Annette Rid

The challenge of making healthcare decisions for incapacitated patients continues to confront stakeholders worldwide. Annette Rid and David Wendler proposed a Patient Preference Predictor (P3) that uses population-level data to infer an incapacitated patient’s likely treatment choices, with the aim of aligning care with the values and preferences they held when last autonomous. Some objectors claimed this would fail to respect patients’ (former) autonomy because the basis for prediction would not be specific to the individual (e.g., based on data reflecting their own specific reasons for preferring one course of action over another). In response, we proposed a ‘Personalised Patient Preference Predictor’ (P4) that would harness the predictive capacities of personalised large language models (LLMs) fine-tuned on individual-level data of various kinds. The envisioned P4, if realized, would be akin to a ‘digital psychological twin’ or AI simulation of the patient that would encode their unique preferences and values to enable an individualised prediction of their likely treatment preferences. The P4, in turn, has been criticised on various grounds: philosophical, practical, and ethical. Here, we comprehensively evaluate the concerns of our critics based on all known published critiques as of the time of writing. While acknowledging the weight of some of these concerns, we argue that they do not entail that a P4 should not be developed. Rather, the concerns point to areas where thoughtful design choices, responsible regulation, and further philosophical reflection are needed to steer the proposal in a positive direction.

As health policy-makers around the world seek to make progress towards universal health coverage they must navigate between two important ethical imperatives: to set national spending priorities fairly and efficiently; and to safeguard the right to health. These imperatives can conflict, leading some to conclude that rights-based approaches present a disruptive influence on health policy, hindering states’ efforts to set priorities fairly and efficiently. Here, we challenge this perception. We argue first that these points of tension stem largely from inadequate interpretations of the aims of priority setting as well as the right to health. We then discuss various ways in which the right to health complements traditional concerns of priority setting and vice versa. Finally, we set out a three-step process by which policy-makers may navigate the ethical and legal considerations at play.

Recruitment challenges in clinical research are widespread, particularly for traditionally under-represented groups. Referral relationships—in which research partners and clinical partners agree to collaborate on selected research studies or programmes, with the expectation that the clinical partners refer appropriate patients as potential participants—may help alleviate these challenges. Referral relationships allow research partners access to expanded and more diverse pools of participants by increasing the engagement of medical providers, leveraging providers’ connections with patients and providing structural support for study participation. Clinical partners can also benefit from the resources offered by research involvement, and patients may benefit from improved access to studies. Yet despite their potential, referral relationships can raise ethical concerns. Here, we discuss ethical considerations for referral relationships in clinical research to address these concerns. When establishing relationships, fair participant selection should guide the sites and studies involved. When defining the terms of a relationship, partners should build trust and respect, collaborating so that health centres or hospitals and communities benefit from their research involvement with the mitigation of associated burdens. When implemented, referral relationships should continue to honour fair participant selection, reduce misunderstanding or miscommunication about research and protect patients’ privacy and confidentiality. Overall, when conducted ethically, referral relationships can help address study recruitment challenges and promote fair access to research opportunities.

This chapter provides an overview of the existing sufficientarian approaches to health or health care justice, as well as concepts or practices in health policy that seem to be committed to the idea of ensuring “enough” health or health care. Sufficientarian approaches are those that attribute moral significance to achieving a threshold level of a currency of justice—for example, resources, welfare or capabilities—that is deemed appropriate. Although few scholars have begun specifying the significant elements of a sufficiency view in relation to health and health care, sufficientarian ideas play a role in the work of numerous other authors’ writing on justice and health. The chapter shows that concepts or practices in health policy—notably, the moral right to an adequate level of health services and two-tiered health systems—resonate with sufficientarian ideas, although they are not necessarily linked to the sufficiency view.

This chapter uses the film _The Constant Gardener_ (2005) to set the stage for a discussion of research ethics in developing countries. The film tells the story of Justin Quayle (Ralph Fiennes), whose lawyer and activist wife Tessa, was found murdered in a remote part of northern Kenya. Tessa had uncovered the fraudulent research activities of a Swiss-Canadian pharmaceutical company and the Kenyan branch of a multinational firm. These companies had been conducting trials of the drug Dypraxa in the slums of Nairobi, which turned out to have serious side effects. The film portrays how, in the Dypraxa trial, the participants' consent was not fully informed or voluntary. The drug trial also illustrates that research in resource-limited settings raises concerns about exploitation. One would think that such research would not be exploitative if it is responsive to local health needs and priorities. But responsiveness to local needs does not safeguard against exploitation. For example, if an investigational drug proves to be safe and effective but is marketed at a high price worldwide, it would probably not be affordable in the country hosting the trial. Thus, hosting communities would assume the risks and burdens of testing the drug whereas its benefits would have accrued mostly to patients in more developed countries.

In a recent paper,1 we proposed a Personalised Patient Preference Predictor (P4), building on earlier work by Rid and Wendler.2 The P4 is a hypothetical computer program that would, in the context of surrogate decision-making (eg, following a substituted judgement standard), use generative artificial intelligence (AI) models to infer a patient’s underlying values and preferences and, on that basis, predict which treatment option they would choose in the current situation. Such AI models, we suggested, could be ‘fine-tuned’ on various pre-existing data or materials produced by, or otherwise pertaining to (eg, including information about), the patient considered as a unique individual.1 3 Annoni has offered a thoughtful critique of this proposal, challenging what he (implicitly) characterises as assumptions underlying our work.4 In his critique, in addition to advancing the negative claim that the P4 would not, as we had suggested,1 allow surrogate decision-makers to more effectively show respect for formerly competent patients, Annoni makes the positive claim that the P4 could help surrogates better honour the patient’s unique identity. We appreciate Annoni’s contribution to this important ethical conversation and welcome the opportunity to clarify our position. We agree with Annoni that the P4 serves ethical purposes beyond showing respect for autonomy, and that this may include honouring their identity.5 We also agree, contrary to what Annoni implies about our position, that respect for autonomy is not simply reducible to mere preference satisfaction. However, we do not agree with Annoni’s claim that the P4 does not, or could not, promote the value of autonomy at all. We argue that Annoni’s view of respect for autonomy is too narrow, insofar as it seems to require occurrent explicit consent, which is impossible for incapacitated patients. We advocate for a spectrum approach to autonomy: When direct choice or …

When making substituted judgments for incapacitated patients, surrogates often struggle to guess what the patient would want if they had capacity. Surrogates may also agonize over having the (sole) responsibility of making such a determination. To address such concerns, a Patient Preference Predictor (PPP) has been proposed that would use an algorithm to infer the treatment preferences of individual patients from population-level data about the known preferences of people with similar demographic characteristics. However, critics have suggested that even if such a PPP were more accurate, on average, than human surrogates in identifying patient preferences, the proposed algorithm would nevertheless fail to respect the patient’s (former) autonomy since it draws on the ‘wrong’ kind of data: namely, data that are not specific to the individual patient and which therefore may not reflect their actual values, or their reasons for having the preferences they do. Taking such criticisms on board, we here propose a new approach: the Personalized Patient Preference Predictor (P4). The P4 is based on recent advances in machine learning, which allow technologies including large language models to be more cheaply and efficiently ‘fine-tuned’ on person-specific data. The P4, unlike the PPP, would be able to infer an individual patient’s preferences from material (e.g., prior treatment decisions) that is in fact specific to them. Thus, we argue, in addition to being potentially more accurate at the individual level than the previously proposed PPP, the predictions of a P4 would also more directly reflect each patient’s own reasons and values. In this article, we review recent discoveries in artificial intelligence research that suggest a P4 is technically feasible, and argue that, if it is developed and appropriately deployed, it should assuage some of the main autonomy-based concerns of critics of the original PPP. We then consider various objections to our proposal and offer some tentative replies.

Background: Current practice relies on patient-designated and next-of-kin surrogates, in consultation with clinicians, to make treatment decisions for patients who lose the ability to make their own decisions. Yet there is a paucity of data on whether this approach is consistent with patients' preferences regarding who they want to make treatment decisions for them in the event of decisional incapacity. Methods: Self-administered survey of patients at a tertiary care center. Results: Overall, 1169 respondents completed the survey (response rate = 59.8%). Of the 229 respondents who had previously designated a surrogate, 78.2% wanted their surrogate to make treatment decisions in the event of decisional incapacity, whereas 21.8% wanted their doctors to make treatment decisions. Of the 822 respondents who had not designated a surrogate, 66.1% wanted their family to make treatment decisions, whereas 33.9% wanted their doctors to make treatment decisions. The most common explanation provided for why respondents wanted their surrogate or family to make treatment decisions for them in the event of decisional incapacity was the belief that loved ones knew the patient's treatment preferences. Conclusions: Contrary to current practice, 33.9% of respondents who had not designated a surrogate and 21.8% of those who had designated a surrogate indicated that they wanted their doctors to make treatment decisions for them in the event of decisional incapacity. Moreover, many of those who wanted their surrogates or family members to make treatment decisions explained this preference by citing a belief that loved ones knew the patient's treatment preferences. This belief is undermined by prior research that suggests that surrogates and family members frequently are unable to predict which treatments their charges would want. Future research should assess these two concerns with current practice and, where necessary, identify approaches to address them.

It has recently been proposed to incorporate the use of a “Patient Preference Predictor” (PPP) into the process of making treatment decisions for incapacitated patients. A PPP would predict which treatment option a given incapacitated patient would most likely prefer, based on the individual’s characteristics and information on what treatment preferences are correlated with these characteristics. Including a PPP in the shared decision-making process between clinicians and surrogates has the potential to better realize important ethical goals for making treatment decisions for incapacitated patients. However, developing and implementing a PPP poses significant practical challenges. The present paper discusses these practical challenges and considers ways to address them.

Background Surrogates frequently are unable to predict which treatment their charges would want and also can experience significant distress as a result of making treatment decisions. A new method, the patient preference predictor (PPP), has been proposed as a possible way to supplement the process of shared decision-making to address these two concerns. The PPP predicts which treatment the patient would want based on which treatment similar patients want in similar circumstances. The present article describes the results of the first evaluation to assess whether patients support the use of a PPP. Methods Self-administered survey of patients at a tertiary care centre. Results Overall, 1169 respondents completed the survey (response rate=59.8%). In the event that the respondent became unable to make decisions due to a car accident, 78.9% would want the PPP to be incorporated into the process of making treatment decisions for them. In contrast, 15.2% of respondents would not want the PPP to be used for them. Respondents who endorsed the PPP cited the possibility that its use could increase the chances that they receive the treatments they prefer and/or reduce the burdens on their surrogate decision-maker. Conclusions The majority of respondents endorsed the possibility of incorporating a PPP into the process of shared decision-making based on its potential to increase surrogates’ predictive accuracy and/or reduce surrogate distress. These data provide strong patient support for further research to assess whether, in practice, the use of a PPP can increase the chances that incapacitated patients receive the treatments they prefer and reduce the burden of making decisions on their surrogates.

The standard approach to treatment decision making for incapacitated patients often fails to provide treatment consistent with the patient’s preferences and values and places significant stress on surrogate decision makers. These shortcomings provide compelling reason to search for methods to improve current practice. Shared decision making between surrogates and clinicians has important advantages, but it does not provide a way to determine patients’ treatment preferences. Hence, shared decision making leaves families with the stressful challenge of identifying the patient’s preferred treatment option. To address this concern, the present paper proposes to incorporate the use of a “Patient Preference Predictor” (PPP) into the shared decision-making process between surrogates and clinicians. A PPP would predict which treatment option a given incapacitated patient would most likely prefer, based on the individual’s characteristics and information on what treatment preferences are correlated with these characteristics. Use of a PPP is likely to increase the chances that incapacitated patients are treated consistent with their preferences and values and might reduce the stress and burden on their surrogates. Including a PPP in the shared decision-making process therefore has the potential to realize important ethical goals for making treatment decisions for incapacitated patients. The present paper justifies this approach on conceptual and normative grounds

Many guidelines and commentators endorse the view that clinical research is ethically acceptable only when it has social value, in the sense of collecting data which might be used to improve health. A version of this social value requirement is included in the Declaration of Helsinki and the Nuremberg Code, and is codified in many national research regulations. At the same time, there have been no systematic analyses of why social value is an ethical requirement for clinical research. Recognizing this gap in the literature, recent articles by Alan Wertheimer and David Resnik argue that the extant justifications for the social value requirement are unpersuasive. Both authors conclude, contrary to almost all current guidelines and regulations, that it can be acceptable across a broad range of cases to conduct clinical research which is known prospectively to have no social value. The present article assesses this conclusion by critically evaluating the ethical and policy considerations relevant to the claim that clinical research must have social value. This analysis supports the standard view that social value is an ethical requirement for the vast majority of clinical research studies and should be mandated by applicable guidelines and policies.

One of the key ethical requirements for biomedical research is that it have an acceptable risk-benefit profile (Emanuel, Wendler, and Grady 2000). The International Conference of Harmonization guidelines mandate that clinical trials should be initiated and continued only if “the anticipated benefits justify the risks” (1996). Guidelines from the Council for International Organizations of Medical Sciences state that biomedical research is acceptable only if the “potential benefits and risks are reasonably balanced” (2002). U.S. federal regulations require that the “risks to subjects” be “reasonable in relation to anticipated benefits, if any, to subjects and the importance of the knowledge” to be gained from the ..

One rationale policy-makers sometimes give for declining to fund a service or intervention is on the grounds that it would be ‘unaffordable’, which is to say, that the total cost of providing the service or intervention for all eligible recipients would exceed the budget limit. But does the mere fact that a service or intervention is unaffordable present a reason not to fund it? Thus far, the philosophical literature has remained largely silent on this issue. However, in this article, we consider this kind of thinking in depth. Albeit with certain important caveats, we argue that the use of affordability criteria in matters of public financing commits what Parfit might have called a ‘mistake in moral mathematics’. First, it fails to abide by what we term a principle of ‘non-perfectionism’ in moral action: the mere fact that it is practically impossible for you to do all the good that you have reason to do does not present a reason not to do whatever good you can do. And second, when used as a means of arbitrating between which services to fund, affordability criteria can lead to a kind of ‘numerical discrimination’. Various attendant issues around fairness and lotteries are also discussed.

Health systems that provide for universal patient access through a scheme of prepayments—whether through taxes, social insurance, or a combination of the two—need to make decisions on the scope of coverage that they secure. Such decisions are inherently controversial, implying, as they do, that some patients will receive less than comprehensive health care, or less than complete protection from the financial consequences of ill-heath, even when there is a clinically effective therapy to which they might have access.Controversial decisions of this sort call for a public justification for covering or not covering a given treatment. Priority-setting agencies play a key role in providing such a justification. A recent...

As health policy-makers around the world seek to make progress towards universal health coverage they must navigate between two important ethical imperatives: to set national spending priorities fairly and efficiently; and to safeguard the right to health. These imperatives can conflict, leading some to conclude that rights-based approaches present a disruptive influence on health policy, hindering states’ efforts to set priorities fairly and efficiently. Here, we challenge this perception. We argue first that these points of tension stem largely from inadequate interpretations of the aims of priority setting as well as the right to health. We then discuss various ways in which the right to health complements traditional concerns of priority setting and vice versa. Finally, we set out a three-step process by which policy-makers may navigate the ethical and legal considerations at play.

Clinical researchers should help respect the autonomy and promote the well-being of prospective study participants by helping them make voluntary, informed decisions about enrollment. However, participants often exhibit poor understanding of important information about clinical research. Bioethicists have given special attention to “misconceptions” about clinical research that can compromise participants’ decision-making, most notably the “therapeutic misconception.” These misconceptions typically involve false beliefs about a study’s purpose, or risks or potential benefits for participants. In this article, we describe a misconception involving false beliefs about a study’s potential benefits for non-participants, or its expected social value. This social value misconception can compromise altruistically motivated participants’ decision-making, potentially threatening their autonomy and well-being. We show how the social value misconception raises ethical concerns for inherently low-value research, hyped research, and even ordinary research, and advocate for empirical and normative work to help understand and counteract this misconception’s potential negative impacts on participants.

What is a just way of spending public resources for health and health care? Several significant answers to this question are under debate. Public spending could aim to promote greater equality in health, for example, or maximize the health of the population, or provide the worst off with the best possible health. Another approach is to aim for each person to have "enough" so that her health or access to health care does not fall under a critical level. This latter approach is called sufficientarian. Sufficientarian approaches to distributive justice are intuitively appealing, but require further analysis and assessment. What exactly is sufficiency? Why do we need it? What does it imply for the just distribution of health or healthcare? This volume offers fresh perspectives on these critical questions. Philosophers, bioethicists, health policy-makers, and health economists investigate sufficiency and its application to health and health care in fifteen original contributions.

This paper responds to the commentaries from Stacy Carter and Alan Cribb. We pick up on two main themes in our response. First, we reflect on how the process of setting standards for empirical bioethics research entails drawing boundaries around what research counts as empirical bioethics research, and we discuss whether the standards agreed in the consensus process draw these boundaries correctly. Second, we expand on the discussion in the original paper of the role and significance of the concept of ‘integrating’ empirical methods and ethical argument as a standard for research practice within empirical bioethics.

Background: It is often claimed that a regulated kidney market would significantly reduce the kidney shortage, thus saving or improving many lives. Data are lacking, however, on how many people would consider selling a kidney in such a market. Methods: A survey instrument, developed to assess behavioural dispositions to and attitudes about a hypothetical regulated kidney market, was given to Swiss third-year medical students. Results: Respondents’ (n = 178) median age was 23 years. Their socioeconomic status was high or middle (94.6%). 48 (27%) considered selling a kidney in a regulated kidney market, of whom 31 (66%) would sell only to overcome a particularly difficult financial situation. High social status and male gender was the strongest predictor of a disposition to sell. 32 of all respondents (18%) supported legalising a regulated kidney market. This attitude was not associated with a disposition to sell a kidney. 5 respondents (2.8%) endorsed a market and considered providing a kidney to a stranger if and only if paid. 4 of those 5 would sell only under financial duress. Conclusions: Current understanding of a regulated kidney market is insufficient. It is unclear whether a regulated market would result in a net gain of kidneys. Most possible kidney vendors would only sell in a particularly difficult financial situation, raising concerns about the validity of consent and inequities in the provision of organs. Further empirical and normative analysis of these issues is required. Any calls to implement and evaluate a regulated kidney market in pilot studies are therefore premature.

In controlled human infection (CHI) studies, investigators deliberately infect healthy individuals with pathogens in order to study mechanisms of disease or obtain preliminary efficacy data on investigational vaccines and medicines. CHI studies offer a fast and cost‐effective way of generating new scientific insights, prioritizing investigational products for clinical testing, and reducing the risk that large numbers of people are exposed to ineffective or harmful substances in research or in practice. Yet depending on the pathogen, CHI studies can involve significant risks or burdens for participants, pose risks to individuals or communities not involved in the research, and lead to public controversy. It is therefore essential to ensure that the risks of CHI studies are justified by their social value—that is, their potential to generate benefits for society—and that public trust can be maintained. In this paper, we aim to clarify how research sponsors, research ethics committees and other reviewers should judge the social value of CHI studies. We develop a list of relevant considerations for making social value judgments based on the standard view of social value. We then use this list to discuss the example of potentially conducting dengue virus CHI studies in endemic settings. We argue that dengue virus CHI studies in endemic settings would fall on the higher end of the spectrum of social value, mostly because of their potential to redirect all fields of future dengue research. Drawing on this discussion, we derive several general recommendations for how reviewers should judge the social value of CHI studies.

In controlled human infection studies (CHIs), participants are deliberately exposed to infectious agents in order to better understand the mechanism of infection or disease and test therapies or vaccines. While most CHIs have been conducted in high‐income countries, CHIs have recently been expanding into low‐ and middle‐income countries (LMICs). One potential ethical concern about this expansion is the challenge of obtaining the voluntary informed consent of participants, especially those who may not be literate or have limited education. In some CHIs in LMICs, researchers have attempted to address this potential concern by limiting access to literate or educated populations. In this paper, we argue that this practice is unjustified, as it does not increase the chances of obtaining valid informed consent and therefore unfairly excludes illiterate populations and populations with lower education. Instead, we recommend that investigators improve the informed consent process by drawing on existing data on obtaining informed consent in these populations and interventions aimed at improving their understanding. Based on a literature review, we provide concrete suggestions for how to follow this recommendation and ensure that populations with lower literacy or education are given a fair opportunity to protect their rights and interests in the informed consent process.

Several influential ethical guidelines and frameworks endorse the view that research with human participants is ethically acceptable only when it has “social value,” meaning that it generates knowledge which can be used to benefit society. For example, the Nuremberg Code requires that medical experiments on human beings “yield fruitful results for the good of society, unprocurable by other methods or means of study”. The Council for International Organizations of Medical Sciences guidelines hold that “health-related research with humans... must have social value” or the “prospect of generating the knowledge and the means necessary to protect and promote people’s health” (CIOMS...