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)

The diagnosis of HIV infection is the point of entry for treatment and prevention services, yet many infected persons in both developed and developing countries remain undiagnosed. To reduce the number of undiagnosed infections, a variety of expanded testing policies have been recommended, including opt-out testing. This testing model assumes that in populations of increased HIV prevalence, voluntary testing should be offered to all patients seen in healthcare settings and performed unless patients specifically decline. While this (...) approach raises ethical issues concerning “voluntariness”, access to care, and stigma, the potential benefits of opt-out testing far outweigh its potential adverse effects. (shrink)

« La fin du SIDA » prévue en 2030 par le plan 90-90-90 de l’ONUSIDA est-elle possible au Québec? L’offre universelle proportionnée et systématique de dépistage avec consentement opt-out (consentement présumé) apparait comme la politique sanitaire la plus pertinente et équitable à mettre en place en vue d’identifier les personnes vivant avec le VIH ignorant leur statut sérologique. Cette démarche à première vue contraignante vis-à-vis des libertés individuelles peut être largement compensée par des bénéfices sanitaires, sociaux, économiques et structurels à (...) l’échelle individuelle et populationnelle. Dans la mesure où le VIH/SIDA reste un révélateur puissant des inégalités sociales, cette approche ne sera prolifique qu’en présence d’une ambition politique d’amélioration de l’accès aux soins et de couverture sanitaire universelle et inclusive à l’égard des individus échappant au dépistage. L’approche opt-out au sein des groupes à forte prévalence est une stratégie éthiquement pertinente pour augmenter les taux de dépistage. Bien que le consentement n’y soit pas explicite, la présomption tiendrait compte de « l’injustice structurelle » auxquels les groupes clés – présentant de forts taux de prévalence – sont soumis initialement. Cette dernière est responsable de leurs difficultés d’accès aux soins et aux dépistages. Cet article propose d’uniformiser l’offre de dépistage. Le Comité des Infections Transmissibles Sexuellement et par le Sang du Québec recommande actuellement l’approche opt-in pour les groupes-clés et le consentement opt-out en population générale. Nous pensons que cette différenciation constitue une barrière dans l’accès au dépistage et produit un effet d’éviction des groupes-clés craignant la stigmatisation. (shrink)

BackgroundPrevention of mother to child transmission of HIV remains a key public health priority in most developing countries. The provider Initiated Opt – Out Prenatal HIV Screening Approach, recommended by the World Health Organization lately has been adopted and translated into policy in most Sub – Saharan African countries. To better ascertain the ethical reasons for or against the use of this approach, we carried out a literature review of the ethics literature.MethodsPapers published in English and French Languages between 1990 (...) and 2015 from the following data bases were searched: Pubmed, Cochrane literature, Embase, Cinhal, Web of Science and Google Scholar. After screening from 302 identified relevant articles, 21 articles were retained for the critical review.DiscussionMost authors considered this approach ethically justifiable due to its potential benefits to the mother, foetus and society. The breaching of respect for autonomy was considered acceptable on the grounds of libertarian paternalism. Most authors considered the Opt - Out approach to be less stigmatizing than the Opt - In. The main arguments against the Opt - Out approach were: non respect of patient autonomy, informed consent becoming a meaningless concept and the HIV test becoming compulsory, risk of losing trust in health care providers, neglect of social and psychological implications of doing an HIV test, risk of aggravation of stigma if all tested patients are not properly cared for and neglect of sociocultural peculiarities.ConclusionsThe Opt – Out approach could be counterproductive in case gender sensitive issues within the various sociocultural representations are neglected, and actions to offer holistic care to all women who shall potentially test positive for HIV were not effectively ascertained. The Provider Initiated Opt – Out Prenatal HIV Screening option remains ethically acceptable, but deserves caution, active monitoring and evaluation within the translation of this approach into to practice. (shrink)

Brain death certification can be a clinically and ethically challenging affair. Healthcare workers are expected to refer patients for brain death certification to identify potential organ donors, but family members may be ill-prepared for this turn of events. Already distraught families may not appreciate delays in brain death certification, but such delays are common because of the need to manage the patient’s altered physiological state to allow testing. Opportunities for donation are sometimes lost because of the unnecessary delay. With (...) focus on an opt-out organ donation law, we discuss causes of delays in brain death certification, and the ethical issues faced by clinicians in using tests to certify patients. To resolve the issues, we argue for the use of supplementary confirmatory tests as part of a more protocol-driven approach to brain death certification to avoid delays. Such tests should be regarded as part of the donation process funded by the state. (shrink)

An Institute of Medical Ethics working party supports the view that explicit permission should normally be sought in the case of testing for HIV antibody. It discusses this in relation to anonymised HIV testing for epidemiological purposes, concluding that this is to be welcomed, given certain safeguards. It next argues that pregnant women may have a greater and more immediate need than others to know their HIV status. It concludes that this need does not justify testing them (...) without their permission, but can be met by voluntary diagnostic testing on an 'opting-out' basis, supported by adequate briefing. (shrink)

Recent global advances in available technology to prevent mother-to-child HIV transmission necessitate a rethinking of contemporary and previous ethical debates on HIV testing as a means to preventing vertical transmission. In this paper, we will provide an ethical analysis of HIV-testing strategies of pregnant women. First, we argue that provider-initiated opt-out HIV testing seems to be the most effective HIV test strategy. The flip-side of an opt-out strategy is that it may end up as involuntary testing (...) in a clinical setting. We analyse this ethical puzzle from a novel perspective, taking into account the moral importance of certain hypothetical preferences of the child, as well as the moral importance of certain actual preferences of the mother. Finally, we balance the conflicting concerns and try to arrive at an ethically sound solution to this dilemma. Our aim is to introduce a novel perspective from which to analyse testing strategies, and to explore the implications and possible benefits of our proposal. The conclusion from our analysis is that policies that recommend provider-initiated opt-out HIV testing of pregnant mothers, with a risk of becoming involuntary testing in a clinical setting, are acceptable. The rationale behind this is that the increased availability of very effective and inexpensive life-saving drugs makes the ethical problems raised by the possible intrusiveness of HIV testing less important than the child's hypothetical preferences to be born healthy. Health care providers, therefore, have a duty to offer both opt-out HIV testing and available PMTCT (preventing mother-to-child transmission) interventions. (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)

Since testing for HIV infection became possible in 1985, testing of pregnant women has been conducted primarily on a voluntary, ‘opt-in’ basis. Faden, Geller and Powers, Bayer, Wilfert, and McKenna, among others, have suggested that with the development of more reliable testing and more effective therapy to reduce maternal-fetal transmission, testing should become either routine with ‘opt-out’ provisions or mandatory. We ask, in the light of the new rapid tests for HIV, such as OraQuick, and the (...) development of antiretroviral treatment that can reduce maternal-fetal transmission rates to <2%, whether that time is now. Illustrating our argument with cases from the United States (US), Kenya, Peru, and an undocumented Mexican worker in the US, we show that when testing is accompanied by assured multi-drug therapy for the mother, the argument for opt-out or mandatory testing for HIV in pregnancy is strong, but that it is problematic where testing is accompanied by adverse events such as spousal abuse or by inadequate intrapartum or follow-up treatment. The difference is not a ‘double standard’, but reflects the presence of conflicts between the health interests of the mother and the fetus – conflicts that would be abrogated by the assurance of adequate, continuing multi-drug therapy. In light of these conflicts, where they still occur, careful processes of informed consent are appropriate, rather than opt-out or mandatory testing. (shrink)

When in 2006 the Centers for Disease Control and Prevention issued revised recommendations for HIV testing in health care settings, vocal opponents charged that use of an ?opt-out? approach to presenting HIV testing to patients; the implementation of nontargeted, widespread HIV screening; the elimination of a separate signed consent; and the decoupling of required HIV prevention counseling from HIV testing are unethical. Here we undertake the first systematic ethical examination of the arguments both for and against the (...) recommendations. Our examination reveals that the ethical concerns raised by the critics predominately pertain not to ethically suspect elements of the recommendations themselves, but to suspicions that they will be implemented improperly. It has not been shown that the recommendations cannot be implemented properly. Here we show that in the United States the recommendations are morally justifiable and that safeguards or regulatory oversight may serve to ensure that the recommendations are properly implemented. (shrink)

Developing ethical standards for clinical use of large-scale genome and exome sequencing has proven challenging, in part due to the inevitability of incidental or secondary findings. Policy of the American College of Medical Genetics and Genomics has evolved but remains problematic. In 2013, ACMG issued policy recommending mandatory analysis of 56 extra genes whenever sequencing was ordered for any indication, in order to ascertain positive findings in pathogenic and actionable genes. Widespread objection yielded a 2014 amendment allowing patients to opt-out (...) from analysis of the extra genes. In 2015, ACMG published the amended policy, providing that patients could opt out of the full set of extra genes, but not a subset. In 2016, ACMG enlarged the set and indicated planned expansion of the roster of extra genes to include pharmacogenetic findings. ACMG policy does not protect the respect for patient choice that prevails in other domains of clinical medicine, where informed consent allows patients to opt in to desired testing. By creating an expanding domain of genomic testing that will be routinely conducted unless patients reject the entire set of extra tests, ACMG creates an exceptional domain clinical practice that is not supported by ethics or science. (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)

Despite decades of prevention efforts, millions of persons worldwide continue to become infected by the human immunodeficiency virus (HIV) every year. This urgent problem of global epidemic control has recently lead to significant changes in HIV testing policies. Provider-initiated approaches to HIV testing have been embraced by the Centers for Disease Control and Prevention and the World Health Organization, such as those that routinely inform persons that they will be tested for HIV unless they explicitly refuse ('opt out'). (...) While these policies appear to increase uptake of testing, they raise a number of ethical concerns that have been debated in journals and at international AIDS conferences. However, one special form of 'provider-initiated' testing is being practiced and promoted in various parts of the world, and has advocates within international health agencies, but has received little attention in the bioethical literature: mandatory premarital HIV testing. This article analyses some of the key ethical issues related to mandatory premarital HIV testing in resource-poor settings with generalized HIV epidemics. We will first briefly mention some mandatory HIV premarital testing proposals, policies and practices worldwide, and offer a number of conceptual and factual distinctions to help distinguish different types of mandatory testing policies. Using premarital testing in Goma (Democratic Republic of Congo) as a point of departure, we will use influential public health ethics principles to evaluate different forms of mandatory testing. We conclude by making concrete recommendations concerning the place of mandatory premarital testing in the struggle against HIV/AIDS. (shrink)

While abortion has been legal in most developed countries for many years, the topic remains controversial. A major area of controversy concerns women’s rights vis-a-vis the rights of health professionals to opt out of providing the service on conscience grounds. Although scholars from various disciplines have addressed this issue in the literature, there is a lack of empirical research on the topic. This paper provides a documentary analysis of three examples of conscientious objection on religious grounds to performing abortion-related care (...) by midwives in different Member States of the European Union, two of which have resulted in legal action. These examples show that as well as the laws of the respective countries and the European Union, professional and church law each played a part in the decisions made. However, support from both professional and religious sources was inconsistent both within and between the examples. The authors conclude that there is a need for clear guidelines at both local and pan-European level for health professionals and recommend a European-wide forum to develop and test them. (shrink)

The combination of the issue of return of individual genetic results/incidental findings and paediatric biobanks is not much discussed in ethical literature. The traditional arguments pro and con return of such findings focus on principles such as respect for persons, autonomy and solidarity. Two dimensions have been distilled from the discussion on return of individual results in a genetic research context: the respect for a participant’s autonomy and the duty of the researcher. Concepts such as autonomy and solidarity do not (...) fit easily in the discussion when paediatric biobanks are concerned. Although parents may be allowed to enrol children in minimal risk genetic research on stored tissue samples, they should not be given the option to opt out of receiving important health information. Also, children have a right to an open future: parents do not have the right to access any genetic data that a biobank holds on their children. In this respect, the guidelines on genetic testing of minors are applicable. With regard to the duty of the researcher the question of whether researchers have a more stringent duty to return important health information when their research subjects are children is more difficult to answer. A researcher’s primary duty is to perform useful research, a policy to return individual results must not hamper this task. The fact that vulnerable children are concerned, is an additional factor that should be considered when a policy of returning results is laid down for a specific collection or research project. (shrink)

Background: In 2006, the Centers for Disease Control and Prevention (CDC) recommended three changes to HIV testing methods in US healthcare settings: (1) an opt-out approach, (2) removal of separate signed consent, and (3) optional HIV prevention counseling. These recommendations led to a public debate about their moral acceptability. Methods: We interviewed 25 members from the fields of US HIV advocacy, care, policy, and research about the ethical merits and demerits of the three changes to HIV testing methods. (...) We performed a qualitative analysis of the participant responses in the interviews and summarized the major themes. Results: In general, arguments in favor of the methods were based upon their ultimate contribution to increasing HIV testing and permitting the consequent benefits of identifying those who are HIV infected and linking them to further care. Conclusions: The prevailing theme of ethical concern focused on suspicions that the methods might not be properly implemented, and that further safeguards might be needed. (shrink)

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

Incidental findings and secondary findings, being results that are unrelated to the diagnostic question, are the subject of an important debate in the practice of clinical genomic medicine. Arguments for reporting these results or not doing so typically relate to the principles of autonomy, non-maleficence and beneficence. However, these principles frequently conflict and are insufficient by themselves to come to a conclusion. This study investigates empirically how ethical principles are considered when actually reporting IFs or SFs and how value conflicts (...) are weighed. A qualitative focus group study has been undertaken, including a multidisciplinary group of professionals from Belgian centres for medical genetics. The data were analysed thematically. All eight Belgian centres participated in this study. Ethical values were frequently referred to for disclosure policies on IFs and SFs. Participants invoked respect for patient autonomy to support the disclosure of IFs and opt-out options for IFs and SFs, non-maleficence for the professional delineation of reportable IFs and opt-out options for IFs and SFs and beneficence for the mandatory reporting of actionable IFs, the delineation of reportable IFs and a current decline of actively pursued SFs. Professional assumptions about patients’ genetic literacy were an important factor in the weighing of values. In line with the traditional bioethical discourse, the mandatory reporting of actionable IFs might be interpreted as a “technological, soft paternalism”. Restricting patients’ choices might be acceptable, but then its motives should be valid and its beneficent outcomes highly plausible. Hence, the presuppositions of technological, soft paternalism - patients’ inability to make informed decisions, normative rationality, the efficacy of beneficent outcomes and the delineated spectrum of beneficence - should be approached critically. Moreover, distributive justice should be considered an important value in the delineation of the current scope of the ethical debate on IFs and SFs. This study of guiding values may stimulate the debate on the ethical grounds for a solid policy on IFs and SFs internationally. (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)

Background: The delivery of public health policies may be in conflict with individualism. Objectives: To propose measures to ethically provide routine HIV testing services to persons visiting a funeral home. Research design: A document analysis of study documents and presentations made to an institutional review board. Participants and research context: Institutional review board members (both lay and professionals) and Study investigators attending an `open session' where study investigators were invited to elaborate on some study procedures. Ethical considerations: Identities of (...) all parties were anonymized. Findings: Opt-out approaches to HIV testing, grief counseling, relational ethics, and a modular consenting process were proposed to safeguard clients' autonomy. The golden-rule approach and protective empowering were suggested to protect clientele beneficence. Discussion and conclusion: It is possible to ethically provide universal HIV testing and counseling services among grieving populations in this setting; elsewhere, this should be contextualized. (shrink)

The application of genetic technologies in China, especially in the area of prenatal genetic testing, is rapidly increasing in China. In the wealthy regions of China, prenatal genetic testing is already very widely adopted. We argue that the government should actively promote prenatal genetic testing to the poor areas of the country. In fact, the government should prioritize resources first to make prenatal genetic testing a standard routine care with an opt-out model in these area. Healthcare (...) professions would be required to inform pregnant women about the availability of genetic testing and provide free testing on a routine basis unless the parents choose not to do so. We argue that this proposal will allow parents to make a more informed decision about their reproductive choices. Secondarily, this proposal will attract more healthcare professionals and other healthcare resources to improve the healthcare infrastructures in the less-developed regions of the country. This will help to reduce the inequity of accessing healthcare services between in different regions of China. We further argue that this policy proposal is not practicing eugenics. (shrink)

Discrepancies between the Uniform Determination of Death Act (UDDA) and the adult and pediatric diagnostic guidelines for brain death (BD) (the “Guidelines”) have motivated proposals to revise the UDDA. A revision proposed by Lewis, Bonnie and Pope (the RUDDA), has received particular attention, the three novelties of which would be: (1) to specify the Guidelines as the legally recognized “medical standard,” (2) to exclude hypothalamic function from the category of “brain function,” and (3) to authorize physicians to conduct an apnea (...) test without consent and even over a proxy’s objection. One hundred seven experts in medicine, bioethics, philosophy, and law, spanning a wide variety of perspectives, have come together in agreement that while the UDDA needs revision, the RUDDA is not the way to do it. Specifically, (1) the Guidelines have a non-negligible risk of false-positive error, (2) hypothalamic function is more relevant to the organism as a whole than any brainstem reflex, and (3) the apnea test carries a risk of precipitating BD in a non-BD patient, provides no benefit to the patient, does not reliably accomplish its intended purpose, and is not even absolutely necessary for diagnosing BD according to the internal logic of the Guidelines; it should at the very least require informed consent, as do many procedures that are much more beneficial and less risky. Finally, objections to a neurologic criterion of death are not based only on religious belief or ignorance. People have a right to not have a concept of death that experts vigorously debate imposed upon them against their judgment and conscience; any revision of the UDDA should therefore contain an opt-out clause for those who accept only a circulatory-respiratory criterion. (shrink)

The aim of this study was to assess the attitudes of Turkish pregnant women and antenatal health care providers towards prenatal HIV testing. A self-administered questionnaire was used. The relationships between the different groups' knowledge and attitudes were analysed by using the chi-squared statistic. A total of 494 pregnant women and 181 care providers participated. Forty-four per cent of the pregnant women thought that prenatal HIV testing should be mandatory, and 84% of the health care providers thought it (...) should be performed routinely or be mandatory. The majority of the pregnant women (74%) and half of the care providers agreed that the test results should be disclosed first to the pregnant woman. The study results also revealed that most of the prenatal care providers would not protect pregnant women's autonomy and privacy, contrary to the pregnant women's own preferences. It is essential to establish national prenatal HIV testing policies in order to prevent unethical practices and ensure satisfaction for pregnant women and health care providers. (shrink)

One new development in the ongoing creationism/ evolution controversy has been the proposal to institute optout policies that would allow creationist parents to exempt their children from any instruction involving evolution. By way of an explanation of some of the philosophical issues at play in the debate over evolution and the nature of science, this article shows the educational folly of such policies. If evolution is taught properly, it should not be possible to opt out of it without opting (...) out of biology. Moreover, if Intelligent Design creationist criticisms of evolution and scientific naturalism were taken as the basis for opting out, then the effect would be even more radical and would require opting out of science entirely. (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)

Mass vaccination has been a successful public health strategy for many contagious diseases. The immunity of the vaccinated also protects others who cannot be safely or effectively vaccinated—including infants and the immunosuppressed. When vaccination rates fall, diseases like measles can rapidly resurge in a population. Those who cannot be vaccinated for medical reasons are at the highest risk of severe disease and death. They thus may bear the burden of others' freedom to opt out of vaccination. It is often asked (...) whether it is legitimate for states to adopt and enforce mandatory universal vaccination. Yet this neglects a related question: are those who opt out, where it is permitted, morally responsible when others are harmed or die as a result of their decision? In this article, we argue that individuals who opt out of vaccination are morally responsible for resultant harms to others. Using measles as our main example, we demonstrate the ways in which opting out of vaccination can result in a significant risk of harm and death to others, especially infants and the immunosuppressed. We argue that imposing these risks without good justification is blameworthy and examine ways of reaching a coherent understanding of individual moral responsibility for harms in the context of the collective action required for disease transmission. Finally, we consider several objections to this view, provide counterarguments and suggest morally permissible alternatives to mandatory universal vaccination including controlled infection, self-imposed social isolation and financial penalties for refusal to vaccinate. (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)

The clinical relevance of whole-exome sequencing is unquestionable. In the prenatal setting, the standard testing process of reflexing from karyotype to microarray to single-gene disorders may take several weeks, leaving a family in prolonged turmoil and often without answers in time to make a decision about the pregnancy. WES provides a powerful amount of data more quickly and with a higher yield of diagnostic results, allowing a timelier plan for medical management and decision-making. However, while results that pertain specifically (...) to the testing indication can be isolated, the potential for incidental findings or results that are unrelated to the original testing indication is significant. In 2013, ACMG published recommendations for reporting incidental or secondary findings, providing a list of 57 clinically actionable genes for which reporting should be obligatory. These recommendations were updated in 2015 to include the option to opt out of receiving all secondary findings. The list includes childhood-onset conditions, for which medical management would be immediately impacted. However, the list also includes adult-onset conditions such as hereditary breast and ovarian cancer and Lynch syndrome. Historically, decisions regarding genetic testing for these conditions have been left up to the individual until they reach the age of consent. While the 2015 recommendations are an improvement over the 2013 recommendations insofar as they allow an option to opt out of receiving secondary findings, the recommendations continue to have potentially troubling ethical consequences. (shrink)

Despite strong evidence that autonomy enhances motivation and achievement, few interventions for promoting student autonomy in higher education have been developed and empirically tested. Here, we demonstrate how two autonomy-supportive policies effectively increase classroom attendance and subject mastery. First, in a randomized controlled field study, we explored the effect of allowing students to choose whether to make their attendance mandatory (i.e., a component of their course grades). We found that nearly all students used the opportunity as a pre-commitment device and (...) were subsequently more likely to attend class than were students whose attendance had been mandated. Second, in a multi-year cohort study, we explored the effect of allowing students to opt out of a challenging, high-effort assessment stream, finding that students given greater autonomy invested more effort into their assignments and attained greater proficiency with the material. We discuss other opportunities for applying choice architecture to improve learning, motivation, and well-being in higher education. (shrink)

In this short comment on Just, Reasonable Multiculturalism, I concentrate on the permissible extent of interference by a liberal state in a community within that state when such interference aims to protect individuals within that community from it. He and I both value individuals and want them protected, of course. This shared value, however, leads us to different conclusions. On any liberal view, individuals must be allowed to act as they wish subject only to specific sorts of justified limitations. In (...) the mainstream approach that Cohen-Almagor accepts, these will include limitations necessary to not merely protect but also to promote autonomy. On my own view, by contrast, it is protection alone that justifies interference. I thus spell out Cohen-Almagor’s view about the need for interference with non-liberal groups within a liberal state and indicate my disagreement. (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 chapter provides an analysis of the long process of introducing an electronic identity for online authentication in Germany. This process is described as a multi-facet innovation, involving actors from different policy fields shifting over time. The eID process started in the late ‘90s in the context of eGovernment and eCommerce with the legislation on e-signatures, which were supposed to allow for online authentication of citizens. When after 5 years it was recognized that this was not the case, a new (...) digital ID card, which had meanwhile been announced, was chosen as token for the eID. This process was dominated by the concerns for visual inspection and border control, including the storage of digital fingerprints. Under the leadership of the Ministry of the Interior (BMI) and technical guidance of the Federal Agency for Information Security (BSI), technical specifications have to a large extent been adopted from the electronic passport, which had been smoothly introduced 2 years before. However, in the legislative process some concern regarding digital fingerprints on the eID card was raised and led to an opt-in solution. In 2009, a bill on the new ID card was passed which regulates the eID function for online authentication as well. This is characterized as a radical innovation by introducing a double-sided, mutual authentication of the citizen and the service provider and implementing the principle of proportionality regarding the access of service providers to data on the chip. At the time of writing, field tests are conducted. Roll-out of the new eID card is to start in November 2010. Therefore no figures about adoption can be provided here. (shrink)

BackgroundIn the context of translational research, researchers have increasingly been using biological samples and data in fundamental research phases. To explore informed consent practices, we conducted a retrospective study on informed consent documents that were used for CARPEM’s translational research programs. This review focused on detailing their form, their informational content, and the adequacy of these documents with the international ethical principles and participants’ rights.MethodsInformed consent forms (ICFs) were collected from CARPEM investigators. A content analysis focused on information related to (...) biological samples and data treatment (context of sampling and collect, aims, reuse, consent renewal), including the type of consent. An automatic assessment of the readability of the ICFs were performed with the IT program “Flesch Score”.Results29 ICFs from 25 of 49 studies were analyzed after selection criteria were applied. Three types of consent were identified: 11 broad consents, six specific consents, and two opt-out consents. The Flesch Scores showed that most of the documents were too complex to be fully understood by most of the potential research participants. Most of the biological samples were collected during the healthcare routine, but the information content about secondary use of biological samples varied between ICFs. All documents mentioned personal data treatment but information about their reuse was not standardized in the ICFs.ConclusionsOur review of current IC procedures of CARPEM showed that practices could be improved considering new translational research methods. “Old fashion written ICFs” should be adapted to the translational research approach, to better respect individual rights and international research ethics principles. In this context, theoretically, a digital tool allowing dynamic information and consent of participants, through an electronic interactive platform may be a good way to promote more active participation in research. Nevertheless, its feasibility in the complex environment of biological samples and data research remains to prove. The way of a combination of a broad consent followed by dynamic information may be alternatively tested. (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)

The HealthyFood program offers members up to 25% cash back monthly on healthy food purchases. In this randomized controlled trial, we tested the efficacy of financial incentives combined with text messages in increasing healthy food purchases among HF members. Members receiving the lowest cash back level were randomized to one of six arms: Arm 1 : 10% cash back, no weekly text, standard monthly text; Arm 2: 10% cash back, generic weekly text, standard monthly text; Arm 3: 10% cash back, (...) personalized weekly text, standard monthly text; Arm 4: 25% cash back, personalized weekly text, standard monthly text; Arm 5: 10 + 15%NET cash back, personalized weekly text, standard monthly text; and, Arm 6: 10 + 15%NET cash back, personalized weekly text, unbundled monthly text. In the 10 + 15%NET cash back, the cash back amount was the baseline 10% plus 15% of the net difference between healthy and unhealthy spending. The generic text included information on HF and healthy eating, while the personalized text had individualized feedback on purchases. The standard monthly text contained the cash back amount. The unbundled monthly text included the amount lost due to unhealthy purchases. The primary outcome was the average monthly percent healthy food spending. Secondary outcomes were the percent unhealthy food spending, and the percent healthy and unhealthy food items. Of the members contacted, 20 opted out, and 2841 met all inclusion criteria. There were no between-arm differences in the examined outcomes. The largest mean difference in percent healthy spending was between Arm 1 and Arm 2, and the largest mean difference in percent unhealthy spending was also between Arm 1 and Arm 2, but no differences were statistically significant after correction for multiple comparisons. None of the tested financial incentive structures or text strategies differentially affected food purchasing. Notably, more than doubling the cash back amount and introducing a financial disincentive for unhealthy purchases did not affect purchasing. These findings speak to the difficulty of changing shopping habits and to the need for innovative strategies to shift complex health behaviors. NCT02486588 Increasing Engagement with a Healthy Food Benefit. The trial was prospectively registered on July 1, 2015. (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)

Objective To determine whether presenting delivery room management options as defaults influences decisions to resuscitate extremely premature infants. Materials and methods Adult volunteers recruited from the world wide web were randomised to receive either resuscitation or comfort care as the delivery room management default option for a hypothetical delivery of a 23-week gestation infant. Participants were required to check a box to opt out of the default. The primary outcome measure was the proportion of respondents electing resuscitation. Data were analysed (...) using χ2 tests and multivariate logistic regression. Results Participants who were told the delivery room management default option was resuscitation were more likely to opt for resuscitation (OR 6.54 95% CI 3.85 to 11.11, p<0.001). This effect persisted on multivariate regression analysis (OR 7.00, 95% CI 3.97 to 12.36, p<0.001). Female gender, being married or in a committed relationship, being highly religious, experiences with prematurity, and favouring sanctity of life were significantly associated with decisions to resuscitate. Discussion Presenting delivery room options for extremely premature infants as defaults exert a significant effect on decision makers. The information structure of the choice task may act as a subtle form of manipulation. Further, this effect may operate in ways that a decision maker is not aware of and this raises questions of patient autonomy. Conclusion Presenting delivery room options for extremely premature infants as defaults may compromise autonomous decision-making. (shrink)

Socially responsible investments (SRI) suffer from a lack of investments from individual investors, despite their positive attitudes toward SRI. This attitude–behavior gap is a serious issue, as SRI is often perceived as a way to promote sustainable development. We investigate nudges, especially the default option, as a way to encourage SRI. In a pre-registered study conducted in October 2021 with 1050 US investors, we pit four nudges against one another to encourage individual investors to invest in SRI. All nudges significantly (...) increased investment in SRI compared with the control group. Making SRI the default option with frictions to opt-out is the most efficient intervention. This is closely followed by a default option without friction to opt out and option partitioning, which are not significantly different from each other. Precommitment, although statistically significant, has a modest effect on investment in SRI and is inferior to the other nudges. Overall, the two types of default as well as option partitioning are significant and impactful solutions for increasing investment in SRI. (shrink)

An increasing vaccine hesitancy among parents, which has resulted in insufficient rates of immunization, provides reason to reconsider childhood vaccination practices. Studies suggest that parents' decision‐making process concerning whether to vaccinate their child is highly influenced by cognitive biases. These biases can be utilized to increase vaccination uptake via changes in the choice context. This article considers childhood vaccination programmes, which involve children being vaccinated in school or daycare unless their parents actively ‘opt out’. We suggest that such programmes reconcile (...) parents' decisional authority and vaccination duties. First, opt‐out childhood vaccination based in schools or daycare centres are not disrespectful of parental authority. Second, the programme aligns the default setting with a moral obligation to vaccinate one's child that most parents have. (shrink)