Advancements in novel neurotechnologies, such as brain computer interfaces and neuromodulatory devices such as deep brain stimulators, will have profound implications for society and human rights. While these technologies are improving the diagnosis and treatment of mental and neurological diseases, they can also alter individual agency and estrange those using neurotechnologies from their sense of self, challenging basic notions of what it means to be human. As an international coalition of interdisciplinary scholars and practitioners, we examine these challenges and make (...) recommendations to mitigate negative consequences that could arise from the unregulated development or application of novel neurotechnologies. We explore potential ethical challenges in four key areas: identity and agency, privacy, bias, and enhancement. To address them, we propose democratic and inclusive summits to establish globally-coordinated ethical and societal guidelines for neurotechnology development and application, new measures, including “Neurorights,” for data privacy, security, and consent to empower neurotechnology users’ control over their data, new methods of identifying and preventing bias, and the adoption of public guidelines for safe and equitable distribution of neurotechnological devices. (shrink)

This paper argues against incorporating assessments of individual responsibility into healthcare policies by expanding an existing argument and offering a rebuttal to an argument in favour of such policies. First, it is argued that what primarily underlies discussions surrounding personal responsibility and healthcare is not causal responsibility, moral responsibility or culpability, as one might expect, but biases towards particular highly stigmatised behaviours. A challenge is posed for proponents of taking personal responsibility into account within health policy to either expand the (...) debate to also include socially accepted behaviours or to provide an alternative explanation of the narrowly focused discussion. Second, a critical response is offered to arguments that claim that policies based on personal responsibility would lead to several positive outcomes including healthy behaviour change, better health outcomes and decreases in healthcare spending. It is argued that using individual responsibility as a basis for resource allocation in healthcare is unlikely to motivate positive behaviour changes, and is likely to increase inequality which may lead to worse health outcomes overall. Finally, the case of West Virginia's Medicaid reform is examined, which raises a worry that policies focused on personal responsibility have the potential to lead to increases in medical spending overall. (shrink)

When it comes to using patient data from the National Health Service for research, we are often told that it is a matter of trust: we need to trust, we need to build trust, we need to restore trust. Various policy papers and reports articulate and develop these ideas and make very important contributions to public dialogue on the trustworthiness of our research institutions. But these documents and policies are apparently constructed with little sustained reflection on the nature of trust (...) and trustworthiness, and therefore are missing important features that matter for how we manage concerns related to trust. We suggest that what we mean by ‘trust’ and ‘trustworthiness’ matters and should affect the policies and guidance that govern data sharing in the NHS. We offer a number of initial, general reflections on the way in which some of these features might affect our approach to principles, policies and strategies that are related to sharing patient data for research. This paper is the outcome of a ‘public ethics’ coproduction activity which involved members of the public and two academic ethicists. Our task was to consider collectively the accounts of trust developed by philosophers as they applied in the context of the NHS and to coproduce an argumentative position relevant to this context. (shrink)

Institutional review boards, tasked with facilitating ethical research, are often pulled in competing directions. In what we call the protection-inclusion dilemma, we acknowledge the tensions IRBs face in aiming to both protect potential research participants from harm and include under-represented populations in research. In this manuscript, we examine the history of protectionism that has dominated research ethics oversight in the United States, as well as two responses to such protectionism: inclusion initiatives and critiques of the term vulnerability. We look at (...) what we know about IRB decision-making in relation to protecting and including “vulnerable” groups in research and examine the lack of regulatory guidance related to this dilemma, which encourages protection over inclusion within IRB practice. Finally, we offer recommendations related to how IRBs might strike a better balance between inclusion and protection in research ethics oversight. (shrink)

BackgroundEthics review is the process of assessing the ethics of research involving humans. The Ethics Review Committee (ERC) is the key oversight mechanism designated to ensure ethics review. Whether or not this governance mechanism is still fit for purpose in the data-driven research context remains a debated issue among research ethics experts.Main textIn this article, we seek to address this issue in a twofold manner. First, we review the strengths and weaknesses of ERCs in ensuring ethical oversight. Second, we map (...) these strengths and weaknesses onto specific challenges raised by big data research. We distinguish two categories of potential weakness. The first category concerns persistent weaknesses, i.e., those which are not specific to big data research, but may be exacerbated by it. The second category concerns novel weaknesses, i.e., those which are created by and inherent to big data projects. Within this second category, we further distinguish between purview weaknesses related to the ERC’s scope (e.g., how big data projects may evade ERC review) and functional weaknesses, related to the ERC’s way of operating. Based on this analysis, we propose reforms aimed at improving the oversight capacity of ERCs in the era of big data science.ConclusionsWe believe the oversight mechanism could benefit from these reforms because they will help to overcome data-intensive research challenges and consequently benefit research at large. (shrink)

This article reflects on the relevance and applicability of the Belmont Report nearly four decades after its original publication. In an exploration of criticisms that have been raised in response to the report and of significant changes that have occurred within the context of biomedical research, five primary themes arise. These themes include the increasingly vague boundary between research and practice, unique harms to communities that are not addressed by the principle of respect for persons, and how growing complexity and (...) commodification in research have shed light on the importance of transparency. The repercussions of Belmont's emphasis on the protection of vulnerable populations is also explored, as is the relationship between the report's ethical principles and their applications. It is concluded that while the Belmont Report was an impressive response to the ethical issues of its day, the field of research ethics involving human subjects may have outgrown it. (shrink)

There is compelling evidence that pain experience is influenced by cognitive states. We explore one specific form of such influence, namely placebo analgesia, and examine its relevance for the cognitive penetration debate in philosophy of mind. We single out as important a form of influence on experience that we term radical cognitive penetration, and argue that some cases of placebo analgesia constitute compelling instances of this phenomenon. Still, we urge caution in extrapolating from this to broader conclusions about cognitive penetration (...) in perceptual experience. Instead, we suggest that the cognitive penetration of pain raises distinctive psychological, epistemological, and ethical issues. (shrink)

It is argued here that the practice of medical students performing pelvic exams on women who are under anesthetic and have not consented is immoral and indefensible. This argument begins by laying out the ethical justification for the practice of informed consent, which can be found in autonomy and basic rights. Foregoing the process of consent within medicine can result in violations of both autonomy and basic rights, as well as trust, forming the basis of the wrong of unauthorized pelvic (...) examinations. Several objections to this argument are considered, all of which stem from the idea that this practice constitutes an exception to the general requirement of informed consent. These objections suggest that nonconsensual pelvic examinations on women under anesthetic are ethically acceptable on utilitarian grounds, in that they offer benefits either to the patient or to society, or on the grounds of triviality, in that consent is already presumed, or the practice is insignificant. Each of these objections is rejected and the practice is deemed indefensible. (shrink)

Population-level biomedical research offers new opportunities to improve population health, but also raises new challenges to traditional systems of research governance and ethical oversight. Partly in response to these challenges, various models of public involvement in research are being introduced. Yet, the ways in which public involvement should meet governance challenges are not well understood. We conducted a qualitative study with 36 experts and stakeholders using the World Café method to identify key governance challenges and explore how public involvement can (...) meet these challenges. This brief report discusses four cross-cutting themes from the study: the need to move beyond individual consent; issues in benefit and data sharing; the challenge of delineating and understanding publics; and the goal of clarifying justifications for public involvement. The report aims to provide a starting point for making sense of the relationship between public involvement and the governance of population-level biomedical research, showing connections, potential solutions and issues arising at their intersection. We suggest that, in population-level biomedical research, there is a pressing need for a shift away from conventional governance frameworks focused on the individual and towards a focus on collectives, as well as to foreground ethical issues around social justice and develop ways to address cultural diversity, value pluralism and competing stakeholder interests. There are many unresolved questions around how this shift could be realised, but these unresolved questions should form the basis for developing justificatory accounts and frameworks for suitable collective models of public involvement in population-level biomedical research governance. (shrink)

Biomedical research funding bodies across Europe and North America increasingly encourage—and, in some cases, require—investigators to involve members of the public in funded research. Yet there remains a striking lack of clarity about what ‘good’ or ‘successful’ public involvement looks like. In an effort to provide guidance to investigators and research organisations, representatives of several key research funding bodies in the UK recently came together to develop the National Standards for Public Involvement in Research. The Standards have critical implications for (...) the future of biomedical research in the UK and in other countries as researchers and funders abroad look to the Standards as a model for their own policy development. We assess the Standards and find that despite offering useful suggestions for dealing with practical challenges associated with public involvement, the Standards fail to address fundamental questions about when, why and with whom public involvement should be undertaken in the first place. We show that presented without this justificatory context, many of the recommendations in the Standards are, at best, fragments that require substantial elaboration by those looking to apply the Standards in their own work and, at worst, subject to potentially harmful misapplication by well-meaning investigators. As funding bodies increasingly push for public involvement in research, the key lesson of our analysis is that future recommendations about how public involvement should be conducted cannot be coherently formulated without a clear sense of the underlying goals and rationales for public involvement. (shrink)

As participatory research practices are increasingly taken up in health research, claims related to experiential authority and expertise are frequently made. Here, in an exploration of what grounds such claims, we consider how feminist standpoint theory might apply to the psy sciences (psychiatry, psychology, psychotherapy, psychoanalysis, and so on). Standpoint theory claims that experiences of marginalization and critical engagement can lead to a standpoint that offers an epistemic advantage within a domain of knowledge. We examine experiences of marginalization and critical (...) engagement in the mental health system, as well as evidence for epistemic advantages resulting from these experiences. This evidence, found in the identification of problematic assumptions and the development of new tools and theories in the field, grounds our argument that standpoint theory is indeed relevant to the psy sciences and that many of those who have experienced marginalization and have engaged critically have an epistemic advantage when it comes to knowledge-production. The implications of this argument are significant: those who have attained a standpoint within the psy sciences ought to be included in research and given both tools and funding to develop research programs. However, we must be wary of the risks of tokenization, cooptation, and essentialization that are likely to accompany such a transformation. (shrink)

Background Institutional Review Boards (IRBs) are federally mandated to include both nonscientific and unaffiliated representatives in their membership. Despite this, there is no guidance or policy on the selection of unaffiliated or non-scientist members and reports indicate a lack of clarity regarding members’ roles. In the present study we sought to explore processes of recruitment, training, and the perceived roles for unaffiliated and non-scientist members of IRBs.Methods We distributed a self-administered REDCap survey of members of the Association for the Accreditation (...) of Human Research Protection Programs familiar with IRB member recruitment. The survey included closed and open-ended questions regarding: the operation of the HRPP/IRB(s), how unaffiliated and non-scientist members are recruited, whether they had faced challenges recruiting for these roles, and training and mentorship offered. The survey also collected information regarding the perceived value and roles of unaffiliated and non-scientist members.Results 76 responses were included in the analysis (38% completion rate). The most common approach for recruitment was referral from current IRB members, with almost half of respondents indicating challenges recruiting unaffiliated members. Over 75% indicated no additional training was provided to unaffiliated or non-scientist members compared to affiliated or scientist members. Most common supports provided were travel/parking expenses and honoraria. Commonly perceived roles were to provide an independent voice from the participant perspective, notably regarding consent processes and materials.Conclusions Respondents indicated challenges in defining unaffiliated and non-scientist members and limited practices toward recruitment and support. Future work should more closely examine the challenges in defining these roles and applying the definitions in practice, as well as strategies that may improve recruitment and retention of unaffiliated and non-scientist members. (shrink)

Well before the COVID-19 pandemic, proponents of digital psychiatry were touting the promise of various digital tools and techniques to revolutionize mental healthcare. As social distancing and its knock-on effects have strained existing mental health infrastructures, calls have grown louder for implementing various digital mental health solutions at scale. Decisions made today will shape the future of mental healthcare for the foreseeable future. We argue that bioethicists are uniquely positioned to cut through the hype surrounding digital mental health, which can (...) obscure crucial ethical and epistemic gaps that ought to be considered by policymakers before committing to a digital psychiatric future. Here, we describe four such gaps: The evidence gap, the inequality gap, the prediction-intervention gap, and the safety gap. (shrink)

The practice of medically assisted dying has long been contentious, and the question of what to call it has become increasingly contentious as well. Particularly among U.S. proponents of legalizing the practice, there has been a growing push away from calling it “physician‐assisted suicide,” with assertions that medically assisted dying is fundamentally different from suicide. Digging deeper into this claim about difference leads to an examination of the difference between two kinds of suffering—suffering from physical conditions and suffering from psychological (...) conditions—and therefore leads also toward an examination of whether requests for medical assistance in dying by those suffering from psychological conditions and those suffering from physical conditions should be painted with the same brush. In this article, I aim both to illuminate some of the considerations that ought to be included in discussions related to medically assisted dying and to shed light on what the indirect effects of such discussions can be. I consider some of the reasons commonly given for holding that suicide and medically assisted dying differ fundamentally and then whether the conclusion that medically assisted dying should not be called “suicide” follows from the premises. I ask what else might justify the conclusion that the two acts ought to be called by different names, and I examine possible justifications for accepting this premise, as well as what justifications might exist for emphasizing how the acts are alike. Finally, I argue that we should be cautious before concluding that medically assisted dying should not be called “suicide.” We need more evidence either that the two acts are fundamentally different or that emphasizing differences between them is not likely to do more harm than good. (shrink)

In their target article, Zamina Mithani, Jane Cooper, and J. Wesley Boyd make a compelling case for the importance of “counter storytelling” in bioethics. They obse...

COVID-19 vaccine research success and emergency use authorizations have shown the life sciences’ potential for positive health impact. But they also underscore potentially divergent and conf...

Racial disparities in pain treatment are well documented. Such disparities are explained with reference to factors related to providers, health care structures, and patient behaviors. Racial differences in pain experiences, although well documented, are less well understood. Explanations for such differences usually involve genetic or psychological factors. Here, we argue that racial differences in pain experiences might also be explained by disparities in pain treatment. Based on what we know about the nature of pain, particularly the cognitive and affective aspects (...) of the phenomenon, it is likely that disparities in the treatment of racialized patients can lead to significant racial differences in pain experience that show up at the population level. We argue that the failure of research programs to consider this causal factor is an example of white ignorance. We also consider several implications of the link between racial disparities in pain treatment and racial differences in pain experience. (shrink)

A recent systematic review of Machine Learning (ML) approaches to health data, containing over 100 studies, found that the most investigated problem was mental health (Yin et al., 2019). Relatedly, recent estimates suggest that between 165,000 and 325,000 health and wellness apps are now commercially available, with over 10,000 of those designed specifically for mental health (Carlo et al., 2019). In light of these trends, the present chapter has three aims: (1) provide an informative overview of some of the recent (...) work taking place at the intersection of text mining and mental health so that we can (2) highlight and analyze several pressing ethical issues that are arising in this rapidly growing field and (3) suggest productive directions for how these issues might be better addressed within future interdisciplinary work to ensure the responsible development of text mining approaches in psychology generally, and in mental health fields, specifically. In Section 1, we review some of the recent literature on text-mining and mental health in the contexts of traditional experimental settings, social media, and research involving electronic health records. Then, in Section 2, we introduce and discuss ethical concerns that arise before, during, and after research is conducted. Finally, in Section 3, we offer several suggestions about how ethical oversight of text-mining research might be improved to be more responsive to the concerns mapped out in Section 2. (shrink)

Hastings Center Report, Volume 52, Issue 1, Page 28-31, January/February 2022.

Many are calling for concrete mechanisms of oversight for health research involving artificial intelligence (AI). In response, institutional review boards (IRBs) are being turned to as a familiar model of governance. Here, we examine the IRB model as a form of ethics oversight for health research that uses AI. We consider the model's origins, analyze the challenges IRBs are facing in the contexts of both industry and academia, and offer concrete recommendations for how these committees might be adapted in order (...) to provide an effective mechanism of oversight for health‐related AI research. (shrink)

While a significant body of bioethical literature considers how the placebo effect might introduce a conflict between autonomy and beneficence, the link between justice and the placebo effect has been neglected. Here, we bring together disparate evidence from the field of placebo studies and research on health inequalities related to race and ethnicity, and argue that, collectively, this evidence may provide the basis for an unacknowledged route by which health disparities are exacerbated. This route is constituted by an uneven distribution (...) of placebo effects, resulting from differences in expressions of physician warmth and empathy, as well as support and patient engagement, across racial and ethnic lines. In a discussion of the ethical implications of this connection, we argue that this contribution to health disparities is a source of injustice, consider ways in which these disparities might be ameliorated and suggest that this conclusion is likely to extend to other realms of inequality as well. (shrink)

During the COVID-19 pandemic, several hospitals implemented “birthing alone” policies, banning companions from accompanying individuals giving birth. We offer an ethical analysis of these policies. First, we examine them through a consequentialist framework of risks and benefits. Second, we consider the significance of birth, highlighting the unique ways in which risks, relationships, and rights are understood in the context of obstetrics. We conclude that birthing alone policies are largely unjustified, as the harm they are certain to cause outweighs their possible (...) benefits and because they fail to take into account what matters to mothers. (shrink)

Wiggins and Wilbanks’s (2019) article draws attention to the rise of citizen science in the medical domain, part of a larger participatory turn in which citizens and patients are increasingly invol...

In the introduction to a recent anthology of contemporary issues in philosophy of psychiatry, editors Jeffrey Poland and Şerife Tekin declare this to be a moment of crisis within the field. They suggest that the state of psychiatry today reflects Thomas Kuhn's conception of a period of extraordinary science, which occurs when anomalies begin to build up, confidence in the dominant paradigm is shook, competing theories arise, and philosophical questions come to the fore. Although perhaps not all would agree that (...) the field is in crisis, there is certainly an abundance of pessimism. Within the realm of research, a mood of explanatory pessimism has been growing, characterized by a... (shrink)

This paper offers a critical analysis of several accounts of the placebo effect that have been put forward. While the placebo effect is most often thought of as a control in research and as a deceptive tool in practice, a growing body of research suggests that it ought to be thought of as a powerful phenomenon in its own right. Several accounts that aim to draw boundaries around the placebo effect are evaluated in relation to current evidence and it is (...) argued that none of them adequately capture the variability and potency of the phenomenon. Two accounts, however, that point towards the underlying mechanisms of the placebo effect, are shown to offer promise in terms of developing a more comprehensive account of the placebo effect. (shrink)

Unrepresented patients are individuals who lack decision makingcapacity and have no family or friends to make medical decisions for them. This population is growing in number in the United States, particularly within emergency and intensive care settings. While some bioethical discussion has taken place in response to the question of who ought to make decisions for these patients, the issue of how surrogate medical decisions ought to be made for this population remains unexplored. In this paper, we argue that standard (...) applications of surrogate decision making principles in health care are not well suited to many unrepresented patients with long-term mental health diagnosis. We argue that when applied to this population, the substituted judgment standard, designed to preserve patient preferences and values, may lead to the exclusion of their preferences. We argue further that the application of the best interest standard runs the risk of leading to harmful cases of overtreatment or undertreatment. We offer an alternative interpretation of the best interest principle that is better able to promote the well-being of unrepresented patients, especially for those who lack capacity because of mental disorders. This alternative is based on the practices and principles of harm reduction and includes three components: emphasis on considering the expressed preferences of unrepresented patients, a focus on reducing harm as well as the delivery of clinical benefits, and a recognition of the importance of promoting trust. (shrink)

We are grateful to everyone who took the time to offer such insightful comments with regard to the protection–inclusion dilemma in research oversight. Nearly all respondents agreed that this dilemm...

According to the World Health Organization, female genital cutting affects millions of girls and women worldwide, particularly on the African continent and in the Middle East. This paper presents a plausible, albeit hypothetical, clinical vignette and then explores the legal landscape as well as the ethical landscape physicians should use to evaluate the adult patient who requests re-infibulation. The principles of non-maleficence, beneficence, justice, and autonomy are considered for guidance, and physician conscientious objection to this procedure is discussed as well. (...) Analyses of law and predominant principles of bioethics fail to yield a clear answer regarding performing female genital cutting or re-infibulation on an adult in the United States. Physicians should consider the patient’s physical, mental, and social health when thinking about female genital cutting and should understand the deep-rooted cultural significance of the practice. (shrink)

Background: Genetic tests for schizophrenia may introduce risks and benefits. Among young adults at clinical high risk for psychosis, little is known about their concerns and how they assess potential risks. Methods: We conducted semistructured interviews with 15 young adults at clinical high risk for psychosis to ask about their concerns. Results: Participants expressed concerns about test reliability, data interpretation, stigma, psychological harm, family planning, and privacy. Participants’ responses showed some departure from the ethics literature insofar as participants were primarily (...) interested in reporting their results to people to whom they felt emotionally close, and expressed little consideration of biological closeness. Additionally, if tests showed an increased genetic risk for schizophrenia, four clinical high-risk persons felt obligated to tell an employer and another three would “maybe” tell an employer, even in the absence of clinical symptoms. Conclusions: These findings suggest opportunities for clinicians and genetic counselors to intervene with education and support. (shrink)

Saunkeah et al. argue that the principles of sovereignty and solidarity form the moral foundation for extending the Belmont Principles to tribal communities, by providing tribes with a right...