Dr. Siobhán O'Sullivan:

I thank the committee for the opportunity to address some of the ethical questions arising in the context of consent for organ donation and, more specifically, the pertinent ethical issues to be considered when introducing a presumed or opt-out consent model. As chief bioethics officer in the Department of Health, my role is to support the Department in achieving its mandate and strategic objectives through the provision of bioethical analysis and advice.

The success of any organ procurement system is contingent upon its capacity to fulfil three interconnected objectives: good outcomes in terms of quantity and quality of organs; the maintenance of public trust in the transplantation system; and respect for ethical principles. As the need for organs increases worldwide as well as here in Ireland, transplantation systems have explored a number of innovative strategies to increase donation rates, many of which have proved ethically challenging. Strategies include expanding the criteria for declaring death, living donation, donation after circulatory death, anonymous donation, directed donation, opt-out policies and even the introduction of economic incentives for donors. These strategies are not necessarily unacceptable, but they are morally debatable. While the ultimate goal is to save lives and improve the quality of life for transplant recipients, this goal needs to be achieved through means that do not violate socially accepted ethical norms.

Gift giving or voluntary donation to benefit another person as an expression of altruism and social solidarity has been the ethical cornerstone of organ procurement and transplantation in this country. Traditionally, the practice has been institutionalised as an opt-in system, which depends on having the express or explicit consent of the person or obtaining the consent of the person’s family after death. The presumed consent model has been adopted by a number of countries in Europe and globally in an effort to boost donor numbers. Ethicists have pointed out that the term "presumed consent" is something of a misnomer, as consent is an active rather than a passive process, and thus we prefer the term "opt-out", which we believe is a more appropriate use of terminology to describe the model.

The principal ethical objection to the opt-out model is the loss of autonomy and the right to self-determination of potential donors. Opponents also argue that the fact that someone did not register an objection to donation does not necessarily mean that he or she agreed to be a donor. It may simply mean that he or she had not read the necessary materials, did not know the relevant facts, or was otherwise unable to participate in the debate over organ donation. This could lead to the removal of organs from those who did not wish to donate - so-called false positives, if one likes. Commentators have argued that this situation is morally unacceptable because it violates the principle of respect for autonomy that underlies our concept of informed consent. Fears have also been expressed that an opt-out system could undermine solidarity and altruism as important motives for organ donation. It has been argued that the State, acting through health professionals and the transplantation system, would be intervening to take organs rather than facilitating their donation. There is at least a risk that some degree of trust in the system could be lost, potentially decreasing the availability of organs for transplant.

Proponents of the opt-out model counter that if a change of policy from opt-in to opt-out were to be broadcast widely, there would be no diminution of the exercise of self-determination and therefore personal autonomy would not be affected. Furthermore, it has been argued that an opt-out system enhances autonomy, as public surveys have shown a high willingness on the part of the public to donate their organs; thus, by failing to remove people’s organs, one is acting contrary to their wishes, even if they may be unexpressed wishes.

Supporters of an opt-out model also employ what we in ethics would call a utilitarian argument. This basically means that one provides the greatest good for the greatest number of people by harming no one and benefiting many. This particular thesis hinges on the fact that the dead or least their surviving interest cannot be harmed and that any curtailment of individual freedom is legitimate in the interest of the common good - that is, the survival of other citizens.

Another argument proffered in support of a policy change to an opt-out system is that it would facilitate a change in attitude - members heard that earlier this morning - so that donation would be increasingly seen as natural or normal, hence increasing the likelihood that families would conclude that donation was in line with their deceased relative's wishes.

I respectfully suggest that there are a number of ethically relevant considerations in introducing an opt-out system in Ireland. I am sure some of these will be considered as part of the pubic consultation process. In advance of any change in the system, the population should be informed of and receive relevant information on changes to the current arrangements concerning organ removal. This is to allow them to exercise their right to self-determination and opt out of the system if they so wish. There should be a simple and convenient procedure for anyone to opt out and it should be possible for individuals to revise their wishes at any time. We are all aware that our values can change over a lifetime depending on our personal experiences, and therefore that kind of facility is essential. It must be ensured that poor language or reading skills, a low level of educational attainment or poor socioeconomic or health status do not result in anyone’s understanding being limited to such an extent that his or her silence could be construed as consent to organ donation. The issue of how we might deal with vulnerable groups requires special attention.

Under a presumed-consent system, hospitals would need to have reliable and continuous access to the latest recorded wishes of potential organ donors. It would require a definition of who is responsible for the documentation, who is allowed to enter records, who has access to the information recorded and when. Some countries - for example, Sweden - do not allow access to the register until brain death has been diagnosed. This is to ensure the population does not get the idea that the system is effectively keeping an eye out for potential donors. Other countries actually allow checking of the register before the second set of brain-death testing takes place. These are all important things to take into consideration. We need to have regard to who would have access to the information and how that information is managed. There are also the more mundane, but nevertheless important, issues of data protection and data security that need to be taken into account. We would need to ensure that records are valid and correctly assigned, because it is important to be able to correctly identify the individual and his or her wishes.

Not least, the State has a responsibility to prevent the social stigmatisation of individuals who might opt out for their own reasons and who may not wish to be part of the process and thus may be regarded by the rest of society as lacking in solidarity. We must do some work in this regard. It is important to emphasise that deceased donation is a complex area, affected not only by law, administration and infrastructure but also by ideology and values. That is why I am especially grateful to have had this opportunity to address the committee on issues which are slightly off-kilter but centrally important.