Investigating the causes of unethical behaviors in academia, such as scientific misconduct, has become a highly important research subject. The current performance measurement practices (e.g., equating research performance with the number of publications in top-tier journals) are frequently referred to as being responsible for scientists’ unethical behaviors. We conducted qualitative semi-structured interviews with different stakeholders of the higher education system (e.g., professors and policy makers; N = 43) to analyze the influence of performance measurement on scientists’ behavior. We followed a (...) three-step coding procedure and found (1) that the participants described a variety of positive behavioral consequences (e.g., higher productivity) but mainly negative behavioral consequences (e.g., questionable publishing practices) of current performance measurement practices in academia; (2) that scientists’ behavior can be described as gaming performance measurement (i.e., achieving performance goals by reducing performance quality and focusing on those tasks that are measured); and (3) that gaming performance measurement shares the same characteristics as deviant workplace behavior (i.e., a voluntary violation of organizational norms that harms the university). We discuss that gaming performance measurement has not been considered as a type of deviant workplace behavior in the previous literature. Furthermore, we draw from research on deviant workplace behavior and goal setting to discuss psychological processes that may underlie gaming performance measurement. Our results indicate the importance of connecting literature on deviant workplace behavior and goal setting to advance our understanding of gaming performance measurement. (shrink)

On Our Allotted Guardian Spirit is a lively and at times perplexing text combining general reflections on the nature of the soul with a discussion of the phenomenon of a personal guardian spirit. Plotinus wants to interpret Plato, and aims to integrate Plato's various statements about daimones into one comprehensive theory. This leads to some views that are, if not exotic, then at least strange on first encounter. However, a closer reading reveals that Plotinus is not interested in demonology per (...) se. Instead, the central concern of the treatise are ideas about the soul, the self, and self-consciousness. Plotinus' explorations produce a theory of the mind as the agent and activity responsible for a person’s ethical choices and conduct of life. The demon emerges as a philosophical tool passed down from Plato, but adapted and rationalized to try to explain motivation to action, the impulse toward the ethical life, and even the various differences in human ethical and psychological constitution. This innovative theory is a response to a strong and ongoing current of thought in the philosophical tradition. The introduction offers an overview of ancient demonologies, starting with Homer and the Presocratics, and is followed by an in-depth examination of Plato, the Stoics, Plotinus, and later Neoplatonic developments. As such the book presents Plotinus’ specific rationalizing response to the idea of a guardian spirit in the context of ancient philosophical demonologies. (shrink)

In Pninis grammar of Sanskrit one finds the ivastras, a table which defines the natural classes of phonological segments in Sanskrit by intervals. We present a formal argument which shows that, using his representation method, Pninis way of ordering the phonological segments to represent the natural classes is optimal. The argument is based on a strictly set-theoretical point of view depending only on the set of natural classes and does not explicitly take into account the phonological features of the segments, (...) which are, however, implicitly given in the way a language clusters its phonological inventory. The key idea is to link the graph of the Hasse-diagram of the set of natural classes closed under intersection to ivastra-style representations of the classes. Moreover, the argument is so general that it allows one to decide for each set of sets whether it can be represented with Pninis method. Actually, Pnini had to modify the set of natural classes to define it by the ivastras (the segment h plays a special role). We show that this modification was necessary and, in fact, the best possible modification. We discuss how every set of classes can be modified in such a way that it can be defined in a ivastra-style representation.1. (shrink)

In recent years, AI research has become more and more computationally demanding. In natural language processing, this tendency is reflected in the emergence of large language models like GPT-3. These powerful neural network-based models can be used for a range of NLP tasks and their language generation capacities have become so sophisticated that it can be very difficult to distinguish their outputs from human language. LLMs have raised concerns over their demonstrable biases, heavy environmental footprints, and future social ramifications. In (...) December 2020, critical research on LLMs led Google to fire Timnit Gebru, co-lead of the company’s AI Ethics team, which sparked a major public controversy around LLMs and the growing corporate influence over AI research. This article explores the role LLMs play in the political economy of AI as infrastructural components for AI research and development. Retracing the technical developments that have led to the emergence of LLMs, we point out how they are intertwined with the business model of big tech companies and further shift power relations in their favour. This becomes visible through the Transformer, which is the underlying architecture of most LLMs today and started the race for ever bigger models when it was introduced by Google in 2017. Using the example of GPT-3, we shed light on recent corporate efforts to commodify LLMs through paid API access and exclusive licensing, raising questions around monopolization and dependency in a field that is increasingly divided by access to large-scale computing power. (shrink)

Different types of consent are used to obtain human biospecimens for future research. This variation has resulted in confusion regarding what research is permitted, inadvertent constraints on future research, and research proceeding without consent. The National Institutes of Health Clinical Center's Department of Bioethics held a workshop to consider the ethical acceptability of addressing these concerns by using broad consent for future research on stored biospecimens. Multiple bioethics scholars, who have written on these issues, discussed the reasons for consent, the (...) range of consent strategies, and gaps in our understanding, and concluded with a proposal for broad initial consent coupled with oversight and, when feasible, ongoing provision of information to donors. This article describes areas of agreement and areas that need more research and dialogue. Given recent proposed changes to the Common Rule, and new guidance regarding storing and sharing data and samples, this is an important and tim.. (shrink)

BackgroundParents affected by cancer are confronted with challenges such as communicating with their children about the disease and dealing with changes in their parental role. Providing appropriate information could support affected parents and their children. Still, high-quality and information booklets are rare. Therefore, we developed an information booklet for affected families. The study aims are: investigating the acceptability and usability of the information booklet, determining parental information needs, and collating suggestions for implementation. Finally, we adapted the booklet according to the (...) findings.MethodsWe interviewed five experts in psychosocial care of parental cancer and nine affected parents using a semi-structured interview guideline. Participants received the developed booklet after giving the consent to participate. Interviews on acceptability and usability of the booklet and information needs were conducted about 1 week after receiving the booklet. The interviews were analyzed using structuring content analysis.Results Experts and parents reported that the information booklet addresses the experiences of affected families and that the content combination makes it useful in an unprecedented way indicating both acceptance and usability. Following dimensions were identified as information needs: communication, support offers, children’s disease understanding and needs, organization of family life, competence in parenting, and sources of additional information material. The booklet should be handed out personally by, e.g., healthcare professionals and might be accompanied by a personal counseling. Minor adaptations on language and content were conducted based on the findings.ConclusionIndicated acceptance and usability of the developed information booklet for parents with cancer suggest a low-threshold, basic support for affected families and health professionals. The diverse parental information needs are covered. The long-term effects of the booklet, e.g., on the use of psychosocial support offers, parental self-efficacy and psychological distress will be quantitatively investigated. (shrink)

abstractBackground: Evidence shows both a tendency for research participants to conflate research and clinical care and a limited public understanding of research. Conflation of research and care by participants is often referred to as the therapeutic misconception. Despite this evidence, few studies have explicitly asked participants, and especially minors, to explain what they think research is and how they think it differs from regular medical care. Methods: As part of a longer semistructured interview evaluating assent and parental permission for research, (...) adolescent research participants (n = 177), including adolescents with illnesses and healthy volunteers, and their parents (n = 177) were asked to describe medical research in their own words and say whether and how they thought being in medical research was different from seeing a regular doctor. Qualitative responses were coded and themes were identified through an iterative process. Results: When asked to describe medical research, the majority described research in terms of its goals of helping to advance science, develop treatments and medicines, and help others; fewer described research as having the goal of helping particular research participants, and fewer still in terms of the methods used in research. The majority of teen and parent respondents said being in research is different than seeing a regular doctor and explained this by describing different goals, different or more procedures, differences in the engagement of the doctors/researchers, and differences in logistics. Conclusions: Adolescents participating in clinical research and their parents generally describe medical research in terms of its goals of advancing science and finding new medicines and treatments, sometimes in combination with helping the enrolled individuals. The majority perceive a difference between research and regular medical care and described these differences in various ways. Further exploration is warranted about how such perceived differences matter to participants and how this understanding could be used to enhance informed consent and the overall research experience. (shrink)

Growing evidence suggests that pathological overactivation of the endocannabinoid system (ECS) is associated with dyslipidemia, obesity and diabetes. Indeed, this signalling system acting through cannabinoid receptors has been shown to function both centrally and peripherally to regulate feeding behaviour as well as energy expenditure and metabolism. Consequently, modulation of these receptors can promote significant alterations in body weight and associated metabolic profile. Importantly, blocking cannabinoid receptor type 1 function has been found to prevent obesity and metabolic dysfunction in various murine (...) models and in humans. Here we provide a detailed account of the known physiological role of the ECS in energy balance, and explore how recent studies have delivered novel insights into the potential targeting of this system as a therapeutic means for treating obesity and related metabolic disorders. (shrink)

The U.S. federal regulations require investigators conducting nonbeneficial research to obtain the assent of children who are capable of providing it. Unfortunately, there has been no analysis of which children are capable of assent or even what abilities ground the capacity to give assent. Why should investigators be required to obtain the positive agreement of some children, but not others, before enrolling them in research that does not offer a compensating potential for direct benefit? We argue that the scope of (...) children's research decision making should be based on the principles of respect for autonomy and nonmaleficence. These principles imply that the threshold for assent should be fixed at 14 years of age, and a dissent requirement should be adopted for all children in the context of nonbeneficial research. (shrink)

In Grimes v. Kennedy Krieger Institute (KKI), the Maryland Court of Appeals, while noting that U.S. federal regulations include risk standards for pediatric research, endorses its own risk standards. The Grimes case has implications for the debate over whether the minimal risk standard should be interpreted based on the risks in the daily lives of most children (the objective interpretation) or the risks in the daily lives of the children who will be enrolled in a given study (the subjective interpretation). (...) The court's use of the objective interpretation to block studies like the KKI study protects individual children who are worse off than the average child. Unfortunately, this approach also may block research intended to improve the lives of these same individuals. A similar dilemma arises in the context of multinational research, suggesting that a "modified objective standard," proposed to address this dilemma in the multinational setting, may offer a framework for addressing the dilemma in the context of pediatric research as well. (shrink)

The principle that physicians should always act in the best interests of the present patient is widely endorsed. At the same time, and often within the same document, it is recognised that there are appropriate exceptions to this principle. Unfortunately, little, if any, guidance is provided regarding which exceptions are appropriate and how they should be handled. These circumstances might be tenable if the appropriate exceptions were rare. Yet, evaluation of the literature reveals that there are numerous exceptions, several of (...) which pervade clinical medicine. This situation leaves physicians without adequate guidance on when to allow exceptions and how to address them, increasing the chances for unfairness in practice. The present article considers the range of exceptions, illustrates how the lack of guidance poses ethical concern and describes an alternative account of physician obligations to address this concern. (shrink)

Research studies and interventions sometimes offer potential benefits to subjects that compensate for the risks they face. Other studies and interventions, which I refer to as “nonbeneficial” research, do not offer subjects a compensating potential for benefit. These studies and interventions have the potential to exploit subjects for the benefit of others, a concern that is especially acute when investigators enroll individuals who are unable to give informed consent. US regulations for research with human subjects attempt to address this concern (...) by mandating strict protections for nonbeneficial research with subjects who cannot consent. Typically, humans who cannot consent, such as children, may be enrolled in nonbeneficial research only when it poses low risks and has the potential to gather information of sufficient value to justify the risks, an appropriate surrogate gives permission on the individual’s behalf and the individual agrees (assents). In contrast, US regulations for nonbeneficial research with nonhuman primates do not include these protections, even though it too involves subjects who cannot consent and who face risks for the benefit of others. Is this difference in regulatory protections justified? Or does the principle of fairness—treat like cases alike—imply that regulations for nonbeneficial research with nonhuman primates should include protections similar to those that apply to nonbeneficial research with humans who cannot consent? (shrink)

In standard medical care, physicians select treatments for patients based on clinical judgment, considering which treatment is best for the individual patient, given the patient's history and circumstances. In contrast, investigators conducting randomized clinical trials select treatments for participants based on a random selection process. Because this process represents a significant departure from the norms of standard medical care, it is widely assumed that potential research participants must understand randomization to give valid informed consent. This assumption, together with data that (...) many research participants do not understand randomization, implies that randomized clinical trials often fail to obtain adequately informed consent. Before accepting this conclusion, and before initiating extensive efforts to improve research participants' understanding of randomization, we should assess the plausible, but rarely analyzed assumption that participants need to understand randomization to give valid informed consent for randomized clinical trials. (shrink)

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. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:When Should “Riskier” Subjects Be Excluded from Research Participation?*Dave Wendler** (bio)AbstractThe exclusion of potential subjects based on increased risks is a common practice in human subjects research. However, there are no guidelines to ensure that this practice is conducted in a systematic and fair way. This gap in the literature and regulations is addressed by a specific account of a “condition on inclusion risks” (CIR), a condition under (...) which potential subjects should be excluded from research on the basis of increased risks. This account provides a general framework for assessing standard exclusions as well as more controversial ones such as the exclusion of pregnant women and women of childbearing potential from certain types of research.The exclusion of potential subjects on the basis of increased risks is a common and, in most instances, noncontroversial practice in human subjects research. Investigators routinely exclude potential subjects with reduced kidney function, bleeding disorders, and allergies to the drugs under investigation. Surprisingly, this use of exclusion criteria takes place in the absence of any explicit guidelines. In the present paper, I attempt to fill this gap in the literature and regulations by offering a specific account of the conditions under which potential subjects should be excluded from research on the basis of increased risk. This account serves two purposes.First, subjects who are excluded on the basis of increased risk are prevented from making their own enrollment decisions. Therefore, it is important to ensure, in spite of the broad range of potential subjects and the varied reasons for excluding them, that potential subjects are excluded in [End Page 307] a systematic and fair way. Second, certain instances of subject exclusion, most notably the exclusion of pregnant women and women of childbearing potential, raise more difficult issues. By providing a general framework for assessing the exclusion of potential subjects based on increased risks, the present analysis covers these cases as well and, thus, offers a solution to one of the thornier ethical dilemmas facing investigators and IRBs today.Briefly, I argue that standard exclusion practices suggest that whenever two groups of potential research subjects offer the same opportunity for scientific and individual benefit, but different levels of risk, the group that would introduce greater risks should be excluded. With this framework in place, I consider potential subjects, such as men and women of child-parenting potential, whose research participation introduces increased risks to third parties. I argue that the present approach is justified, not because it reduces harms to specific individuals, but because it reduces aggregate harms. Therefore, it should be applied to all riskier potential subjects regardless of who faces the risks in question. After defending this approach, I consider several objections.First, I argue that the present approach is not paternalistic; the exclusions it calls for are not justified by what is thought to be in the best interests of the individuals excluded. Rather, the argument is that these exclusions minimize the aggregate harm of human subjects research. In addition, the present approach does not violate the obligation of researchers to respect subject autonomy because it does not reduce the number of potential subjects who are given the opportunity to enroll in a particular protocol. Finally, the exclusions are consistent with reasonable side constraints on attaining the goals of research.“Riskier” SubjectsWhen it comes to evaluating risks, most guidelines on human subjects research stipulate simply that the risks entailed must be reasonable given the potential for benefit. The Australian National Health and Medical Research Council’s guidelines, for instance, require only that “the investigator... must be satisfied that the possible advantage to be gained from the work justifies any discomfort or risk involved” (ANMRC 1992, Clause 3). To determine whether the risks of a protocol are justified, one sums the risks of the various procedures in the protocol, whatever those procedures may be, and compares the result to the procedures’ potential for benefit. This evaluation of risks assumes that the aggregate risks of a [End Page 308] given protocol are fixed and thus will not help to determine whether and when the risks of particular protocols should be reduced by excluding riskier subjects. The United States Department of Health... (shrink)

This article investigates the deep-rooted logical structures underlying our thinking about other animals with a particular focus on topics relevant for cognitive primate research. We begin with a philosophical propaedeutic that makes perspicuous how we are to differentiate ontological from epistemological considerations regarding primates, while also accounting for the many perplexities that will undoubtedly be encountered upon applying this difference to concrete phenomena. Following this, we give an account of what is to be understood by the assertion of a thesis (...) of anthropological difference, identifying, inter alia, a property that fulfils the exclusivity, universality, and constitution criteria and demarcates the differentia specifica between humans and other animals. Also, we systematically develop how such theses can be formulated more moderately. Furthermore, we account for different theoretical frameworks, argumentative schemes, and sociological factors whose employment is associated with theses as such. This endeavor is carried out under the guise of anthropomorphism and anthropodenial. Doing so, we show that both are favored by the logic of cognitive primate research. Put briefly, concepts like cladistic parsimony and arguments by analogy favor anthropomorphism whereas concepts like traditional parsimony and Morgan’s canon favor anthropodenial. We close by framing these topics in the light of the self-other category mistake that lies in ascribing exclusive self-properties to some other. Lastly, we probe this category mistake for potency and scope of implications and find it to be central to and unavoidably ingrained in our thinking about other animals. (shrink)

Clinical research with adults who are unable to provide informed consent has the potential to improve understanding and care of a number of devasting conditions. This research also has the potential to exploit some of society's most vulnerable members. Recently, a number of task forces and individual writers have proposed guidelines to ensure that such research is both possible and ethical. Yet, there is widespread disagreement over which safeguards should be adopted. In the present paper, I consider to what extent (...) these disagreements can be resolved by appeal to a general account of the interests of subjects who are unable to consent and the conditions that must be satisfied for research enrollment to constitute exploitation of their inability to make their own decisions. (shrink)

When a patient lacks decision-making capacity and has not left a clear advance directive, there is now widespread agreement that patient-designated and next-of-kin surrogates should implement substituted judgment within a process of shared decision-making. Specifically, after discussing the “best scientific evidence available, as well as the patient's values, goals, and preferences” with the patient's clinicians, the patient-designated or next-of-kin surrogate should attempt to determine what decision the patient would have made in the circumstances. To the extent that this approach works, (...) it seems to provide about as much respect for the autonomy of incapacitated patients as we could ask for. But, as articles in this issue of the Report by Jeffrey Berger and by Ellen Robinson and colleagues emphasize, reality presents challenges. (shrink)

Although many of the issues surrounding innateness have received a good deal of attention lately, the basic concept of token innateness has been largely ignored. In the present paper, I try to correct this imbalance by offering an account of the innateness of token traits. I begin by explaining Stephen Stich's account of token innateness and offering a counterexample to that account. I then clarify why the contemporary biological approaches to innateness will not be able to resolve the problems that (...) beset Stich's account. From there, I develop an alternative understanding of the innateness of token traits, what I call a causal/explanatory account. The argument to be made is that token innateness is both a causal, and an explanatory, concept. After clarifying this understanding of innateness, and showing how it handles several counterexamples to other accounts, I end with some comments on what the causal/explanatory account suggests for our understanding of innateness in general. (shrink)

The U.S. federal regulations require investigators conducting nonbeneficial research to obtain the assent of children who are capable of providing it. Unfortunately, there has been no analysis of which children are capable of assent or even what abilities ground the capacity to give assent. Why should investigators be required to obtain the positive agreement of some children, but not others, before enrolling them in research that does not offer a compensating potential for direct benefit? We argue that the scope of (...) children's research decision making should be based on the principles of respect for autonomy and nonmaleficence. These principles imply that the threshold for assent should be fixed at 14 years of age, and a dissent requirement should be adopted for all children in the context of nonbeneficial research. (shrink)

Many people believe that animals possess moral status, but human beings possess higher moral status than animals. To try to identify a theoretical basis for this view, Robert Nozick proposed Utilitarianism for Animals, Kantianism for People. The present manuscript evaluates Nozick’s proposal by identifying the tradeoffs in welfare that it permits in medical research with animals and assessing whether those tradeoffs are indeed permissible. This analysis suggests that at least some deontological side constraints apply to the treatment of sentient animals, (...) hence, Utilitarianism for Animals, Kantianism for People is mistaken. Because Nozick’s proposal represents a prominent attempt to provide a theoretical basis for the common belief that human beings possess higher moral status than animals, this conclusion is noteworthy in its own right. Moreover, by granting equal moral weight to the interests of animals, but reserving deontological side constraints for human beings, Utilitarianism for Animals, Kantianism for People offers one of the more plausible bases for the claim that there are degrees of moral status among those who matter morally. The manuscript thus ends by considering the implications of the present analysis for the possibility that moral status comes in degrees. (shrink)

What is the status of the reduction in realistic phenomenology? Approaching this question presupposes understanding what realistic phenomenology is. Five ways of defining realistic phenomenology are delineated: 1) lineage definitions, 2) locality definitions, 3) thematic definitions, 4) definitions from the essence of philosophy, and 5) methodological definitions. The question of reduction’s status concerns mostly a combination of 4) and 5) but also draws on historical considerations. An overview of the realists’ critiques of the phenomenological reduction reveals that this method was (...) not unilaterally rejected and, thus, demonstrates that there is not only methodological epochism but indeed also methodological reductionism within realistic phenomenology. The common denominator of these critiques is that the reductive method in transcendental phenomenology depends on a phenomenological theory of reality. An indepth discussion of Scheler’s philosophical anthropology shows that it hinges on a principled revision and systematic completion of the reduction. Reduction is no longer viewed as a scientific method but as a technique of inner acting. From the vantage point of his voluntative realism, Scheler’s technological reductionism is spelled out in terms of a stratified scheme relating reality experiences as resistance to the levels of the vital-psychic sphere: 1) primary resistance, 2) ecologically bound resistance, 3) internalized resistance, 4) ego-dystonic resistance and 5) (dis-)inhibition and objectification of drive impulses. Drawing on Celms’s distinction between 1) reducendum, 2) reductive base, 3) reduction as an epistemic act, and 4) result of the reduction, a new and systematic interpretation of Schelerian reductions is developed for the scientific, phenomenological/Apollonian, Dionysian, and cathartic reductions. Each reductive technique cultivates man’s facultative dispositions (intellect, will, feeling). Only their concerted cooperation unlocks man’s full cognitive and ethical potential. (shrink)

Those involved in research with humans confront a host of ethical issues and a maze of regulations. James M. DuBois’s Ethics in Mental Health Research: Principles, Guidance, and Cases is here to help. The book covers a broad range of issues in research ethics, including informed consent, risks and benefits, privacy and confidentiality, and conflicts of interest. Thus, while the title focuses on mental health research, the book should also be of interest to individuals involved in other types of research (...) with humans. (shrink)

Deep Disagreements from the Logico-Pragmatical Point of View: An Analysis of Disagreements Based on Moyal-Sharrock’s Interpretation of Wittgenstein’s On Certainty. Argumentation is central to philosophy. One of its primary functions is to resolve disagreement. Yet, there are cases of disagreement that undercut the conditions of possibility for argumentation themselves: deep disagreements. In his seminal paper, Fogelin conceived of deep disagreements in Wittgensteinian terms by highlighting their “grammatical” character. Other than normal disagreements, which are located in the space of giving and (...) receiving reasons, deep disagreements are concerned with what enables reasoning in the first place. Hence, they cannot be rationally resolved. Drawing on an interpretation of Moyal-Sharrock’s account of Wittgensteinian certainties, my logico-grammatical account proposes that deep disagreements pertain to certainties, viz. non-proposional ways of acting in the life-world that are epistemologically basic. Furthermore, the logico-grammatical analysis entails a gradual conception of the transition from normal to deep disagreements by differentiating different types and origins of certainties and specifying which forms of certainty can and cannot be dropped. Also, it allows to identify participating in the human form of life and discursive capabilities as conditions of possibility of disagreements. Consequently, it can specify the turning-point at which disagreement transforms into mere difference. It is at this point that the focus of a dispute switches from the rationality of the discourse to that of the agents of discourse. (shrink)

Guidelines around the world require children to provide assent for their participation in most research studies. Yet, little further guidance is provided on how review committees should implement this requirement, including which children are capable of providing assent and when the requirement for assent may be waived on the grounds that the research offers participating children the potential for important clinical benefit. The present paper argues that the assent requirement is supported by the importance of allowing children who are capable (...) to make their own decisions. This suggests children are capable of assent when they become able to understand the research in question. While development varies across individual children, existing data suggest most children develop this ability by approximately age 14. Until instruments are developed to assess the assent capacity of individual children, this age should be used as the threshold for assent. In addition, the importance of protecting children from harm suggests that the sustained dissent of all children, including those who are unable to provide assent, should be respected. While the assent requirement may be waived when research participation offers the potential for important medical benefit that is unavailable outside the research context, analysis suggests that children’s sustained dissent should be respected in all cases. (shrink)

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 .. (shrink)

In this issue of the Hastings Center Report, Danielle Wenner looks at a few prominent analyses of the social value requirement for clinical research, claiming that they are all based on what she calls a transactional model of research ethics. She argues that the transactional model fails to provide a secure foundation for the social value requirement, and then, appealing to John Rawls, she argues that a more secure foundation lies in the principles of social justice. Wenner's attempt to locate (...) the source of the social value requirement raises important questions regarding its scope and strength. To determine what the social value requirement requires, we need to know why it's a requirement. Does the social value requirement apply to all trials or only to a subset? Is it a necessary condition on ethical research or an important consideration that can conflict with, and sometimes be defeated by, other considerations? Wenner's attempt to answer these questions is obscured by the fact that she mistakenly regards a minority view of research ethics as the mainstream view. Once we correct for that, her analysis of the foundation of the social value requirement provides a valuable opportunity to consider how the ethics of research as an institution might supplement or alter the ethics of individual clinical trials. (shrink)

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. (shrink)

Work on the therapeutic misconception suggests that investigators should ensure that potential research subjects understand the fundamental differences between clinical research and clinical care. Yet, what potential research subjects should understand depends on their circumstances and the study in question. This analysis implies that researchers and review committees should stop attempting to define, measure, and dispel the therapeutic misconception, and instead should focus on what potential subjects should understand to participate in individual studies.

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. (shrink)

In a previous article, I attempted to assess the likely impact of the most prominent versions of the therapeutic misconception (TM) on research subjects’ informed consent. I concluded that the TM is not nearly as significant a concern as is commonly thought, and that focusing on it is more likely to undermine than promote research subjects’ informed consent.A recent commentary rejects these conclusions, as least as they pertain to the “consensus” definition of the TM. The authors of the commentary argue (...) that work on the TM remains central to ensuring the appropriateness of research subjects’ consent and, by implication, the ethical acceptability of clinical research.The present work evaluates the arguments offered in support of these claims. This analysis reveals that the authors offer few substantive responses to my arguments, and the responses they do offer fail to undermine my prior conclusions. Furthermore, consideration of an additional issue—the emergence of learning healthcare systems—suggests that the TM is likely to be even less significant in the future, hence, focusing on it may be even more problematic than I argued previously. (shrink)

Discussion of the ethics of clinical trials in lower income countries has been dominated by concern over double standards. Most prominently, clinical trials of interventions that are less effective than the worldwide best treatment methods typically are not permitted in higher income countries. Commentators conclude that permitting such trials in lower income countries involves an ethical double standard. Despite significant attention to this concern, and its influence over prominent guidelines for research in lower income countries, there has been little analysis (...) of what constitutes an ethical double standard in clinical research. The present article attempts to address this gap in the literature. This analysis finds that ethical double standards involve a kind of disrespect, and yields a three-step decision procedure for evaluating when trials of less than the worldwide best methods raise this concern. Application of this procedure reveals that permitting these trials in lower income countries rarely involves an ethical double standard. Instead, the real challenge is determining when clinical trials of interventions that are less effective than the worldwide best represent a permissible and effective response to differences in access to healthcare between higher income and lower income countries. To protect research subjects, without blocking clinical trials that have the potential to improve health in lower income countries, research review committees and other stakeholders should focus on this issue, not on ethical double standards. (shrink)

There is much philosophical literature on the duty to rescue. Individuals who encounter and could save, at relatively little cost to themselves, a person at risk of losing life or limb are morally obligated to do so. Yet little has been said about the other side of the issue. There are cases in which the need for rescue could have been reasonably avoided by the rescuee. We argue for a duty to take rescue precautions, providing an account of the circumstances (...) in which it arises. This novel duty has important implications for public policy. We apply it to the situation of some of the uninsured in the United States. Given the US clinician's duty to provide emergency care to all people regardless of ability to pay, some of the uninsured have a moral duty to purchase health insurance. We defend the duty against objections, including the possibility that a right to rescue can be waived, thus undermining a duty to take rescue precautions, that the duty of many professionals is voluntarily incurred, and that a distinction between actively assumed and passively assumed risks matters morally. (shrink)

Many research projects rely on human biological materials and some of these projects generate revenue. Recently, it has been argued that investigators have a moral claim to share in the revenue generated by these projects, whereas persons who provide the biological material have no such claim (Truog, Kesselheim, and Joffe 2012). In this paper, we critically analyze this view and offer a positive proposal for why tissue providers have a moral claim to benefit. Focusing on payment as a form of (...) benefit, we argue that research is a joint project and propose a contribution principle for paying participants in those joint projects. We distinguish between contributions that shape a project’s revenue generating properties, grounding a claim to payment, and contributions that fail to ground such a claim. We conclude, contrary to existing arguments and practices, that some tissue providers have a moral claim to payment beyond compensation for risk and burden. This conclusion suggests that investigators, institutions, and sponsors should reconsider the fairness of their current practices. (shrink)

Weighted lottery proposals give guidance in rescue dilemma situations by balancing the demands of comparative and absolute fairness. While they do not advocate for saving the greater number outright, they are responsive to absolute fairness insofar as they show a certain sensitivity to the numbers involved. In this paper we investigate what criterion of absolute fairness we should demand weighted lotteries to fulfill. We do so by way of critically examining what is probably the most sophisticated weighted lottery on the (...) market: Gerard Vong's Exclusive Composition-Sensitive (EXCS) lottery. We find that both the standard that seems most common in the debate, and a different standard Vong uses to criticize Jens Timmermann's Individualist Lottery are in contradiction to basic demands placed upon weighted lotteries and are therefore unsuitable as necessary conditions for absolute fairness. We instead propose a purely gradual understanding of absolute fairness. (shrink)

Clinical research with children generates special ethical concern, raising the need for additional protections beyond those for research with competent adults. Most guidelines permit research with children when it offers a prospect of direct benefit, or poses minimal risk. Unlike many other guidelines, the U.S. federal regulations also allow institutional review boards to approve pediatric research that does not offer a prospect of direct benefit when the risks are no greater than a minor increase over minimal risk. To approve research (...) in this category, IRBs must find that two additional conditions obtain:1). The intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations; and 2). The intervention or procedure is likely to yield generalizable knowledge about the subjects disorder or condition which is of vital importance for the understanding or amelioration of the subjects disorder or condition. (shrink)

Individuals do not have a right to participate in clinical trials. But, they do have a right against being denied participation for inappropriate reasons. Despite the widespread endorsement of these two claims, there has been little discussion regarding which conditions for participation in clinical trials are appropriate and which are inappropriate. The present manuscript attempts to address this gap in the literature. We first describe and then argue against the claim that conditions on enrollment or continued participation are appropriate only (...) when they are needed to answer the scientific question(s) posed by the trial. We then offer an alternative view according to which the appropriateness of conditions depends on whether they help to satisfy the ethical requirements of clinical research. Because these requirements include social value, the present view implies that promoting social value is an acceptable reason to impose conditions on research participation. With this in mind, we explain why it is not coercive to require potential participants to accept conditions on enrollment that promote a trial's social value, even when the participants find those conditions unwelcome. We conclude by evaluating the present proposal's implications for the common practice of requiring participants to agree to the possible use of their leftover biospecimens in a broad range of future research. We argue, contra current regulatory policy, that this practice can be acceptable even when the present trial offers participants the prospect of clinical benefit and the samples are being reserved for future research that is unrelated to the present trial. (shrink)

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. (shrink)

Research regulations around the world do not impose any limits on the risks to which consenting adults may be exposed. Nonetheless, most review committees regard some risks as too high, even for consenting adults. To justify this practice, commentators have appealed to a range of considerations which are external to informed consent and the risks themselves. Most prominently, some argue that exposing consenting adults to very high risks has the potential to undermine public trust in research. This justification assumes that (...) it is not the magnitude of the risks themselves which raises concern, but the way in which the public might respond to them. This justification thus depends on the possibility that the public will find out about the risks and respond to them in the specified way. Like the other proposed external justifications, it thereby fails to offer a reason to think that exposing consenting adults to very high risks is problematic in itself. In the present paper, we describe and endorse a different justification. Rather than appealing to external factors, we argue that limits on risks for consenting adults trace to internal limits on informed consent, to limits on the things consent can and cannot make ethically permissible. In doing so, we aim to provide a firmer conceptual basis for the view that some research risks are unacceptably high, no matter how the research is conducted. (shrink)

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. (shrink)

Controversy persists over the ethics of compensating research participants and providing posttrial benefits to communities in developing countries. Little is known about residents' views on these subjects. In this study, interviews about compensation and posttrial benefits from a hypothetical HIV vaccine trial were conducted in Uganda’s Rakai District. Most respondents said researchers owed the community posttrial benefits and research compensation, but opinions differed as to what these should be. Debates about posttrial benefits and compensation rarely include residents' views like these, (...) but future ones should. (shrink)