This paper defends an ‘opt-out’ scheme for organ procurement, by distinguishing this system from ‘presumed consent’ (which the author regards as an erroneous justification of it). It, first, stresses the moral importance of increasing the supply of organs and argues that making donation easier need not conflict with altruism. It then goes on to explore one way that donation can be increased, namely by adopting an opt-out system, in which cadaveric organs are used unless the deceased (or their family) registered (...) an objection. Such policies are often labelled ‘presumed consent’, but it is argued that critics are right to be sceptical of this idea—consent is shown to be an action, rather than a mental attitude, and thus not something that can be presumed. Either someone has consented or they have not, whatever their attitude to the use of their organs. Thankfully, an opt-out scheme need not rest on the presumption of consent. Actual consent can be given implicitly, by one's actions, so it is argued that the failure to register an objection (given certain background conditions) should itself be taken as sign of consent. Therefore, it is permissible to use the organs of someone who did not opt out, because they have—by their silence—actually consented. (shrink)

Deceased organ donation is widely considered as a case of easy rescue―that is, a case in which A may bestow considerable benefits on B while incurring negligent costs herself. Yet, the policy implications of this observation remain unclear. Drawing on Christopher H. Wellman’s samaritan account of political obligations, the paper develops a case for a so-called opt-out system, i.e., a scheme in which people are defaulted into being donors. The proposal’s key idea is that we may arrange people’s options in (...) specific ways for the sake of others. (shrink)

A chief objection to opt-out organ donor registration policies is that they do not secure people's actual consent to donation, and so fail to respect their autonomy rights to decide what happens to their organs after they die. However, scholars have recently offered two powerful responses to this objection. First, Michael B Gill argues that opt-out policies do not fail to respect people's autonomy simply because they do not secure people's actual consent to donation. Second, Ben Saunders argues that opt-out (...) policies do secure people's actual—if not explicit—consent, provided that certain conditions are satisfied. I argue that Gill and Saunders’ arguments are not successful. My conclusion does not imply that jurisdictions should not implement opt-out policies—their failure to secure people's actual consent may be outweighed by other considerations. But, my conclusion does imply that Gill and Saunders are mistaken to claim that opt-out policies are respectful of people's autonomy. (shrink)

A number of authors criticise opt-out (or ‘deemed consent’) systems for failing to secure valid consent to organ donation. Further, several suggest that mandated choice offers a more ethical alternative. This article responds to criticisms that opt-out does not secure informed consent. If we assume current (low) levels of public awareness, then the explicit consent secured under mandated choice will not be informed either. Conversely, a mandated choice policy might be justifiable if accompanied by a significant public education campaign. However, (...) if this entitles us to assume that members of the public are informed, then an opt-out system would also be justified in the same circumstances. The alleged advantages of mandated choice seem to rest on an unfair comparison, between mandated choice with a public education campaign and an opt-out system without one. While it may be that some countries with opt-out systems should do more to inform their publics, I see no reason to assume that this cannot be done. Indeed, advocates of mandated choice seem committed to thinking it possible to raise awareness. If opt-out systems adopt the same methods, such as writing to every individual, this should also address concerns about whether consent is informed. (shrink)

Much has been written about the global convergence on constitutional supremacy. Yet, a closer look suggests that while constitutional convergence trends are undoubtedly extensive and readily visible, expressions of constitutional resistance or defiance may in fact be regaining ground worldwide. This may point to a paradox embedded in global constitutionalism: the more expansive constitutional convergence trends are, the greater the likelihood of dissent and resistance are. In this article, I chart the contours of three aversive responses to constitutional convergence: neo-secessionism, (...) nullification, and deference to local authority, and draw on an array of comparative examples to illustrate the distinct logic and characteristics of each of these responses. Taken together, these increasingly common expressions of defiance provide ample evidence that global constitutionalism is not the only game in town. Neo-secessionism, nullification, and other forms of constitutional dissent and “opting out” may thus be viewed as a reaction against the centralization of authority and the decline of the local in an increasingly—constitutionally and otherwise—universalized reality. (shrink)

In this reply to Wilkinson and De Wispelaere, I argue that an opt-out donation system can be regarded as tacit consent. I first separate the opt-in/opt-out issue from that of the role that the family ought to play. I then argue that what De Wispelaere calls minimal approval-tracking is not obviously necessary and that, even if it were, opt-out schemes can satisfy this requirement.

We live in a liberal, pluralistic, largely secular society where, in theory, there is fundamental protection for freedom of conscience generally and freedom of religion in particular. There is, however, both in statute and common law, increasing pressure on religious believers and conscientious objectors to act in ways that violate their sincere, deeply held beliefs. This is particularly so in health care, where conscientious objection is coming under extreme pressure. I argue that freedom of religion and conscience need to be (...) put on a sounder footing both legislatively and by the courts, particularly in health care. I examine a number of important legal cases in the UK and US, where freedom of religion and conscience have come into conflict with government mandates or equality and anti-discrimination law. In these and other cases we find one of two results: either the conscientious objector loses out against competing rights, or the conscientious objector succeeds, but due to what I consider unsound judicial reasoning. In particular, cases involving cooperation in what the objector considers morally impermissible according to their beliefs have been wrongly understood by some American courts. I argue that a reasonable theory of cooperation incorporated into judicial thinking would enable more acceptable results that gave sufficient protection to conscientious objectors without risking a judicial backlash against objectors who wanted to take their freedoms too far. I also venture into broader, more controversial waters concerning what I call freedom of dissociation – the fundamental right to withdraw from associating with people, groups, and activities. It is no more than the converse of freedom of association, which all free societies recognise as a basic right. How far should freedom of dissociation go? What might society be like if freedom of dissociation were given more protection in law than it currently has? It would certainly give freedom of religion and conscience a substantial foundation, but it could also lead to discriminatory behaviour to which many people would object. I explore some of these issues, before going back to the narrower area of freedom of conscience and religion in health care, making some proposals about how the law could strengthen these basic pillars of a liberal, free society. (shrink)

Understanding why individuals opt out of living donation is crucial to enhancing protections for all living donors and to identify modifiable barriers to donation. We developed an ethical approach to conducting research on individuals who opted out of living kidney donation and applied it in a small-scale qualitative study at one US transplant centre. The seven study participants had varied reasons for opting out, the most prominent of which was concern about the financial burden from lost wages during the postoperative (...) period. Several reported feeling alone during their decision-making process. Although no participants used an alibi, a centre-provided statement of non-eligibility to donate, all believed that centres should offer alibis to help preserve donor autonomy. Given the complexity of participants' decisions and the emotions they experienced before and after deciding not to donate, we suggest approaches for independent living donor advocates to support this population. This study demonstrates that research on individuals who opt out of donation is feasible and yields valuable insight into methods to improve the evaluation experience for potential living donors. (shrink)

The Organ Donation Act 2019 has introduced an opt-out organ donor register in England, meaning that consent to the donation of organs upon death is presumed unless an objection during life was actively expressed. By assessing the rights of the dead over their organs, the sick to those same organs, and the role of consent in their requisition, this paper interrogates whether such paradigms for deceased organ donation are ethically justifiable. Where legal considerations are applicable, I focus on the recent (...) changes in England as a case in point; however, this paper ultimately challenges the justifiability of opt-out systems in any form, concluding that ethical solutions to organ shortage do not lie in opt-out systems of deceased organ procurement. (shrink)

As the HIV epidemic continues to grow worldwide, women are increasingly and disproportionally affected. With the introduction of anti-retroviral medications that have been found to effectively prevent perinatal transmission of HIV, the approach to HIV testing in pregnant women has grown increasingly more controversial. In recent years, the model of voluntary counseling and testing (VCT) has come into question with opt-out testing now advocated for by the Centers for Disease Control and occurring widely in pregnancy. The benefits of opt-out testing (...) are numerous and may justify its use in replacing the VCT that many have come to see as insufficient. An ethical analysis of opt-out testing suggests it may be at odds with true informed consent and involve a degree of coercion that would not be allowed outside the prenatal setting. If opt-out testing is going to remain the standard of care then the ethical issues it raises must be made transparent. Strategies need to be designed for ensuring that HIV counseling and testing in pregnancy is done in accordance with ethical and reproductive rights principles. (shrink)

We live in a liberal, pluralistic, largely secular society where, in theory, there is fundamental protection for freedom of conscience generally and freedom of religion in particular. There is, however, both in statute and common law, increasing pressure on religious believers and conscientious objectors (outside wartime) to act in ways that violate their sincere, deeply held beliefs. This is particularly so in health care, where conscientious objection is coming under extreme pressure. I argue that freedom of religion and conscience need (...) to be put on a sounder footing both legislatively and by the courts, particularly in health care. I examine a number of important legal cases in the UK and US, where freedom of religion and conscience have come into conflict with government mandates or equality and anti-discrimination law. In these and other cases we find one of two results: either the conscientious objector loses out against competing rights, or the conscientious objector succeeds, but due to what I consider unsound judicial reasoning. In particular, cases involving cooperation in what the objector considers morally impermissible according to their beliefs have been wrongly understood by some American courts. I argue that a reasonable theory of cooperation incorporated into judicial thinking would enable more acceptable results that gave sufficient protection to conscientious objectors without risking a judicial backlash against objectors who wanted to take their freedoms too far. -/- I also venture into broader, more controversial waters concerning what I call freedom of dissociation – the fundamental right to withdraw from associating with people, groups, and activities. It is no more than the converse of freedom of association, which all free societies recognise as a basic right. How far should freedom of dissociation go? What might society be like if freedom of dissociation were given more protection in law than it currently has? It would certainly give freedom of religion and conscience a substantial foundation, but it could also lead to discriminatory behaviour to which many people would object. I explore some of these issues, before going back to the narrower area of freedom of conscience and religion in health care, making some proposals about how the law could strengthen these basic pillars of a liberal, free society. (shrink)

One way of increasing the supply of organs available for transplant would be to switch to an opt-out system of donor registration. This is typically assumed to operate on the basis of presumed consent, but this faces the objection that not all of those who fail to opt out would actually consent to the use of their cadaveric organs. This paper defuses this objection, arguing that people's actual, explicit or implicit, consent to use their organs is not needed. It borrows (...) David Estlund's notion of ‘normative consent’ from the justification of political authority and applies it to the case of organ donation. According to this idea, when it is wrong to withhold consent to something, the moral force of that lack of consent may be null and void. If it is wrong of a person to refuse to donate their cadaveric organs to others, then it may be that their actual consent is not needed. This supports an opt-out system, which provides protection for those who have genuine reasons to refuse donation, and spares the worries as to what the deceased would actually have wanted. (shrink)

In an effort to solve the shortage of transplantable organs, there have been several proposals to introduce an opt-out approach to deceased organ donation in England. In seeking to enact the so-called ‘opt-out proposal’ via an amendment to the Human Tissue Act 2004, The Organ Donation Bill 2017–19 represents the most recent attempt at such legal reform. Despite popular calls to the contrary, I argue in this paper that it would be premature for England, or, indeed, any country, to adopt (...) an opt-out approach at this time. Not only is the available evidence inconclusive on whether introduction of the opt-out proposal would increase the supply of transplantable organs, but there is also a chance that doing so might bring about an otherwise avoidable moral harm through an unjustified interference with individual autonomy. I maintain that the resources required to change the law to such effect would be better expended on alternative, provenly efficacious and less contentious mechanisms for increasing the supply of transplantable organs, such as: improving communication with the family of the deceased, developing infrastructure, raising public awareness and enhancing staff training, attitudes and understanding towards organ donation. (shrink)

Volume 25, Issue 3, September 2019, Page 283-286.

Utilising empirical ethics analysis, we evaluate the merits of systems proposed to increase deceased organ donation in South Africa. We conclude that SA should maintain its soft opt-in policy, and enhance it with ‘required transplant referral’ in order to maximise donor numbers within an ethically and legally acceptable framework. In SA, as is the case worldwide, the demand for donor organs far exceeds the supply thereof. Currently utilising a soft opt-in system, SA faces the challenge of how to increase donor (...) numbers in a context which is imbued with inequalities in access to healthcare, multiplicitous personal beliefs and practices, distrust of organ transplant and varying levels of education and health literacy. We argue that a hard opt-in, opt-out or mandated consent system would be problematic, and we present empirical data from Gauteng Province illustrating barriers to ethically sound practice in soft consent systems. Ultimately, we argue that in spite of some limitations, a soft opt-in system is most realistic for SA because its implementation does not require extensive public education campaigns at national level, and it does not threaten to further erode trust at a clinical level. However, to circumvent some of the clinical-level barriers identified in our empirical study, we propose a contextually sensitive option for “enabling” soft opt-in through “required transplant referral”. We argue that this system is legally defensible, enhances ethical practice and could also increase donor numbers as it has in many other countries. (shrink)

The General Data Protection Regulation (GDPR) was introduced in 2018 to harmonize data privacy and security laws across the European Union (EU). It applies to any organization collecting personal data in the EU. To date, service-level consent has been used as a proportionate approach for clinical trials, which implement low-risk, routine, service-wide interventions for which individual consent is considered inappropriate. In the context of public health research, GDPR now requires that individuals have the option to choose whether their data may (...) be used for research, which presents a challenge when consent has been given by the clinical service and not by individual service users. We report here on development of a pragmatic opt-out solution to this consent paradox in the context of a partner notification intervention trial in sexual health clinics in the UK. Our approach supports the individual’s right to withhold their data from trial analysis while routinely offering the same care to all patients. (shrink)

From all corners of the globe, the on-line revolution is proclaimed. The imperative is to connect; to shop, work, learn, be governed, even fall in love on-line. Government initiatives proliferate globally, stressing the urgency for citizens to become part of the so called Information Society. In the midst of all this euphoria the question must be raised 'Is this opportunity for all, or just a few?' Information and Communication Technologies are being introduced to the teaching and learning process at an (...) increasing pace. E-government ministers are particularly concerned about the 'have-nets' and 'have-nots' in this 'digital revolution'. Our research in schools and the HE sector, looking at women learning on-line, has indicated barriers. We discuss how gendered relations in the home, work and education go far beyond having access to IT. We illustrate how these relations contribute to the shaping of the gendered experiences of using technology in education. So whilst women are urged to get connected, we ask whether or not they will want to use technology as a tool to learn with. We suggest that the current gendered discourse surrounding technology and its use in all areas of society should inform government on-line learning policies globally, cutting through the euphoric hype. (shrink)

Significant differences in perceptions between teachers in primary and secondary grant-maintained schools are reported and analysed. Parents were more frequently involved in promoting opting-out in primary schools, primary teachers had more favourable attitudes to the grant-maintained school policy and, in primary schools, grant-maintained status delivered improvements in classroom conditions, most notably reduced class size and increased para-professional support in classrooms. The findings are discussed in terms of the management of primary schools, of theorising about reputation management in grant-maintained schools, and (...) of the explicit objectives of the grant-maintained policy. It is further suggested that the evidence provided about grant-maintained primary schools could be used to inject new life into a policy faltering in secondary schools. (shrink)

Significant differences in perceptions between teachers in primary and secondary grant-maintained schools are reported and analysed. Parents were more frequently involved in promoting opting-out in primary schools, primary teachers had more favourable attitudes to the grant-maintained school policy and, in primary schools, grant-maintained status delivered improvements in classroom conditions, most notably reduced class size and increased para-professional support in classrooms. The findings are discussed in terms of the management of primary schools, of theorising about reputation management in grant-maintained schools, and (...) of the explicit objectives of the grant-maintained policy. It is further suggested that the evidence provided about grant-maintained primary schools could be used to inject new life into a policy faltering in secondary schools. (shrink)

So far overlooked by the international business ethics literature, we introduce, characterize, and normatively analyze the use of affective ties and networks in South Korea from an ethical point of view. Whereas the ethics of using Guanxi in China has been comprehensively discussed, Korean informal networks remain difficult to manage for firms in South Korea due to the absence of existing academic debate and research in this field. In this study, we concentrate mainly on the question of whether foreign firms (...) will and can use affective ties in Korea. The informal social network forms are classified and contrasted with the conventional ethical approaches used in international business ethics to assess which categories can be regarded as ethical or unethical. Finally, foreign firms are advised how to cope with and use different affective network types. Although the nature of affective ties and networks in Korea differs from that found for instance in China, consistent with the conclusion of prior research, we recommend particularistic analysis and decision making regarding the circumstances in which to conclude affective ties and networks and when to opt out. We conclude that foreign firms in Korea should invest in establishing Inmaek, refrain from engaging in Yonjul, and support host country nationals’ Yongo ties. Moreover, it is suggested that foreign firms should find ways to monitor and manage informal ties effectively. (shrink)

This paper looks at the ethics of opt-in vs. opt-out of organ donation as Scotland has transitioned its systems to promote greater organ availability. We first analyse studies that compare the donation rates in other regions due to such a system switch and find that organ increase is inconclusive and modest at best. This is due to a lack of explicit opt-out choices resulting in greater resistance and family override unless there are infrastructures and greater awareness to support such change. (...) The paper then looks at the difference between informed consent of the opt-in vs. presumed consent in the opt-out approaches. Patient autonomy and dignity are better reflected with informed consent. Eighteen months have passed since the new organ donation policy has come into effect, this paper recommends more research into organ donors’ psychological motivations to help governments and the healthcare profession obtain more organs for transplantation. (shrink)

Mari Ruti offers a comprehensive overview of the current state of queer theory, including debates about affect theory, subjectivity, negativity, defiance, agency, and bad feelings. She gives an accessible yet theoretically rigorous account of the political divisions that have animated the field in the last decade. In particular, Ruti argues that contemporary efforts by queer theorists to grapple with negativity and bad feelings challenge our society's normative understanding of the good life and have the potential to transform ethical theory and (...) practice. (shrink)

This paper examines the influences on differential behaviors of multinational enterprises (MNEs) with respect to the adoption and implementation of voluntary codes of conduct in their host country operating environments. Both external institutional and internal leadership and organizational culture factors are offered as those conditions that are expected to predict the respective ability and willingness of firms to conduct their operations in socially responsible ways. A framework for furthering research in this area is developed.

La possibilité de transplantation d’organes a posé de nouveaux problèmes à l’éthique médicale aussi bien qu’à la médecine clinique. Deux systèmes tentent de résoudre l’un de ces problèmes, celui qui concerne l’approvisionnement en organes. Nombre d’États ont adopté le système « optin » qui cherche à répandre la conscience du problème et du choix personnel de l’individu de faire le don de ses organes. Un autre système, appelé « optout » ou « accord tacite », où tous les membres de (...) la société sont considérés comme donateurs potentiels, a été introduit dans certains pays. Dans ce système, les individus doivent indiquer explicitement qu’ils ne souhaitent pas donner leurs organes, faute de quoi ils sont considérés comme donateurs. En essayant de baser notre argumentaire sur les diverses justifications, nous soutenons que le système « optout » est plus juste, compte tenu du droit à l’accès aux soins médicaux nécessaires. Il devrait par conséquent être introduit à la place de « optin ». (shrink)

Die Möglichkeit zur Organtransplantation kreierte neue Probleme für die Medizinethik wie auch für die klinische Medizin. Eines davon, die Organbeschaffung, versucht man hauptsächlich mithilfe zweier Systeme anzugehen. Zahlreiche Staaten haben das ‚OptinSystem’ angenommen, das die Bewusstseinserhöhung sowie Selbstentscheidung der Einzelnen zur Organspende anzielt. Das andere System, das ‚Optout’ bzw. die ‚angenommene Zustimmung’, das sämtliche Gesellschaftsmitglieder als potenzielle Organspender ansieht, wurde von einigen Staaten übernommen. In diesem System sollen Einzelne ausdrücklich erklären, sie wollen keine Organe spenden, anderenfalls werden sie für Organspender (...) gehalten. Indem wir unser Argument auf unterschiedliche Rechtfertigungen zu gründen suchen, behaupten wir, das OptoutSystem zur Organbeschaffung sei eine gerechtere Option in puncto Recht auf Zugang zur notwendigen Gesundheitsfürsorge, und demzufolge solle es anstelle des Optin implementiert werden. (shrink)

The possibility of organ transplantation has created new problems for medical ethics as well as clinical medicine. One of them, organ procurement, is tried to be solved mainly by two systems. Many countries have adopted the ‘optin system’, which aims to raise awareness and make the individuals donate their organs by their own will. The other system, ‘optout’ or ‘presumed consent’, which considers all members of society as potential donors, was adopted by some countries. In this system, individuals should state (...) that they do not wish to donate their organs; otherwise they are considered as donors. By trying to ground our argument with various justifications, we claim that optout system for organ procurement is a fairer option regarding the right to access to healthcare needed, and therefore it should be implemented instead of optin. (shrink)

Mogućnost transplantacije organa je otvorila nove probleme kako u medicinskoj etici tako i u kliničkoj medicini. Jedan od njih, pribavljanje organa, pokušava se riješiti uglavnom pomoću dva sustava. Mnoge države su prihvatile ‘optin’ sustav, koji teži širenju svijesti o problemu i vlastitom izboru pojedinca da donira svoje organe. Drugi sustav, ‘optout’ ili ‘pretpostavljeni pristanak’, u kojem se svi članovi društva smatraju potencijalnim donorima, uveden je u nekolicini zemalja. U tom sustavu, pojedinci trebaju izričito navesti da ne žele donirati svoje organe; (...) u suprotnom se smatraju donorima. U pokušaju utemeljenja našeg argumenta na različitim opravdanjima, tvrdimo da je ‘optout’ sustav pribavljanja organa pravednija opcija, uzimajući u obzir pravo na pristup potrebnoj zdravstvenoj skrbi, te bi stoga treba biti uveden umjesto ‘optin’ sustava. (shrink)

The Knowledge Norm of Assertion claims that it is proper to assert that p only if one knows that p. Though supported by a wide range of evidence, it appears to generate incorrect verdicts when applied to utterances of “I don't know.” Instead of being an objection to KNA, I argue that this linguistic data shows that “I don't know” does not standardly function as a literal assertion about one's epistemic status; rather, it is an indirect speech act that has (...) the primary illocutionary force of opting out of the speaker's conversational responsibilities. This explanation both reveals that the opt-out is an under-appreciated type of illocutionary act with a wide range of applications, and shows that the initial data in fact supports KNA over its rivals. (shrink)

Background and purpose Changes to deceased organ donation policy in the USA, including opt-out and priority systems, have been proposed to increase registration and donation rates. To study attitudes towards such policies, we surveyed healthcare students to assess support for opt-out and priority systems and reasons for support or opposition. Methods We investigated associations with supporting opt-out, including organ donation knowledge, altruism, trust in the healthcare system, prioritising autonomy and participants’ evaluation of the moral severity of incorrectly assuming consent in (...) opt-in systems or opt-out systems, by conducting an online survey among healthcare students at a large academic institution. Results Of 523 respondents, 86% supported opt-out, including 53% who strongly supported the policy. The most popular reason for supporting opt-out was the potential for increased donation rates, followed by convenience for those not registered but willing to donate. The most popular reason for opposing opt-out was the belief that presuming consent is morally wrong. Those strongly supporting opt-out viewed the opt-in error as more morally unacceptable, and had higher knowledge and altruism scores. Those opposing opt-out viewed the opt-out error as more unacceptable, and had higher autonomy scores. 48% of respondents supported priority within opt-in systems; 31% supported priority in opt-out. Conclusions There is strong support for opt-out organ donation among healthcare students, influenced by both practical and moral considerations. (shrink)

The authors of the feature article argue against implied consent in all episiotomy cases, but allow that opt-out consent might be appropriate in limited circumstances.1 However, they do not indicate how clinicians should assess whether the pregnant person is capable of consenting in this way during an obstetric emergency. This commentary will focus on how capacity should be determined during these circumstances, suggest next steps for clinicians if capacity is deemed uncertain or absent, and discuss the appropriate role for opt-out (...) consent in labour. Previous studies investigating the extent to which pregnant persons retain decision-making capacity during labour have shown poor recall, a component of capacity, about consent processes during obstetric emergency procedures in 14%–49% of cases.1 2 As the feature article acknowledges, this does not mean that pregnant persons should be assumed to lack decision-making capacity during labour. Although pain, labour intensity, exhaustion and medications can make consenting processes during labour more difficult and it is possible that these factors will result in the impaired ability of the pregnant person to make informed and voluntary decisions about treatment options, this possibility of impaired capacity should not be taken as the expected outcome nor should it be used as an excuse to skip consenting procedures.1 2 The default to treat labouring patients as able to make their own decisions still stands, although signs that a person lacks …. (shrink)

Volume 19, Issue 5, May 2019, Page 80-81.

Objectives To increase postmortem organ donation rates, several countries are adopting an opt-out (presumed consent) policy, meaning that individuals are deemed donors unless they expressly refused so. Although opt-out countries tend to have higher donation rates, there is no conclusive evidence that this is caused by the policy itself. The main objective of this study is to better assess the direct impact of consent policy defaults per se on deceased organ recovery rates when considering the role of the family in (...) the decision-making process. This study does not take into account any indirect effects of defaults, such as potential psychological and behavioural effects on individuals and their relatives. -/- Design Based on previous work regarding consent policies, we created a conceptual model of the decision-making process for deceased organ recovery that included any scenario that could be directly influenced by opt-in or opt-out policies. We then applied this model to internationally published data of the consent process to determine how frequently policy defaults could apply. -/- Main outcome measures We measure the direct impact that opt-in and opt-out policies have per se on deceased organ recovery. -/- Results Our analysis shows that opt-in and opt-out have strictly identical outcomes in eight out of nine situations. They only differ when neither the deceased nor the family have expressed a preference and defaults therefore apply. The direct impact of consent policy defaults is typically circumscribed to a range of 0%–5% of all opportunities for organ recovery. Our study also shows that the intervention of the family improves organ retrieval under opt-in but hinders it under opt-out. -/- Conclusions This study may warn policy makers that, by emphasising the need to introduce presumed consent to increase organ recovery rates, they might be overestimating the influence of the default and underestimating the power granted to families. (shrink)

Introduction No consent for health and medical research is appropriate when the criteria for a waiver of consent are met, yet some ethics committees and data custodians still require informed consent. Methods A single-blind parallel-group randomised controlled trial: 1129 families of children born at a South Australian hospital were sent information explaining data linkage of childhood immunisation and hospital records for vaccine safety surveillance with 4 weeks to opt in or opt out by reply form, telephone or email. A subsequent (...) telephone interview gauged the intent of 1026 parents (91%) in relation to their actions and the sociodemographic differences between participants and non-participants in each arm. Results The participation rate was 21% (n=120/564) in the opt-in arm and 96% (n=540/565) in the opt-out arm (χ2 (1 df) = 567.7, p<0.001). Participants in the opt-in arm were more likely than non-participants to be older, married/de facto, university educated and of higher socioeconomic status. Participants in the opt-out arm were similar to non-participants, except men were more likely to opt out. Substantial proportions did not receive, understand or properly consider study invitations, and opting in or opting out behaviour was often at odds with parents' stated underlying intentions. Conclusions The opt-in approach resulted in low participation and a biased sample that would render any subsequent data linkage unfeasible, while the opt-out approach achieved high participation and a representative sample. The waiver of consent afforded under current privacy regulations for data linkage studies meeting all appropriate criteria should be granted by ethics committees, and supported by data custodians. Trial registration number Australian New Zealand Clinical Trials Registry ACTRN12610000332022. (shrink)