Effect of Opt-out System for Organ Donation After Brain Death on Ethical Legitimacy and Potential Efficacy in a Mathematical Model.

OBJECTIVES: We aimed to compare the possible outcomes of the current (opt-in) system and an opt-out system for organ donation in South Korea using a mathematical model. MATERIALS AND METHODS: A structured questionnaire was used to investigate the decision on organ donation and family consent after brain death under the current system and an opt-out system. The survey was conducted in August 2018 by means of a voluntary survey of 100 opposite-sex married couples. RESULTS: Sixty-three percent of participants wished to self-donate their organs after brain death: 69.5% were positive and 30.5% were negative regarding the implementation of the opt-out system. Among 200 participants, the total number of possible donors increased from 110 (55.0%) in the current system to 139 (69.5%) in the opt-out system. Positive autonomy was defined as obtainment of consent from the donor and the spouse, and negative autonomy was defined as concordaence of refusal between the donor and the spouse. Comparisons between the systems showed that the rate of autonomy increased from 57.0% in the current system to 61.5% in the opt-out system. Although the achievement of positive autonomy increased from 59.5% in the current system to 74.6% in the opt-out system, the achievement of negative autonomy decreased from 52.7% in the current system to 39.2% in the opt-out system. CONCLUSIONS: An opt-out system can increase the number of organ donors; however, achievement of negative autonomy can decrease.

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.

Deceased organ donation in Nova Scotia: Presumed consent and system transformation.

In recent years, rates of deceased organ donation in Nova Scotia have remained stagnant, falling behind provinces that have invested in their organ donation programs. The Nova Scotia provincial government has recently committed to health system transformation, which will include enactment of presumed consent legislation in 2020. Although impressive rates of deceased organ donation are often observed in countries with presumed consent legislation, improvements in performance can more often be attributed to the accompanying health system transformation. Key components of high performing deceased organ donation systems include highly trained organ donation specialists, practice guidelines, healthcare professional education, performance metric reviews, accountability frameworks, and public awareness campaigns in addition to adequate legislation. For Nova Scotia's organ donation program to succeed, the provincial government must also invest the frontline financial resources required to develop and maintain adequate program infrastructure and implement key strategies to support a culture of donation.

[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.

It Takes a Village to Raise a Child: Solidarity in the Courts-Judicial Justification for Posthumous Use of Sperm by Bereaved Parents.

The practice of posthumous use of sperm raises social, ethical, and legal questions. We examine the issue of who should be allowed to use the sperm-only the deceased's spouse or the deceased's parents as well-from the perspective of solidarity and relational autonomy. Following a theoretical discussion of various accounts of solidarity and relational autonomy, the legal status of posthumous assisted reproduction is examined in three jurisdictions-the USA, Australia, and Israel-in which most applications to the courts were submitted by the deceased's parents. In Israel, we found fifteen court rulings on requests for posthumous use of sperm and fourteen in Australia. A smaller number were found in the case of the USA. The analysis reveals that Israeli and Australian courts employ solidarity-based arguments to justify their decisions to allow posthumous use of sperm, particularly when the deceased's true wishes are unknown. We thus conclude that the posthumous use of sperm can be legally extended to include the deceased's parents based on solidarity and relational autonomy arguments.

'If I donate my organs it's a gift, if you take them it's theft': a qualitative study of planned donor decisions under opt-out legislation.

BACKGROUND: There is a worldwide shortage of donor organs for transplantation. To overcome this, several countries have introduced an opt-out donor consent system. This system, soon planned for Scotland and England means individuals are automatically deemed to consent for organ donation unless they register an opt-out decision. This study was designed to explore the reasons underpinning donor choices for people who plan to actively opt-in to the register, take no action and be on the register via deemed consent, opt-out, and those who are unsure of their decision. METHODS: This study reports the analysis of free-text responses obtained from a large survey of intentions towards opt-out legislation in Scotland, England and Northern Ireland (n = 1202). Of the n = 1202 participants who completed the questionnaire, n = 923 provided a free text response explaining their views. Thematic analysis was used to explore the reasons why participants plan to: opt-in (n = 646), follow deemed consent (n = 205), opt-out (n = 32) and those who were not sure (n = 40). RESULTS: A key theme for people planning to opt-in is that it ensures one's donor choice is explicitly clear and unequivocal. Some regarded deemed consent as unclear and open to ambiguity, thus actively opting-in was viewed as a way of protecting against family uncertainty and interference. For the deemed consent group, a key theme is that it represents a simple effortless choice. This is important from both a pragmatic time-saving point of view and because it protects ambivalent participants from making a challenging emotive choice about organ donation. Key themes for those planning to opt-out relate to fears around medical mistrust and bodily integrity. Notably, both participants who plan to opt-out and opt-in perceived presumed consent as "authoritarian" and a method of increasing Government control of organs. In response, registering an active decision protected their freedom of choice. CONCLUSIONS: The findings highlight the importance of registering deliberate active consent for people who choose opt-in, due to concerns over possible family refusal under deemed consent. These findings could inform the development of communication campaigns that encourage family communication before the implementation of opt-out legislation.

Implementing Regulatory Broad Consent Under the Revised Common Rule: Clarifying Key Points and the Need for Evidence.

The revised Common Rule includes a new option for the conduct of secondary research with identifiable data and biospecimens: regulatory broad consent. Motivated by concerns regarding autonomy and trust in the research enterprise, regulators had initially proposed broad consent in a manner that would have rendered it the exclusive approach to secondary research with all biospecimens, regardless of identifiability. Based on public comments from both researchers and patients concerned that this approach would hinder important medical advances, however, regulators decided to largely preserve the status quo approach to secondary research with biospecimens and data. The Final Rule therefore allows such research to proceed without specific informed consent in a number of circumstances, but it also offers regulatory broad consent as a new, optional pathway for secondary research with identifiable data and biospecimens. In this article, we describe the parameters of regulatory broad consent under the new rule, explain why researchers and research institutions are unlikely to utilize it, outline recommendations for regulatory broad consent issued by the Secretary's Advisory Committee on Human Research Protections (SACHRP), and sketch an empirical research agenda for the sorts of questions about regulatory broad consent that remain to be answered as the research community embarks on Final Rule implementation.

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.

Media content analysis of the introduction of a "soft opt-out" system of organ donation in Wales 2015-17.

In an attempt to improve organ donation rates, some countries are considering moving from "opt-in" systems where citizens must express their willingness to be an organ donor, to "opt-out" systems where consent is presumed unless individuals have expressed their wishes otherwise, by, for example, joining an "opt-out" register. In Wales-a part of the United Kingdom-the devolved government recently legislated for an "opt-out" system. For the change to be effective, a public awareness campaign was critical to the policy's success. Using quantitative and qualitative content analysis, we explored media coverage of the change to better understand the relationship between the state, policy actors, media and the public when such policy changes take place. Our findings illustrate how a state communication campaign can effectively set the media agenda within which we saw a degree of interdependency created with the state using the media to promote policy, and the media relying on the state for credible information. Yet we also found that the media is not uncritical and observed how it uses its autonomy to influence policy setting. Over the period of study, we found that a change in tone and view towards deemed consent organ donation has taken place in the media. However, while this may influence or reflect public attitudes, it is yet to be seen whether the media campaign translates into behavioural change that will result in increases in organ donations.

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.

Welsh 2013 deemed consent legislation falls short of expectations.

Wales, in 2013, was the first country in the United Kingdom to pass legislation introducing presumed (or deemed) consent for organ donation, and remains the only one. It was introduced in an attempt to increase the number of life-saving transplants taking place in the UK, in a move that policy makers hoped would mirror Spain's success. More recently, pressure has been mounting for England to follow suit, with a public consultation currently in progress. However, the Welsh system has been far from a success, raising the question of why campaigners are so adamant that it should be replicated. Before the Welsh Government introduced the Human Transplantation (Wales) Act there had been no strong evidence to suggest it would make a difference, with countries boasting both high organ donation rates and presumed consent legislation demonstrating no clear causal relationship between the two facts. In addition, a recent report evaluating the Act has highlighted its failure to improve donation rates, and has even presented some potentially concerning statistics that may suggest a negative impact. This paper first considers presumed consent in other countries - Spain and Brazil - before illustrating the underwhelming progression of Wales' new system and the need to look to other options.