Withholding consent to lifesaving treatment: three cases.

The refusal of children or their parents to consent to treatment that professionals regard as essential always results in a dilemma. Responding to such refusals demands careful and sensitive clinical and thicolegal intervention and close cooperation among professionals, in particular doctors and social workers. Since the introduction of the Children Act 1989 the number of cases in which children have withheld consent to lifesaving treatment has risen, and it is now increasingly recognised that children have a right to have their views legally represented if a local authority or health authority seeks a court''s leave to carry out treatment. Professionals have to consider which legal route, under either the Children Act or the Mental Health Act, is likely to be best for the individual child.     

WHICH BENEFITS OF RESEARCH PARTICIPATION COUNT AS ‘DIRECT’?

It is widely held that individuals who are unable to provide informed consent should be enrolled in clinical research only when the risks are low, or the research offers them the prospect of direct benefit. There is now a rich literature on when the risks of clinical research are low enough to enroll individuals who cannot consent. Much less attention has focused on which benefits of research participation count as ‘direct’, and the few existing accounts disagree over how this crucial concept should be defined. This disagreement raises concern over whether those who cannot consent, including children and adults with severe dementia, are being adequately protected. The present paper attempts to address this concern by considering first what additional protections are needed for these vulnerable individuals. This analysis suggests that the extant definitions of direct benefits either provide insufficient protection for research subjects or pose excessive obstacles to appropriate research. This analysis also points to a modified definition of direct benefits with the potential to avoid these two extremes, protecting individuals who cannot consent without blocking appropriate research.     

Schoolchildren cooperate more successfully with non-kin than with siblings

Cooperation plays a key role in the development of advanced societies and can be stabilized through shared genes (kinship) or reciprocation. In humans, cooperation among kin occurs more readily than cooperation among non-kin. In many organisms, cooperation can shift with age (e.g. helpers at the nest); however, little is known about developmental shifts between kin and non-kin cooperation in humans. Using a cooperative game, we show that 3- to 10-year-old French schoolchildren cooperated less successfully with siblings than with non-kin children, whether or not non-kin partners were friends. Furthermore, children with larger social networks cooperated better and the perception of friendship among non-friends improved after cooperating. These results contrast with the well-established preference for kin cooperation among adults and indicate that non-kin cooperation in humans might serve to forge and extend non-kin social relationships during middle childhood and create opportunities for future collaboration beyond kin. Our results suggest that the current view of cooperation in humans may only apply to adults and that future studies should focus on how and why cooperation with different classes of partners might change during development in humans across cultures as well as other long-lived organisms.     

Using data to improve surrogate consent for clinical research with incapacitated adults

Current practice relies on surrogates to enroll incapacitated adults in research. Yet, it is unclear to what extent this practice protects adults who have lost the ability to consent for themselves. To address this question, we conducted two literature searches to identify articles which report empirical data on three issues central to protecting adults who have lost the ability to consent: (1) adults' willingness to participate in research should they lose the ability to consent; (2) adults' willingness to allow a surrogate to make research decisions for them; and (3) the extent to which surrogates' enrollment decisions are consistent with their charges' preferences and values. These searches identified 21 articles, representing 20 distinct datasets. The data indicate that many adults are willing to participate in research should they lose the ability to consent, and many are willing to allow their family members to make research decisions for them if they become incapacitated. The data also raise concern that surrogates may be making research enrollment decisions that, in some cases, are inconsistent with their charges' preferences and values. These findings suggest that modifications to current practice should be considered to better protect adults who have lost the ability to consent. One option would be to require, in addition to surrogate permission and subject assent, sufficient evidence that enrollment is consistent with the individual's preferences and values.     

ON THE NEED FOR IMPROVED PROTECTIONS OF INCAPACITATED AND NON‐BENEFITING RESEARCH SUBJECTS

In this article, it is claimed that the protective provisions for adults with impaired decision‐making capacity are misguided, insofar as they do not conclusively state whether research on this group should be permitted only as an exception, and as they arbitrarily allow for some groups to benefit from such research while others will not. Moreover, the presumed or former will of the subject is given insufficient weight, and the minimal risk standard does not make sense in this context. Because of these problems, the present guidelines allow for the possibility of vulnerable people being exploited, something that is hidden behind a guise of solidarity. Instead we need to address the real issues at stake by rewriting the present statutes. It is suggested that new guidelines should be in some continuity with earlier efforts. However, in order to protect these subjects there is additional need for appointed representatives who monitor research and for legal obligations to compensate for any injuries suffered. Without these or similar measures we won't have an adequate system in place for the protection of non‐benefiting persons who are unable to consent to research.     

Autonomy is a Right,Not a Feat: How Theoretical Misconceptions have Muddled the Debate on Dynamic Consent to Biobank Research

Should people be involved as active participants in longitudinal medical research, as opposed to remaining passive providers of data and material? We argue in this article that misconceptions of ‘autonomy’ as a kind of feat rather than a right are to blame for much of the confusion surrounding the debate of dynamic versus broad consent. Keeping in mind two foundational facts of human life, freedom and dignity, we elaborate three moral principles – those of autonomy, integrity and authority – to better see what is at stake. Respect for autonomy is to recognize the other's right to decide in matters that are important to them. Respect for integrity is to meet, in one's relationship with the other, their need to navigate the intersection between private and social life. Respect for authority is to empower the other – to help them to cultivate their responsibility as citizens. On our account, to force information onto someone who does not want it is not to respect that person's autonomy, but to violate integrity in the name of empowerment. Empowerment, not respect for autonomy, is the aim that sets patient‐centred initiatives employing a dynamic consent model apart from other consent models. Whether this is ultimately morally justified depends on whether empowerment ought to be a goal of medical research, which is questionable.     

Group bias in cooperative norm enforcement

A hallmark of human social cognition is the tendency for both adults and children to favour members of their own groups. Critically, this in-group bias exerts a strong influence on cooperative decision-making: people (i) tend to share more with members of their in-group and (ii) differentially enforce fairness norms depending on the group membership of their interaction partners. But why do people show these group biases in cooperation? One possibility is that the enforcement of cooperative norm violations is an evolved mechanism supporting within-group cooperation (Norms-Focused Hypothesis). Alternatively, group bias in cooperation could be a by-product of more general affective preferences for in-group members (Mere Preferences Hypothesis). Here, we appraise evidence from studies of both adults and children with the goal of understanding whether one of these two accounts is better supported by existing data. While the pattern of evidence is complex, much of it is broadly consistent with the Mere Preferences Hypothesis and little is uniquely supportive of the Norms-Focused Hypothesis. We highlight possible reasons for this complexity and suggest ways that future work can continue to help us understand the important relationship between group bias and cooperation.     

Against Harmful Research on Non‐Agreeing Children

The Code of Federal Regulations permits harmful research on children who have not agreed to participate, but I will argue that it should be no more permissive of harmful research on such children than of harmful research on adults who have not agreed to participate. Of course, the Code permits harmful research on adults. Such research is not morally problematic, however, because adults must agree to participate. And, of course, the Code also permits beneficial research on children without needing their explicit agreement. This sort of research is also not problematic, this time because paternalism towards children may be justifiable. The moral problem at the center of this paper arises from the combination of two potential properties of pediatric research, first that it might be harmful and second that its subjects might not agree to participate. In Section 2 of this article I explain how the Code permits harmful research on non‐agreeing children. Section 3 contains my argument that we should no more permit harmful research on non‐agreeing children than on non‐agreeing adults. In Section 4, I argue that my thesis does not presuppose that pediatric assent has the same moral force that adult consent does. In Section 5, I argue that the distinction between non‐voluntary and involuntary research is irrelevant to my thesis. In Section 6, I rebut an objection based on the power of parental permission. In Section 7 I suggest how the Code of Federal Regulations might be changed.     

Transitional Paternalism: How Shared Normative Powers Give Rise to the Asymmetry of Adolescent Consent and Refusal

In many jurisdictions, adolescents acquire the right to consent to treatment; but in some cases their refusals – e.g. of life‐saving treatment – may not be respected. This asymmetry of adolescent consent and refusal seems puzzling, even incoherent. The aim here is to offer an original explanation, and a justification, of this asymmetry. Rather than trying to explain the asymmetry in terms of a variable standard of competence – where the adolescent is competent to consent to, but not refuse, certain interventions – the account offered here focuses more closely on the normative power to render actions permissible. Where normative powers are shared they can readily give rise to an asymmetry between consent and refusal. We then turn to why it is justifiable that normative powers be shared in adolescence. Transitional paternalism holds that the acquisition of normative powers by competent adolescents should not be an instant one, achieved in a single step, but that there should be a transitional period where paternalistic protection is rolled back, but not entirely withdrawn until a later date. Transitional paternalism could be implemented without generating the asymmetry between consent and refusal but, it is argued, the asymmetric version of transitional paternalism is to be preferred insofar as it offers a greater respect for the adolescent's decisions than the symmetrical alternative.     

The smell of cooperation: rats increase helpful behaviour when receiving odour cues of a conspecific performing a cooperative task

Reciprocity can explain cooperative behaviour among non-kin, where individuals help others depending on their experience in previous interactions. Norway rats (Rattus norvegicus) cooperate reciprocally according to direct and generalized reciprocity. In a sequence of four consecutive experiments, we show that odour cues from a cooperating conspecific are sufficient to induce the altruistic help of rats in a food-exchange task. When rats were enabled to help a non-cooperative partner while receiving olfactory information from a rat helping a conspecific in a different room, they helped their non-cooperative partner as if it was a cooperative one. We further show that the cues inducing altruistic behaviour are released during the act of cooperation and do not depend on the identity of the cue provider. Remarkably, olfactory cues seem to be more important for cooperation decisions than experiencing a cooperative act per se. This suggests that rats may signal their cooperation propensity to social partners, which increases their chances to receive help in return.     

Benevolent Characteristics Promote Cooperative Behaviour among Humans

Cooperation is fundamental to the evolution of human society. We regularly observe cooperative behaviour in everyday life and in controlled experiments with anonymous people, even though standard economic models predict that they should deviate from the collective interest and act so as to maximise their own individual payoff. However, there is typically heterogeneity across subjects: some may cooperate, while others may not. Since individual factors promoting cooperation could be used by institutions to indirectly prime cooperation, this heterogeneity raises the important question of who these cooperators are. We have conducted a series of experiments to study whether benevolence, defined as a unilateral act of paying a cost to increase the welfare of someone else beyond one''s own, is related to cooperation in a subsequent one-shot anonymous Prisoner''s dilemma. Contrary to the predictions of the widely used inequity aversion models, we find that benevolence does exist and a large majority of people behave this way. We also find benevolence to be correlated with cooperative behaviour. Finally, we show a causal link between benevolence and cooperation: priming people to think positively about benevolent behaviour makes them significantly more cooperative than priming them to think malevolently. Thus benevolent people exist and cooperate more.     

Capuchins do cooperate: the advantage of an intuitive task

We used a cooperative pulling task to examine proximate aspects of cooperation in captive brown capuchin monkeys, Cebus apella. Specifically, our goal was to determine whether capuchins can learn the contingency between their partner's participation in a task and its successful completion. We examined whether the monkeys visually monitored their partners and adjusted pulling behaviour according to their partner's presence. Results on five same-sex pairs of adults indicate that (1) elimination of visual contact between partners significantly decreased success, (2) subjects glanced at their partners significantly more in cooperative tests than in control tests in which no partner-assistance was needed, and (3) they pulled at significantly higher rates when their partner was present rather than absent. Therefore, in contrast to a previous report by Chalmeau et al. (1997, Animal Behaviour, 54, 1215-1225), cooperating capuchins do seem able to take the role of their partner into account. However, the type of task used may be an important factor affecting the level of coordination achieved. Copyright 2000 The Association for the Study of Animal Behaviour.     

Why What Juveniles Do Matters in the Evolution of Cooperative Breeding

The evolution of cooperative breeding is complex, and particularly so in humans because many other life history traits likely evolved at the same time. While cooperative childrearing is often presumed ancient, the transition from maternal self-reliance to dependence on allocare leaves no known empirical record. In this paper, an exploratory model is developed that incorporates probable evolutionary changes in birth intervals, juvenile dependence, and dispersal age to predict under what life history conditions mothers are unable to raise children without adult cooperation. The model’s outcome variable (net balance) integrates dependent children’s production and consumption as a function of varying life history parameters to estimate the investment mothers or others have to spend subsidizing children. Results suggest that maternal-juvenile cooperation can support the early transition toward a reduction in birth intervals, a longer period of juvenile dependence, and having overlapping young. The need for adult cooperation is most evident when birth intervals are short and age at net production is late. Findings suggest that the needs of juveniles would not have been an early selective force for adult cooperation. Rather, an age-graded division of labor and the mutual benefits of maternal-juvenile cooperation could be an important, but overlooked step in the evolution of cooperative breeding.     

Does benefit justify research with children?

The inclusion of children in research gives rise to a difficult ethical question: What justifies children's research participation and exposure to research risks when they cannot provide informed consent? This question arises out of the tension between the moral requirement to obtain a subject's informed consent for research participation, on the one hand, and the limited capacity of most children to provide informed consent, on the other. Most agree that children's participation in clinical research can be justified. But the ethical justification for exposing children to research risks in the absence of consent remains unclear. One prevalent group of arguments aims to justify children's risk exposure by appealing to the concept of benefit. I call these ‘benefit arguments’. Prominent versions of this argument defend the idea that broadening our understanding of the notion of benefit to include non‐medical benefits (such as the benefit of a moral education) helps to justify children's research participation. I argue that existing benefit arguments are not persuasive and raise problems with the strategy of appealing to broader notions of benefit to justify children's exposure to research risk.     

On the further integration of cooperative breeding and cooperation theory

We present a synopsis about the commentaries to the target article "Integrating cooperative breeding into theoretical concepts of cooperation", in which we attempted to integrate general mechanisms to explain cooperative behaviour among unrelated individuals with classic concepts to explain helping behaviour in cooperative breeders that do not invoke kin-based benefits. Here we (1) summarize the positions of the commentators concerning the main issues we raised in the target article and discuss important criticisms and extensions. (2) We relate our target article to some recent reviews on the evolution of cooperation and, (3) clarify how we use terminology with regard to cooperation and cooperative behaviour. (4) We discuss several aspects that were raised with respect to cooperative interactions including by-product mutualism, generalised reciprocity and multi-level selection and, (5) examine the alternatives to our classification scheme as proposed by some commentaries. (6) Finally, we highlight several aspects that might hinder the application of game theoretical mechanisms of cooperation in cooperatively breeding systems. Although there is broad agreement that cooperative breeding theory should be integrated within the more general concepts of cooperation, there is some debate about how this may be achieved. We conclude that the contributions in this special issue provide a fruitful first step and ample suggestions for future directions with regard to a more unified framework of cooperation in cooperative breeders.     

Evolution of cooperative cross-feeding could be less challenging than originally thought

The act of cross-feeding whereby unrelated species exchange nutrients is a common feature of microbial interactions and could be considered a form of reciprocal altruism or reciprocal cooperation. Past theoretical work suggests that the evolution of cooperative cross-feeding in nature may be more challenging than for other types of cooperation. Here we re-evaluate a mathematical model used previously to study persistence of cross-feeding and conclude that the maintenance of cross-feeding interactions could be favoured for a larger parameter ranges than formerly observed. Strikingly, we also find that large populations of cross-feeders are not necessarily vulnerable to extinction from an initially small number of cheats who receive the benefit of cross-feeding but do not reciprocate in this cooperative interaction. This could explain the widespread cooperative cross-feeding observed in natural populations.     

Life history strategy and human cooperation in economic games

Across five studies using samples from both Japan and United States (N = 2345), we take a multi-method approach to test the prediction from life history theory that a slow, compared to fast, life history strategy promotes investment in cooperative relationships. Studies 1 and 2 examined how different measures as proxies for life history strategy (i.e., Mini-K and High-K Strategy Scale) relate to cooperation in various economic games. Studies 3 to 5 measured early childhood environments (i.e., childhood harshness and unpredictability), manipulated resource scarcity using previously validated methods, and then measured cooperation. Across our studies, we also examined four hypothesized psychological mechanisms that could explain the relation between life history strategy and cooperation: temporal discounting, concern for reputation, social value orientation, and trust in others. Overall, we found no support for the hypothesis that life history strategy predicts cooperation or that early childhood environments interact with current resource scarcity to predict cooperation. Thus, our initial findings imply that life history theory may not account for individual variation in cooperation with unknown others.     

The use of stored tissue samples from minors for genetic research: interviews with professionals

Stored tissue sample collections from minors are useful for genetic research. The ethics of the use of stored tissue samples for genetic research continues be a much debated topic of discussion. The use of pediatric samples poses specific ethical questions. Although a substantial corpus of empirical literature exists on the use of samples from adults, not much is known about the opinion of professionals on the use of samples from children. We conducted ten interviews with professionals in the field. Their primary concerns were the fact that consent procedures should not be too bureaucratic, the need for proper research design and privacy protections, the fact that research should not burden children and guidance from ethics committees.     

Erosion of informed consent in U.S. research

This paper evaluates four recent randomized clinical trials in which the informed consent of participants was either not sought at all, or else was conducted with critical information missing from the consent documents. As these studies have been taking place, various proposals to conduct randomized clinical trials without consent have been appearing in the medical literature. Some of the explanations offered for why it is appropriate to bypass consent or disclosure requirements appear to represent a fundamental misunderstanding of applicable government regulations and even the research enterprise. Others are the result of conceptual disagreements about the importance and application of traditional research ethics norms to ‘comparative effectiveness research’ and modern research environments. Common among these explanations, however, is a failure to appreciate when a research intervention, rather than merely an observation or review of data, is taking place. Review committees and investigators are failing to see, or choosing to ignore, interventions in the lives of research subjects. When these studies have come to light, government agencies with oversight authority have done little or backed down. Prestigious medical journals have published research results knowing that the required consent was not obtained, or they have stood by the published studies even after the inadequacy of consent is discovered. This article critically examines this erosion of consent in theory and practice and calls for restoring the requirement of informed consent to its proper place as a priority in human subjects research.     

Child assent and parental permission for clinical research--some considerations

The success of our future efforts to understand and improve the ethics of pediatric informed consent may depend, in large measure, on our willingness and ability to conceive of child assent and parental permission as joint, mutually affective processes. Given current trends, our empirical efforts may need to unfold at the interface of assent and parental permission, rather than exclusively or even primarily in one domain or the other. This shift will permit researchers to identify those areas in which the two mechanisms function in concert--in the best interests of patients, parents, and clinicians--and those in which they do not. Targeting these problematic areas for intervention and improvement may result in a more effective consent process for clinical research involving minors.