Overall Comments

The Society welcomes this document as a productive attempt to open debate on a number of important ethical issues. There is however serious concern that the ethical issues surrounding transplantation from people who have died and from living donors has been included in a document which deals largely with the removal and retention of use of human organ and tissues for pathology, research, education, training and public health surveillance. It was felt that where organs are to be used for therapeutic purposes such as organ transplantation the ethical framework is different and the need to encourage and improve the rates of organ donation for this purpose should be kept separate from those of organs and tissues for pathology, research, education, training and public health surveillance. This recognises the requirement to protect and preserve human life taking precedence over the requirement to respect the rights and previously indicated wishes of a dead person.

Section 11: Oversight and Compliance

11 A - E It is clear that as medical practice has evolved and new procedures have been developed that there is a need for a review of the existing law and practice. This supports the need for a single body to oversee the removal and retention and use of human organs and tissues for any purpose but, in line with the comments in the introduction above, it is important to distinguish between the use of human organs and tissues for therapeutic purposes to benefit living individuals and for the many other (useful) purposes outlined in the discussion document. This suggests the need for a separate body to oversee transplantation which could be constructed along the lines of the existing organisations UK Transplant and ULTRA to oversee and regulate the conduct of tissues and organ transplants. If a single overarching body to deal with all the issues raised in "Human Bodies; Human Choices" is formed then it is imperative that a distinct subgroup to manage the therapeutic use of organs and tissues is also created. Such a body could assume and extend the responsibilities of ULTRA and have responsibility for codes of practice and statutory regulatory functions. Further discussion of the role of UKT within this body would be required as it is also important to distinguish between the rights of the donor and the need increase organ transplantation.

It would be a mistake to subject all transplant procedures to statutory regulation or approval but the distinction between living related and unrelated transplantation seems artificial and where there is potential risk to a living individual who is involved in a transplant procedure (whether related or unrelated to the recipient) it would seem sensible to recommend that this should be subject to statutory approval from a specified body. Organ donation from a dead person carries no risk to the donor and thus could be subject to codes of practice rather than statutory approval.

Any such body would of course have responsibility to produce regular reports, conduct audit and involve the transplant community in informed debate.

Section 13: Transplantation in people who have died

13 A & B The revised legislation should include a working statutory definition of death and the one given in the document is reasonable and has stood the test of at least four years examination. The diagnosis of death could be established in codes of practice rather than defined in statute and the existing codes of practice have proved workable and robust.

13 C The inclusion of a requirement to comply with the current code of practice to establish the diagnosis of death would be a safeguard to protect patients and reassure relatives and the public. In most centres this is already undertaken by means of a standard proforma and it would not be difficult to devise such a procedure which was not too bureaucratic.

13 D Once death is established and consent for organ donation has been given, it is unethical not to take steps to preserve organ function in the donor, as the duty of care is to the living individual who will ultimately benefit from the transplant procedure and not to the deceased. Due respect should be paid to the body of the deceased in this process.

It is an important safeguard to separate the diagnosis of death from the procedures that then may be employed to facilitate organ transplantation.

Difficulty arises where procedures are undertaken on the dead person's body without consent. It is the feeling of the BTS that it is ethical to, for example, cannulate and perfuse the organs where it can be established beyond reasonable doubt that the individual in life wished to become an organ donor after death. If such a wish cannot be established then an independent individual (perhaps HM coroner) could be given the authority to consent to organ donation in the absence of the next of kin. Next of kin would still retain the capacity to override this permission should they subsequently become involved.

There is a quandary which is not readily resolved over whether the wishes of the next of kin (a living person) should override the wishes of the dead person when these were clearly for organ donation to take place. In these circumstances the distress caused to next of kin and negative impact of possible adverse publicity on organ transplantation as a whole should be taken into consideration and it might be helpful to incorporate a code of practice that would seek to take into account the next of kin's objection to the process.

It must be recognised that the circumstances of organ donation can be very difficult for the next of kin and therefore to insist on written consent at the point of donation in every case could give rise to increased anguish for the relatives or loss of organs. A provision for nonwritten consent would spare the bereaved family this stress.

13 E Yes, it is important that death is diagnosed by a practitioner independent of the transplant team.

13 F A code of practice as above would be helpful, defining suitable donors, consent procedures and surgical procedures that may be undertaken with a view to preserving organs for subsequent transplantation following a death.

13 G Yes, and current guidelines have proved robust and workable.

13 H Ethically it is the view of the Society that the deceased individual's wishes in life should take precedence over the relatives' wishes after death. This is enshrined in law in for example the distribution of the deceased's property. It is recognised, however, that the human body is not property as such, although body parts have been imbued with property rights after some procedure has been carried out to preserve or change them. There is then the issue of who would own these rights, and thus have authority to give consent to transplantation.

Practically however the negative impact of possible adverse publicity and distressed relatives that would ensue from imposition of organ donation against the wishes of the next of kin would be deleterious to organ transplantation as a whole. If consent of relatives for organ donation is not to be sought under any circumstances then this needs wider debate within the Society and introduction as part of an agreed consensus. Practically relatives retain the right to veto organ transplantation and this should be protected in the code of practice.

13 I Individual's wishes should be expressed beyond reasonable doubt, and this could include a signed organ donor card or registration with the NHS Organ Donor Registry or a living will.

13 J Introduction of assumed or presumed consent requires wider debate within the community. Opinion is usually split. The principles of autonomy dictate that the individual's rights take priority and if these are not known then they can only be assumed if there is a strong consensus that organs should be used for transplantation after death. It is more likely that legislation to require referral would have majority support and this poses no particular ethical difficulty.

13 K Permission for organ donation under the age of majority should be governed by a judgement on capacity of the individual to make an informed choice. If the individual is judged to have had capacity to make an informed choice then their wishes should be respected as in adults.

13 L This has been discussed above, but if assumed consent was to be included in further legislation then this would require a code of practice.

13 M & N Again this has been discussed above. If principles of autonomy are respected then individuals' rights would be paramount and not overridden by the next of kin. The Society feels that this would potentially be more damaging than helpful and it would be preferable to stipulate the rights of next of kin to object to organ transplantation in a code of practice. To override this would require a change in public view with strong consensus view supporting removal of cadaveric organs without permission.

13 O - P The time immediately following the death of a relative is a difficult period for rational decision making and these issues would be resolved by a clear statutory framework or clear code of practice governed by statute. This could give the priority order for consent from various family members should such a conflict of views arise. It is expected that in most cases a consensus will emerge if the consent process is managed by a suitably qualified and experienced individual co-ordinator.

13 Q Yes, donation of organs from a dead person should always be on the basis of unconditional non-directed gift.

13 R No, a standard organ donation consent form would be satisfactory for this purpose. Most transplant centres have devised such a form, and it would not be difficult to produce a national version of such a standard consent form that did not introduce any additional bureaucracy. It would be helpful to have a separate consent form from the new forms that have been introduced to document consent for procedures in living patients.

13 T The code of practice needs to establish what constitutes 'beyond reasonable doubt' that consent would not be refused and that the individual in life wished to become an organ donor after death. The provision for a senior independent clinician or manager or official to give such permission would be helpful and perhaps HM Coroner is the appropriate person. HM Coroner would require guidelines within which to work and this could be built into the consent for donation form.

13 U No, it is a non-directed and unconditional gift, as such ownership if such a word can be used, passes to the recipient following transplantation.

13 V Yes, commercialism in organ transplantation should remain prohibited. The Society supports the law outlawing commercialisation of organ transplantation as does the International Transplant Society. Such a law protects individuals from exploitation and distances the transplant process from financial consideration.

13 W Yes.

13 X It would not be appropriate for the transplant surgeon to be required to repeat the brain stem death tests. It is, however, the professional responsibility of the surgeon responsible for removing organs from the dead person to satisfy him or herself that death had taken place, that consent had been given and that donation was medically appropriate and this is sufficient. It is important that death is diagnosed by an independent clinician who is not linked to the transplant team.

13 Y & Z In practice this is perfectly satisfactory and is an issue for the surgical Royal College to address. The removal of organs from the abdomen for transplantation is a highly skilled procedure. It is, however, current practice for suitably trained individuals to retrieve some tissues and there is no ethical reason why this should not be widened. Such individuals should work under the supervision of a registered medical practitioner (usually a transplant surgeon) who would assume responsibility for the donation process so that there was clear accountability.

Section 14: Transplantation with Living Donors

General Comments

The definition of an organ is difficult, and the existing definition in the 1989 Act is inadequate. There does not seem to be any fundamental reason why organs and tissues should be differentiated although perhaps the distinction should be related to the capacity of the tissue or organ to regenerate following removal. Procedures of blood and bone marrow donation are subject to similar ethical considerations as are donation of solid organs such as the kidney or liver. There is a spectrum of risk of donation which dictates the need to involve the donor in an informed consent procedure for any donation procedure.

14 A & B A statutory framework should also recognise the ethical requirement to improve and innovate in medicine. It should thus not close doors to new techniques or procedures. If a list of transplant procedures was enshrined in law it would be very inflexible and could give rise to considerable difficulties. The principles that govern living transplantation would be similar in each case and the Society feels that a proscriptive approach would be too restrictive on practice.

The designation of centres or individuals to carry out such transplant procedures should be subject to professional regulation rather than governed by statute.

14 C The distinction between the genetic relation and emotional relationship is artificial as coercion can apply in any situation. It is therefore suggested that the bureaucratic framework is streamlined and changed to reinforce the importance of informed consent and autonomy of the individual. An independent scrutineer could be designated as a check and balance on such procedures whether related or unrelated. As for designation, this would be best left to Codes of Practice rather than enshrined in statute and based on professional expertise. An independent scrutineer would be able to take a view on newer, perhaps higher risk, procedures as a safeguard for donors.

14 D & E No, these procedures could be considered by an independent scrutineer (which may or may not be ULTRA) as are other living transplant procedures.

14 F & G See above.

14 H & I This is an extremely difficult issue as in general it is taken that adults without capacity cannot give consent for any procedure and therefore the practitioner must act in the best interests of the patient. This does not, therefore, allow the doctor to consider the benefit of another individual. This would not of course apply to the domino situation mentioned. The ethical issue is - does the principle of greater good override the doctor's duty of care to the potential donor. An individual decision is probably required as there are circumstances where the donor would benefit from the transplant procedure (e.g. if it was to save the life of the donor's carer). Wide debate is required before enshrining in statute and general principles only should be stated to allow flexible interpretation by perhaps an independent scrutineer.

14 J, K & L In general the convention on human rights is satisfactory though the safeguards are a bit too restrictive in that they restrict the recipient to a sibling and again the comments above about greater good and duty of care are applicable. There is no ethical difference between donation of regenerative tissue and a kidney and as stated above there is a spectrum of risk rather than a cut off.

14 M - Q Again the issue around children is one of capacity. See comments on 13K above.

14 R If a child has capacity to give consent but refuses consent then this should be paramount. Thus if a child under the age of 18 has capacity then their autonomy and wishes should be respected. If the reverse occurred, however, where the child gave consent but parents objected then codes of practice should dictate that organ transplantation should not occur for the same reasons as applied to the cadaveric situation where the next of kin does not give consent for organ donation.

14 S & T Altruistic organ donation poses no more difficulty than living related or unrelated donation. The same safeguards and principles should apply. Donation should be anonymous unless both parties agree otherwise. Donation should be non-directed and unconditional. The individual must be assessed properly and this should include a psychological assessment of capacity. The organs should be allocated through existing national allocation principles and in paired donation it would be preferable if the procedures were carried out simultaneously in different centres. These latter considerations are practicalities rather than principles as there is ethically no objection to this situation.

14 U Yes of course. If an individual's conscience prevents them participating in a therapeutic procedure then it should be open for them to withdraw from participation. This situation is analogous to that which applies to the procedure of termination of pregnancy. The individual concerned should of course be obliged then to offer the patient an alternative opinion.

14 V & W The same considerations apply to the donation of regenerative or non-regenerative tissues although there is a different degree of risk to the donor. Informed consent should be sought, but there would not be a need to asses the donor as stringently as in the case of more risky procedures.

Dr Peter A Rowe MD, FRCP
Consultant Nephrologist & Clinical Director Renal Services
Honorary Senior Clinical Research Fellow in the Peninsula Medical School
Chairman of the Ethics Committee of The British Transplantation Society
13th October 2002

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