Mental health-related data generated by app users during the routine use of Consumer Mental Health Apps (CMHAs) are being increasingly leveraged for research and product improvement studies. However, it remains unclear which ethical safeguards and practices should be implemented by researchers and app developers to protect users during these studies, and concerns have been raised over their current implementation in CMHAs. To better understand which ethical safeguards and practices are implemented, why and how, 17 app developers and researchers were interviewed (...) who had been involved in using CMHA data for studies. Interviewees discussed the impact on stakeholder interests, sufficiency thresholds and procedural alterations of informed consent, data protection, gathering app user perspectives and representing users in app design and study conduct, and ensuring adequate support. Although the reasoning behind how and why these ethical safeguards and practices should be implemented showed considerable variability and several gaps, interviewees converged on various general lines of reasoning. This allowed for the development of a coherent and nuanced account that could prove useful for future CMHA studies and which could stimulate further normative investigation of the role of ethical safeguards and practices in these studies. (shrink)

Background Respect for autonomy is a key principle in bioethics. However, respecting autonomy in practice is complex because most people define themselves and make decisions influenced by a complex network of social relationships. The extent to which individual autonomy operates for each partner within the context of decision-making within marital or similar relationships is largely unexplored. This paper explores issues related to decision-making by couples for health care and the circumstances under which such a practice should be respected as compatible (...) with autonomous decision-making. Discussion We discuss the concept of autonomy as it applies to persons and to actions, human interdependency and gender roles in decision-making, the dynamics and outcomes of couples’ joint decision-making, and the ethics of couples’ joint decision-making. We believe that the extent to which couples’ joint decision-making might be deemed ethically acceptable will vary depending on the context. Given that in many traditional marriages the woman is the less dominant partner, we consider a spectrum of scenarios of couples’ joint decision-making about a woman’s own health care that move from those that are acceptably autonomous to those that are not consistent with respecting the woman’s autonomous decision-making. To the extent that there is evidence that both members of a couple understand a decision, intend it, and that neither completely controls the other, couples’ joint decision-making should be viewed as consistent with the principle of respect for the woman’s autonomy. At the other end of the spectrum are decisions made by the man without the woman’s input, representing domination of one partner by the other. Conclusions We recommend viewing the dynamics of couples’ joint decision-making as existing on a continuum of degrees of autonomy. This continuum-based perspective implies that couples’ joint decision-making should not be taken at face value but should be assessed against the specific cultural, ethnic, and religious backgrounds and personal circumstances of the individuals in question. (shrink)

Over the last few decades, multiple studies have examined the understanding of participants in clinical research. They show variable and often poor understanding of key elements of disclosure, such as expected risks and the experimental nature of treatments. Did the participants in these studies give valid consent? According to the standard view of informed consent they did not. The standard view holds that the recipient of consent has a duty to disclose certain information to the profferer of consent because valid (...) consent requires that information to be understood. The contents of the understanding and disclosure requirements are therefore conceptually linked. In this paper, we argue that the standard view is mistaken. The disclosure and understanding requirements have distinct grounds tied to two different ways in which a token of consent can be rendered invalid. Analysis of these grounds allows us to derive the contents of the two requirements. It also implies that it is sometimes permissible to enroll willing participants who have not understood everything that they ought to be told about their clinical trials. (shrink)

Soda taxes are controversial. While proponents point to their potential health benefits and the public projects that could be funded with their revenue, critics argue that they are paternalistic and regressive. In this paper, we explore the prospects for designing a just soda tax, one that appropriately balances the often-competing ethical considerations of promoting social welfare, respecting people’s autonomy, and ensuring distributive fairness. We argue that policymakers have several paths forward for designing a just soda tax, but that the considerations (...) relevant to ethical policy design are more complicated than is sometimes acknowledged. (shrink)

Advances in immunotherapy pave the way for vaccines that target not only infections, but also unhealthy behaviors such as smoking. A nicotine vaccine that eliminates the pleasure associated with smoking could potentially be used to prevent children from adopting this addictive and dangerous behavior. This paper offers an ethical analysis of such vaccines. We argue that it would be permissible for parents to give their child a nicotine vaccine if the following conditions are met: (1) the vaccine is expected to (...) result in a net benefit to each individual vaccinated, (2) the expected harms from the side effects of the vaccine are lower than the non-voluntary harms of smoking, and (3) there are no less manipulative methods available that are as effective at preventing smoking initiation. Finally, we show how the framework developed here could be used to analyze the ethics of other chemical interventions designed to modify children’s behavior. (shrink)

It has been alleged that compatibilists are committed to the view that agents act freely and responsibly even when subject to certain forms of radical manipulation. In this paper I identify and elucidate a form of compatibilist freedom, social autonomy, that is essential to understanding what is wrong with ordinary indoctrination and argue that it also holds the key to understanding what goes wrong in more fanciful manipulation cases.

Respect for autonomy is a key principle in bioethics. However, respecting autonomy in practice is complex because most people define themselves and make decisions influenced by a complex network of social relationships. The extent to which individual autonomy operates for each partner within the context of decision-making within marital or similar relationships is largely unexplored. This paper explores issues related to decision-making by couples for health care and the circumstances under which such a practice should be respected as compatible with (...) autonomous decision-making. We discuss the concept of autonomy as it applies to persons and to actions, human interdependency and gender roles in decision-making, the dynamics and outcomes of couples’ joint decision-making, and the ethics of couples’ joint decision-making. We believe that the extent to which couples’ joint decision-making might be deemed ethically acceptable will vary depending on the context. Given that in many traditional marriages the woman is the less dominant partner, we consider a spectrum of scenarios of couples’ joint decision-making about a woman’s own health care that move from those that are acceptably autonomous to those that are not consistent with respecting the woman’s autonomous decision-making. To the extent that there is evidence that both members of a couple understand a decision, intend it, and that neither completely controls the other, couples’ joint decision-making should be viewed as consistent with the principle of respect for the woman’s autonomy. At the other end of the spectrum are decisions made by the man without the woman’s input, representing domination of one partner by the other. We recommend viewing the dynamics of couples’ joint decision-making as existing on a continuum of degrees of autonomy. This continuum-based perspective implies that couples’ joint decision-making should not be taken at face value but should be assessed against the specific cultural, ethnic, and religious backgrounds and personal circumstances of the individuals in question. (shrink)

Suppose that a patient is receiving treatment options from her doctor. In one case, the doctor says, “the surgery has a 90% survival rate.” Now, suppose the doctor instead said, “the procedure has a 10% mortality rate.” Predictably, the patient is more likely to consent on the first description and more likely to dissent on the second. This is an example of a framing effect. A framing effect occurs when “the description of [logically-equivalent] options in terms of gains (positive frame) (...) rather than losses (negative frame) elicits systematically different choices.” Framing effects are ubiquitous, but they are particularly troublesome in medicine. Many worry that there is tension between valuing informed consent and using framing effects in clinical settings. In this paper, I answer this question: if an individual is subject to a framing effect when she gives her consent, does this undermine the validity of her consent? I argue that framing effects do not undermine consent in general. (shrink)

In “Informed Consent: What Must be Disclosed and What Must be Understood?”, we reject a dogma at the heart of research ethics. We demonstrate that the constitutive claim...

Richard Thaler and Cass Sunstein define a nudge as “any aspect of the choice architecture that alters people's behavior in a predictable way without forbidding any options or significantly changing their economic incentives.” Much has been written about the ethics of nudging competent adult patients. Less has been written about the ethics of nudging surrogates’ decision‐making and how the ethical considerations and arguments in that context might differ. Even less has been written about nudging surrogate decision‐making in the context of (...) pediatrics, despite fundamental differences that exist between the pediatric and adult contexts. Yet, as the field of behavioral economics matures and its insights become more established and well‐known, nudges will become more crafted, sophisticated, intentional, and targeted. Thus, the time is now for reflection and ethical analysis regarding the appropriateness of nudges in pediatrics. We argue that there is an even stronger ethical justification for nudging in parental decision‐making than with competent adult patients deciding for themselves. We give three main reasons in support of this: (1) child patients do not have autonomy that can be violated (a concern with some nudges), and nudging need not violate parental decision‐making authority; (2) nudging can help fulfill pediatric clinicians’ obligations to ensure parental decisions are in the child's interests, particularly in contexts where there is high certainty that a recommended intervention is low risk and of high benefit; and (3) nudging can relieve parents’ decisional burden regarding what is best for their child, particularly with decisions that have implications for public health. (shrink)