Qualitative Content and Discourse Analysis Comparing the Current Consent Systems for Deceased Organ Donation in Spain and England.

England switched to an opt-out system of consent in 2020 aiming to increase the number of organs available. Spain also operates an opt-out system yet has almost twice the organ donations per million population compared with England. We aimed to identify both differences and similarities in the consent policies, documents and procedures in deceased donation between the two countries using comparative qualitative content and discourse analysis. Spain had simpler, locally tailored documents, the time taken for families to review and process information may be shorter, there were more pathways leading to organ donation in Spain, and more robust legal protections for the decisions individuals made in life. The language in the Spanish documents was one of support and reassurance. Documents in England by comparison appeared confusing, since additions were designed to protect the NHS against risk and made to previous document versions to reflect the law change rather than being entirely recast. If England's ambition is to achieve consent rates similar to Spain this analysis has highlighted opportunities that could strengthen the English system-by giving individuals' decisions recorded on the organ donor register legal weight, alongside unifying and simplifying consent policies and procedures to support families and healthcare professionals.

Impact of the life-sustaining treatment decision act on organ donation in out-of-hospital cardiac arrests in South Korea: a multi-centre retrospective study.

BACKGROUND: The demand for organ transplants, both globally and in South Korea, substantially exceeds the supply, a situation that might have been aggravated by the enactment of the Life-Sustaining Treatment Decision Act (LSTDA) in February 2018. This legislation may influence emergency medical procedures and the availability of organs from brain-dead donors. This study aimed to assess LSTDA's impact, introduced in February 2018, on organ donation status in out-of-hospital cardiac arrest (OHCA) patients in a metropolitan city and identified related factors. METHODS: We conducted a retrospective analysis of a regional cardiac arrest registry. This study included patients aged 16 or older with cardiac arrest and a cerebral performance category (CPC) score of 5 from January 2015 to December 2022. The exclusion criteria were CPC scores of 1-4, patients under 16 years, and patients declared dead or transferred from emergency departments. Logistic regression analysis was used to analyse factors affecting organ donation. RESULTS: Of the 751 patients included in this study, 47 were organ donors, with a median age of 47 years. Before the LSTDA, there were 30 organ donations, which declined to 17 after its implementation. In the organ donation group, the causes of cardiac arrest included medical (34%), hanging (46.8%), and trauma (19.2%). The adjusted odds ratio for organ donation before the LSTDA implementation was 6.12 (95% CI 3.09-12.12), with non-medical aetiology as associated factors. CONCLUSION: The enactment of the LSTDA in 2018 in South Korea may be linked to reduced organ donations among patients with OHCA, underscoring the need to re-evaluate the medical and legal aspects of organ donation, especially considering end-of-life care decisions.

National Consensus on Contraindications for Corneal Donation for Transplantation in Switzerland.

PURPOSE: To establish a national consensus on contraindications for corneal donation for transplantation in Switzerland. METHODS: Swisstransplant (SWT), the Swiss national foundation coordinating tissue and organ donations, convened a working group consisting of six national corneal surgeons and eye bankers and donation experts to create a contraindication list for corneal donation. The group reviewed available national and international guidelines and recommendations, while adhering to Swiss law and transplant regulations. In cases of opposing opinions, the group held follow-up meetings until a consensus was reached. A consensus was defined as agreement among all parties present. RESULTS: From March 2021 to November 2021, the study group held six meetings and created a standardized minimal contraindication list for corneal donation in Switzerland. Thanks to this list, SWT has created a mandatory working and documentation file for donor coordinators to use when evaluating multiorgan donors for corneal harvesting. The authors agreed that while the national consensus list provides standardized minimal contraindication criteria, local eye banks may choose to introduce additional, more rigorous criteria. CONCLUSION: Given that corneal transplantation is the most commonly performed transplantation, establishing a consensus on contraindications is crucial for recipient safety. The creation of a consensus on contraindications for corneal donation in Switzerland is an essential contribution to fulfil the legal requirements concerning quality assurance and provides sufficient high-quality donor tissue within the country. Therefore, periodic review and revision of the consensus is considered critical.

Anonymous Gamete Donation: a Case for Balancing Under Article 8 ECHR.

Anonymous gamete donation creates a specific conflict between human rights and public interests under Article 8 of the ECHR. This was first assessed in the ECtHR's landmark decision in Gauvin-Fournis and Silliau v. France of 7 September 2023. This article critically analyses this judgment, taking into account the European legal framework for anonymous gamete donation, the recommendations of the competent authorities and the previous case law of the ECtHR on the right to know one's biological origin as an integral part of one's identity that is protected under the right to private and family life.

Biobank donation in search of public benefits and the potential impact of intellectual property rights over access to health-technologies developed: A focus on the bioethical implications.

The availability of biomaterials is a key component of health research and the development of new health-technologies (including, diagnostics, medicines, and vaccines). People are often encouraged by biobanks to donate samples altruistically to such biobanks. While empirical evidence suggests many donors are motivated by the desire to contribute towards developing new health-technologies for society. However, a tension can arise as health-technologies whose development is contributed to by donors' biomaterials will often be protected by intellectual property rights (IPRs), including patents. Patents give rightsholders control over how patented technologies are used and can be used in a way that impedes public access to technologies developed. Yet, there are no binding European legal obligations mandating disclosure to donors of how IPRs can operate over downstream health-technologies and how they could impact access to health-technologies developed, nor are there legally binding obligations to ensure public accessibility of technologies developed. Focusing on the bioethical implications posed, this article argues that the current situation can impact donors' autonomy and dignity interests. A more holistic approach is needed for biobank donation, which embeds a consideration of donors' expectations/interests from the point of donation through to how such samples are used and how health-technologies developed are accessed. We put forward avenues that seek to address such issues.

[Legal and forensic medical problems of postmortem donation]. / Pravovye i sudebno-meditsinskie problemy posmertnogo donorstva.

The article is devoted to legal and forensic medical problems of postmortem donation. The substantive provisions of postmortem donation, as well as normative legal documents regulating the processes of organs harvesting from deceased persons for subsequent transplantation and governing the work of transplantologists and forensic medical experts have been considered. The practical examples illustrating the essence and nature of the problem of postmortem forensic medical expertise of persons with absent organs has been given and the importance of the participation of a forensic medical expert involved in the decision-making process on possibility (or impossibility) of the corpse's organs and tissues explantation without prejudice to the further expert examination has been emphasized. The authors pay particular attention to the inadequacy of the legal framework, including the lack of a clear understanding of the legal status of the person holding the position of forensic medical expert, who provides an expert opinion on the organs' explantation.

Shared intent in third-party donation will underpin the success of new surrogacy laws.

The demands for surrogacy treatments continue to grow worldwide. However the legal guidance for non-commercial surrogacy treatments remains inadequate, and this commentary argues how the forthcoming guidance on surrogacy from the UK Law Commissions would benefit from a bold decision based on previous experience derived from similar developments in three other areas of assisted conception.

A NHS Foundation Trust v MC [2020] EWCOP 33: Revisiting Best Interests and 'Altruistic' Incapacitous Stem Cell Donation.

In A NHS Foundation Trust v MC, the Court of Protection revisits the question of whether adults should be allowed to act as bone marrow or peripheral blood stem cell donors if they lack decision-making capacity. This case note explores the positive and problematic implications of the case based on points that were raised in the judicial reasoning that specifically relate to i) practical implications concerning the key players in this environment, ii) the risk analysis within the best interest determination, iii) altruism and iv) the wider context as it relates to minor donors who lack capacity.

Examining consent for interventional research in potential deceased organ donors: a narrative review.

In the last decade, research in transplant medicine has focused on developing interventions in the management of the deceased organ donor to improve the quality and quantity of transplantable organs. Despite the promise of interventional donor research, there remain debates about the ethics of this research, specifically regarding gaining research consent. Here, we examine the concerns and ambiguities around consent for interventional donor research, which incorporate questions about who should consent for interventional donor research and what people are being asked to consent for. We highlight the US and UK policy responses to these concerns and argue that, whereas guidance in this area has done much to clarify these ambiguities, there is little consideration of the nature, practicalities and context around consent in this area, particularly regarding organ donors and their families. We review wider studies of consent in critical care research and social science studies of consent in medical research, to gain a broader view of consent in this area as a relational and contextual process. We contend a lack of consideration has been given to: what it might mean to consent to interventional donor research; how families, patients and health professionals might experience providing and seeking this consent; who is best placed to have these discussions; and the socio-institutional contexts affecting these processes. Further, empirical research is required to establish an ethical and sensitive model for consent in interventional donor research, ensuring the principles enshrined in research ethics are met and public trust in organ donation is maintained.

Body donation in Italy: Lights and shadows of law No. 10/2020.

INTRODUCTION: Recently, law No. 10 of February 10, 2020, entitled "Rules regarding the disposition of one's body and post-mortem tissues for study, training, and scientific research purposes" was introduced in Italy. Although its provisions respond to a constructive subject, some practical issues are evident in the approved text. MATERIALS AND METHODS: A systematic review of the literature was performed by searching online medical and juridical databases to identify publications and Italian law provisions related to body donation programs. RESULTS: The updated regulatory framework was outlined and compared to that in force previously, and the following features are discussed: (a) matter of law; (b) donors' information and consent; (c) reference centers and funding, and (d) procedural regulatory details. Several critical issues were detected in the approved wording with respect to teaching/training recipients, the role of university anatomy institutes, family members' exclusion from participating in the donation process in any capacity, the duration of donation, the management of corpses, partial donations, and the compatibility with organ donation. Suggestions are provided to overcome certain operational limitations in implementing the regulation, which is still being drafted to date. CONCLUSIONS: This article shares with the international scientific community the principles and controversies underlying a regulatory innovation introduced in Italy to allow legislative amendments to inadequate provisions of body donation, as well as draw the attention of the entire anatomic community to critical issues if other countries undertake the same legislative reform.

Where do these cadavers come from?

Cadaveric surgical courses are highly useful in developing operative skills, however, the provenance of the cadavers themselves remains opaque. Trade in cadaveric parts is an important source of material for courses, and this has spawned the unique service of body brokerage. Body brokers, however, operate in an unregulated market and obtain bodies by exploiting family members' altruistic instincts and financial concerns. Unethical and illegal sale of body parts has been well-documented, while the use of cadavers for uses other than that consented by donors is also a key concern. Undoubtedly, cadaveric surgical courses would have used bodies sourced from brokers, and questions remain about the moral and ethical implications of this. We discuss this issue using an ethical and historical context as well as offering solutions to ensure the ethical sourcing of cadavers for surgical training.

Anonymity in EU Health Law: Not an Alternative to Information Governance.

Data sharing has long been a cornerstone of healthcare and research and is only due to become more important with the rise of Big Data analytics and advanced therapies. Cell therapies, for example, rely not only on donated cells but also essentially on donated information to make them traceable. Despite the associated importance of concepts such as 'donor anonymity', the concept of anonymisation remains contentious. The Article 29 Working Party's 2014 guidance on 'Anonymisation Techniques' has perhaps helped encourage a perception that anonymity is the result of data modification 'techniques', rather than a broader process involving management of information and context. In light of this enduring ambiguity, this article advocates a 'relative' understanding of anonymity and supports this interpretation with reference not only to the General Data Protection Regulation but also to European Union health-related legislation, which also alludes to the concept. Anonymity, I suggest, should be understood not as a 'technique' which removes the need for information governance but rather as a legal standard of reasonable risk-management, which can only be satisfied by effective data protection. As such, anonymity can be not so much an alternative to data protection as its mirror, requiring similar safeguards to maintain privacy and confidentiality.

Assessment of Somatic Support Process for Pregnant Brain Death Patients Occurring in a Transition Country Between Asia and Europe from Medical, Ethical, Legal and Religious Aspects.

In spite of the fact that brain death during pregnancy is not a common occurrence, it is an important ethical problem for all cultures and religions can have a significant influence on the donation decision after brain death. Therefore, this study aimed to present the case of a pregnant patient developing brain death which occurred in our intensive care unit and to compare the medical, ethical and legal problems relating to pregnant cases developing brain death with 24 cases in the literature. A 21-year-old 19-week pregnant case with gestational diabetes was monitored in the anesthesia intensive care unit and developed brain death due to intracranial mass and intraventricular hemorrhage. Though brain death is a situation well understood by organ transplant professionals, brain death developing in pregnant patients still involves many medical, ethical and legal problems.

[An ethical evaluation of presumed consent for organ donation in Switzerland]. / Une évaluation éthique du consentement présumé pour le don d'organes en Suisse.

Following a current trend in European countries, Switzerland is about to decide to adopt (or reject) a presumed consent legislation for organ donation. In such a system, every citizen is considered as a potential organ donor except in case of expressed refusal during lifetime. The presumed consent system raises ethical and practical issues that need to be carefully understood and weighed before deciding on its fate. This article reviews the most pressing ethical issues and provides the empirical data necessary for assessing the presumed consent legislation in Switzerland. At the end of the analysis, the reader will be able to form her own informed opinion on the issue.

A l'image d'autres pays européens, la Suisse est sur le point de décider d'adopter (ou de rejeter) une législation du consentement présumé pour le don d'organes. Dans un tel système, tout citoyen est considéré comme donneur potentiel, sauf en cas de refus exprimé de son vivant. Le consentement présumé soulève des enjeux éthiques et pratiques qu'il importe de comprendre et pondérer soigneusement avant de statuer sur son sort. Cet article fournit les principales clefs d'analyse ainsi que les données empiriques nécessaires à cet exercice. Au terme de l'analyse, le lecteur pourra se forger une opinion informée et réfléchie sur le sujet.

Comparison of organ donation and transplantation rates between opt-out and opt-in systems.

Studies comparing opt-out and opt-in approaches to organ donation have generally suggested higher donation and transplantation rates in countries with an opt-out strategy. We compared organ donation and transplantation rates between countries with opt-out versus opt-in systems to investigate possible differences in the contemporary era. Data were analysed for 35 countries registered with the Organisation for Economic Co-operation and Development (17 countries classified as opt-out, 18 classified as opt-in) and obtained organ donation and transplantation rates for 2016 from the Global Observatory for Donation and Transplantation. Compared to opt-in countries, opt-out countries had fewer living donors per million population (4.8 versus 15.7, respectively) with no significant difference in deceased donors (20.3 versus 15.4, respectively). Overall, no significant difference was observed in rates of kidney (35.2 versus 42.3 respectively), non-renal (28.7 versus 20.9, respectively), or total solid organ transplantation (63.6 versus 61.7, respectively). In a multivariate linear regression model, an opt-out system was independently predictive of fewer living donors but was not associated with the number of deceased donors or with transplantation rates. Apart from the observed difference in the rates of living donation, our data demonstrate no significant difference in deceased donation or solid organ transplantation activity between opt-out versus opt-in countries. This suggests that other barriers to organ donation must be addressed, even in settings where consent for donation is presumed.

"As Long as You Ask": A Qualitative Study of Biobanking Consent-Oncology Patients' and Health Care Professionals' Attitudes, Motivations, and Experiences-the B-PPAE Study.

INTRODUCTION: Consent to biobanking remains controversial, with little empirical data to guide policy and practice. This study aimed to explore the attitudes, motivations, and concerns of both oncology patients and health care professionals (HCPs) regarding biobanking. MATERIALS AND METHODS: Qualitative interviews were conducted with oncology patients and HCPs purposively selected from five Australian hospitals. Patients were invited to give biobanking consent as part of a clinical trial and/or for future research were eligible. HCPs were eligible if involved in consenting patients to biobanking or to donate specimens to clinical trials. RESULTS: Twenty-two patients participated, with head and neck (36%) and prostate (18%) the most common cancer diagnoses; all had consented to biobanking. Twenty-two HCPs participated, from across eight cancer streams and five disciplines. Themes identified were (a) biobanking is a "no brainer"; (b) altruism or scientific enquiry; (c) trust in clinicians, science, and institutions; (d) no consent-just do it; (e) respecting patient choice ("opt-out"); (f) respectful timing of the request; (g) need for emotional/family support; (h) context of the biobanking request matters; and (i) factors for biobanking success. DISCUSSION: These findings reinforced previous findings regarding high public trust in, and support for, biobanking. An initial opt-in consent approach with the option of later opt-out was favored by patients to respect and recognize donor generosity, whereas HCPs preferred an upfront opt-out model. Factors impacting biobanking success included the context of the request for use in a trial or specific research question, pre-existing patient and HCP rapport, a local institution champion, and infrastructure. IMPLICATIONS FOR PRACTICE: Patients and health care professionals (HCPs) who experienced cancer biobanking consent were overwhelmingly supportive of biobanking. The motivations and approaches to seeking consent were largely mirrored between the groups. The findings of this study support the opt-in model of biobanking favored by patients; however, HCPs preferred an opt-out model. Both groups recognize the importance of making the request for biobanking at an appropriate time, preferably with emotional or family support, and respecting the timing of the request and privacy of the patient. Biobanking success can be promoted by hospital departments with a research focus by identifying an institutional biobanking champion and ensuring local infrastructure is available.

Attitudes of anonymous and identity-release oocyte donors towards future contact with donor offspring.

STUDY QUESTION: What are the attitudes and expectations of past oocyte donors concerning contact with their donor offspring and contact between donor offspring and their own children? SUMMARY ANSWER: The large majority (95%) of open-identity oocyte donors, as well as voluntarily registered donors (registered before the Finnish 2007 ART law), expressed positive or neutral feelings towards contact with their donor offspring and mainly positive expectations towards contact between donor offspring and their own children. WHAT IS KNOWN ALREADY: Although there is a growing support for openness and identity-release programmes in gamete donation, there is not much knowledge on how donors feel about potential contact with their offspring. Most previous studies have investigated donor expectations with a relatively short follow-up time, using small samples or participants in voluntary donor linkage services. STUDY DESIGN, SIZE, DURATION: A retrospective cross-sectional survey of all women who had donated oocytes between 1990 and 2012 at three fertility clinics in Finland was carried out in 2013. A self-administered questionnaire was sent out to a total of 569 former oocyte donors. PARTICIPANTS/MATERIALS, SETTING, METHODS: In total, 428 former oocyte donors answered a questionnaire assessing experiences and attitudes related to donation (response rate 75.2%). In this study, 358 donors who were unknown to the recipient were included. The mean follow-up time after the donation was 11.2 years. Before 2008, donors were non-identifiable but could voluntarily consent to release their identifying information to their donor offspring. After 2008, persons born as a result of gamete donation can, from the age of 18, receive information identifying the donor. Altogether 290 respondents had participated in a donation programme in 1990-2007 (before the Finnish ART-law), and 68 participated after the enactment of the ART-law, enabling us to compare attitudes by type of legislation during donation. MAIN RESULTS AND THE ROLE OF CHANCE: Most voluntarily registered and open-identity donors welcomed or were neutral to potential contact with their donor offspring but were slightly more cautious towards contact between their own children and a donor-conceived child. Open-end comments revealed some ambiguity and uncertainty as to what to expect from such contact and feelings varied from neutral curiosity and interest to desire to meet the donor-conceived child. LIMITATIONS, REASON FOR CAUTION: It is not possible to assess whether the opinions of the study participants is representative of all donors in 1990-2012, as 25% of all contacted former donors did not respond to the survey. WIDER IMPLICATIONS OF THE FINDINGS: This study is one of only a few studies among oocyte donors to evaluate long-term psychosocial consequences of the donation and expectations towards contact with donor offspring, using a large sample. Results from this study show that persisting concerns about adverse outcomes of identity release policies are largely unwarranted, but there is a need to develop counselling practices and material for identity-release donors about how to prepare for and adjust to potential contact with donor offspring. STUDY FUNDING/COMPETING INTEREST(S): This study was supported by grants from the Medical Society Life and Health, and from the Otto A. Malm Foundation. The authors have no competing interests to report. TRIAL REGISTRATION NUMBER: N/A.

Update regarding xenotransplantation in Japan.

To overcome the donor shortage, a promising solution could be xenotransplantation. The pig is generally considered the most suitable donor species for xenotransplantation. A clinical xenotransplantation has not been conducted in Japan. However, many progresses have recently been made in this field. Japan has regulations for conducting cell xenotransplantation and guidelines to prevent zoonosis. Most Japanese patients and their family members have a positive opinion about islet xenotransplantation. A grant for clinical islet xenotransplantation research and development has been approved, and germ-free pigs have been developed. Further research may bring the successful application of xenotransplantation closer to reality.

Presumed Consent: A Potential Tool for Countries Experiencing an Organ Donation Crisis.

BACKGROUND: There is currently an inadequate supply of allografts to meet the number of transplant candidates worldwide. A number of controversial policies, including implementation of a presumed consent organ donation system, have been considered to rectify the organ donation crisis. AIMS: A secondary retrospective data analysis aimed to assess the impact of switching to a presumed consent organ donation model on organ donation rates. METHODS: Deceased organ donation rates were compared before and after countries adopted presumed consent. RESULTS: Six countries met entry criteria. All six countries had an increase in liver donation rates, while 4 out of the six countries had an increase in kidney donation rates. The overall mean (± SD) liver donation rate was 3.23 (± 0.97) per million population (pmp) before the transition and 6.46 (± 1.81) pmp after the transition (p < 0.0001). The overall mean (± SD) kidney donation rate was 17.94 (± 3.34) pmp before the transition and 26.58 (± 4.23) pmp after the transition (p < 0.0001). The percentage increase in liver and kidney donation rates varied among countries, ranging from 28 to 1186%. CONCLUSION: The transition from explicit to presumed consent was associated with a significant increase in liver donation rates in all countries that met our criteria, while the effect on kidney donation rates was partially realized. Although presumed consent alone is unlikely to explain the increase in donation rates, the adoption of such a policy may prove to be a worthwhile risk for countries experiencing consistently low organ donation rates.