Public Consultation Introduction of an Opt-Out System of Consent for Organ Donation
Overview of Written Submissions
Currently in Ireland, when a potential organ donor is identified, the deceased person’s next-of-kin is asked for their consent to allow organ donation to take place. This is known as express consent or an opt-in process to becoming an organ donor. In other words, the choice and the decision to become an organ donor rests with the next-of-kin of the deceased, including where the deceased person had an organ donor card or had indicated their wish to become an organ donor on their driving licence.
The Government now intends to change this system of consent to one of opt-out consent. Consent will be deemed unless the person has, while alive, registered his/her wish not to become an organ donor after death. However, it is proposed that, even though consent is deemed, the next of kin will in practice always be consulted prior to removing any organ. If the next of kin objects to the organ donation, the donation will not proceed. This is known as a “soft” opt-out system.
The Department placed an advertisement in the Irish Independent, the Irish Times, the Irish Examiner and the Star on July 19th inviting interested parties to submit their views on the practical aspects of introducing a system of opt-out consent for organ donation. Interested parties were invited to submit their general views and were also invited to consider specific issues which were set out in a consultation document (attached at Appendix A). The latest date for receipt of responses was Friday, September 20th 2013.
A total of 57 submissions were received. 40 submissions were received from individuals while 17 submissions were received from the following organisations / representative groups:
- Bioethics Consultative Group of the Irish Catholic Bishops’ Conference
- Department of Nephrology and Transplant Nephrology Beaumont Hospital
- Forum on End of Life in Ireland
- Health Information and Quality Authority
- Houses of the Oireachtas Joint Committee on Health and Children
- Intensive Care Society of Ireland
- Irish Heart Foundation
- Irish Hospice Foundation
- Irish Kidney Association
- Irish Lung Fibrosis Association
- Irish Medical Organisation
- Irish Medicine’s Board
- Irish Nephrology Society
- Irish Thoracic Society
- Joint submission from the Alpha One Foundation, Cystic Fibrosis Ireland, Irish Heart and Lung Transplant Association, Irish Lung Fibrosis Association
Summary of Responses
The following table summarises the views of the 17 organisations/ representative bodies that made a submission to the consultation.
|Submission||Summary of Views Expressed|
|Bioethical Consultative Group of the Irish Catholic Bishops’ Conference||Welcomes any effort of the Irish Government to address ways in which the high levels of public support for organ transplantation may be channelled more effectively, while respecting human rights concerns, such as personal autonomy, the relationship between the state and citizen and respect for religious beliefs and family ties.|
|Department of Nephrology and Transplant Nephrology, National Kidney Transplant Centre, Beaumont Hospital||Wholeheartedly welcome these developments. The implementation of a presumed consent law combined with investment in infrastructure for donor co-ordinators and transplantation specialists can increase transplantation rates significantly. The Minister is to be congratulated for his proposal to introduce presumed consent in Ireland.|
|Forum on End of Life in Ireland||Welcomes the introduction of a soft opt-out system.|
|Health Information and Quality Authority||No explicit view|
|Houses of the Oireachtas Joint Committee on Health and Children||Strongly of the view that any transition to soft-opt out must be supported by increased investment in essential infrastructure, transplant surgeons and trained support staff.|
|Intensive Care Society of Ireland||Committed to supporting measures which can lead to increased organ donation for transplantation. Opinions within the Society differ on the likely effects of ‘Opt-Out’ consent|
|Irish Heart Foundation||Supports the introduction of soft opt-out but highlights the need to make progress across all the key components of an effective donation system.|
|Irish Hospice Foundation||Welcomes the introduction of a soft opt-out system.|
|Irish Kidney Association||Has serious concerns regarding the plan to alter the consent system for donating organs from the deceased. They failed to see any concrete rationale as to why this change should be made.|
|Irish Medical Organisation||Had previously advocated for the Hard Mandated Choice model but accepts that the Government has chosen to go with the opt-out model.|
|Irish Medicines Board||Supportive of any practice or organisational change made to the current Irish transplant infrastructure that can improve the donation rates, while ensuring that a robust system of consent is put in place to ensure the quality and safety of the organ(s) donated.|
|Irish Nephrology Society||Supports the introduction of presumed consent with the soft opt out system and stresses the importance of investment in the infrastructure and organisation of transplant services to maximise organ donation rates.|
|Irish Thoracic Society||Supports the proposal to introduce legislation for presumed consent in ‘soft opt out’ form|
|Joint Submission from: Alpha One Foundation, Cystic Fibrosis Ireland, Irish Heart & Lung Transplant Assoc, Irish Lung Fibrosis Association||Welcomes the change to soft opt-out but emphasizes that this change needs to be part of a package of measures to address existing gaps and weaknesses in organ donation and transplant infrastructure in Ireland.|
Overview of Responses
In its consultation document, the Department invited interested parties to submit their general views on the practical aspects of introducing a system of opt-out consent for organ donation and also posed a number of specific questions. An overview of the responses received is set out below. The authors have edited some of the comments.
Submissions in support of Opt-Out
The Joint Submission from Alpha One Foundation, Cystic Fibrosis Ireland, Irish Heart and Lung Transplant Association and the Irish Lung Fibrosis Association noted that countries with high organ donation rates had both a soft opt-out system and good transplant and organ donation infrastructure. This submission acknowledged that the effectiveness of opt-out is interdependent with the standard of donor and transplant infrastructure.
The submission from the Houses of the Oireachtas Joint Committee on Health and Children favoured the introduction of soft opt-out supported by increased investment in essential infrastructure, transplant surgeons and trained support staff as well as a significant public awareness campaign prior to such changes taking effect.
The Irish Thoracic Society believed that to successfully implement this policy and to protect the welfare and interests of donors and their families, it must be accompanied by the appropriate donation infrastructure. This submission suggested that this should include the employment of adequate medical and nursing professionals with a focus on organ donation and the establishment of an independent National Organ Procurement Office.
The Irish Heart Foundation was of the view that a soft opt-out system of consent would better reflect the wishes of the majority of the population who support organ donation. The IHF recognised that a number of other factors must be developed to strengthen the infrastructure for donations and to encourage a culture of organ donation within society. The IHF said that this change to consent provides the potential to further increase positive attitudes to donation and thereby to increase the number of organs available for transplantation. It advocated investment in training for healthcare professionals, particularly for transplant co-ordinators and staff working in A&E and intensive care and suggested that effective management pathways for donors must also be developed so that identification of donors and organ retrieval is a routine part of hospital practice.
While they supported the introduction of opt-out, the main concerns identified by the Irish Hospice Foundation’s and the National Council of the Forum on End of Life in Ireland’s submissions were
- Dignity and respect for the remains of the deceased person
- Respect for the expressed wishes of the deceased person regarding organ donation
- With the introduction of a soft opt-out system, our focus would be on the needs of family and loved ones
- Need for training and support for staff in good communication skills
- Need for public education about organ donation
- The availability of bereavement support.
The Irish Nephrology Society was of the view that infrastructure and legislation both need to be addressed as crucial components to improve the rate of organ donation and to address the imbalance between supply and demand in this area. It stated that a change to the legislation would not on its own be sufficient to achieve the numbers necessary but would need to be underpinned by investment in the organisation and infrastructure for transplantation particularly in the provision of full time transplant coordinators in the major medical centres. Enhanced public awareness and education would also be essential.
A selection of comments received from individuals is set out below:
- If affected by heart or kidney disease, people would not hesitate to accept an organ, so they should be willing to donate one too.
- A change to opt-out would be most beneficial to Irish patients and Irish society. It wouldn’t infringe on a person’s rights as it is not compulsory. While it would be important to consult with a patient’s family, the patient’s wishes should be binding, such that further consent is not required from the patient’s family.
- Many people have great intentions about making their intentions known as organ donors but often forget. So an opt out system would ensure there are plenty of organs available should they be needed. Works very well in other countries. Great idea Minister Reilly
- I personally would be behind you 100% on this. Had it been in operation a few years ago it could have helped my friend and she would still be with us. Definitely a great initiative. I hope it is brought in.
- The introduction of a soft-opt out model for organ donation is a positive advancement and is urgently needed to maximise the rate of organ donation and utilisation in Ireland.
- This should have been in place before now!
- I would like to express my full backing for such a new system to be implemented as soon as possible. The general response from my peers and colleagues would also be of a similar view.
- I feel anyone who felt strongly about not donating would have ample opportunity to notify either family or their own doctor of their wishes, and this would open many more chances to save people who would otherwise be left on ridiculous waiting lists for life saving operations.
Those Not in Support of Opt-Out
The Irish Kidney Association was of the opinion that misinformation on the success of consent in improving deceased donor rates across Europe abounds. In its view, the organisational changes in the management of the organ donation process are completely the reason for higher organ donation rate countries. The IKA would support the following infrastructural changes:
- The National Organ Donation and Transplantation Office (NODTO) should be funded and developed.
- The Organ Donor Coordinator, (ODC) role needs to be established and their employment and training should be developed by the NODTO.
- An audit of hospital activity, surrounding potential organ donation, needs to be designed and implemented by the ODC’s for the NODTO. This information and evidence would inform the future decision surrounding consent for organ donation.
Below is a selection of comments submitted from individuals who did not support opt-out.
Prof John Fabre – Professor Emeritus at Kings College London and President of the British Transplantation Society from 1992 to 1995 stated that many observers have wrongly attributed Spain’s success since 1989 to its presumed consent legislation. He, as well as the Irish Kidney Association, referred to a paper co-authored by the Director of the Spanish Organ Donation Organisation, Dr Rafael Matesanz, which was published in the British Medical Journal in October 2010. In this paper, the authors stated that “Crucially, Spain does not have an opt-out register for those who do not wish to become organ donors. Not a penny is spent on recording objections to organ donation by Spanish citizens, nor on public awareness of the 1979 legislation. Clearly, the presumed consent law in Spain is dormant, and it pre-dates key policy changes made in 1989. In these circumstances, Spain’s outstanding deceased organ donor rate cannot reasonably be attributed to its presumed consent laws”. Prof Fabre was of the view that the high level of consent consistently achieved in Spain has been achieved by promoting better public understanding of transplantation, better public appreciation of its outstanding benefits, and optimal approaches to the family at the time of donation. He also referred to the UK Department of Health’s strategy to 2020 which has improved consent rates as one of its major objectives – but not by legislation. He was of the view that presumed consent is expensive, divisive and unnecessary. He described it as a simplistic idea that does nothing to help desperate patients waiting for a transplant.
Dr David Honan, Consultant Anaesthetist pointed to the fragile, altruistic transplant system here, and was of the view that introducing presumed consent would risk destroying it. He suggested that Irish people may choose to opt out in droves if an element of compulsion is introduced which negates their altruism.
Gary Rutherford founder of www.donorconsent.com was of the view that an opt-out system would be detrimental to our current organ procurement system which, in his view, works well but can be improved. He was concerned that this latest public consultation was constructed in such a way as to disregard the findings of the 2009 public consultation. He suggested that opt-out might raise legal/constitutional issues by implying or creating the perception that the State has certain rights over a citizen’s body and organs post mortem
Other comments submitted by individuals included:
- What is proposed is not organ donation but rather is compulsory organ harvesting by the state.
- I would like to express my horror that the Government is even considering just taking the organs of people who have not opted out from the scheme. Many people, elderly, or of limited education or intelligence, who would not want their organs taken may not even be aware that they have to opt out.
- Even though I fully appreciate the merits of having an essentially unlimited source of organs for transplantations, I do not see how this can be regulated to avoid its abuse. Why would anyone want access to organs from people who don’t want to (or never thought of) donating organs?
- It is my opinion that this is another step too far by a lazy, arrogant Executive and is a grossly inappropriate way of dealing with an important, sensitive, sometimes painful issue. The Government should put in place a public information pack, to emphasise the need for organ donations and the many benefits from doing so.
- If an extremely injured young person – who is otherwise healthy – is brought into A&E I believe there is an unwritten, unspoken ‘system’ to view this person as a multi-organ donor and all due opportunities/treatment is compromised for this person especially if this person is treated in a known transplant hospital. Opt out is now going to strengthen this feeling of fear. I believe it is morally wrong and I am totally against it.
- I feel strongly that people should have power to control what they wish to happen to their body
- I do not trust systems like this as they have been proven to be open to abuse.
- People have the right to private property meaning a person has the choice to keep their property which means it must be opt in.
- This is a step too far by the Government
A number of general comments which were neither specifically in support or against opt-out consent were received. A selection of these comments are set out below.
The Department of Nephrology and Transplant Nephrology, National Kidney Transplant Centre, Beaumont Hospital stated that all potential organ donors are not being utilised and frequently in intensive care units across the country, families are not given the opportunity to consider offering their loved ones organs for transplantation. There are many reasons why this happens including a natural reluctance to potentially further upset a grieving family. In its view, presumed consent legislation is not used to retrieve organs against the wishes of the next of kin. Instead, it facilitates discussion about possible donation in difficult circumstances.
The Irish Medical Organisation stated that the impact of donor policies in Europe found no obvious correlation between consent systems and donor efficiency. They pointed to factors other than the consent system which seem to be responsible for increased rates of organ donation particularly measures undertaken in hospitals to optimise donor procurement and public awareness about the relevant aspects of organ donation. The IMO also suggested that the legislation introducing the opt-out model of consent should be clear and transparent. They suggested that a regular review process be put in place to ensure that there is accountability for the procurement and use of all organs. They also proposed that the donor’s next of kin be kept up-to-date with the process. The IMO acknowledged that this is an issue about choice and that information is paramount to enable citizens to make informed decisions and that individual choice needs to be respected and accounted for.
The Intensive Care Society of Ireland was of the view that great care would need to be taken with the implementation of opt-out. If there was a perception that the needs of transplant recipients were placed above critically ill patients in ICU this could undermine the relationship of trust between clinicians and family in ICU or it could reduce the existing strong public support for organ donation. The ICSI used the term ‘authorisation’ to indicate that the family have the authority or power to decide whether or not the organs of the deceased will be donated. The ICSI suggested that families must be able to prevent organ donation if they know this was not the wish of the potential donor or if it is contrary to their own wishes. The choice should be documented in writing and signed. This process should be formal and structured, easy to understand, allow time for discussion and for reflection unbiased towards a particular position, prompt the legal surrogate to consider the patient’s own views in reaching a decision and avoid undue delay to organ procurement or to funeral arrangements. The ISCI also made the following points in its submission:
- The primary role of ICU staff is preservation of life. If this is unsuccessful, staff should explore the option of organ donation with the family. Staff in ICU frequently combine both these roles and there must be a distinction between these roles even if undertaken by the same person. This will prevent conflicts of interest and any perception of a conflict of interest. Therefore, the formal process of ‘authorisation’ should start only after brain death has been established and it is clear the prognosis for the patient is hopeless.
- The introduction of presumed or opt-out consent to organ donation should be confined to patients diagnosed as being brain dead. Donation after Cardiac Death (DCD) should not proceed on an opt-out basis but only on the basis of consent from a surrogate (as at present).
- The formal process of obtaining ‘authorisation’ should be undertaken by one of the Organ Donation Personnel (Nurse or Doctor) or by medical staff in the ICU. Both alternatives should be possible, as circumstances will dictate which is more appropriate for each individual case.
- Any Consultant with responsibility for the patient could document that organ donation has been ‘authorised’ or ‘objected to’. In cases where the Consultant is not immediately available they should be able to delegate this role to a nominated NCHD. A minimum of 5 years’ experience since full registration might be a reasonable requirement for an NCHD to undertake this.
- The reasons why patients who are diagnosed brain dead and for whom the process of ‘authorisation’ is not undertaken should be understood and evaluated but no legal or regulatory penalties should apply.
- Organ donation cannot proceed unless the formal process of ‘authorisation’ is followed, with written confirmation from hospital staff and from the patient surrogate.
- The process of discussing organ donation with the family should not be initiated until the prognosis for the patient is clearly hopeless (unless the family initiate a discussion). Enhanced education and training about organ donation and transplantation is important to ensure that ICU staff are fully informed for these discussions with family.
- The introduction of legal standing for a ‘hierarchy of relatives’ would facilitate the process of organ donation.
- If no family (or legal surrogate) are available, the decision re ‘authorisation’ could be referred to the Coroner.
- There should be an official “Code of Practice’ to guide professionals in the procedures surrounding organ donation. This would set out, in clear and unambiguous terms, the legal duties and responsibilities of healthcare professionals, as well as the legal status and rights of surrogates.
- Substantial resources will be needed to implement this initiative successfully and to sustain it in the long-term. Initially there should be a public information campaign to explain the change in legislation and to ensure public support. On a long-term basis there is a need for Organ Donation Personnel to support the whole process of organ donation. This will include both Organ Donor Coordinators and local ICU staff (Doctors and Nurses) to support the recruitment of all possible organ donors and to run audit and quality control programmes. Existing educational programmes for staff in ICU, Emergency Dept etc. should be enhanced, in liaison with local ODPs and the Training bodies in Medicine and Nursing.
- Appropriate infrastructure is required for successful implementation of this initiative.
The Bioethics Consultative Group of the Irish Catholic Bishops’ Conference stated that a decision-making process that respects freedom and trust (and so the logic of giving) is critical. Before death, the freedom of individuals to opt-out of the register must be in no way cumbersome or seemingly obstructive. Furthermore, such a register should protect the rights to confidentiality of each individual. After death, trust must be built into the legal framework and consultative process with the next-of-kin. On one hand, the legal framework itself must have built-in protections against abuses that may arise due to presuming consent. On the other hand, the consultative process requires real and substantial funding and resources in order that appropriate and trained health care professionals may engage with the next of kin in an inclusive manner that affords a real and respected opportunity to decline. If the proper consent of the donor or the donor’s next-of-kin is not respected and safeguarded by law, then poorly thought out arrangements could have the opposite effect of more people opting out or more next-of-kin refusing consent. This submission suggested that legal safeguards could include:
- The obligation to identify, inform, consult or otherwise involve the next-of-kin.
- That the objections of next-of-kin take precedence over presumed consent, in situations without the expressed consent of the individual.
- The protection of vulnerable groups; in particular those without next-of-kin and therefore no-one to speak for them.
- That family division is avoided.
- That there is a system of accountability where transplantation occurs without taking reasonable steps to consult the next-of-kin.
A submission from an individual was concerned that whereas in the current system, the public understands that if they wish to donate, they must carry a donor card and make their wishes known to their next-of-kin; under the proposed system, the public may feel that there is no longer the need to carry a card etc. because their consent is presumed. In such a situation, the next-of-kin is more likely to object. (James Daly)
Gary Rutherford founder of www.donorconsent.com advocated the following:
- Specialist hospital staff and systems dedicated to organ donation
- New funding for hospitals
- National professional awareness and education
- Coordinated ongoing community awareness and education
- Support for donor families
- Safe, equitable and transparent national transplantation process
- National eye and tissue donation and transplantation
- Additional national initiatives, including living donation programs
This submission proposed a donor consent model offer a unique online photographic donor card with documented individual and next of kin consents made accessible and retrievable in a matter of minutes. In his view, www.donorconsent.com offers a system of opt-in consent which is simple to use and internet based and would offer a de facto Organ Donor Registry
Some suggestions put forward by individuals included:
- Opting in and opting out don’t have to be mutually exclusive. A website could be set up where people can indicate either that they would like to opt-in or to opt-out. In practice if people had registered it makes it easier for healthcare professionals to discuss their loved ones wishes at a really difficult time.
- An opt-in and opt-out register could be made available online and could include an option to notify by email and text up to ten family/friends to inform them that I have registered my wishes and the details of my wishes. These contact details could then be made available to medical personnel.
Another submission stated that it was an individual’s choice and their choice alone to become an organ donor. The author resented the fact that the family have to be consulted when they all know my wishes. Donors wishes should be respected and adhered to.
Specific Questions Posed in the Consultation Document
The consultation document posed a number of specific questions and the submissions received in response to these questions are summarised below.
1. What in your view are the major ethical or moral issues associated with the introduction of an opt-out model of consent?
The major ethical issue would be to ensure that the necessary infrastructure is in place to support soft opt-out. Without these measures the impact of soft opt-out could be severely blunted. (Joint Submission from Alpha One Foundation, Cystic Fibrosis Ireland, Irish Heart and Lung Transplant Association and Irish Lung Fibrosis Association)
Clinicians have an ethical obligation to ensure donors’ rights and interests are respected as well as trying to save the lives of those on organ waiting lists and respecting the emotional wellbeing of the donor’s loved ones. (Irish Hospice Foundation and the National Council of the Forum on End of Life in Ireland)
We do not have any major ethical or moral concerns with the introduction of an opt-out model of consent. However, we stress the importance of information being made available in the public sphere to ensure that more public awareness about organ donation is generated. Additionally, legislation should be clear and transparent. It is also advisable that a regular review process be put in place to ensure that there is accountability for the procurement and use of all organs. It is important that the donor’s next of kin be kept up-to-date with the process. Regardless of the model of consent the IMO acknowledges that this is an issue about choice and that information is paramount to enable citizens to make informed decisions and that individual choice needs to be respected and accounted for. (Irish Medical Organisation)
The major ethical or moral issues are that organ donation can proceed without consent. If this is put into practice, the consequences of press publicity from family who are not available to object to organ donation will destroy the public confidence and support for organ donation. A legal challenge for compensation would probably not succeed but the moral ground and public sympathy will be in favour of the bereaved family. No person wants this potentially explosive situation but it is not difficult to imagine it happening or the public backlash that could ensue. The ethical dilemma will be imposed on the individuals who are expected to proceed to produce organs without available consent. As a consequence, no one in their right mind will proceed to procure organs without consent in practice. Making law does not remove the ethical and moral issues for the personnel involved in organ procurement. (Irish Kidney Association)
The concept of the State assuming ownership of body parts after death in a utilitarian manner is repugnant to many. The State or EU may be influenced by Pharmaco-Economic interests involved in transplantation (e.g., immunosuppressant drugs are a multi-billion euro industry). Individuals may feel coerced not to opt out, for fear of themselves or their relatives being put to the bottom of a transplant waiting list. It may trigger large-scale opting-out (e.g. Muslims as a Group in Singapore, a location where there has been civil unrest in 2007 when organs were forcibly taken in defiance of family refusal). If medical staff happen to share the growing scepticism about the validity of the concept of brainstem death, they must be ethically free not to be involved in organ procurement, should they so wish (as is currently the case with regard to ethics of involvement with abortion), irrespective of any new legal requirements. (Dr David Honan, Consultant Anaesthetist)
I feel there is a moral obligation to help where we can in this world. After my death I would love up have the opportunity to save lives. (Hazel Dunne)
The major ethical/moral issues associated with this model surround the lack of express positive consent. These are outweighed by the ethical and moral benefits. It is important that the next-of-kin do not feel that the taking of organs is morally or ethically questionable. (James Daly)
It is very important that older generations are made particularly aware that they need to opt out as they may not have next of kin who can object, they also may not find information on the internet as readily as a younger person. (Joe Panama)
It is unethical and unacceptable for organs to be harvested without express consent of deceased or next of kin of deceased. This consent is not an optional extra. Where no next-of-kin is known or found the deceased’s organs should not be harvested. This is a total violation. The State and/or its agencies have no right or entitlement to assume consent unless the deceased or their next of kin has expressed a desire to donate organs irrespective of organ donor shortage or organ need. (Anonymous)
2. What are the practical and operational issues to be examined in implementing this model?
Assignment of donor coordinators to major ICU hospitals; adequate public awareness programmes involving both the State and the patient groups and adequate resources for the National Organ Donation and Transplantation Office. (Joint Submission from Alpha One Foundation, Cystic Fibrosis Ireland, Irish Heart and Lung Transplant Association and Irish Lung Fibrosis Association)
There may be issues where relatives/ loved ones oppose a donation. It is vital that conversations with loved ones are conducted sensitively and respectfully and that information on organ donation is communicated effectively. Additional training may be required for healthcare staff (in addition to transplant coordinators) who may be having these conversations with people. Families who have refused to donate organs may experience regret and guilt following this decision. In a system of presumed consent, the burden of decision making is lifted from the family which may make the situation easier for them. In addition to any such change in the law, it is important that there would be further investment in transplantation programmes in Ireland including:
- Network of Donor Coordinators
- More resources to National Organ Donation and Transplantation Office
- National Organ Procurement Office established on an independent basis
- Greater public awareness
(Irish Hospice Foundation and the National Council of the Forum on End of Life in Ireland)
Any national database would require development of a system to accurately identify each member of the public through a unique health identification system. This system would need independent oversight to ensure integrity and protection of the data consistent with national legislation. Where organs are retrieved from someone who has opted out, there may be a need to report this to the appropriate oversight authority. An ongoing publicity campaign advocating the need for organ donation but maintaining the right to opt out would be required. Opt out mechanisms should be straightforward and clear for members of the public. (Irish Medicines Board)
A national database or register should ideally be established documenting the preferences of all potential organ donors. However, a system to record those who have opted out cannot safely and reliably be implemented in the absence of a national system of identifiers. In the opt-out system what arrangements will be in place to contact next of kin in time to facilitate decision making? (HIQA)
The practical and operational issues are wide and varied. To implement the procurement of organs without consent whilst giving the family an opportunity to object to donation is unchartered ground in the Irish health system. Establishing identity of the potential donor is paramount in establishing whether they have already opted out. Family cooperation is an important way of obtaining the medical and lifestyle history of the donor. Putting the family on the back foot and not seeking consent from them could and will antagonise them and reduce their willingness to cooperate with a process that they are being told is going to happen. Will they be informed that they have a right to object to the organ donation? If not, are the staff involved in the process going to be challenged for not informing the next-of-kin of the rights to object to the donation process. We will end up with a situation that informed consent is replaced by a necessity to inform the next-of-kin of the right to object. This regime will be bizarre and counter-productive in our view. (Irish Kidney Association)
Information regarding the potential donor and their consent status need to be collected in the most practical and time efficient manner as possible. The capturing of information on a large scale and maintaining confidentiality and information security is of the utmost importance. It should be automatic that non-residents should be excluded from organ donation. Other factors to be considered in implementing this model include appropriate resources to design, implement and maintain central registry for transplant coordinators, a sustained media campaign to generate public awareness, transplant coordinators – improved function and increased number and increased funding towards training and equipment for transplant operations. (Irish Medical Organisation)
Current Irish Medical Council guidelines on consent are not compatible with Opt Out systems and do not work in practice. (Gary Rutherford)
Access to an Opt-Out Register. (Dr David Honan, Consultant Anaesthetist)
Problems are likely to arise when family disagree with the wishes of the donor. Because of the immediacy of organ donation there should be a conflict resolution method in place that does not rely on going to the courts. (Gerard Menezes)
Presumably, there would need to be electronic consent for each citizen, perhaps with the use of the new social services card. (Joe Panama)
The need for a secure database for those who wish to opt-out of organ donation, protection for vulnerable people (such as the homeless, mentally incapacitated and those with poor literacy skills), those with no access to an on-line database, those who wish to change their minds or those who wish to specify which organs can be used all need to be addressed in a logical, robust, fair, open and honest manner. Furthermore, the needs of patients, potential organ donors and their next of kin need to be taken into account and protected. To facilitate the move to a soft-opt out model of organ donation, the introduction of key donation staff and transplant coordinators in ITU hospital departments, increased infrastructure, additional resources and a commitment to providing a strong and structured financial and governance framework are absolute requirements. (Nicola Cassidy)
The State has proved itself incapable of securing individual’s private data. I would have no faith that the State would correctly identify those deceased individuals who have opted out especially in cases where no next-of-kin are known. If those under 18 years are deemed to require special treatment what about those with disability, the elderly, those with cognitive and intellectual impairment? How will the homeless and substance dependent deceased be dealt with? Assume to have opted out? Or presumed to have opted in because of a need for more material for biomedical research? Men who have sex with men cannot donate blood. Does this mean that they can donate organs or are they off the list of suitable donors? (Anonymous)
One of the biggest stumbling blocks we will have is that no doctor is going to enter an Intensive Care Unit and actually proceed to take organs without consent from grieving relatives. (Brendan McLaughlin)
3. Under a new statutory system, how should people opt out?
We suggest that people should be able to register at a variety of locations, e.g., GP surgeries, pharmacies, hospitals or health centres. (Irish Medicines Board)
Written consent should be obtained from individuals while they have the mental capacity to give consent. It would be helpful if a copy of this written consent was held centrally on a national database / register. It could also be helpful if individuals who wish to opt-out were provided with an ID type card which explicitly documented their wish to opt-out. (HIQA)
It is vital that people are well informed about organ donation and can easily register an objection should they wish to do so. Ideally this would be done via a central electronic database but in advance of the development of such a system, it could be done by carrying an opt-out card similar to the opt-in cards currently available. Another method would be to link the opt-out to a person’s PPS number or driver’s license, social welfare card, or their name on the electoral register as this could make it easier to discover any such objection in the event of death, particularly if an electronic database were later developed to record the names of those who choose not to become donors. (Irish Hospice Foundation and the National Council of the Forum on End of Life in Ireland)
This is a legal question. Simply informing their next of kin is the current way, presuming the family remember to agree at the time. A secure online database is the obvious answer but opting out must be available in writing, also on an up-to-date database for all donation hospitals’ key donation staff to examine. In our view this is an expensive necessity to collect the opt-out database. We would favour an organ donor registry that collected both the positive and negative consent to organ donation. It would allow public awareness to be directed to the data collecting website complementing the organ donor card system and the positive response of the drivers licence application forms. Never should a person be forced to say yes or no to being an organ donor on a website. This experiment failed dramatically in Texas and 40% of people opted to say no because they were compelled to decide. (Irish Kidney Association)
Whilst it must be made easy to opt out and whilst it must be confidential, the information must be accessible to each Intensive Care Unit. It is unfair to require individuals to carry a document or card at all times, and not everyone possesses a driving licence. Also, IT systems are not always wholly reliable. (Dr David Honan, Consultant Anaesthetist)
We need to create a National Registry that allows this decision to be recorded regardless of their reasons (illness, belief, culture) and regardless of the consent system in place. (Gary Rutherford)
In theory the best place to opt out would be on a centralised computerised register but with no national patient identifier and no simple way of doctors being able to find the donor’s details without a unique identifier this will be problematic. A donor opt out card may be the simplest way around this until the unique identifier is bedded down. (Gerard Menezes)
Opt out should be by card and online only – not through conversation with next of kin. (Hazel Dunne)
Under the new system, opting out should be very easy. If it is in any way difficult, then many people will not get around to opting out. This will undermine the entire system because it will be unrealistic to presume that anyone who has not opted out does not have any problem with donation. (James Daly)
It would be worth distributing the relevant documents to local public health services, colleges and to GPs and to put infrastructure in place to enable people to register their choice through the post office or social welfare systems. It would be remiss not to allow people to opt out online. Perhaps, once a person makes their choice, they receive a phone call from the Department of Health to confirm that they indeed made that decision. (Joe Panama)
The burden should not be on those who wish to opt out but on those who avidly wish to opt in and make their wishes known. The process to opt out should be reliable and secure. (Anonymous)
4. Should specific vulnerable groups be excluded from deeming their consent e.g. incapacitated adults?
Normal protocols should apply to vulnerable groups such as those with an impaired ability to make a choice to opt out. (Joint Submission from Alpha One Foundation, Cystic Fibrosis Ireland, Irish Heart and Lung Transplant Association and Irish Lung Fibrosis Association)
Any exclusion of specific groups from consent should be clearly specified in any primary legislation. (Irish Medicines Board)
The legislation must apply only to adults considered to have the capacity to make this decision. (Irish Hospice Foundation and the National Council of the Forum on End of Life in Ireland)
Incapacitated persons should rely on their legal surrogate to make the decision for them (in the same way they provide assent for other procedures). We do not see a reason they should be excluded from opt-out provisions. (Intensive Care Society of Ireland)
The requirement for consent is recognised for all people in national, international and European human rights law and under the Irish Constitution. Therefore, this will have to be determined on a case by case basis. It is up to the system to facilitate vulnerable groups with capacity to consent to do so. It is also important to be cognisant of any relevant provisions made in the Assisted Decision Making Bill 2013 and other relevant legislation. (HIQA)
Legislation should allow for a process involving their legal guardians to facilitate children and incapacitated adults to make that decision. An age of consent should also be covered in legislation. (Irish Medical Organisation)
Without doubt, all vulnerable groups should be defined and excluded from the opt-out system if they do not have the capacity to object to organ donation the presumption of their consent fails. The informed family consent must be mandatory for these donations to proceed. It also begs the question, who will determine that the potential organ donor is in a vulnerable group or not, if the next-of-kin are not available for consultation. (Irish Kidney Association)
Yes, otherwise you de-humanise them. (Dr David Honan, Consultant Anaesthetist)
How or who would assess capacity and how would this be established in the time sensitive nature required for cadaveric organ donation. Why should it matter about the donor’s capacity when presumably what matters should only be that they are a viable organ donor? (Gary Rutherford)
Incapacitated adults should not routinely be excluded however there may be some special cases which need further medical supervision. (Gerard Menezes)
Yes, have a common sense approach. Are they able to make legal, and statutory decisions? If no then automatic opt out unless a card is carried. (Hazel Dunne)
I do not believe that specific vulnerable groups should be excluded, but I do believe that their next-of-kin should be consulted after death and before donation. (James Daly)
Absolutely, unless permission is expressly provided by next of kin. (Joe Panama)
The authors of this consultation document already deem under 18 year olds and those not ordinarily resident in the State to be excluded highlighting misgivings about ethics and morals of making automatic decisions on behalf of others in this important and very sensitive matter. It is wrong for the State to meddle in this area and for a decision to be made on behalf of anyone without that person in life consenting or their loved ones or in death their next-of-kin if expressed wishes of deceased are not known. Where known, the expressed wishes of the deceased should always be adhered to and where there is no next-of-kin no organs or tissues should be taken. (Anonymous)
5. How should groups with religious or cultural objections be accommodated?
Through consultation with the potential donor’s family or through the ability to opt-out. (Joint Submission from Alpha One Foundation, Cystic Fibrosis Ireland, Irish Heart and Lung Transplant Association and Irish Lung Fibrosis Association)
Any exclusion of specific groups from consent should be clearly specified in any primary legislation. (Irish Medicines Board)
The indications of groups with religious or cultural objections should be captured via the registration of a formal objection during their lifetime if they do not wish to become an organ donor after death. All information for members of the public on organ donation and the opt-out system should explicitly explain how to opt-out and also describe how a “soft” opt-out system would work in practice. Such information should be available in accessible / easy to read formats. This will facilitate members of the public to make fully informed decisions with regard to organ donation. (HIQA)
Freedom of religious and cultural preferences must be respected and accommodated while at the same time the same level of public education on organ donation should be available to all. (Irish Hospice Foundation and the National Council of the Forum on End of Life in Ireland)
If a person is known to be from a particular religious or cultural group, there is no reason to presume that they themselves object to being an organ donor. It simply highlights the label they choose to be known by. It should be up to these groups themselves to promote organ donation or not and object to organ donation if they want to as individuals on a register. The spiritual leaders can make their own minds up and proceed as they wish. No effort should be made to highlight the wishes pro or con by specific groups particularly if they object to organ donation. (Irish Kidney Association)
An individual must express their objection formally against organ donation through the national register. (Irish Medical Organisation)
Religious groups and cultural objections should not be considered any different from anyone else. If someone has a religious or cultural objection then they should follow the opt out method. (Gerard Menezes)
Easy access to opt out like everybody else. In order to help with implementation we should consult with all religious groups for their input into how to best roll this out sensitively (Hazel Dunne)
People with religious or cultural objections should be able to easily opt out. After death and before donation, the consultation with the next-of-kin should uncover any such objections. (James Daly)
There should be provision made to ensure that any groups with such objections be met and given the chance to opt out as a group. It would then fall to the groups to ensure that they keep their future members informed. (Joe Panama)
The onus should not be on this group but on those who wish to donate to make their wishes known and carry a donor card. (Anonymous)
6. Can an opt-out system of consent operate in the absence of a national register to record the wishes of those who wish to opt-out?
It does not seem possible to operate a system in the absence of a national register. (Irish Medicines Board)
A Register of those who do not wish their organs to be donated is necessary. This should include a provision for selective donation of particular organs. The process of entering one’s name in the Register should be made easy but appropriate safeguards to ensure privacy must also be ensured. Lack of inclusion of a person’s name on a Register will not establish their approval of organ donation and families must be consulted also. Other issues include validation of a person’s entry, mistaken identity issues, privacy and Data Protection issues, technical problems like difficulties with accessing the Register out of hours, a possible public perception that inclusion on the Register will hinder their own access to transplantation etc. (Intensive Care Society of Ireland)
An online, secure, central register is essential to enable individuals to register their decision to opt-out of organ donation. Individuals should be able to register to opt-out at any point during their lives. Sufficient funding will be required to establish and maintain the register. (Irish Heart Foundation)
A register that is easy to access by relevant professionals would be essential to the effective operation of an opt-out system. (Irish Hospice Foundation and the National Council of the Forum on End of Life in Ireland)
An opt-out system by definition requires a method whereby individuals can opt out. What other method other than a registry could satisfy the opt-out element in the consent is beyond us. (Irish Kidney Association)
No. A secure, central register is essential for recording if individuals are opting out. It should be run independently from those carrying out transplant operations to ensure its integrity. It is not feasible to expect every individual’s family to know their situation in relation to opting-out. As such, a national register is essential. (Irish Medical Organisation)
No. A system needs to be put in place to ensure the details of those who opt-out are known. However, a system to record those who have opted out cannot safely and reliably be implemented in the absence of a national system of identifiers. (HIQA)
Absolutely not. If we have a National Registry why not allow people to do something positive and opt in. People can also take the opportunity when registering to opt out or change from one to the other as they progress through their lives. (Gary Rutherford)
No (Dr David Honan, Consultant Anaesthetist)
An opt out system of consent could operate in the absence of a national register however carrying a card could be considered to be a backward step. (Gerard Menezes)
Yes, opt out cards and online. (Hazel Dunne)
The absence of a national register would probably undermine the opt-out system. (James Daly)
No, everyone and every choice must be recorded and constantly monitored and changed as necessary. People will change their minds, as it their right. (Joe Panama)
The onus should not be on those not wishing to be a donor or a subject of biomedical research. The onus should be on those who want to be involved. If a register is the way to go to register lack of consent, one has to have faith that it will be consulted, safely kept and updated and that all medical staff know the register exists and to consult it before procedure and to engage with the family. It will also require a huge information campaign to inform the public of the issue and of the register and details of the register and how to sign up etc. must be available on all relevant websites dealing with organ donation and transplant issues. (Anonymous)
7. If a register is required who should hold this information?
A National Register on Withholding Consent to Organ Donation should be established which would be automatically accessible to organ procurement services and managed by health departments. (Houses of the Oireachtas Joint Committee on Health and Children)
This information would most readily reside in a National Organ Procurement Service or any future organ transplant authority. (Irish Medicines Board)
To ensure its integrity, the register should be run independently of those conducting transplantations and should only be accessible to transplant co-ordinators who are independent of transplant teams. (Irish Heart Foundation)
A register is required and is should be a positive and negative register to assist promotion of organ donation generally. The register should be the property of the HSE and all willing organisations can drive the public via awareness campaigns to the registry. The registry will have to be secure. The UK use a central hub in NHSBT in Bristol and all potential donors wishes are checked by donation hospital staff by phone to a 24 hour call centre. This is a positive registry. A negative registry would have to have the same capacity 24/7. So why not include the positive responses as well as the negative ones? Clear statistics are available as to the usefulness of a positive register’s ability to inform family who, when they are informed, are much more likely to donate their next-of-kin’s organs. This should not be forgotten even if the soft opt-out system is tried in Ireland. (Irish Kidney Association)
A specific body or unit should be assigned overall responsibility and accountability for the register. The register should ideally be accessible on a 24 hour basis. Access controls should be established to ensure that the appropriate staff have access to the register. (HIQA)
The information should be recorded in a national database that is a secure record only to be accessed by transplant co-ordinators, and not medical staff that are part of a transplant team. Its security and protection is paramount to ensure individual choice and the inability to manipulate records from people outside the transplant coordination process. Information provided to people administering the database should be absolutely confidential. The easiest way to ensure identification would be by photo-identification or by an individual’s PPS number. Consumer friendly processes should be applied to ensure that individuals are not intimidated by the procedure of registering their preference. (Irish Medical Organisation)
A Register should be held by a statutory body which does not have a vested interest in organ donation. The Irish Medicines Board as the regulatory body is an option but they do not operate outside office hours. (Intensive Care Society of Ireland)
It would be unsafe to entrust this information only to a single National Transplant Office, as they would be perceived as a biased vested interest. A new neutral Legal Entity would need to be established. (Dr David Honan, Consultant Anaesthetist)
Not the HSE. (Hazel Dunne)
The Transplant Authority should maintain this National Registry. A network of hospital based Transplant Coordinators should have access to this system. (Gary Rutherford)
I would think that the Department of Health or HSE should hold the opt-out register, since it is going to be a HSE employee who takes the organs and who will have to find out the deceased’s wishes. (James Daly)
The Department of Health and the Ombudsman on request. I see no problem in making that information accessible to anybody who can access census results. (Joe Panama)
A reliable institution regretfully in this country our State, our leaders and its institutions have a poor record in being fit for purpose and reliable. It should not be an NGO or quango. (Anonymous)
8. Should an opt-out system only cover the procurement of organs or should it also cover tissues that may be removed along with an organ e.g. heart valves?
There should be a mechanism to obtain consent for donation of organs and tissues at the same time and this could be best facilitated by being specified in primary legislation.(Irish Medicines Board)
There seems no reason to treat tissues like heart valves any differently to organs in regard to opt-out consent. (Intensive Care Society of Ireland)
Information on organ donation and what exactly this entails, including the issue of whether organs only or organs and tissues are to be removed should be clearly explained in the organ donation and opt-out system information provided to members of the public. Such information should be available in accessible / easy to read formats. This will facilitate members of the public to make fully informed decisions with regard to organ donation. (HIQA)
It should also cover tissues that may be removed along with organs. (Irish Hospice Foundation and the National Council of the Forum on End of Life in Ireland)
Organ donation consent should be for organs and tissue but it should be explained that some tissue will be procured later than the organs at the subsequent post-mortem process. The difference between organs and tissue should be clearly explained in more detail. Organs will have to be used immediately – less than 24 hours – but tissue can be stored for weeks before its subsequent use. (Irish Kidney Association)
This question is clinically meaningless (or badly phrased), as valves form part of a heart. (Dr David Honan, Consultant Anaesthetist)
No, but once again this is something that should not be taken for granted. It is a decision that should and could be taken and recorded in advance if the correct systems were in place. (Gary Rutherford)
Organs and associated tissues should be considered the same if you opt out you opt out of everything. Keep it simple. (Gerard Menezes)
All above. Not just organs, everything. (Hazel Dunne)
I would think that the system should cover whatever tissue is ordinarily necessary for organ transplantation. No more should be removed than what is necessary. (James Daly)
It should cover any and all tissues and/or organs health service professionals require to help benefit or save a living person’s life. (Joe Panama)
The opt-out system should cover tissues that may be removed along with an organ. However, this ought to be made clear through legislation and through a public education and information programme. An individual must be able to opt-out and register objections should he/she wish. The deceased person’s family must be consulted prior to removing any tissue. The Human Tissue Bill should set out a detailed consent framework in relation to donation of organs and tissues by living people for transplantation and research. (Irish Medical Organisation)
It must cover all. (Anonymous)
9. Should a person be able to register an objection to donating specific organs?
Any provision for ‘partial’ consent should be clearly specified in legislation and the process itself should be simple enough to complete. (Irish Medicines Board)
People should be able to register an objection to donating specific organs on the opt-out register. The register should also enable people to raise partial objections on the register, i.e. to opt not to donate certain organs. (Irish Heart Foundation)
Yes a person should be able to register an objection to donating specific organs. A national register should have the capacity to accommodate the specific wishes of an individual. (Irish Medical Organisation)
Yes. In the respect of each person’s right to self-determination and autonomy, all individuals should be facilitated to agree or object to donating specific organs. (HIQA)
No we do not think that a register should go into such detail. The donor cards in the past had sections for this detail and few used it and we moved to multi-organ donor cards without any difficulty. If one goes down this route, tissue will have to be listed also. This will soon over-burden a registry and make mistakes much more of a reality. (Irish Kidney Association)
Yes. (Irish Hospice Foundation and the National Council of the Forum on End of Life in Ireland)
Nobody should be able to register an objection to donating a specific organ. (Gerard Menezes)
No I think it should be all or nothing. (Hazel Dunne)
A person should be able to object to donating specific organs. (James Daly)
Yes (Dr David Honan, Consultant Anaesthetist)
Yes (Gary Rutherford)
Yes. (Joe Panama)
Of course. (Anonymous)
10. Pending the development of a national system for individual health identifiers in this country, how can the record of those who have opted- out be best accessed in an accurate and timely fashion?
Unique identifying numbers (UIN) are needed in our health system for a registry to work properly. This would much improve the ability to securely identify individuals. We are all getting a Public Service Card in the near future and they should be ready long before the Human Tissue Act is passed. This card should also be a UIN and should be used for identifying the individuals. The introduction of postal codes will also assist the process. Obviously the date of birth should be used also. The opportunity to use the Public Service Card as an identifier for positive organ donation should not be underestimated. The drivers licence code 115 is an under-developed resource also. (Irish Kidney Association)
A system to record those who have opted out cannot safely and reliably be implemented in the absence of a national system of identifiers. (HIQA)
By effective transfer of this information from the various possible sources (driving licence, electoral register, welfare cards). (Irish Hospice Foundation and the National Council of the Forum on End of Life in Ireland)
Perhaps opt-outs could be recorded on a medical file or there could be something that a person carries with them (similar to the idea of a donor card). Certainly someone who wants to opt out should inform their next of kin. Pending the development of a national system, medical practitioners should be very reluctant to presume consent where there is any uncertainty. It is very important to retain the confidence of the public. (James Daly)
Clearly, you cannot proceed if you do not have a Register. (Dr David Honan, Consultant Anaesthetist)
By taking advantage of a system like www.donorconsent.com which is a simple user friendly system developed in Ireland. It offers a unique online photographic recorded individual and next of kin consent. In this model, the basic information is collected online, but hard copy consents are maintained securely offline for quick retrieval. These can then be presented to next of kin to remind them of the decision. The Next of Kin forms also provided for a space to record a handwritten note to the donor’s next of kin. (Gary Rutherford)
Via an electronic database, universally accessible to doctors and registrars in Irish hospitals (Joe Panama)
Speed and accuracy are the two key factors. Time pressure and potential for human error especially when deceased has no next-of-kin and to ascertain consent from – proves how fishy this proposed measure is as no financial compensation or apology will remedy a monumental error of harvesting organs against the expressed wishes of the deceased. (Anonymous)
11. If organs procured under the opt-out system are found to be unsuitable for transplantation, should these organs be eligible for use in research (which generally requires an explicit consent)?
Any primary legislation for consent should include reference to the possibility of consent for research and discard so that, when obtaining consent for organ or tissue donation the potential use for research and possibility of discard could be consented to at the same time. (Irish Medicines Board)
At the moment, organs procured for transplantation that are found unsuitable for transplantation are used for research or are disposed of. The donor family should be told which organs were procured and not used. Yes is the answer to the overall question. Organs procured by any consent system should be used for research but the next-of-kin should also be informed if organs were eventually not transplanted. For tissue donation it may be more difficult to establish their use or not. (Irish Kidney Association)
Consent to research is a separate issue and would require a comprehensive system to obtain consent from donors and next of kin, beyond the current issue of consent for organ donation. (Irish Heart Foundation)
The use of organs for research should require specific opt-in consent. If there is a perception that opt-out consent is being used to procure organs for research it could undermine community support for organ donation. Research is not directly lifesaving like organ donation and there is a different ethical and moral imperative in this case. (Intensive Care Society of Ireland)
Consent for research purposes should follow national and international legislation, guidelines and best available evidence. Information on organ donation and what exactly this entails, including the issue of what happens to organs found to be unsuitable for transplantation purposes would need to be explicitly explained as part of the information provided to members of the public on organ donation and the opt-out system. Such information should be available in accessible / easy to read formats. This will facilitate members of the public to make fully informed decisions with regard to organ donation. (HIQA)
Organs deemed unsuitable for transplantation should only be eligible for use in research if explicit consent has been acquired. (Irish Medical Organisation)
No. This would only serve to confirm public suspicions that EU Pharmaco-Economic and research and development interests have driven this proposed change, and that paid legal and medical lobbyists have brought this about. (Dr David Honan, Consultant Anaesthetist)
No, consent should be explicit, recorded and an audit trail available to prevent abuse and further organ retention scandals. (Gary Rutherford)
Explicit consent should be retained for all forms of research. (Gerard Menezes)
That should form part of consent. In order to make everything 100% clear. (Hazel Dunne)
I do not believe that organs unsuitable for transplantation should automatically be eligible for use in research without the consent of the deceased or next-of-kin. (James Daly)
Yes. (Joe Panama)
Consent cannot and should not be disposed of under any circumstances. If a blanket consent is being given it needs to be full and informed with an understanding of all circumstances under which organs may be used including for research/commercial or other. Where it is to be used for research it should be all about disease understanding and patient care and not sadly as it is today, all about the PI and his/her team and the race to be the first author on the paper. People opting in to this proposed new system should know they are opting in to use for transplantation and if organ/tissue is not suitable then agreeing use for medical research. If people are not comfortable with one or another potential use then they should register their non-consent to whichever use – no to medical research, no if transplantation or yes if transplantation and no to medical research, etc. (Anonymous)
12. What information is essential to include in a public awareness campaign about the opt-out system of organ donation?
A public awareness campaign should focus on the need for organ donation and the life-saving benefits it provides. It should fully explain the meaning of opt-out and, possibly, some potential scenarios could be used by way of illustration. The campaign should also highlight the methods for opting out, and for taking oneself off the register at any future time. Any safeguards that are proposed, such as the right of family members to veto donation even if the donor is not listed on the opt-out register, should also be clearly outlined. (Irish Medicines Board)
Initially media campaigns will be required to ensure that all members of society are aware of the change to the system of consent. After this initial period, ongoing communication is essential to ensure that everyone continues to be properly informed about the system, particularly people reaching the age of maturity and people taking up residency in Ireland. The education system should be used to promote awareness of the benefit of donations for individuals and society. The state should utilise key engagements with citizens to promote both awareness of the opt-out system and the benefits of organ donation, i.e. including information on the potential to opt-out with Leaving Cert results, when people are getting / renewing their driving licence, when people register with a GP, as well as providing more general communications about organ donation at public buildings with high foot-fall and in polling stations. An important part of the awareness campaign should be encouraging families to talk about their wishes known before they die. All awareness campaigns must be evaluated to ensure that they are achieving a high level of penetration amongst the population, as well as being effective in communicating both the details of the consent system and the value of organ donation for society. (Irish Heart Foundation)
A public awareness campaign for the opt-out system is a much harder proposition to sell to the public than the informed consent system. People have had 49 years of being requested to donate organs and now the proposal is to tell them they can object to organ donation. This concept required careful consideration as already the public are more suspicious of presumption in general compared to being asked. In our view, this is the cornerstone of why we should not use soft opt-out unless the system is much more transparent and reaction from the press articles which will inevitably have negative stories are managed by an independent authority which has oversight over organ donation. The reaction from the public to organ donation will change to one of greater suspicion. (Irish Kidney Association)
Information provided on organ donation and the opt-out system should be available in accessible/easy to read formats for members of the public. While an initial public information campaign would be most beneficial there may need to be regular updates to this initial public information campaign every few years to maintain the level of public awareness and understanding that will be needed for the opt-out system to work. Information to be conveyed as part of a public information campaign could include:
- Overview of organ and tissue donation
- Legislative provisions
- Explanation of opt-out system (soft opt out system) and what this means for individuals and their families to include information on how to opt out; what information is held on the national register; how are procured organs allocated and used; what happens to procured organs found to be unsuitable for transplantation purposes; which organs and / or tissues (as applicable) are procured as part of this system; what if a family disagrees with a family member’s wish to donate their organs
- Information for donors (what they need to know) to include information on: what happens to donated organs – how will they be allocated and used; what happens if organs are not suitable for transplantation purposes; what organs and / or tissues (as applicable) are included in the organ donation process; what to do if one does not wish to donate certain organs / tissues; how exactly to opt out.
- Information for relatives / families (what they need to know) to include information on: what happens if we disagree with our family member’s request to donate organs; how to make a complaint and what the complaint process entails.
- Where more information can be obtained from, who to contact for further information: It may be helpful to provide a telephone number for an advice or helpline where people can ask additional questions or find out more about the process. It may also be helpful to provide contact information including telephone numbers for advocacy services.
The core elements of the public awareness campaign need to focus on the central key messages to be successful and therefore, cannot provide all the information so it should also act as a signpost to direct people to where they can get more information from. A public information campaign should utilise as many communication channels as possible and provide information in as many accessible formats as possible to ensure that members of the public are informed of what exactly organ donation entails, the decisions that they need to make in relation to same and how to opt out if they so wish. This could include television, radio and newspaper advertisements, a media relations campaign involving national and regional media, the provision of posters and leaflets in GP surgeries, hospitals, community pharmacies, libraries, Citizen Advice Centres, among other locations and to advocacy and patient associations as well as to other relevant groups. Partnering with relevant community groups to get the messages to the public, providing information stands at relevant major events, and so on. All relevant government and public sector agencies should also be fully briefed so that they would know where to direct any enquiries they receive to. (HIQA)
An ongoing media campaign in order to raise public awareness must saturate all areas of society, informing them of the facts and processes of organ donation, along with assurances that their family will be consulted and how to register their objection. Additionally, organ donation awareness should also be introduced into the educational environment, to ensure that adolescents reaching maturity are aware of the process, and to enable them to make an informed choice when they are older. (Irish Medical Organisation)
The capacity of organ donation to save lives; the importance of people clearly articulating and registering their wishes and informing their loved ones to ensure that they are aware of their preferences. There are low levels of awareness about organ donation and how it happens. Studies have shown that people who opted to donate organs cited their opinions of family and friends as the most important influences on their decision. As such, any public awareness campaign should seek to start a public conversation about organ donation and its benefits. The New Jersey Hero Act (2008) provides for education initiatives as a compulsory part of secondary school curriculum. There should also be more information provided to the public about how to access bereavement support. (Irish Hospice Foundation and the National Council of the Forum on End of Life in Ireland)
How to opt out; How easy it is to opt out; Reassurance that opting out carries no prejudice, penalty or sanction; Details of assistance with opting out; An opt-out Helpline. (Dr David Honan, Consultant Anaesthetist)
The rates of donation, real life stories. The most moving thing is to see a loved one live because some good person said yes to have their loved one donate their organs. (Hazel Dunne)
It is essential that the public know how they can easily opt out. It is also essential to present donation as the “normal and right thing to do”. The benefits of donation should be highlighted and the public should be reassured that they can have full trust in the system. The public awareness campaign should prove that the public can trust the system by highlighting the procedures around consent. (James Daly)
That it applies to anybody over 18; Where you can opt out; Exactly what organs/tissues may be taken; Exactly what they might be used for; Who will have access to that information (Joe Panama)
Reason for organ need including failure of all those who are supposedly in favour actively assuming they have a donor card and make family, friends and others aware of their desire to be an organ donor. Many say they are in favour but don’t bother to get an organ donor card. Publicise the fact that there is a facility to acknowledge the donor and the need to thank bereaved families. It is a simple gesture that means so much. Detail if not suitable for transplantation what possible uses within medical research organs and tissues can be put. If researchers collaborated more and shared results and that includes pharma, less duplication would result and organs and tissues could be made better use of. An information campaign should acknowledge the commercial aspects of research. Make it clear if no next-of-kin is known and the views of the deceased are not known, no organ or tissue will be removed. (Anonymous)
Cancer, Blood and Organs Policy Unit
Department of Health
Introduction of an Opt-Out System of Consent for Organ Donation
This consultation document relates to new proposals on organ donation by deceased people.
Organ transplantation adds years of life as well as quality of life to organ recipients. Ironically, however, its success, has led to organ shortages in Ireland and throughout Europe, and so heightens the need for more donations and transplant procedures to be undertaken.
In 2012, there were a total of 78 deceased donors which resulted in 244 organs being retrieved. This equates to a donor rate of 17.03 per million population (pmp). In comparison, Spain had a rate of 35.3 pmp (in 2011) while the UK had a rate of 17.4 in 2012. There are approximately 650 people on the organ transplant waiting lists.
Given the scarcity of organs available in Ireland for transplantation, it is important that as a society we do all that we can to increase the number of organs available for transplantation. A critical part of this is to build on the current positive attitude towards organ donation. In this context, the Programme for Government commits to introducing an opt-out system of organ donation, with a view to improving the availability of organs for patients in need of transplantation.
Currently in Ireland, when a potential organ donor is identified, the person’s family is asked for their consent to allow organ donation to take place. This is known as “express” consent or an “opt-in” process to becoming an organ donor. In other words, the choice and the decision to become an organ donor rests with the family of the deceased.
The Government now intend to change this system of consent to one of opt-out consent. What this will mean in practice is that the health professionals involved will not have to actively seek the deceased’s family’s express consent for organ donation. Instead, consent will be deemed unless the person has, while alive, registered his/her wish not to become an organ donor after death. This is known as “opting-out”. However, it is proposed that, even though consent is deemed, the family will in practice always be consulted prior to removing any organ and if the family objects to the organ donation, the donation will not proceed. This is what is known as a “soft” opt-out system.
The Department is currently preparing legislative proposals for a Human Tissue Bill which will legislate for the giving of consent for the removal, retention, storage, use and disposal of organs and tissues from deceased persons in the context of post-mortems, transplantation, research or anatomical examination. The Human Tissue Bill will also set out a detailed consent framework in relation to donation of organs and tissues by living people for transplantation and research.
A public consultation took place in 2009 seeking views on the question of which system of consent for organ donation Ireland should adopt in regard to organ donation by deceased people. The views of interested parties were sought on three systems – opt-in (the current system), opt-out and mandated choice/required request.
While the Government at the time decided to proceed with the Human Tissue Bill on the basis of maintaining the current system of consent i.e. opt-in, the Programme for Government commits to introducing an opt-out system of consent.
Countries which operate an opt-out system generally have higher organ donation rates. Ireland is among a minority of EU Member States, including the United Kingdom, the Netherlands and Germany that don’t operate an opt-out system.
The Department is aware that changing the system of consent is just one aspect in a package of measures that will be required to increase organ donation rates. In this regard, the Department, in conjunction with the HSE’s National Organ Donation and Transplantation Office, is considering what practices and organisational changes, along with a change to the consent system, could further improve donation rates in this country.
What Will Opt-Out Mean in Practice?
If a person does not wish to become an organ donor after death, they will need to register a formal objection during their lifetime – a process known as opting out. If, on the other hand, a person wishes to become an organ donor after death, they do not need to take any action during their lifetime.
The deceased’s family or next of kin will still have an important role to play in the process of organ donation. While the next of kin will not be required to give their consent to the donation itself, they will be consulted and asked to provide as much information as possible on the person’s medical and social history. As stated earlier, it is intended that, in practice, there would be no instance whereby organ donation would proceed against the wishes of the next of kin of the deceased. It is also intended that safeguards will be included in the legislation to protect vulnerable groups in society.
The system to be introduced could therefore be described as one of “soft opt-out”.
Who Will Be Affected by this Policy Change?
Following enactment of the legislation, all those over the age of 18 who live and die in Ireland will be considered as potential organ donors unless they opt out in their lifetime. A person will need to be “ordinarily resident” in Ireland for 12 months or more for the new opt-out consent law to apply to them. After this period, people will be deemed to have given their consent to donation, unless they had already stated they did not wish to be a donor.
Who Will Not Be Affected by this Policy Change?
Not every person who dies in Ireland will be deemed to have consented to organ donation. The proposed opt-out arrangements will not apply to children (i.e. people under the age of 18) or to people living in Ireland at the time of their death but who are not ordinarily resident in this country. The Human Tissue Bill will set out separate consent provisions for such people. In addition, operational arrangements may be needed to support some groups in making a decision.
We Would Like Your Views
The Department wishes to invite interested parties to submit their views on the practical aspects of introducing a system of opt-out consent for organ donation.
The Department would be interested to hear your general views but would particularly like your views on the following questions:
- What in your view are the major ethical or moral issues associated with the introduction of an opt-out model of consent?
- What are the practical and operational issues to be examined in implementing this model?
- Under a new statutory system, how should people opt out?
- Should specific vulnerable groups be excluded from deeming their consent e.g. incapacitated adults?
- How should groups with religious or cultural objections be accommodated?
- Can an opt-out system of consent operate in the absence of a national register to record the wishes of those who wish to opt-out?
- If a register is required who should hold this information?
- Should an opt-out system only cover the procurement of organs or should it also cover tissues that may be removed along with an organ e.g. heart valves?
- Should a person be able to register an objection to donating specific organs?
- Pending the development of a national system for individual health identifiers in this country, how can the record of those who have opted- out be best accessed in an accurate and timely fashion?
- If organs procured under the opt-out system are found to be unsuitable for transplantation, should these organs be eligible for use in research (which generally requires an explicit consent)?
- What information is essential to include in a public awareness campaign about the opt-out system of organ donation?
How to Respond
Written responses by individuals, groups or organisations are welcome and should be sent by e-mail to: firstname.lastname@example.org or posted to: Opt-Out Consent Consultation, Department of Health, R. 309, Hawkins House, Hawkins Street, Dublin 2. Latest date for receipt of responses is Friday, September 20th 2013
For further information please contact the Blood and Organs Policy Unit at the Department of Health at (01) 6354732 or (01) 6354196.
How Your Response Will Be Used
The Department will publish a summary of the submissions received as part of this consultation on its website. It is likely that this summary will contain a list of those who have made submissions and may include direct quotes from some submissions. In such cases it is intended to attribute these quotes to the person or group who made the submission.
If you do not want your submission to be referred to in the circumstances described above, please let the Department know at the time of your submission.
All submissions received will be subject to the Freedom of Information Acts 1997 and 2003 and may be released in response to a Freedom of Information request.