University of Nicosia Medical School. Organ Donation & Transplantation 2023-2024 Notes PDF

ORGAN DONATION & TRANSPLANTATION ETHICS MD6 Y1 2023-2024 Dr Eirini Kampriani Assistant Professor of Medical Anthropology & Medical Ethics [email protected] LOBs Discuss the ethical issues surrounding organ donation & transplantation. Explain the relevance of definitions of death & the concept o...

ORGAN DONATION & TRANSPLANTATION ETHICS MD6 Y1 2023-2024 Dr Eirini Kampriani Assistant Professor of Medical Anthropology & Medical Ethics [email protected] LOBs Discuss the ethical issues surrounding organ donation & transplantation. Explain the relevance of definitions of death & the concept of personhood. Describe different religious/cultural/country perspectives on organ donation and transplantation. Outline the legal/professional framework with regards to Organ Donation in one country & discuss the ethical implications. OUTLINE 1. Introduction to the topic and Definitions Organ transplantation types Organ donation types 2. Organ donation systems and their ethical implications Statistics and country variation Organ donation systems UK legal framework Ethical implications of different approaches/systems 3. Allocation of donated organs for transplantation Criteria and Principles for organ allocation to recipients 4. Ethical complexity in clinical practice Guidelines for good medical practice PART 1; INTRO AND DEFINITIONS Organ donation U.S. Department of Health & Human Services Organ Transplantation; Classification Organ transplantation refers to the surgical replacement of a malfunctioning organ by another organ the transfer (engraftment) of human cells, tissues or organs from a donor to a recipient with the aim of restoring function(s) in the body. Auto-grafts which originate from recipients themselves (i.e. skin) Allo-grafts which are transplants between genetically nonidentical individuals Xeno-grafts which are living animal organs/tissue transplanted to humans TYPES OF ORGAN DONATION; LIVING vs DECEASED LIVING DONATION DECEASED DONATION living patient consents to donate a single organ/part of organ donation after death (cadaveric donation) Living related; donating to a family member Living unrelated; donating to a non-family member; sometimes as part of paired or polled donation Donation after brain death; death diagnosis on neurological criteria Donation after circulatory death; nonheart beating donation; diagnosis on circulatory criteria, usually after withdrawal of mechanical ventilation Deceased donation Definition of brain death Irreversible loss of brainstem function Defined criteria NHS criteria for diagnosing brain death - a person must be unconscious and fail to respond to outside stimulation - a person's heartbeat and breathing can only be maintained using a ventilator - there must be clear evidence that serious brain damage has occurred and it cannot be cured https://www.nhs.uk/conditions/brain-death/diagnosis/ Deceased donation; issues Notions of personhood; where is it located in the human body? When does a person cease to exist? (see theories of personhood) UK approach; A person seizes to exist when they have lost the capacity to have consciousness The human organism dies only when it ceases to function in an integrated way (Papanikitas, 2015) Organ donation across traditions https://www.coe.int/en/web/human-rights-channel/organ-donation TYPES OF ORGAN DONATION Non-directed donation A person offers to donate an organ to anyone who might benefit Living unrelated Directed donation when a person (or frequently their next-ofkin) agrees to donate organs only if they are allocated to a specific recipient Living related TYPES OF ORGAN DONATION Pooled donation (donation chain) Paired donation Potential donor A and potential recipient B are in a relationship but are not genetically compatible. Potential donor C and potential recipient D are in the same position. A is compatible with D and C is compatible with B. Thus A gives to D and C gives to B. Like paired, but more than two pairs involved in the swap https://www.hta.gov.uk/faq/what-paired-pooled-donation TYPES OF ORGAN DONATION Conditional donation when a person agrees to donate organs on the condition that they are allocated to (or withheld from) a specific type of recipien Controversies; conditional donation Should people be allowed to set conditions on who receives their organs after their death? A conditional donation occurred in the UK in 1998 when a white man’s next-of-kin specified that his organs could not be allocated to non-whites. The organs were accepted and allocated to white people (who, by coincidence, would have been the recipients regardless of the restrictions), and several lives were saved/improved. Conditional donation; UK and US examples UK; all conditional deceased donation should be prohibited DoH Guidelines 2010; need to distinguish between ‘conditional donation’ and ‘requests for directed allocation’. requests for directed donation to recipients in ‘qualifying relationships’ (family members or close friends) to be considered, provided that: i) the agreement to donate is not conditional on the request being granted; ii) granting the request would not deprive a ‘superurgent’ recipient of a transplant. US; LifeSharers organization allows people to register as donors and request that their organs are first offered to members of LifeSharers. Donation is similar to a request for directed donation. potential recipients are prioritized by the donor not based on a preexisting relationship, but because they are members of the same ‘club’ Ethical issues related to organ donation/transplant ❑ living organ donation – many more people are willing to receive organs rather than they are to donate ❑ deceased organ donation – issues relating to the definition of death; ownership of the body and decision-making ❑ Xenotransplantation – an alternative to help meet increasing demand of organs for transplantation; Concerns with mixing of the species; risk of transfer of diseases from animal to human PART 2; ORGAN DONATION SYSTEMS & ETHICAL IMPLICATIONS Ethical complexity Who could and should give an organ? ? STATISTICS; Organ donation and transplantation in Europe High demand vs Shortage of donated organs https://www.edqm.eu/en/EODD https://www.coe.int/en/web/human-rights-channel/organ-donation Organ Donation in Europe; country variation in deceased donation rates Organ donation and transplantation. Facts, figures and European Union action. 2020 LEGAL FRAMEWORK; Organ donation systems Opt-in system (soft/hard) People must actively join the register Opt-out system (“presumed consent”) (soft/hard) People must actively remove themselves from register Other systems: Mandated choice People must record their wishes regarding organ donation after death at some stage(s) in their lives Benefits in kind Offering reimbursement or health insurance or priority Market England Organ Donation (Deemed Consent) Up to early 2020, England operated an opt-in system. Human Tissue Act (2004); donation after death on NHS Organ Donor Register Donation rates seemed relatively static from May 2020, everybody is considered willing to donate their organs after they die unless they have recorded a decision not to do so Max and Keira’s law See: NHS Blood and Transplant - https://www.blood.co.uk/news-and-campaigns/the-donor/organ-donationand-you-busting-the-myths/ England Organ Donation (Deemed Consent) Bill all adults in England considered potential donors unless they have recorded a decision not to donate on the NHS Organ Donation Register or if they are in one of the following excluded groups: ❑Those under the age of 18 ❑People who lack the mental capacity to understand the new arrangements and take the necessary action ❑Visitors to England, and those not living here voluntarily ❑People who have lived in England for less than 12 months before their death https://www.organdonation.nhs.uk/uk-laws/organ-donation-law-in-england/ CASE STUDY Mrs Mo is a 71-year old woman who collapsed at home after complaining of a severe headache. On arrival of the ambulance, she is intubated and transferred urgently to the hospital. A CT scan shows extensive sub-arachnoid haemorrhage. She is comatose with fixed dilated pupils, but has intermittent respiratory effort. Neurosurgeons have assessed and discussed Mrs Mo’s prognosis with her family. Surgery is possible, but the outcome is thought to be extremely poor. In accordance with Mrs Mo’s wishes, the family and neurosurgeons have decided that she should not have a surgery and should have treatment withdrawn. Mrs Mo has an organ donation card in her pursue, but her family do not agree to organ donation. *Case adapted from: Wilkinson et al 2020; chapter 15 Ethical considerations Legal framework Family involvement Arguments for presumed consent (optout system) ❑Autonomy - consistent with a view of a majority population so presumably better 81% of people in England support organ donation but only 36% have opted in 63% of families approached agree to organ donation Some people who would want to donate do not (2017 survey) ❑a presumption is made: that majority of individuals wish to be donors or to the contrary. In any case, a proportion will be wronged by having their autonomous will violated. ❑Alleviates some burden on family members ❑Countries with opt-out donation systems have higher donation rates on average Arguments against presumed consent (opt-out system) ❑Applying presumed consent means that an organ is no longer a gift or donation in the true sense of the word. It appears as something that has been ‘taken’ from the dead. ❑Some patients do not wish to donate their organs but may not get around to opting out ❑Countries with opt out systems do not automatically have high rates of donation ❑Family burden; If a soft opt-out system, families will be asked about donation. If families not asked, additional distress to cope with along with death of loved one Opt-out system in Spain Successful case of Opt out system in Europe While the legislation (presumed consent) has remained unmodified since 1979, organ donation rates increased during the 1990s. In Spain the high donation rate is thought to be mainly due to the way organ transplantation is co-ordinated. High number of ICU beds Large number of transplant centres/surgeons Economic reimbursement incentives for hospitals Proactive donor detection programme Catholic church advocates donation if the procedure respects human life and human dignity Legislating to encourage organ donation in Israel Before 2008, organ donation was a serious problem in Israel. In order to receive transplants, Israelis often had to look abroad new policy; Organ Transplant Act 2008/into effect in January 2010. a ‘priority and reimbursement’ system. People who sign up to the organ donation register are given priority on the transplant list should they require an organ themselves in the future. They are also financially reimbursed for any medical expenses and lost work. A significant impact was felt almost immediately. Between 2011 and 2013, the number of Israeli living organ donors increased by 67 percent over the preceding three-year period. In 2013... transplants received by Israeli patients abroad fell to a quarter of their 2007 peak. Organ markets Two brothers, from what is called the ‘Nepal kidney bank’ district, report how they were duped by kidney traffickers and show their scars Image Source: CNN – Nepal’s organ trail: how traffickers steal kidneys https://edition.cnn.com/2014/06/26/world/asia/freedom-project-nepals-organ-trail/index.html Organ trafficking & transplant tourism The Declaration of Istanbul 2008 Organ trafficking and transplant tourism violate the principles of equity, justice and respect for human dignity and should be prohibited. The poor who sell their organs are being exploited, whether by richer people within their own countries or by transplant tourists from abroad. Moreover, transplant tourists risk physical harm by unregulated and illegal transplantation. Participants in the Istanbul Summit concluded that transplant commercialism, which targets the vulnerable, transplant tourism, and organ trafficking should be prohibited. PART 3; ALLOCATION OF ORGANS FOR TRANSPLANTATION Ethical complexity Who could and should receive an organ? ? Allocation of organs for transplantation UK - NHS Blood and transplant; a) guidelines to guide patient selection (for entry onto the waiting list) Restrictive selection for transplantation Conditions associated with positive outcome Clinical criteria Co-morbidities; medical conditions & other factors b) allocation of organs (amongst those on the waiting list) Some key factors in allocating organs Urgency Chance of success Age of donor Difference in age/size between donor and recipient Proximity of medical centre Allocation of organs for transplantation ethical principles ❑Utility an action/practice to be right if it promotes more benefit than any alternative action/practice allocation should maximize the estimated overall good adjusted for potential accompanying harms (Considering all possible goods and harms, the quantity and probability of the various outcomes, e.g. giving an organ to A instead of B) Possible factors to consider in the application of the utility principle include; Patient survival, Graft survival, Quality of life, Availability of alternative treatments, Age Social acceptance that we do not include things like socioeconomic status, career, race, or education in determining who ought to receive an organ Allocation of organs for transplantation ethical principles ❑Justice equality & distributive justice all people should have an equal right to the benefits of transplantation regardless of their genetic makeup including race, gender, quality of life, age, or other factors that go into determining utility. This principle is concerned not only with the degree of good that is produced, but also with the way in which that good is distributed among potential beneficiaries Possible adjustments that might include adding weight to factors such as time on the waiting list (prioritizing those who have been waiting longest), or a marker for previous exposure to foreign tissue that decreases the chance of finding a suitable organ. PART 4; ETHICAL COMPLEXITY IN CLINICAL PRACTICE UK Guidelines - Key Ethical Principles in Living Donor Kidney Transplantation Altruism has been the basis of organ donation in the UK; as a selfless gift to others without expectation of remuneration Autonomy; Valid consent required by living donor before an organ can be removed Beneficence actions that serve the best interests of patients. Dignity BTS/RA Living Donor Kidney Transplantation Guidelines 2018 (4th edition) inherent dignity or special status of the human body; dignity & price are mutually incompatible Non-maleficence ‘doing no harm’ Reciprocity providing benefits or services to another as part of a mutual exchange. (i.e. paired/pooled LDKT) Is it unethical for doctors to encourage healthy adults to donate a kidney to a stranger? NO - Antonia Cronin believes that it is ethically acceptable for doctors to encourage altruistic donation (BMJ 2011 Nov 15;343:d7140) 1. A good thing? Offering a gift - of life; Latin – ‘Donum’ - gift & ‘Dare’ to give 2. “If something is not wrong to do but is actually a good thing, then it cannot be wrong to encourage the doing of it” The ‘good’ Cronin speaks of is the ‘medical good of society’ secondary to the ‘individual medical good’ the doctor primarily seeks. Therefore the first argument still holds i.e. the good of the individual patient Is it unethical for doctors to encourage healthy adults to donate a kidney to a stranger? Yes - Walter Glannon argues that doctors should not encourage their patients to put themselves at risk for the benefit of others (BMJ 2011;343:d7179) 1.First do no harm 2. “Doctors have a secondary duty to promote organ donation and transplantation as one way of promoting public health. But this secondary duty should not supersede their primary duty” 3. Act in best interests of patients and respect their autonomy 4. Doctor asking may be seen as coercion due to the power imbalance in doctor/patient relationship - valid consent consequences may ensue GMC – Good medical practice; Organ donation You should follow any national procedures for identifying potential organ donors and, in appropriate cases, for notifying the local transplant coordinator. You must take account of the requirements in relevant legislation and in any supporting codes of practice, in any discussions that you have with the patient or those close to them. You should make clear that any decision about whether the patient would be a suitable candidate for donation would be made by the transplant coordinator or team, and not by you and the team providing treatment. (82) GMC – Good medical practice - Treatment and care towards the end of life: good practice in decision making https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/treatment-and-care-towards-theend-of-life ❖There are different types of organ donation and transplantation ❖There are insufficient organs for all those who could benefit from receiving them; ❖different policies and strategies have been promoted to increase the supply of human organs ❖Resource allocation decisions also have to be made as to who should have priority for the organs that are available ❖There are crucial ethical questions that arise in organ donation 1. Outline different types of organ donation 2. What is the relevance of religious and cultural views in organ donation and transplantation? 3. Outline different approaches of organ donation systems 4. Discuss arguments for and against presumed consent policies/opt-out systems 5. Outline ethical issues arising from organ donation practices From the book Papanikitas A. (2015) Crash Course Medical Ethics and Sociology (ebook) ▪ Chapter 4; Ethics and Law at the beginning and end of life (pages 65-68) [PLEASE NOTE: section titled “the law and organ transplantation”, pp 66-67 is excluded; since the UK law has changed] ▪ Chapter 5; Healthcare commissioning and resource allocation (see section titled “Organ transplantation and resource allocation!, page 76) Wilkinson D, Herring J., and Savulescu J (2020) Medical Ethics and Law; a curriculum for the 21st century. 3rd edition (in the library) Chapter 15; Organ transplantation and definitions of death (pages 239-248) British Medical Association (2012) Medical Ethics Today: The BMA’s Handbook of Ethics and Law. John Wiley & Sons; 3rd edition (e-book contents accessible via library) Chapter 12: Responsibilities after a patient’s death [esp section “Organ and tissue transplantation”, pp. 512-515] Further Self-directed reading You may also want to have a look at the following : G. Randhawa, (2012) Death and organ donation: meeting the needs of multiethnic and multifaith populations, BJA: British Journal of Anaesthesia, 108(suppl_1) pp. i88–i91 https://doi.org/10.1093/bja/aer385 Oliver M., Woywodt A., Ahmed A. and I. Saif (2011) Organ donation, transplantation and religion. Nephrol Dial Transplant 26: 437–444 doi: 10.1093/ndt/gfq628 Prabhu, P. K. (2019). Is presumed consent an ethically acceptable way of obtaining organs for transplant?. Journal of the Intensive Care Society, 20(2), 92-97. NHS Blood and Transplant. Organ donation and transplant activity Wales, (2017) https://nhsbtdbe.blob.core.windows.net/umbraco-assets/1518/wales.pdf Types of organ donation https://www.americantransplantfoundation.org/directeddonation-vs-non-directed-donation/ Types of donors https://www.royalfree.nhs.uk/services/kidney-services/kidneytransplants/types-donors APPENDIX: SELFREFLECTION ❑ Your attitude to organ donation Have you ever considered becoming an organ donor? Can you name two ethical challenges related to organ donation? Should organ donation be regulated? CONSIDER ❑ Should a person with HIV or any other chronic incurable disease be given an organ? ❑ Should people whose lifestyles choices damaged their organ be given a chance at organ transplant? ❑ What happens when after the person receiving an organ developed cancer in that organ after transplant? SAMPLE EXAM QUESTION SAMPLE SBA In view of the scarcity of human organs donated, different countries proceed with signing memorandums of understanding for bilateral collaboration in an attempt to facilitate the identification of compatible donors for patients in need of an organ for transplantation, in their respective populations. Which of the following terms more closely links with this practice? A. B. C. D. E. Living donation Paired donation Pooled donation Directed donation Non-directed donation