Consent For. Organ Donation

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1 IRISH HOSPITAL CONSULTANTS ASSOCIATION HERITAGE HOUSE TELEPHONE: DUNDRUM OFFICE PARK FAX: DUBLIN 14 Website: Consent For Organ Donation Submission to the Department of Health & Children in respect of various options for consent for organ donation 28 March 2009

2 1 The Challenge Demand for organ transplantation exceeds supply of donated organs because transplantation is seen to have fat greater benefits than risks.. Successful transplantation results in improved outcome for recipients. A number of factors have influenced this development. a. Improvement in immunosuppressive drugs, especially after the use of cyclosporine in the 1980 s b. Increased number of surgeons and physicians with specialised knowledge c. Increased incidence and prevalence of diseases amenable to treatment by transplantation d. As payment for organ donation is outlawed in most countries there is a zero price to the recipient for the graft material, which suggests an infinite demand from an economic point of view. The challenge for society is to increase the supply of organs to meet demand in a manner that is acceptable to society. Factors that impact negatively on the supply of suitable grafts are: a. Decreased traffic accident rates. Ireland had its lowest number of road fatalities in many decades last year b. The potential donor must have healthy and well functioning organs, free of infection and cancer. c. Donors must be declared brain dead following appropriate tests carried out by more than one doctor. d. Availability of organs must be notified so that a suitable recipient who best matches with the available organ can be identified e. Consent procedures must be complied with f. The organ(s) must then be retrieved and transplanted within a medically acceptable time frame. The challenge facing us in Ireland and in other countries is to increase the supply of donated organs so that the demand can be met, thereby improving health in general.

3 2 Ethical Considerations Donor v Relatives The right to self-determination gives the individual authority to decide what should happen to his or her body. As medical decisions can be crucial to a person s welfare, the right to consent is therefore justified. It has been pointed out in the House of Lords (Re W (A minor) (Medical Treatment)(1q1992) 9 BMLR 22) that there are two primary purposes for obtaining consent for medical procedures. Firstly, the clinical purpose of consent is to enlist the patient's faith and confidence in the efficacy of the treatment. This is a major factor in contributing to the success of the treatment. Secondly, consent provides the treating physician with a legal defence aqgainst the criminal charge of assault or battery or a claim for civil damages. Whilst this principle is clear in respect of the living it is less clear, from a legal perspective, following death. However, in this jurisdiction (and many others), the wishes of the deceased are recognised and catered for to the greatest extent possible. The deceased person s will is generally uncontested and complied with. The deceased s wishes with regards to burial or cremation are also generally complied with. They can be overturned at the request of or by the action of relatives. Doctors in Ireland are particularly sensitive to the wishes of relatives, particularly after the concerns raised regarding the retention of children s organs. In addressing the issue of consent for organ donation, this paper deals with the consent of deceased adults who were competent to make decisions regarding their organs when they were alive. It is fully acknowledged that in the case of minors, the right to consent remains with the parents or guardians of the deceased child. Within the present arrangements for seeking the consent of relatives, we may end up ignoring the actual wishes of the deceased person. Presently, donors may elect to donate their organs. When relatives are consulted after the death of the potential donor, they may be unaware of the deceased s actual wishes or may over-ride those wishes taking their own views of organ donation as a proxy for those of the deceased. Aside from that, we must also be mindful of the significant psychological harm that relatives can suffer if their wishes about the disposal of the body are frustrated. Benefits v Harms The challenge for lawmakers and others involved in determining the best approach to consent is to balance the greater public good brought about by organ transplantation against the harm that may be caused to relatives of

4 the deceased and possible denial of the right of donors to self determination, even after death, through a consent methodology. Doctors are particularly conscious of the concerns raised by parents of deceased children in Ireland whose organs had been retained. The profession responded to these by immediately changing the consent processes and practices to avoid similar occurrences in the future. Regrettably, the level of organ donation declined subsequently. In the meantime demand for organ transplantation has increased inexorably, with the consequential inability to meet that demand. Live v Cadaveric Transplantation Difficulties in sourcing cadaveric organs have led to an increase in live donations of specific organs, such as kidneys and liver lobes. Whilst the risk to live donors is statistically small it is preferable to source organs in manner that poses zero risk to a donor. Consequently, all other things being equal, cadaveric organs are preferable. In light of the shortfall in available organs every avenue should be explored to increase cadaveric organs in preference to live organs. Treating Doctor s Responsibility The ethical responsibility of the treating doctor is to do what is on the nest interests of his patient, without consideration of any issues after death. The doctor cannot have his or her clinical judgement influenced by a need to preserve organs for the purposes of transplantation alone. It is important to separate the responsibility of caring for the dying patient from retrieval of organs that may be available for transplant 3 Department s Options The Department has embarked on a consultative process with regards to organ donation. It has sought views on the following options: Option Option A Opt out Sometimes called presumed consent The person is presumed to have consented to donate his/her organs unless he/she has specified otherwise. A1. Hard opt out system without exemption A2. Hard opt out system with provision for exemptions Description Doctors can remove organs from every adult who dies unless a person has registered to opt out. This applies even if relatives know that the deceased would object to donation but had failed to register during life. Example: Austria. Doctors can remove organs from every adult who dies unless a person has registered to opt out OR the person belongs to a group that is defined in law as being against an opt out system. Example: Singapore where Muslims chose to opt out as a group.

5 otherwise. Option B Opt in Sometimes called explicit consent The person can decide in advance to consent, or to nominate someone to make the decision on his/her behalf after death. Where the deceased has not made a decision his or her family may do so. Option C Mandated choice /required consent A system of mandated choice would require people to exercise a choice whether or not to donate. A3. Soft opt out without family consultation A4. Soft opt out with family consultation B1. Soft opt in system with family veto B2. Soft opt in system with family consultation B3. Hard opt in system without family consultation C1. Soft mandated choice system C2. Hard mandated choice system Doctors can remove organs from every adult who dies unless a person has registered to opt out OR the person s relatives tell doctors not to take organs. It is up to the relatives to tell the doctors because the doctors may not ask them. Example: Belgium. Doctors can remove organs from every adult who dies unless a person has registered to opt out. It is good practice for doctors to ask the relatives for their agreement at the time of death Example: Spain. Doctors can remove organs from adults who have opted in. It is up to each person to decide if they want to opt in. It is normal practice to let relatives know if the person has opted in and doctors will not proceed if faced with opposition from relatives. Example: Ireland Doctors can remove organs from adults who have opted in. It is up to each person to decide if they want to opt in. It is normal practice to let relatives know if the person has opted in and doctors can decide not to proceed if faced with opposition from relatives, although they have the legal entitlement to proceed according to the individual s wishes. Example: UK Doctors can remove organs from adults who have opted in. It is up to each person to decide if they want to opt in. Relatives are not able to oppose the person s wishes. People are asked to register their choice to opt in or opt out at specified points and CAN choose whether to do so or not. People are asked to register their choice to opt in or opt out at specified points and MUST choose one option. C3. Required Request A system of required request would require that a person s wishes MUST be determined before death. Potential donors are identified in hospital Accident and Emergency Departments and Intensive Care Units and the individual or his / her family must be approached and their wishes in relation to organ donation determined. As will become clear later, this range of options may not be broad enough. 4 IHCA Survey

6 The Association circulated its membership eliciting views and choices and received responses from 13% of the membership, which was distributed across specialties and regions. It should be noted that responses were received from a number of groups of consultants with a special interest in the subject. Where the members of these groups were identified, the group s submission was taken as representing each individual member identified. We also received a submission from one group that represents circa 135 consultant members in this jurisdiction. Due to data protection legislation it has not been possible to identify the individual members of that group. Based on the Association s membership representing circa 87% of practising consultants in Ireland, we have taken that percentage of that group into our calculations. The overriding consideration of respondents was to do what was best for recipients, donors and donors relatives as they saw it. Whilst a clear majority of those who gave a straightforward answer favoured option A4 as their choice, their understanding of the experience in Spain in very many cases, influenced their preference. This was evidenced by specific references to Spain in many of their responses. Table 1 shows the results of those members who responded directly identifying one of the options in the Department s list as their preferred option.

7 Table 1 Organ Donation Consent Respondents A1 A2 A3 A4 B1 B2 B3 C1 C2 C3 Option

8 Table 2 incorporates the views of those groups from which responses were received. The Department equated the soft opt-out with family consultation option with the Spanish model. Spain has the highest level of organ donation internationally. Whilst studies have shown that an opt-out system tends to produce a higher rate of donation it does not fully explain the Spanish success. In addition to the legislative framework in Spain, there is also a comprehensive system of transplant co-ordinators and organ retrieval teams in place coupled with widespread public education of the benefits of organ donation. In light of the experience in other countries where presumed consent does not lead to significantly higher donation rates, it is incumbent on us to assume that these factors are important contributors to the success of the Spanish authorities in achieving such a high donation level. The groups representing important cohorts of consultants gave detailed responses and drew attention to this aspect of the Spanish success. In so doing they outlined further options for consideration, which we have included as Options D1 and D2 in Table 2. Option D1 This option that has been promoted by a group of Consultants directly involved in transplantation and has the following key components. Ireland should have a National Transplant Authority that would be responsible for a range of activities including; Promotion of public awareness. The Authority would be mandated and funded to develop and a programme of public awareness highlighting the positive benefits of organ transplantation and the type of organs that are suitable for transplantation. This includes the need for the organ to be disease and cancer free. The excellent work undertaken at present by the Irish Kidney Association and Irish Donor Network is acknowledged but their efforts are restricted. Develop a National Transplant Database, which provide national and regional information for the general public on a range of issues, including organ donor rates, transplant activity and patient outcomes. From this Association s perspective, such a database would have the facility to record potential donor s wishes with regard to donation after their death Govern standards and policy in relation to organ transplantation against which practitioners can be benchmarked.

9 Appoint a cohort of Donor Procurement Coordinators, who would also liaise with the National Organ Procurement Centre, which needs to be established. Donor Procurement Coordinators would have a lead role in discussing the possibility of organ donation with potential donors and / or next of kin. Liaise with the UK and European transplantation bodies for organs that require organ sharing. Proponents of Option D1 favour B1 (Soft opt-in with family consultation, e.g. Ireland) from the Department s range of options for consent. Option D2 This set of proposals advocates for the following activities outlined in Option D1; Promote public awareness Develop a National Transplant Database Appoint a cohort of Donor Procurement Coordinators and also makes the following additional proposals; Education & training for staff. Staff directly involved in caring for patients diagnosed with brain death should have specific training in the following: o Diagnosis of brain death o Grief and bereavement o Communication with grieving families about medical management of the potential donor and organ and tissue donation Provision of suitable facilities for discussing such matters with grieving families With regards to the consent options proposed by the Department, this group favours option B2 (soft opt-in with family consultation). The Group also believes that following brain death, that the next of kin be consulted about the possibility of donation. Table 2 outlines the totality of responses taking account of the submissions of groups representing cohorts of consultants. The two stacked bars incorporate options D1 & D2 respectively to the selected B option

10 Table 2 Organ Donation Consent Option D2 Option D1 Options A - D A1 A2 A3 A4 B1 B2 B3 C1 C2 C3 D1 D2 Options

11 5 Conclusions It is clear from the literature that the challenge of increasing organ donation rates requires more than a legislative approach dealing with the issue of mandatory or optional consent. In light of that, the Association recommends the following: 1 That an ongoing pro organ donation public awareness campaign be undertaken highlighting the benefits that can be bestowed on sick patients. 2 That a national team of Donor Procurement Coordinators be appointed who would be responsible for identifying potential organ donors and seeking consent. 3 That responsibility for organ retrieval is assigned to the institution(s) in which the transplantation will take place. Organ retrieval teams would be based at these hospitals 4 That appropriate facilities be provided in each hospital within which discussions with relatives about transplantation can take place. 5 That a National Transplant Database be developed which will provide a definitive source of transplantation activity. This would inherently have facilities within which to record potential donors wishes prior to death. 6 That Ireland maintains its present Soft Opt-In with Family Consent arrangements for the present. It may be prudent to re-visit this in the future when sufficient public awareness has taken place if organ donation rates have not risen to a satisfactory level.

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