In the 1950’s kidney surgeons departed from the long held belief that can be traced back to Hippocrates – “do no harm”. The pioneering surgeons, Doctors Murray and Harrison, transferred a healthy kidney from Ronald to his brother Richard who was dying of kidney disease. This took place on December 23rd, 1954 at the Peter Bent Brigham Hospital in Boston. (What is now part of the Brigham and Women's Hospital.)

Clearly a calculated risk was made by the Brigham team and the Herrick twins that the risk of kidney donation by Richard was far out-weighed by the benefits that could be derived by Ronald. The team knew that transplants between identical twins would virtually eliminate the risk of organ rejection and that Richard’s quality and length of life would be improved. To my knowledge the donor twin was alive in 2004 when Ronald attended a dinner to celebrate the 50th anniversary of the transplant operation that saved his brother’s life (Ronald Herrick is shown below standing to the right of the photo with Dr Joseph Murray.) As a fit and healthy 73 year old Ronald was honoured as the real hero of that historic event. His brother Richard married his care nurse, had two children but died in 1962 of kidney disease. From this viewpoint the risks of the transplant procedure were justified. The outcome was successful.

The picture above shows the Herrick twins with their kidney transplant team.The photo below to the right shows Dr Joseph Murray with Ronald Herrick in 2004, who 50 years earlier had donated one of his kidneys to his brother Richard. The picture source can be found here: [Brigham and Women's Hospital website link]

Once this medical success had been achieved there was no turning the clock back. Bio scientists and surgeons looked for ways to extend the transplant programme so that grafts between non-identical twins could be successfully managed.

The crucial fact about the Herrick twins revolves about the issue of supply and demand. One brother had the need for a kidney and the other brother was able to satisfy that need. Moral and ethical decisions about consent were relatively easy to resolve. Provided the donor, Ronald, was not placed under any emotional duress and was in no way bullied into giving one of his kidneys to his brother no objections could be made about the operation. Indeed the reverse seems to be true. Ronald Herrick was applauded for his magnanimity and altruism. “Isn’t this what any person would do for another citizen?” The notion of the ‘Good Samaritan’ lives on.

Even up to the night before the operation to save his life Richard had doubts about whether he should put his brother’s life at risk, in order to postpone his own death. Richard did not want to jeopardise his brother's health.

Either of the brothers could have had spiritual or religious objections to the kidney transplant in the sense that the procedure interfered with the natural order of events not ordained by a higher deity. There is also the concern that there is a ‘tyranny of gift’. At a social and psychological level the nature of the relationship between the donor and recipient will inevitably change once Ronald has given the ‘gift of life’ by donating his kidney to his brother. Emotional responses to this type of risk are difficult to assess in the lead up to the operation and would remain unpredictable and circumstantial. What seemed the most natural thing to do at the time of the operation may develop into a source of aggravation some years in the future. In simple terms does a living donor fundamantally alter the nature of the relationship between them self and the recipient? Does the nature of the relationship change turning the gift into an obligation? Why was Ronald risking his own life to save Richard? Was this an act of supreme sacrifice - taking a risk to benevolently help another person? Moral obligation or gift?

Autonomy and Explicit Consent

In December 1954 the Herrick twins were able to resolve the supply and demand challenge perfectly. The donor, Ronald, was under no obligation to donate a kidney to his brother. He was not coerced. He was able to make a competent decision with full mental capacity to be a donor. You could argue that as Richard’s brother he was under family pressure to save his brother’s life. The emotional guilt of not donating a kidney would be hard to contend with if Richard had died without a transplant. Was it fair to place Ronald under this pressure?

Fair or not, Richard was able to exercise his own free will in deciding to donate a kidney to his brother. He freely transferred authority to the surgeons to take a calculated risk with his body. Independently Ronald made the autonomous decision to benevolently give Richard an organ. He entered into this process voluntarily with his eyes wide open. This was Ronald’s legitimate choice – not a decision that had been imposed on him by an external legal authority. Presumably Ronald exercised rational thought to give informed consent to save his brother’s life. Ronald retained exclusive control over his body. This is the model of consent that is used with all living donors in the UK today laid down in the statutory guidelines of the 2004 Human Tissue Act.

Medical decisions of this type depend on certain values or criteria. Clearly defined protocols and procedures have to be followed to protect the best interest of the patient and the medical staff.

As with all medical procedures the transplant team of medics led by Dr Murray would have explained the risks and benefits to both brothers. Ronald and Richard would have signed an indemnity form releasing the hospital from the risk of being sued if the medical procedure went wrong. This is the traditional basis on which doctor-patient relationships are managed. The medical team are given advanced informed consent to do what is in the best interest of the patient. Provided that the patient has medical capacity or competence to make a decision the signature on the consent form becomes a binding agreement based on trust and knowledge.

Medical capacity or competence in this context means that the patient has a clear understanding of the medical procedures that he or she is about to go through. The patient has to show the ability to recall what they have been told and explain the implications of the medical procedure. If the patient cannot meet these conditions then that authority can be transferred to another responsible person – a relative, friend or designated professional.

The nature of transplants changes dramatically when lungs, livers and hearts are under consideration. The situation the Herrick twins were in no longer applies. Lung and liver lobes can now be transplanted from living donors, but these organs generally come from deceased donors. All hearts do! Where Ronald Herrick was able to give explicit and informed consent before one of his kidneys was removed and implanted in Richard, most organ donors are not in the position to do this because they are on a ventilator fighting for their life prior to their ultimate brain stem death. So explicit consent can only be given in advance by the potential donor or an alternative approach has to be employed. In the UK only about 30% of organs come from deceased donors that were on the Organ Donor Register. In 70% of cases consent for organ retrieval in fact comes from the dead person’s family, partner or carer. When asked 40% of families refuse the request for organ retrieval. Yet we are regularly told that national surveys show that between 60-90% of the UK population support organ donation. [Click here to view an article in the British Medical Journal]

That is where the debate on presumed consent enters the scene. If enough organs could be procured or retrieved with explicit or informed consent to satisfy the demand for organs we would not be discussing this issue at all. If the opt-in, voluntary system in the UK satisfied demand for organs on moral and ethical grounds there would be no reason to change the system.

Does death alter the meaning of consent?

The simple answer to this question is “no” in an ideal world. Explicit consent is needed from living patients and donors, so surely this type of consent is just as important for people who have died. Some would say it is even more important – the sanctity of the dying or dead has to be fully respected because there is no second chance to put it right if events go ‘wrong’. If the express wishes of the decedent are not known the legitimate decision making authority conventionally transfers to a partner or next of kin. (The hierarchy of authority is defined in the Human Tissue Act – a section in the 'Code of Practice on Consent' illustrates this point below.)

When the explicit wishes of the deceased are known the post mortem arrangements become less complicated. If the decedent is on the Organ Donor Register the family are guided by this intention to be a donor. This makes it easier for them to discuss donation with critical care staff or donor transplant coordinators who will make the approach for organ retrieval.

Advocates for the presumed consent system believe that families and NHS staff will find the grieving process and request for donation easier to handle if as a society everyone is expected to be a donor unless they have opted out. Presumed consent removes a difficult responsibility from the carers of the deceased person. The justification for presumed consent is that more donations will take place leading to more life saving transplants. The assumption that everyone wants to be a donor may reduce individual or family autonomy but will achieve a greater benefit for society as a whole.

Is this an acceptable standpoint? Your powers of empathy are required here. Put yourself in the position of the grieving partner or family members. Typically organs and tissue are retrieved from adults that were in the prime of their lives. Very often their death has come as a complete shock through unforeseen circumstances – a fatal road accident, a brain haemorrhage or sudden heart attack. The patient has been rushed to hospital and may have been moved quickly through the Emergency Department to the critical care unit. The patient could then be placed onto ventilation depending on the nature and severity of the trauma they have experienced.

The critical care staff try all in their power to save the person’s life during which time partners and family members are arriving at the hospital. The medics have to decide on the best course of action – they are duty bound to do what is in the “best interests” of the patient. If they decide that treatment is futile they must withdraw all support from the dying patient, to do otherwise could be regarded as assault.

The diagnosis of brain stem death legally defines the patient as dead. They become potential heart beating donors if their body is being mechanically ventilated.This contrasts with non heart beating donors whose hearts have stopped naturally and are cardio-respiratorially dead. If we disregard living donors, approximately 75% of organs come from deceased patients that have been diagnosed as brain stem dead - not cardiac dead. That is why more work effort has to be invested in procuring organs from non heart beating donors.

When two doctors have carried out the brain stem tests twice to diagnose death, then and only then, will the family be approached about organ donation. This is an extraordinarily difficult task for health professionals who have just been fighting to keep the same person alive. I know from very personal experience that they fight like hell to keep patients alive. The misconception that doctors would not fight to keep you alive if they know you are on the Organ Donor Register I find unbelievable. When the medical team are fighting for your life they do not even know if you are on the register! The assessment of brain stem activity is not carried out by any member of a transplant team – there is no vested interest in letting a patient die. Cynically it does not look good in the mortality rate league tables when patients die.

So, the situation is that you have just been told that a young relative is on a ventilator and has been diagnosed as brain stem dead. Through this tragedy the family loses all control over events. Through very careful bereavement support an element of control can be put back into the hands of the family by asking them how they can be helped to achieve the dying wishes of the patient. If a relative of mine was in this situation I would not want to be excluded from these end of life choices. Presumed consent brings the potential risk that this could happen. By the same token I would expect to be asked about organ donation. Too many deaths occur in hospitals where the issue is not even considered, let alone discussed. It should be the responsibility of all health profesionals to give dying patients or their bereaved next of kin compassionate end of life choices. These choices must include the right to be a potential donor.

No assumptions can be made by health professionals on behalf of the patient or the family. Maybe the patient’s wishes are not known so the next of kin take on this surrogate or 'stewardship' responsibility supported by NHS staff. End of life choices have to be offered to the family in these tragic circumstances. Guidance and support are required to complete Last Offices; fill out official documents, allow relatives to see the deceased, maybe have to wait for a post mortem, prepare the body for burial or cremation and so on. The request for organ donation grows out of this process of bereavement support. For many families the opportunity to affirmatively and positively support the request for donation restores some control back into their hands. The request for donation gives the family some crumb of solace, some slight positive outcome out of a tragic loss. This positive act of benevolence to an unknown recipient may be viewed as a gift or even indeed as a sacrifice. This magnanimous act gives some positive meaning to what is often a premature, senseless waste of life. An element of control is given back to the family or partner.

In this context does presumed consent make sense? I don’t think so. Presumed consent runs the risk of marginalising the wishes of the deceased or their family. It leaves doubt over whether the decedent’s end of life choices were respected. The family has to live with this forever. Presumed consent runs the risk of side lining the family at a time when they want to guarantee the fulfilment of their loved one’s wishes. Moral authority at this precious time has to be retained by the family on behalf of the deceased. Presumed consent undermines this autonomy. At this moment of human tragedy sensitivity and compassion are needed. The NHS is working very hard to improve its end of life strategies. With an ageing population profile more people are dying in hospitals. I fear that a move to presumed consent would undermine the compassionate support for the family replacing it with a directive by the state. I agree, people would have the right to opt-out if presumed consent was to be introduced. But in all other medical relationships consent has to be proactively given, not taken. Consent has to be informed, not presumed, if the transplant process is to be trusted. Any proposals that could undermine public trust in the fairness and justice of the transplant procedure should be avoided at all costs. Only explicit, informed consent that is positively given by the dying patient or their next of kin can guarantee this.

Alder Hey and Bristol

Although tissue and organ retention for medical research purposes is not motivated by the same objectives as organ procurement for transplantation purposes, the same principles of consent apply. The revelations of organ retention at the Royal Liverpool Children’s Hospital (Alder Hey) and the Royal Bristol Infirmary led to justifiable public outrage when parents of children that had died in various hospitals learnt that organs had been retained illegally and unethically for research purposes. In many cases limited consent had been given for hospital post mortems to take place using specific tissue or organs. In some cases organs were retained after a hospital post mortem without consent. (A coroner’s post mortem requires no consent from the family if a person dies in violent, unknown, unexpected or unexplained circumstances.) In some situations all organs were removed from the dead children, contrary to the consent that had been given.

Two inquiries reinforced the need for explicit, informed consent. The public outcry led to the 2004 Human Tissue Act which replaced the Human Tissue Act 1961, Anatomy Act 1984 and the Human Organ Transplants Act 1989.

The terms of consent in the 2004 Human Tissue Act followed a number of government enquiries and framework papers in response to the Royal Liverpool Children’s (Alder Hey) Inquiry chaired by Michael Redfern QC in 1999 (http://www.rlcinquiry.org.uk/index.htm) and the Royal Bristol Inquiry chaired by Professor Ian Kennedy in 1998. (http://www.bristol-inquiry.org.uk/index.htm). Informed consent is the bedrock on which the 2004 Human Tissue Act is based – see the table below.

I agree with Professor David Price. As Professor of Medical Law at Leicester De Montfort Law School he submitted his views to a recent House of Lords committee on European Transplant policy. He says:

"In one sense, explicit consent is indeed the "ideal". If one seeks informed first person agreement to organ donation, explicit consent from the preposthumous person, either by the person adding his name to the relevant organ donor register or signing an organ donor card, is the best unambiguous evidence that a person wanted and had decided to donate. It must be conceded that it is inevitable in various instances of presumed consent, even with a full and proper education process for the public in general, that organs will be taken and used for transplantation from some persons who did not want this to happen or at least had not decided that this should happen. Those at the margins of society are one cohort likely to be within this group, due to being outside relevant official and educational loops, and another would be those individuals who, due to some form of mental incapacity, are unable to reach a decision ie choose, whether to become an organ donor or not. Support for the explicit consent model seems to be principally premised on the notion that any such unwilling removal and use renders such a (presumed) system unethical and unacceptable. Yet even under current explicit consent systems such supposedly unethical removal will consistently occur also, in particular where relevant relatives are unaware of individuals' wishes or act upon their own views"

The opt-in, explicit consent approach is an ‘ideal’ system provided that the donor has been able to convince their family members to accept their particular end of life choice. But simply signing the Organ Donor Register does not guarantee that such a discussion will have taken place. An estimated 40% of families decline the request for organ retrieval to take place when a family member dies – evidently this figure drops to 10% when the family have discussed the issue prior to death. In 7 out 10 cases donation takes place without any written evidence of the donor’s wishes being known. In such cases the donor had not signed the Organ Donor Register. In such circumstances organ procurement may not have been what the deceased person wanted – but at least the partner or family was consulted for their interpretation of this end of life choice. Clearly there is the risk that the family’s interpretation is wrong, but they and they alone have the responsibility for any decision making, not health professionals or the state. Nurses and doctors can guide and support the next of kin in a collaborative way, but the role of the state to assume responsibility for the deceased person is a step too far, unless the family chooses to pass this authority to the NHS.

You can read or download this Professor Price's memo to the House of Lords by clicking on the following button:  

I do not share Professor Price’s view that presumed consent would more accurately authorise organ retrieval than the current situation. He reasons that most public opinion surveys indicate a very high support for organ donation. Yet support does not translate into donation. Is this because people are lazy and cannot be bothered to register or are they responding to survey questions in a manner that gives the appearance of social responsibility? Perhaps deep down people have no intention of allowing their actions to follow their words? If asked “would you save a life by becoming an organ donor?” I suspect most people would say “yes”. In discussions with college students I frequently hear well intended sentiments like:

“They can have any part of my body when I die. When you’re dead, you’re dead.”

This is a very strongly expressed end of life choice made by people who hopefully are decades away from the reality of dying. The conviction is so strong that appropriate terms and conditions are not considered – “let them get on with it” is the attitude conveyed. The reality of the dying process is far more emotionally complex than this. The rhetoric is laudable, but I suspect in a lot of cases it remains rhetoric.

There is a view that when the Organ Donor Register reaches 51% of the eligible population presumed consent should automatically be introduced. The majoritarian view should be allowed to override the wishes of people reluctant to be donors. Where does this leave the notion of democratic choice and the wishes of the bereaved family? There are few circumstances in which the state removes individual autonomy without exceptional justification or at such times that the existing law has to be upheld. Indeed, when the Brazilian government introduced presumed consent the frequency of donation fell in 1989 and the country reverted to an opt-in system in 2001.

If a close family member of mine became eligible to be a deceased donor I would expect to be included in that end of life decision making process. I would not want a law on presumed consent to exclude me from this emotionally charged decision. I sincerely hope that my experience as a double organ recipient has encouraged all my relatives to have already given their explicit consent to be donors. Family discussions on this sensitive issue are crucial to the whole process of organ donation. This is where considerable educational work has to be done to encourage people to discuss their attitudes about end of life choices. I fully appreciate it is difficult to ask people to consider their mortality, especially when they are hopefully decades away from their demise. I fear that if presumed consent was to be introduced less discussion would take place than it does now because the state would have imposed a default position over the choices of the individual and their families.

Extracts on consent from the Human Tissue Authority The current legal position on consent is defined in the 2004 Human Tissue Act. The following extracts from the Authority’s “Code of Practice 1 on Consent” outline the responsibilities that health professionals should follow when establishing consent: Valid consent 30. The giving of consent is a positive act. For consent to be valid it must be given voluntarily, by an appropriately informed person who has the capacity to agree to the activity in question. 31. This code sets out guidance for practitioners on how to make sure appropriate consent is valid. All consent must be valid in the context of the Human Tissue Act. It is important to respect the consent given, regardless of its scope or duration (see sections on scope of consent, paragraphs 35–36, and duration of consent, paragraphs 37–38). 32. For consent to be valid, the person should understand what the activity involves and, where appropriate, what the risks are. When seeking consent, healthcare professionals or other suitably experienced people should ensure that it is appropriate for the intended purpose. 75. If those close to the deceased person object to the donation, for whatever purpose, when the deceased person (or their nominated representative, see paragraphs 78–83) has explicitly consented, the healthcare professional should seek to discuss the matter sensitively with them. They should be encouraged to accept the deceased person’s wishes and it should be made clear that they do not have the legal right to veto or overrule those wishes (see the code of practice on Donation of solid organs for transplantation). Qualifying relationships 83. If the deceased person has not indicated their consent (or refusal) to post-mortem removal, storage or use of their body or tissue for scheduled purposes, or appointed a nominated representative, then the appropriate consent may be given by someone who was in a ‘qualifying relationship’ with the deceased person immediately before their death. Those in a qualifying relationship are found in the HT Act in the following order (highest first) [www.opsi.gov.uk/acts/acts2004/ukpga_20040030_en_3#pt2-pb3-l1g27] : a) spouse or partner (including civil or same sex partner) The HT Act [www.opsi.gov.uk/acts/acts2004/ukpga_20040030_en_5#pt3-pb2-l1g54] states that, for these purposes, a person is another person’s partner if the two of them (whether of different sexes or the same sex) live as partners in an enduring family relationship. b) parent or child (in this context a child may be of any age and means a biological or adopted child) c) brother or sister d) grandparent or grandchild e) niece or nephew f) stepfather or stepmother g) half-brother or half-sister h) friend of long standing 84. Consent is needed from only one person in the hierarchy of qualifying relationships and should be obtained from the person ranked highest. If a person high up the list refuses to give consent, it is not possible to act on consent from someone further down the list. For example, if a spouse refuses but others in the family wish to give consent, the wishes of the spouse must be respected. However, the guidance in paragraphs 85 and 87 should be observed in line with this principle. If there is no one available in a qualifying relationship to make a decision on consent (and consent had not been indicated by the deceased person or a nominated representative), it is not lawful to proceed with removal, storage or use of the deceased person’s body or tissue for scheduled purposes. Parliament has recently approved the HTA's new codes of practice in relation to tissue & organ transplants/research (August 2009). These can be accessed through the following web link: [HTA codes of practice web link link]

"Saving lives - Valuing Donors"

The 2004 Human Tissue Act develops the theme of informed, explicit consent that runs from the findings of the Alder Hey and Bristol inquiries to the publication of a government consultation paper entitled “Human Bodies, Human Choices” (http://www.dh.gov.uk/en/Consultations/Responsestoconsultations/DH_4069366) in 2002 which in turn the led to the document called “Saving Lives, Valuing Donors -A Transplant Framework for England” published in July 2003. (http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4006700). The Transplant framework states that the retrieval and retention of organs and tissues for research or transplant purposes should adhere to the following eight points:

• Respect: Treating the person who has died and their families with respect
• Understanding: Realising that to many parents and families their love and feelings of responsibility to the person who has died are as strong as they were in life
• Informed consent: Ensuring that permission is sought and given on the basis that a person is exercising fully informed choice; consent is a process not a one-off event
• Time and space: recognising that family members may need time to consider whether to agree to a donation of tissue and organs and will not wish to feel under pressure to agree
• Skill and sensitivity: NHS staff must be sensitive to the needs of the relatives of someone who has died and sufficient staff skilled in bereavement counselling must be available
• Information: Much better information is required, both generally by the public and specifically for relatives who are recently bereaved, and for living donors
• Cultural competence: Attitudes to organ donation, and particularly to the use of organs and tissues after death, differ greatly between different religions and cultural groups; health professionals need to be aware of these factors and respond to them with sensitivity
• A gift relationship: The recognition that tissue or organs are given as a gift to help others and deserving of gratitude to those making donations.

All government legisaltion reinforces the need for explicit, informed consent. Consent is crucial if a relationship of trust and respect is to thrive between health professionals and the public they serve. It is the bedrock on which the relationship is based. The Alder Hey organ retention scandal destroyed that trust in the eyes of many families.

The legal necessity to secure informed consent provides a safeguard for the public when being treated by the National Health Service and for NHS staff. The need for consent ensures patient autonomy which may be transferred to a designated person in the event of the patient’s death. The process of dying does not alter the need for explicit consent. In fact I suspect the converse is true. A bereaved partner or relative assumes ‘stewardship’ of the person that has died. That is the cultural reality in the UK. The next of kin acts as an intermediary on behalf of the deceased person. If the express wishes of the dead person were outlined prior to death the family has a moral responsibility to honour those wishes as part of a social contract. Research shows us that family attitudes are crucial in relation to the request for organ donation.

So, less than a decade after the Alder Hey inquiry why should society want to remove explicit consent for organ donation? Do we have such short memories? A move to presumed consent, for example, would place the onus on each individual to opt-out from being a donor. The state could then presume that everyone has given permission by omission to be a donor. The right to opt-out protects the interests of people who do not want to be donors but such an approach does little to deliver the eight crucial points from the “Saving Lives, Valuing Donors” framework document. In the space of six years their significance has not diminished. To presume that someone would give permission for an activity to take place is surely a contradiction in terms. Imposing sex on an unwilling partner is called rape – positive consent is needed to make the act of sex legal between individuals over the age of 16; taking a vehicle without consent is known as theft. What would opponents of presumed consent call the removal organs without explicit consent?

They might call it a gross intrusion into the civil liberties of the individual. They might regard it as the state taking possession of the deceased body without considering the explicit wishes of the decedent or their relatives. American health professionals refer to this process as ‘routine salvaging’.

Those that call for a change to presumed consent justify this on the grounds that the “ends justify the means” – they firmly believe that an opt-out system would result in a greater number of retrieved organs and lives saved through transplants. Proof? Definitive, statistical proof is difficult to find because presumed consent has always been introduced in other countries at the same time as other significant changes have been made.

It is very difficult to be impartial and unbiased on this issue. When you are asking people to consider the sanctity of the living or the dead; the donor or the recipient; their attitudes towards mortality and end of life choices many conflicting emotions come into play.

Objectively, in a rational perspective, people want to save lives – by whatever means are available. This includes tissue and organ donation. But in the context of a premature, unexpected death good intentions are eclipsed by grief. That is why this very important end of life choice to be a donor should not be imposed by legislation, but to the individuals that are intimately involved. I can also respect the views of individuals who want this responsibility or weight taken off their shoulders. The worst eventuality is that people give the donor issue no thought at all. Such disinterest forces the hand of the state to make decisions on behalf the people. Apathy also means that people on transplant waiting lists die needlessly in the absence of sufficient viable organs. Neither situation is desirable.

The Organ Donation Taskforce declined to support the move to presumed consent until such time as their 14 recommendations had been given a chance to succeed – see the recommendations for yourself.['ODT Recommendations' web page]. The recommendations develop further the principles outlined in the “Saving Lives, Valuing Donors -A Transplant Framework for England” from 2003.

The justification for the Taskforce position on presumed consent can be found at the following web link: “The potential impact of an opt out system for organ donation in the UK: an independent report from the Organ Donation Taskforce” - November 2008 [Department of Health web link]

By choosing to be a donor

you give other people the choice of life