Dana Howard

In recent years, some have argued that supported decision-making can be ethically superior to surrogate decision-making with respect to decisions involving adults with cognitive and intellectual impairments or disabilities. In this paper, we argue that supported decision-making could also be ethically superior to surrogate decision-making in the context of clinical research that involves greater than minimal net risks. In current practice, adults who lack decisional capacity are often excluded from research that involves greater than minimal net risks (call this the minimal risk requirement). While this approach is intended to protect them, it can be ethically problematic, in part because excluding adults who cannot consent blocks scientifically valuable research that needs to enroll them and undermines the generalizability of the research that excludes them. With this concern in mind, we argue that supported decision-making can provide an ethical means to enroll adults who cannot independently consent in greater than minimal net risk research. Supported decision-making thus offers a valuable modification to the surrogate enrollment requirement, and provides good reason to reject the minimal risk requirement as well.

We advocate for a change in the way individuals with cognitive impairment are enrolled in minimal risk clinical research. We do so in the hope that such a change will lead to more cognitively impaired individuals being enrolled in research. Our proposal applies only to cases where would-be participants retain some interest in decision-making as well as the ability to express a decision. In these cases, we argue that the common practice whereby researchers either obtain consent from the individual or consent from a surrogate and assent from the individual, is ethically unnecessary. Instead, a process of facilitated decision-making based on SDM (supported decision-making) should be employed. Although it is possible that this process of facilitation will enable some individuals to make a capacitated choice who would not otherwise have done so, this should not be a requirement of getting to choose. In those cases where a would-be participant, despite support, fails to make a capacitated choice, the individual should still have the final say about participation. In this respect, our proposal deviates from standard practice. However, we argue that our proposal offers participants as much ethical protection as the more common procedures involving surrogates.

This paper argues that research ethics for individuals with intellectual and developmental disabilities must attend to the value of non-domination. First, we highlight the role of domination in the history of abusive research practices against individuals with intellectual and developmental disabilities, practices which directly led to existing protections for this vulnerable population. Second, we argue that existing protections do not adequately safeguard potential participants from domination in decision-making about whether to participate. This is a distinct concern from the well-established criticisms that existing protections may wrongfully exclude potential participants. Finally, we outline and defend an account of supported decision-making grounded in the value of non-domination in order to safeguard potential participants from domination. Our account nonetheless preserves supported decision-making’s possibilities for greater inclusion of individuals with intellectual and developmental disabilities in research participation.

Information disclosure during the informed consent process presents a dilemma. If too little information is presented, participants are unable to make an informed decision. Exhaustive disclosure is, however, a practical impossibility. In the United States, this dilemma was historically navigated in the research context by requiring that disclosure include enumerated items: the purpose of the research, potential risks, etc. In 2018, federal guidelines were updated to require that disclosure adhere to the reasonable person standard, whereby participants must be given all information that an “average” person would want to know. Drawing on the Autistic community’s unique concerns regarding research, we argue that, because of its emphasis on the informational wants of the “average” person, the reasonable person standard systematically fails to meet the informational needs of (many) people from minoritized populations. We argue for an individualized understanding of the reasonable person standard and provide recommendations for research teams.

Intensifying state-level abortion restrictions following the Dobbs v Jackson Women’s Health Organization (2022) decision could lead clinicians to leave states that ban abortion. While large-scale changes are not yet apparent among obstetrician-gynecologists, the abortion care workforce may be uniquely at risk We examined the proportion of abortion-providing clinicians who changed primary state of practice, comparing those who left states that banned abortion with those who left states that did not ban abortion after Dobbs, and the ban status of the states to which they relocated.

Question: Do clinicians providing abortion practicing in states that restrict abortion experience more moral distress than those practicing in states that protect abortion? Findings: In this national, purposive survey study of 310 clinicians providing abortion, moral distress was elevated among all clinicians, with those practicing in restrictive states reporting higher levels of moral distress compared with those practicing in protective states. Meaning: The findings suggest that structural changes addressing bans on necessary health care, such as federal protection for abortion, are needed at institutional, state, and federal policy levels to address clinician moral distress.

Context Opioid treatment agreements (OTAs) are documents that clinicians present to patients when prescribing opioids that describe the risks of opioids and specify requirements that patients must meet to receive their medication. Notwithstanding a lack of evidence that OTAs effectively mitigate opioids’ risks, professional organizations recommend that they be implemented, and jurisdictions increasingly require them. We sought to identify the jurisdictions that require OTAs, how OTAs might affect the outcomes of lawsuits that arise when things go wrong, and instances in which the law permits flexibility for clinicians and health care institutions to adopt best practices. Methods We surveyed the laws and regulations of all 50 states and the District of Columbia to identify which jurisdictions require the use of OTAs, the circumstances in which OTA use is mandatory, and the terms OTAs must include (if any). We also surveyed criminal and civil judicial decisions in which OTAs were discussed as evidence on which a court relied to make its decision to determine how OTA use influences litigation outcomes. Findings Results show that a slight majority (27) of jurisdictions now require OTAs. With one exception, the jurisdictions’ requirements for OTA use are triggered at least in part by long-term prescribing. There is otherwise substantial variation and flexibility within OTA requirements. Results also show that even in jurisdictions where OTA use is not required by statute or regulation, OTA use can inform courts’ reasoning in lawsuits involving patients or clinicians. Sometimes, but not always, OTA use legally protects clinicians from liability. Conclusions Our results show that OTA use is entwined with legal obligations in various ways. Clinicians and health care institutions should identify ways for OTAs to enhance clinician–patient relationships and patient care within the bounds of relevant legal requirements and risks.

Much recent philosophical discussion has explored the political value of holding onto certain hopes for shared ends. This paper considers whether there is correlative political value of letting go of certain hopes or at least of refraining from publicly affirming particular hopes for our collective future. For instance, recently a coalition of scientists and governance scholars have called on governments, international agencies, and other actors to agree to a moratorium on a controversial climate-change mitigation strategy known as solar geoengineering. They argue that there is no place for hope for a successful global solar geoengineering strategy in a just and inclusive climate policy portfolio. This paper asks: (i) what sort of demand are these coalitions making? (ii) Is giving up hopes the sort of thing that is warranted for people to do on the basis of these calls? And (iii) is this the sort of thing that can be legitimately demanded of others? Ultimately, I defend both the political value of our own letting go of certain hopes as well as the legitimacy of making such demands on others (at least in certain cases). This is because what I take people to be doing when they make such demands of others is not necessarily to get others to create new desires or to be more or less optimistic about a certain course of action; rather they are making such demands to outline the terms of continued political engagement as they work towards a shared future.

Alex John London’s new book, For the Common Good: Philosophical Foundations of Research Ethics highlights the fact that establishing just social arrangements is not only a matter of incentivizing popular will to act for the common good; it also requires filling in informational gaps about which policies, arrangements, and interventions will advance the basic interests of members in an equitable, effective and efficient manner. Promoting justice requires, in part, acquiring the knowledge for how to do so. In developing this point, London carefully traces these missteps in the main philosophical debates and then resuscitates the importance of questions of justice at the heart of research ethics. In doing so, it provides a transformative corrective for the field. This review critically examines one of the central pillars of London’s egalitarian research imperative approach: the way in which the social value of research is closely linked with minimizing uncertainty among reasonable experts.

BACKGROUND Patients with chronic pain face significant barriers in finding clinicians to manage long-term opioid therapy (LTOT). For patients on LTOT, it is increasingly common to have them sign opioid treatment agreements (OTAs). OTAs enumerate the risks of opioids, as informed consent documents would, but also the requirements that patients must meet to receive LTOT. While there has been an ongoing scholarly discussion about the practical and ethical implications of OTA use in the abstract, little is known about how clinicians use them and if OTAs themselves modify clinician prescribing practices. OBJECTIVE To determine how clinicians use OTAs and the potential impacts of OTAs on opioid prescribing. DESIGN We conducted qualitative analysis of four focus groups of clinicians from a large Midwestern academic medical center. Groups were organized according to self-identified prescribing patterns: two groups for clinicians who identified as prescribers of LTOT, and two who did not. PARTICIPANTS 17 clinicians from General Internal Medicine, Family Medicine, and Palliative Care were recruited using purposive, convenience sampling. APPROACH Discussions were recorded, transcribed, and analyzed for themes using reflexive thematic analysis by a multidisciplinary team. KEY RESULTS Our analysis identified three main themes: (1) OTAs did not influence clinicians’ decisions whether to use LTOT generally but did shape clinical decision-making for individual patients; (2) clinicians feel OTAs intensify the power they have over patients, though this was not uniformly judged as harmful; (3) there is a potential misalignment between the intended purposes of OTAs and their implementation. CONCLUSION This study reveals a complicated relationship between OTAs and access to pain management. While OTAs seem not to impact the clinicians’ decisions about whether to use LTOT generally, they do sometimes influence prescribing decisions for individual patients. Clinicians shared complex views about OTAs’ purposes, which shows the need for more clarity about how OTAs could be used to promote shared decision-making, joint accountability, informed consent, and patient education.

This chapter explores whether it is possible to treat incompetent persons paternalistically. What is often seen to be wrong about acting paternalistically towards others is that one is treating these others as if they cannot make their own decisions about their own good. So how should one think about situations where one must make decisions on behalf of people who indeed cannot make their own decisions about their own good – especially if these people are still to some extent capable of expressing their desires and concerns about what happens to them? This is often the case in the medical setting, when a patient has lost decisional capacity or has not developed such a capacity in the first place. Focusing on the medical setting, this chapter argues that insofar as someone has the component elements of agency, they can be the target of unjustified paternalism. The chapter first explores the ways in which patients may lack decisional capacity and whether such patients nevertheless retain a sense of agency that can be disrespected. It then examines whether, on some plausible accounts of paternalism, what constitutes disrespect towards the competent constitutes a similar disrespect to the agential capacities of the incompetent.

Many people view disabilities as misfortunes, call this the standard view. In this paper, I examine one criticism that has been launched against the Standard View. Rather than determine in advance whether having a disability is good or bad for a person, some critics argue that the Standard View is reflective of and brings about inappropriate emotional responses toward people with disabilities and their circumstances. For instance, philosophers have recently argued that in holding the standard view, we become prone to a destructive kind of unwarranted pity or that the view leads us to hold certain untenable or inappropriate hopes for our children and for our society. I think this sort of challenge to the Standard View has a lot of appeal, but I worry that if it is not properly articulated, the approach is vulnerable to what has been known as “The Wrong Kind of Reason” problem. The paper highlights and addresses this worry.

Danielle Spencer's book, "Metagnosis: Revelatory Narratives of Health and Identity," does many things. It is a work of autotheory, putting Spencer's own embodied narrative in constant conversation with the testimony of others along with a remarkably diverse set of critical and theoretical approaches. In the book, Spencer coins a new term, "metagnosis", which occurs when one is newly diagnosed in adulthood with a lifelong condition. The book explores Spencer's own metagnostic experience involving her eyesight along with chronicling the experiences of others to highlight the ways in which newfound knowledge of a diagnosis can in itself transform us.Born with strabismus—"misaligned eyes," Spencer is practiced at...

Background: Current practice frequently fails to provide care consistent with the preferences of decisionally-incapacitated patients. It also imposes significant emotional burden on their surrogates. Algorithmic-based patient preference predictors (PPPs) have been proposed as a possible way to address these two concerns. While previous research found that patients strongly support the use of PPPs, the views of surrogates are unknown. The present study thus assessed the views of experienced surrogates regarding the possible use of PPPs as a means to help make treatment decisions for decisionally-incapacitated patients. Methods: This qualitative study used semi-structured interviews to determine the views of experienced surrogates [n=26] who were identified from two academic medical centers and two community hospitals. The primary outcomes were respondents’ overall level of support for the idea of using PPPs and the themes related to their views on how a PPP should be used, if at all, in practice. Results: Overall, 21 participants supported the idea of using PPPs. The remaining five indicated that they would not use a PPP because they made decisions based on the patient’s best interests, not based on substituted judgment. Major themes which emerged were that surrogates, not the patient’s preferences, should determine how treatment decisions are made, and concern that PPPs might be used to deny expensive care or be biased against minority groups. Conclusions: Surrogates, like patients, strongly support the idea of using PPPs to help make treatment decisions for decisionally-incapacitated patients. These findings provide support for developing a PPP and assessing it in practice. At the same time, patients and surrogates disagree over whose preferences should determine how treatment decisions are made, including whether to use a PPP. These findings reveal a fundamental disagreement regarding the guiding principles for surrogate decision-making. Future research is needed to assess this disagreement and consider ways to address it.

Recently, bioethicists and the UNCRPD have advocated for supported medical decision-making on behalf of patients with intellectual disabilities. But what does supported decision-making really entail? One compelling framework is Anita Silvers and Leslie Francis’ mental prosthesis account, which envisions supported decision-making as a process in which trustees act as mere appendages for the patient’s will; the trustee provides the cognitive tools the patient requires to realize her conception of her own good. We argue that supported decision-making would be better understood as a collaborative process, giving patients with intellectual disabilities the opportunity to make decisions in a respectful relationship with trusted others. We offer an alternative account of supported decision-making where the primary constraint is to protect the patient from domination by the trustee. This is advantageous in its preservation of the prospects for genuine collaboration, for the mental prosthesis approach ultimately reinforces a problematic ideal of isolated patient self-determination.

The increasing use of opioid treatment agreements has prompted debate within the medical community about ethical challenges with respect to their implementation. The focus of debate is usually on the efficacy of OTAs at reducing opioid misuse, how OTAs may undermine trust between physicians and patients and the potential coercive nature of requiring patients to sign such agreements as a condition for receiving pain care. An important consideration missing from these conversations is the potential for racial bias in the current way that OTAs are incorporated into clinical practice and in the amount of physician discretion that current opioid guidelines support. While the use of OTAs has become mandatory in some states for certain classes of patients, physicians are still afforded great leeway in how these OTAs are implemented in clinical practice and how their terms should be enforced. This paper uses the guidelines provided for OTA implementation by the states of Indiana and Pennsylvania as case studies in order to argue that giving physicians certain kinds of discretion may exacerbate racial health disparities. This problem cannot simply be addressed by minimising physician discretion in general, but rather by providing mechanisms to hold physicians accountable for how they treat patients on long-term opioid therapy to ensure that such treatment is equitable. There are no data in this work.

When people are making certain medical decisions – especially potentially transformative ones – the specter of regret may color their choices. In this paper, I ask: can predicting that we will regret a decision in the future serve any justificatory role in our present decision-making? And if so, what role? While there are many pitfalls to such reasoning, I ultimately conclude that considering future retrospective emotions like regret in our decisionmaking can be both rational and authentic. Rather than indicating that one is about to make a mistake or that there is some underlying value that one already cares about but is overlooking, the prediction that one will regret a decision in the future makes one confront how her present values and priorities may change as a result of her choice in ways she cannot presently anticipate.

This paper considers the responsibilities of the FDA with regard to disseminating information about the benefits and harms of e-cigarettes. Tobacco harm reduction advocates claim that the FDA has been overcautious and has violated ethical obligations by failing to clearly communicate to the public that e-cigarettes are far less harmful than cigarettes. We argue, by contrast, that the FDA’s obligations in this arena are more complex than they may appear at first blush. Though the FDA is accountable for informing the public about the health risks and benefits of products it regulates, it also has other roles that inform when and how it should disseminate information. In addition to being a knowledge purveyor, it is also a knowledge producer, an advisor to the public, and a practical agent shaping the material conditions in which people make health-related choices. In our view, those other roles call for caution in the way the FDA interprets and communicates the available evidence.

Those arguing that conscientious objection in medicine should be declared unethical by professional societies face the following challenge: conscientious objection can function as an important reforming mechanism when it involves health care workers refusing to participate in certain medical interventions deemed standard of care and legally sanctioned but which undermine patients’ rights. In such cases, the argument goes, far from being unethical, conscientious objection may actually be a professional duty. I examine this sort of challenge and ultimately argue that these acts of conscience done in the interest of reforming professional norms or medical regulations are best understood as episodes of civil disobedience rather than episodes of conscientious objection. In contrast to the private, exempting nature of conscientious objection, civil disobedience is a public breach of a norm or law undertaken with the aim of bringing about a change in governmental policies or professional standards. Consequently, clinicians may have a duty to engage in civil disobedience even while professional societies are right to declare limitations on the ethical appropriateness of conscientious objection.

John Rawls, among others, has argued that one of aims political philosophy is that it provides reasonable hope in the possibility of justice in the future. But what makes hope reasonable? What sorts of theories of justice are best suited to foster reasonable hope in us? To answer these questions, this paper investigates Rawls’s conception of reasonable hope and the kinds of unreasonableness Rawls sought to guard against with his account of a realistic utopia. Rawls's idea of reasonable hope goes beyond the weaker kind of “reconciliation” put forward by Rousseau’s account of a conjectural history that sketches a picture of how we could have developed into the kind of people and the kind of society where justice is possible. It is one thing to believe, with Rousseau, that our deep natures are not incompatible with the possibility of a just society. It is something further to harbor any hope for this in the future. I argue that this temporal aspect, which is built into what Kant and Rawls mean by reasonable hope, is useful approach to the practice of political philosophy. An approach that takes the need for reasonable hope seriously is one that moves political theorizing from a more passive framework of theoretical imagination toward a more active one that entails political anticipation.

We often find ourselves in situations where it is up to us to make decisions on behalf of others. How can we determine whether such decisions are morally justified, especially if those decisions may change who it is these others end up becoming? In this paper, I will evaluate one plausible kind of justification that may tempt us: we may want to justify our decision by appealing to the likelihood that the other person will be glad we made that specific choice down the line. Although it is tempting, I ultimately argue that we should reject this sort of appeal as a plausible justification for the moral permissibility of our vicarious decisions. This is because the decisions that we make on behalf of another may affect the interests and values that that person will hold in the future. As I will show, this complicates the justificatory relationship between present decisions and future attitudes, since the latter can depend on the former. This is not to say that the predicted future attitudes of others can play no significant role in justifying our decisions on others’ behalf. Rather, appealing to the future attitudes in our moral justifications may play an important role in our practical thinking but only when we consider the future attitudes of all relevant possible futures.

In The Minority Body, Elizabeth Barnes rejects prevailing social constructionist accounts of disability for two reasons. First, because they understand disability in terms of oppressive social responses to bodily impairment, they cannot make sense of disability pride. Second, they maintain a problematic distinction between impairment and disability. In response to these challenges, this paper defends a version of the social model of disability, which we call the Social Exclusion Model. On our account, to be disabled is to be in a bodily or psychological state that is represented as an impairment in the prevailing ideology of one’s society, and to be excluded from valuable activities on the basis of this representation. While this model refers to a distinction between disability and impairment, it makes no presuppositions about which bodies function ‘normally’ and which do not. It is the ideology of impairment rather than impairment itself that does any work to determine whether a person is disabled. We argue that this model answers some of the important objections that Barnes raises against prevailing social constructionist accounts of disability, and that it’s focus on the oppressive social positioning of disabled people gives it explanatory power that Barnes’s own account lacks.

The WHO recently made news by apparently advising couples in Zika affected areas to delay pregnancy. On closer inspection, however, it is not so clear what advice was actually being offered in their interim guidance regarding the prevention of the sexual transmission of Zika. In this paper, we lay out a framework for considering the ethical issues that arise in the context of advising and use it to evaluate the WHO guidance. We argue that advising is not merely an informative act. The choices that agencies make in how and whom they advise are ethical choices with practical implications; these choices change not only how people ought to think about their options but also how they indeed ought to act. While we focus on these interim guidance updates from the WHO, the framework we provide can shed light more generally on the ethical issues surrounding advising in other public health contexts.

Within bioethics, two prevailing approaches structure how we think about the role of medical surrogates and the decisions that they must make on behalf of incompetent patients. One approach views the surrogate primarily as the patient's agent, obediently enacting the patient's predetermined will. The second approach views the surrogate as the patient's custodian, judging for herself how to best safeguard the patient's interests. This paper argues that both of these approaches idealize away some of the ethically relevant features of advance care planning that make patient preferences so inscrutable and surrogate decision-making so burdensome. It proposes a new approach to surrogate decision-making, the Fiduciary Agency Approach. On this novel approach, the surrogate has authority to not only act on the patient's behalf as the patient's agent but also to decide on the patient's behalf as the patient's fiduciary. One upshot of this new approach is that surrogates must sometimes go against the expressed dictates of the patients' advance directives not necessarily because doing so would be in the patient's best interest but rather because doing so would best represent the patients' will.