

* the woman consents to the modification based on information concerning both the standard procedure and on the modification?

15A. Abortion is not a morally acceptable procedure, and altering the procedure so as to retrieve fetal tissue would add insult to injury, in reducing the unborn child still further to the status of property. Those using the tissue would be more deeply complicit in the abortion if it had been engineered precisely to make such tissue available.

15B. Is the approach to consent described in paragraph 15.16 above acceptable? If not, how should it be modified?

15B. Those involved in the death of the unborn child should not give permission for the use of his or her remains. Use of fetal remains from abortions should be ruled out entirely. As a matter of humanity, a request from either parent of the aborted child to be given the child's remains for burial or cremation should be positively met. However, this should be the limit of the parents' control over the body of their child.

15C. Is it ever necessary or desirable to use a fetus or fetal tissue from a woman who cannot give consent in either research or therapy? If so, why?

If it might be necessary or desirable to use such a fetus or fetal tissue, should this be permissible and if so under what conditions?

15C. No, fetal tissue from a miscarriage or stillbirth should not be used without the consent of the mother, and, where practicable, of both parents. Fetal tissue from abortion should not, in any case, be used for research.

15D. Where a post mortem examination, or testing, is sought on a fetus following miscarriage or termination of pregnancy either:

* to establish the nature of any condition affecting the fetus; or

* to identify any implications for the future health or reproductive choices of the
woman concerned,

is it acceptable for consent to be required from the woman only? If not, what alternative scheme should be applied?

15D. If it is practicable to involve both parents in the case of miscarriage this should be done. Where tissue donation is in question the permission of both parents should be required (see 15E). However, for a post mortem to clarify the cause of death the permission of either should suffice and the other should not have a veto, as wanting knowledge of the cause of death is a legitimate desire.

15E. Does the approach set out in paragraph 15.29 adequately protect individual interests, including that of the man, in research on the fetus or fetal tissue? If not, what alternative scheme should be applied?

15E. This approach is adequate in the case of research involving small tissue samples from the fetus, and where the end of life has not been brought about by deliberate abortion. However, donation of significant amounts of tissue or the production of cell lines should require the consent of both mother and father - at least to the extent that either should be allowed the power of veto.

15F. Should legislation provide for an intermediary body or bodies? If so, what would be the objective of such a provision and how would problematic cases (e.g. the need for fresh fetal tissue) be catered for?

15F. The mere presence of a go-between cannot make the use of tissue from an aborted child morally acceptable. Such use should be utterly excluded. In the case of natural miscarriage, an intermediary body would not be necessary, though it may be appropriate for the mother or parents to be approached by (for example) the midwife, rather than the researcher him/herself.

15G. Should legislation specify that the body of a fetus, and fetal tissue as such, should not be the subject of property rights?

15G. Yes. In the current social climate, the unborn child is especially liable to be seen as property, both before and after death.

15H. Should it be permissible for fetal tissue to be subject to property rights if it has acquired different attributes through the application of work and skill? What would be the advantages or disadvantages of such an approach?

15H. Fetal tissue taken after miscarriage should be subject to the same rules as adult tissue in this regard. However, in the case of abortion, the abortionist or person who extracts the tissue and those who receive it from him or her (or a go-between) should not be permitted to derive profit from the tissue, whatever application of work and skill they may apply.

15I. Should legislation provide for conscientious objection to participation in research or therapy using fetal tissue? If not, why not?

15I. Yes, and such a right should be broadly interpreted as covering care of patients or participants at least before and possibly after the procedure. Health professionals who object to using fetal tissue in research or therapy should not be expected to prepare the patient or participant for such research or therapy.

15J. Is incineration acceptable for foetuses, particularly at very early gestation, where no wishes have been expressed about disposal?

15J. No - whole bodies, limbs and whole organs of fetus, infant or adult should never be incinerated together with clinical waste. This is incompatible with respect for the remains of human beings of any age.

15K. If incineration is not acceptable, what other methods of disposal should be used and who should pay for the additional costs involved?

15K. Whole bodies, limbs or whole organs should be disposed of respectfully according to the directions of parents, next of kin or executor where applicable, but otherwise by cremation clearly separate from the burning of refuse. The hospital should pay the costs involved.

15L. Are there other issues concerning foetuses or fetal tisuse that should be taken in to account in this review of the law?

15L. There should be a review of the practice of using fetal tissue from abortions, which we believe is ethically unacceptable. Fetal tissue or cell lines obtained from ethical sources (e.g. natural miscarriage with the parents' permission) should be clearly labelled for the benefit of those with a conscientious objection to abortion. Where a new cell line is needed (for example, to make a new vaccine) only such ethical sources should be used.

16B. Should the Human Fertilisation and Embryology Authority (or anyone else) have the power to waive the requirement for personal consent to the storage of gametes for the duration of a child's incapacity?

16B. Only in the context of storing tissue which may contain gametes (or their precursors) for future transplantation into the patient to restore his/her natural fertility. Techniques which restore a patient's own fertility should be distinguished from techniques (such as IVF) which do not restore this fertility, but bring about conception via a manufacturing process. Such techniques do not respect the child in his or her conception, and are frequently accompanied by much loss of life and discarding of embryos created.

16C. If so, should consent from a person with parental responsibility or the court be required?

16C. Consent of a person with parental responsibility should suffice, as restoring natural fertility by transplantation of reproductive tissue back into the patient (if this becomes possible) would be in accordance with the patient's medical best interests.

16D. Should the courts have a power to consent to the continued storage of gametes once someone reaches the age of 18? If not, why?

16D. Yes in the case of an incapacitated person, but only if the aim is to restore his or her natural fertility once capacity has been regained.

16E. At the time of giving consent to storage of gametes of a child who lacks legal capacity, should the person with parental responsibility or the court be asked to specify that, in the event of the child's death, the gametes are either:

* donated for research, or

* disposed of?

16E. The person with parental responsibility, not the court, should make this decision. If consent is given to use the gametes in research, such research should not involve fertilisation or similar procedures (for example, cloning or parthenogenesis). Such research is incompatible with respect for human fertility, and for the lives which would or might be created.

16F. Should it be possible for such gametes to be donated for use in assisted reproduction treatment after the death of that child?

16F. No. The use of donor gametes in assisted reproduction techniques leads to genetic confusion for the child, quite apart from the dehumanising nature of such techniques in themselves. People should not be made parents of children in whose future lives they cannot or will not be involved. If the children later gain the right to information on their genetic parents, it will be disturbing to their sense of identity to discover that one parent died as a child and became a parent after death.

16G. Views are invited on any alternative approaches to determining what to do with the gametes in the event of the child's death.

16G. Alternatively, the gametes or their precursors could be destroyed in all cases.

16H. Should the removal of gametes from an adult who lacks capacity be in accordance with the principles governing other medical interventions on that person?

16H. The removal of individual gametes should not be permitted, though reproductive tissue containing gametes or precursors to gametes could be removed for transplantation back into the patient, assuming he or she will acquire or reacquire capacity at some stage.

16I. If not, why and what alternative scheme should apply?

16I. See 16H.

16J. Should any distinction be drawn between the position of an incapacitated adult who is thought likely to recover from an illness or accident and one who is not? If so, on what basis; and what criteria should be applied?

16J. Yes, as there will be insufficient reason to restore the person's fertility if he or she will never be capable of marrying or caring for a child.

16K. Should court approval be mandatory before gametes are removed from an adult who lacks capacity?

16K. Individual gametes should not be removed from an incapacitated person, though reproductive tissue could be removed for later transplantation back into the patient. Such removal should not require court permission if there is hope that the person will recover capacity and might need the healthy tissue.

16L. At the time of giving authorization for gamete removal, should the court have the power to specify that, in the event of the person's death or permanent incapacity, the gametes are either:

i donated for treatment;
ii donated for research, or
iii disposed of?

16L. No. Individual gametes should not be removed, though reproductive tissue may be removed with a view to later transplantation back into the patient. Gametes should not be used for treatment, which would involve (among other things) the deliberate separation of genetic from social parenthood, which is harmful to the sense of identity of the person so created. Parents or next of kin, but not a court, may decide to give consent to use of gametes in research; however, this research must not include fertilisation or similar procedures.

16M. Views are invited on any alternative approaches to determining the fate of the gametes in the event of the person's death or permanent incapacity.

16M. Alternatively, gametes and their precursors could be destroyed in this case.

17A. Are there any circumstances in which research on cell lines (excluding stem cells) meeting the conditions described in paragraph 17.7 require ethical review?

17A. No, but fetal cells from abortions and embryonic stem cells do not fulfil these criteria of ethical origin.

17C. Should any other safeguards be applied to research on cell lines (excluding stem cells)?

17C. There should be clarity about which cell lines do fulfil the criteria of 17.7, and can therefore be used by those who object to using cell-lines from aborted fetuses or embryos killed in research, which do not fulfil these criteria. For example, cell-lines derived from naturally miscarried children, with the permission of their parents, should be clearly marked as such.

17F. Should donors whose tissues are used to develop cell lines or tissue engineered products be asked to give up all rights in that tissue, such that they could not benefit from any profit that may eventually accrue from such developments?

17F. Donors should not be asked to give up property rights as there should be no property rights in human tissue as such.


Notes
1 This Response has been prepared by Dr Helen Watt, the Director of the Centre, and Anthony McCarthy, its Research Fellow. We gratefully acknowledge the help of Dr David Jones in writing the Response.
2 See, for example, John Paul II, Address to the XVIII International Congress of the Transplantation Society, August 29, 2000.
3 See D. Alan Shewmon, `The Brain and Somatic Integration: Insights Into the Standard Biological Rationale for Equating `Brain Death' With Death', Journal of Medicine and Philosophy 2001, Vol.26, No. 5, pp.457-478.