Elective non-therapeutic intensive care and the four principles of medical ethics
- Antoine Baumann1,
- Gérard Audibert1,
- Caroline Guibet Lafaye2,
- Louis Puybasset3,
- Paul-Michel Mertes1,
- Frédérique Claudot4
- 1Anesthésie Réanimation Chirurgicale, Centre Hospitalier Universitaire de Nancy, Nancy, France
- 2Centre Maurice Halbwachs, CNRS, Paris, France
- 3Neuro Anesthésie Réanimation, Centre Hospitalier Universitaire Pitié-Salpétrière, Paris, France
- 4Service de Médecine légale et de Droit de la Santé, Faculté de Médecine, Nancy, France
- Correspondence to Dr Antoine Baumann, Anesthésie Réanimation Chirurgicale, Centre Hospitalier Universitaire de Nancy, Nancy 54000, France; ,
- Received 30 July 2012
- Revised 7 December 2012
- Accepted 3 January 2013
- Published Online First 26 January 2013
The chronic worldwide lack of organs for transplantation and the continuing improvement of strategies for in situ organ preservation have led to renewed interest in elective non-therapeutic ventilation of potential organ donors. Two types of situation may be eligible for elective intensive care: patients definitely evolving towards brain death and patients suitable as controlled non-heart beating organ donors after life-supporting therapies have been assessed as futile and withdrawn. Assessment of the ethical acceptability and the risks of these strategies is essential. We here offer such an ethical assessment using the four principles of medical ethics of Beauchamp and Childress applying them in their broadest sense so as to include patients and their families, their caregivers, other potential recipients of intensive care, and indeed society as a whole. The main ethical problems emerging are the definition of beneficence for the potential organ donor, the dilemma between the duty to respect a dying patient's autonomy and the duty not to harm him/her, and the possible psychological and social harm for families, caregivers other potential recipients of therapeutic intensive care, and society more generally. Caution is expressed about the ethical acceptability of elective non-therapeutic ventilation, along with some proposals for precautionary measures to be taken if it is to be implemented.
Introduction: definitions and setting the issues
Elective ventilation (EV)—also called elective intensive care (EIC) or non-therapeutic intensive care—is provision of intensive care for a patient who is thought not to be able to benefit from it, in order to protect his/her organs for donation purposes. This strategy first appears in the late 1980s and has been developed progressively in several countries because of the worldwide organ shortage.1 Since its beginning it has raised a number of ethical issues which are still debated today.2 ,3
Two types of situation may be eligible for EIC:
Patients definitely evolving towards brain death.
Patients who may be suitable as non-heart beating organ donors (NHBD)4 for whom mechanical ventilation and life-supporting therapies have been assessed as futile (incapable of providing benefit to the patient). This option is known as controlled NHBD or Maastricht 3 type organ donation.5 This type of organ donation after cardiac death can be an important means of increasing the number of organs available for transplant.6 Because of the chronic worldwide lack of organs for transplantation and the continuing improvement of methods for in situ organ preservation, non-therapeutic EIC has recently gained a renewed interest.7
In the UK, elective ventilation was introduced, with strict controls, in Exeter in 1988 and led to a 50% increase in the number of organs suitable for transplantation. It was stopped abruptly in 1994, however, when the Department of Health advised that the practice was unlawful (NHS Executive (1994) Identification of potential donors of organs for transplantation (HSG(94)41). 10 October).8 Indeed, with regard to the ethical risks entailed by this practice—and the consequent professionals’ concern9—in 1994 it was declared to be illegal and contrary to the patient's best interests, to constitute a battery, and hence to be actionable.10 In 2009, in a context of worldwide expansion of NHBD, EV was finally endorsed by the Department of Health in an attempt to address the professionals’ concerns.
Here, we analyse the ethical acceptability of EIC using the four principles of medical ethics of Beauchamp and Childress.11 The ‘four principles plus scope’ approach developed by the Americans Beauchamp and Childress is a now classical approach to ethical issues in healthcare. It is based on four common, basic prima facie moral commitments—respect for autonomy, beneficence, non-maleficence and justice—plus concern for their scope of application. The principles include effects on the relatives of patients or even the medical practitioners and caregivers, other patients, the overall population and on economic issues when making medical decisions.
Autonomy—from Greek autos: self and nomos: the law—is the capacity to give oneself the law of one's action without having it imposed by another. Autonomy concerns the will of an individual. It refers to the notion of independence, power and capacity. Immanuel Kant's principle of autonomy is: ‘Always so to choose that the same volition shall comprehend the maxims of our choice as a universal law’.12 In Kantian theory, autonomy is the particular property of the rational agent ‘who is determined only by virtue of his/her own law, that is to conform to the duty dictated by practical reason’.12 The autonomy of the dying person does not materialise in his/her faculty of willing without constraint.13 The autonomous being cannot want rationally what is not universalisable as requested by Kant in his tenet ‘Act only according to that maxim by which you can at the same time will that it should become a universal law’. EIC at the request of the patient seems ethically universalisable in the same way as the other self-donations to save others (blood donation, donation of bone marrow, organ donation after death, organ donation between living donors).14
NHBD allows the option to meet the wishes of a dying person who previously has expressed a wish to become an organ donor but does not meet the criteria for brain death. Controlled NHBD after the withdrawal of life support both enables fulfilment of the wishes of more patients who have indicated that they would like to donate their organs while also increasing the availability of organs for transplantation.15
In this setting, it is important to consider that temporary organ preservation measures may include cardiac compressions, mechanical ventilation, heparin administration or even extracorporeal membranous oxygenation. Opinions are divided over whether temporary organ preservation measures are ethically acceptable without previous consent. However, without temporary organ preservation, the opportunity to donate may be lost, and individuals who are later found to have wanted to become organ donors will not have had their wish upheld. The opposing view is that temporary organ preservation measures without previous consent may violate patients’ end-of-life wishes and threaten public trust in the overall practice of organ donation. So, efforts aimed solely at organ preservation are ethically acceptable only when the clinical team has explicit informed consent.16
Informed consent: adequate information is a necessary prerequisite for exerting one's autonomy. In this context, the concept of autonomy loses all meaning without public information. Raising public awareness about organ donation possibilities should be made so that everyone knows the various possibilities and can make his or her choice. Depending on the country that choice could be expressed by signing a donor chart or a national register of refusals. Refusal or acceptation can also be expressed by any other means.
The consent process for organ donation in brain dead patients should address the possibility of subsequent cardiac arrest and a possible need for cardiac resuscitation by relatives’ information.17
For whom is the beneficence of EIC? The transplanted patients? Society? The memory of the deceased patient?
Classically, elective ventilation and non-therapeutic intensive care are considered to only benefit a third party. Could the respect of patient's will regarding organ donation be considered to benefit him/her by honouring his/her autonomy right up to his or her last moments? Some authors argue that healing of the patient should be the sole purpose of medicine.18 Therefore, medical beneficence is perceived as a principle which overrides the others. But not respecting a patient's ethically validated altruistic will is morally suspect.14 In some way and considering the extended view of the four principles of medical ethics, respect for a patient's autonomy could be regarded as beneficence and non-respect as maleficence.
Regarding the family, organ donation often enables mourning proxies to bring meaning to the death of their loved one. Furthermore, some families perceive organ donation as a partial survival of their loved one in other human beings.
Regarding the society, EV could enable the maximisation of available organs and thus the improvement of the health of a maximum of patients.
Avoiding maleficence for the patient
Futility of treatment and the risk of prolonged surviving in a vegetative state: An important aspect of non-maleficence is the avoidance of futility. A treatment incapable of benefiting the patient is said to be futile. Furthermore, the main risk of EIC in patients with hopeless stroke is the non-occurrence of brain death and the evolution towards persistent vegetative state ‘that reasonable persons most often regard worse than death’ if death does not occur.19 ,20 Conversely, organ resuscitation in patients definitely evolving towards death entails no risk for the donor.
The rapid occurrence of death after extubation is a necessary condition for organ donation (OD) and also for acceptability to the donor's family. A long delay after extubation until cardiac arrest both prevents OD because of warm ischaemia and increases relatives’ suffering. Furthermore, the return of a patient to ICU because he/she is still alive long after disconnection of the ventilator is extremely traumatic. In case of NHBOD hypothesis, tests to assert prognosis and to predict cardiac arrest seem highly advisable before withdrawing of life support.21 Currently, neurological prognosis is best assessed by cerebral multimodal MRI and evoked potential investigation.22 The problem of the prediction of rapid cardiac arrest after life support withdrawal has been best addressed by different authors.21 ,23
Conflict of interest: Withdrawal of care in the non brain stem dead patient is based on a medical value judgment, is clearly within medical control and can be considered vulnerable therefore to a conflict of interests.9 Similarly, there can be a conflict of interest between the diagnosis of futility and the decision to harvest organs after death. There can be a conflict of interest between the decision to stop all the life-supporting therapies and the decision to pursue it for organ preservation purpose before possible donation. To rule out any conflict of interest, the two decisions shall be independently made by two separate medical teams, and the decision to stop vital support shall precede the question of organ donation.22 Ideally, medical criteria for the decision of withdrawal of life-supporting therapies have to be specified and endorsed by the law.22
Autonomy under pressure and the risk of a shift in normative rules: Social and political discourses emphasise the ‘shortage’ of transplantable organs. In both international and national contexts, there is pressure to extend the scope of potential organ donors with implicit pressure from patients awaiting organ grafting, from surgical teams and from society to increase organ donation. There may also be financial pressures on hospitals too such as incentives or reimbursements from organ procurement organisations (OPOs) or the Health Service.24 The risk is a progressive shift in normative rules towards obtaining organs from non-voluntary patients and towards systematic instrumentalisation of death.
Avoiding maleficence for the families
A key point is respect for the dying person, requiring no change in the patient's and proxies’ care while aiming at possible organ donation. Controlled NHBD can shift human care of the patient at the end of his/her life to technological aspects and dehumanise the ultimate moments. As a result, the family are separated from the donor during the last moments and humane and metaphysical aspects of their parting are weakened.25
Avoiding maleficence for the caregivers
Controlled NHBD can entail conflicts of duties for the doctors and the caregivers. There could be a feeling of utilitarianism, instrumentalism and transgression of universal traditional values. Poor acceptance by some ICU or operating room nurses, moral suffering, misunderstanding and cases of resignation indicate that Maastricht 3 type organ donation can create a very difficult, traumatic and perplexing situation for the caregivers involved.26
Avoiding maleficence for the whole of society
Generalising this ‘other way of dying’ could create serious consequences for the social aspect of dying and death for future generations. Namely, the concept of usefulness of death is a slippery slope towards systematic utilitarian end-of-life care and negation of the respect due to the dying person. Beyond the risk of jeopardising public confidence, the risk is to negate the ethical ‘good’ of medicine at the end of life and even the true foundations of medicine.
Moreover, there is a significant risk to drift towards ‘utilitarian euthanasia’. It is not hard to imagine that generous vulnerable people might opt for premature end of life from a desire to stop being a burden to others and to be useful.
Effect on the dead donor rule
For some authors, EIC leads to the end of ‘the dead donor rule’ requiring that patients must be declared dead before the vital organ donation procedure starts, and living patients should not be killed for or by organ procurement.27 This rule implies that the possibility of organ donation should not cause or hasten death, and should not adversely interfere with the care of the donor and of his/her loved ones.28 In this context, a major ethical issue concerns the transition between the withdrawal of life-sustaining treatments and the subsequent procedures required for possibility of organ donation after death has occurred. Sometimes palliative sedation is deemed indicated, and a multiauthor group urges that this should only be carried out according to a written protocol and be both tailored to the patient's needs and proportionate to the patient's symptoms.22 It is ethically unsound to use palliative sedation as a means of speeding up cardiac arrest after the withdrawal of life support; and implementation of palliative sedation to secure OD seems both morally unacceptable and highly counterproductive for the public acceptability of Maastricht 3 organ donation.
Justice: public health and collective ethics
Solidarity of individuals towards the whole of society is one of the pillars of the functioning of our societies and of our healthcare systems. Utilitarianism is an important theory which has long been prominent in most western societies, holding that the proper course of action is the one that maximises overall welfare. An intervention is just if it contributes to the improvement or to the protection of the health of the largest number of persons at the expense of the slightest inconvenience affecting the smallest number. Regarding organ grafting, it would strongly advocate the minimisation of the waste of potentially life-saving organs. The objection that ‘utilitarianism does not take the distinction between persons, nor the protection of individual rights seriously came to prominence in 1971 with the publication of John Rawls’ A Theory of Justice. The altruism of voluntary EIC is also an important aspect of human solidarity and justice and a fundamental value in our societies. Severe stroke is currently the main cause of brain death in many countries. In this context, the question of the justice of elective non-therapeutic ventilation and resuscitation arises, aiming to enable patients for whom a decision to stop all the therapeutics has been made to evolve towards brain death and organ donation.29
The scarcity of available beds in intensive care units in most countries raises another justice related question: that of medical resource allocation and availability of ICU beds for patients for whom intensive care is most certainly beneficial, that is, capable of restoring the patient to health with a good quality of life.
The risk of medical and moral maleficence is high, for the patients, for the families and for the whole of society. Thus, we have to remain very cautious about accepting EIC at all. Should EIC policy be initiated, then strict measures of precaution should be implemented at the same time.
Regarding admission to ICU of a potential future brain dead donor:14
The patient's condition entails a very high probability of rapid evolution towards brain death and some explicit criteria for brain death imminence: Glasgow Coma Score 3 or 4, bilateral mydriasis, absence of photomotor and corneal reflexes, for example.
The provisional agreement of the organ procurement organisation for organ harvesting (ie, the absence of any medical contra-indication to organ donation).
Clear and honest information to the patient's family or other proxies regarding the goals of EIC.
Unequivocal information from advance directives such as Mental Capacity Act, the family or other proxies of the patient's desire to donate or at least of the patient's non-opposition to donation.
The assessment and agreement of an external medical consultant independent of the ICU and the OPO.
The prevention of pain and of any other suffering of the patient.
A reasonable time (2 or 3 days) to enable brain death occurrence, after which intensive care will be stopped.14
Some specific measures have been proposed regarding potential Maastricht 3 NHBD:22
Verification of neurological prognosis of definitive unconsciousness and futility.
Criteria predictors of rapid death after extubation/cessation of vital support.21
Furthermore, continuing assessment and follow-up of each case, perhaps by a national ad hoc committee after each EIC harvesting procedure, would be desirable so as to monitor the effects of EIC and minimise its potential harms.
Public information and education are critical both about the possible introduction of EIC and about its possible implications. Ideally all of us would draft advance directives or at least tell a trusted person our wishes concerning this particular end-of-life organ donation issue.
The authors greatly thank Lucy Georges and Sylvia Bylinski-Bronowicki for English language reviewing.
Contributors AB and FC have designed the paper and drafted it. CGL participated to drafting. GA, LP and PMM made critical revisions.
Competing interests None.
Provenance and peer review Not commissioned; externally peer reviewed.