Research on human subjects aims to obtain knowledge of vital importance for human health and functioning. Neuroscientific research specifically is understood as oriented towards three goals: the maintenance of neurological health, the treatment of neurological diseases or syndromes, and the enhancement of neurological functioning. Most guidelines or regulations for pediatric research (whether in the U.S. or elsewhere) require that if a research intervention exposes subjects to more than minimal risk, a prospect of direct benefit is required—along with some other (...) important criteria. It is also required for any research project, that the methods and design will yield scientifically valid knowledge. This is typically met via placebo-controlled trials. This chapter presents an argument to the effect that more than minimal risk research on pediatric subjects cannot meet both ethical requirements. The basic idea is that either the subjects in the control or experimental arm will receive a prospect of direct benefit, but not both. This chapter also argues that the ethical weight or importance of this dilemma is very acute for neuroscientific research given the complexity of the brain’s functioning and the correlated difficulty of judging whether there is a “prospect” of direct benefit. The second half responds to this argument via a case study in neuroscientific research. The solution recapitulates a type of component analysis according to which different ethical principles apply to different activities of a research study. (shrink)

The American Journal of Bioethics, Volume 11, Issue 6, Page 29-31, June 2011.

Paying research participants in developing countries like Uganda raises ethical concerns over potential for undue inducement. This article, based on an exploratory study, reviewed 49 research protocols from a national HIV/AIDS research ethics committee database. Payments mainly adhered to the reimbursement and compensation payment models. Offers made were diverse but basic in order to limit undue inducement. Implications in terms of undue inducement and possible impact on participants and research are discussed. We end by recommending standardization across comparable studies in (...) the interests of promoting high-quality research, altruism, voluntariness, and restraining unfair reimbursement practices in research. (shrink)

United States federal regulations for pediatric research with no prospect of direct benefit restrict institutional review board (IRB) approval to procedures presenting: 1) no more than "minimal risk" (§ 45CFR46.404); or 2) no more than a "minor increase over minimal risk" if the research is commensurate with the subjects' previous or expected experiences and intended to gain vitally important information about the child's disorder or condition (§ 45CFR46.406) (DHHS 2001). During the 25 years since their adoption, these regulations have (...) helped IRBs balance subject protections with the pursuit of scientific knowledge to advance children's welfare. At the same time, inconsistency in IRB application of these regulations to pediatric protocols has been widespread, in part because of the ambiguity of the regulatory language. During the past decade, three federally-charged committees have addressed these ambiguities: 1) the National Human Research Protections Advisory Committee (NHRPAC) (Washington, DC), 2) the Institute of Medicine (IOM) Committee on the Ethical Conduct of Clinical Research Involving Children (Washington, DC); and 3) the United States Department of Health and Human Services Secretary's Advisory Committee for Human Research Protections (SACHRP) (Washington, DC). The committees have reached similar conclusions on interpretation of language within regulations § § 45CFR46.404 and 406; these conclusions are remarkably consistent with recent international recommendations and those of the original National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1977) report from which current regulations are based. Drawing on the committees' public reports, this article identifies the ethical issues posed by ambiguities in regulatory language, summarizes the committees' deliberations, and calls for a national consensus on recommended criteria. (shrink)

Objectives To evaluate whether the requirement of “minimal risk and burden” for paediatric research without direct benefit to the subjects compromises the ability to obtain data necessary for improving paediatric care. To provide evidence-based reflections on the EU recommendation that allows for a higher level of risk. Design and setting Systematic analysis of the approval/rejection decisions made by the Dutch Central Committee on Research involving Human Subjects (CCMO). Review methods The analysis included 165 proposals for paediatric research without (...) class='Hi'>direct benefit that were reviewed by the CCMO between January, 2000, and July, 2007. A separate, in-depth analysis of all drug studies included 18 early phase drug studies and nine other drug studies without direct benefit. Results 11 out of 165 studies were definitively rejected because the CCMO did not regard the risk and/or burden to be minimal. In three of these 11 cases (including two early phase drug studies) the requirement of minimal risk and burden was cited as the only reason for rejection. Four other early phase drug studies also involved risks and/or burdens that were not regarded to be minimal but were nevertheless approved. Conclusions The requirement of minimal risk and burden, aiming to protect research subjects, occasionally leads to rejection of protocols. Early phase drug studies relatively often do not comply with the requirement. Committees may find ways to approve important studies that formally should be rejected, but that is not a desirable solution. The regulatory framework should be revised to make such occasional exceptions to the requirement legitimate and transparent. (shrink)

Volume 20, Issue 4, May 2020, Page 102-103.

Volume 20, Issue 4, May 2020, Page 108-110.

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. (shrink)

Advance directives are not a part of the healthcare service in Turkey. This may be related with the fact that paternalism is common among the healthcare professionals in the country, and patients are not yet integrated in the decision-making process adequately. However, starting from the enactment of the Regulation of Patient Rights in 1998, this situation started to change. While the paternalist tradition still appears to be strong in Turkey, the Ministry of Health has been taking concrete measures in the (...) recent years to ensure that patient rights are implemented in healthcare practice. Therefore, Turkey now seems to be in a transitional period where a move towards a more patient-autonomy centred approach is being supported by the regulatory authorities, as well as the academic circles and the public at large. In the light of this background, this paper aims to examine the potential benefits of advance directives, particularly with regard to their possible effect in the clinical decision-making process of Turkey's context. It will be argued that advance directives, if correctly understood and implemented in the right settings, may be beneficial, particularly for improving communication between patients and healthcare professionals and for implementing of the right to refuse treatment. (shrink)

Advance directives are not a part of the healthcare service in Turkey. This may be related with the fact that paternalism is common among the healthcare professionals in the country, and patients are not yet integrated in the decision‐making process adequately.However, starting from the enactment of the Regulation of Patient Rights in 1998, this situation started to change. While the paternalist tradition still appears to be strong in Turkey, the Ministry of Health has been taking concrete measures in the recent (...) years to ensure that patient rights are implemented in healthcare practice. Therefore, Turkey now seems to be in a transitional period where a move towards a more patient‐autonomy centred approach is being supported by the regulatory authorities, as well as the academic circles and the public at large. In the light of this background, this paper aims to examine the potential benefits of advance directives, particularly with regard to their possible effect in the clinical decision‐making process of Turkey's context. It will be argued that advance directives, if correctly understood and implemented in the right settings, may be beneficial, particularly for improving communication between patients and healthcare professionals and for implementing of the right to refuse treatment. (shrink)

ABSTRACTIn the face of widespread poverty, Peter Singer argues that the best response is giving money to charitable organizations that give aid to the poor. In response, much criticism has been leveled by cosmopolitan philosophers that philanthropy is unable to effectively combat poverty for many reasons: such funds fall prey to corrupt bureaucrats, the poor will waste the money, or become dependent upon donations rather than providing for themselves. In this paper, I argue that the work of the organization GiveDirectly (...) offers an approach that can overcome the criticisms leveled against philanthropy. GiveDirectly works by providing direct cash transfers to the poor; by adopting such a straightforward method, GiveDirectly provides practical benefits to the poor, and overcomes key philosophical critiques. The poor are empowered to make choices to meet their own needs, and do not become dependent upon donations. While GiveDirectly does not constitute the solution to the problem of global poverty, it does pro... (shrink)

Este trabajo presenta como objetivo revelar la influencia de los contextos socioeconómicos en las maneras de afrontamiento al cáncer como enfermedad. Se muestra un análisis sobre el cáncer como problema social y de salud; se analiza el papel de algunos entes sociales involucrados, el acceso de los enfermos a las terapias y de los productores de fármacos a las nuevas tecnologías. Se reflexiona acerca de la sobreevaluación de los fármacos que dificulta el acceso a novedosas y efectivas terapias; la supeditación (...) del saber tecnocientífico a los intereses del capital; la creciente contaminación ambiental como detonante al incremento de casos; y la escasez de tecnologías para la prevención y el saneamiento en países subdesarrollados. Finalmente se refiere el programa cubano de lucha contra el cáncer, su situación actual y proyecciones. This paper aimes at revealing the influence of the socioeconomic contexts on the way cancer is faced as a disease. An analysis about cancer as a social and health problem is presented; the role of some social organizations involved the sick's access to therepies and drug producers' access to new technologies. It is reflected on the over-asessment of drugs which makes access to new and effective therapies difficult; the subordination of the technoscientific knowledge to the interests of the capital; the growing environmental pollution as a trigger for cases increase; and the limited technological resources for prevention and cleanup in underdeveloped countries. Finally, it is made reference to the Cuban cancer fighting program, its current status and scope. (shrink)

When allocating scarce healthcare resources, the expected benefits of alternative allocations matter. But, there are different kinds of benefits. Some are direct benefits to the recipient of the resource such as the health improvements of receiving treatment. Others are indirect benefits to third parties such as the economic gains from having a healthier workforce. This article considers whether only the direct benefits of alternative healthcare resource allocations are relevant to allocation decisions, or whether (...) indirect benefits are relevant too. First, we distinguish different conceptions of direct and indirect benefits and argue that only a recipient conception could be morally relevant. We analyze four arguments for thinking that indirect benefits should not count and argue that none is successful in showing that the indirectness of a benefit is a good reason not to count it. We conclude that direct and indirect benefits should be evaluated in the same way. (shrink)

David KC Cooper,1 David Ayares21Thomas E Starzl Transplantation Institute, University of Pittsburgh Medical Center, Pittsburgh, PA, USA; 2Revivicor, Blacksburg, VA, USA: The transplantation of organs and cells from pigs into humans could overcome the critical and continuing problem of the lack of availability of deceased human organs and cells for clinical transplantation. Developments in the genetic engineering of pigs have enabled considerable progress to be made in the experimental laboratory in overcoming the immune barriers to successful xenotransplantation. With regard to (...) pig organ xenotransplantation, antibody- and cell-mediated rejection have largely been overcome, and the current major barrier is the development of coagulation dysregulation. This is believed to be due to a combination of immune activation of the vascular endothelial cells of the graft and molecular incompatibilities between the pig and primate coagulation–anticoagulation systems. Pigs with new genetic modifications specifically directed to this problem are now becoming available. With regard to less complex tissues, such as islets, neuronal cells, and corneas, the remaining barriers are less problematic, and graft survival in nonhuman primate models extends for >1 year in all three cases. In planning the initial clinical trials, consideration will be concentrated on the risk–benefit ratio, based to a large extent on the results of preclinical studies in nonhuman primates. If the benefit to the patient is anticipated to be high, eg, insulin-independent control of glycemia, and the potential risks low, eg, minimal risk of transfer of a porcine infectious agent, then a clinical trial would be justified.Keywords: infection, pigs, genetically-engineered, xenotransplantation, islets, xenotransplantation, organs. (shrink)

When does benefiting from others’ wrongdoing effectively make one a moral accomplice in their evil deeds? If stem cell research lives up to its therapeutic promise, this question (which has previously cropped up in debates over fetal tissue research or the use of Nazi research data) is likely to become a central one for opponents of embryo destruction. I argue that benefiting from wrongdoing is prima facie morally wrong under any of three conditions: (1) when the wrongdoer is one’s agent; (...) (2) when acceptance of benefit directly encourages the repetition of the wrongful deed (even though no agency relationship is involved); and (3) when acceptance of a benefit legitimates a wrongful practice. I conclude by showing that, because of the ways in which most embryonic stem cell lines come into being, people who oppose embryo destruction may use human embryonic stem cells without incurring moral blame. (shrink)

One of the central ethical tenets of research in developing countries is the sponsor's obligation to benefit host participants and communities. Two known models of benefits provision dominate the ethical discourse of research in developing countries. The first model, known as the “reasonable availability,” endorses the obligation to provide interventions proven to be effective at the end of a study. This contrasts with the second model, known as “fair benefits,” which endorses other forms of benefits that host (...) communities may deem as fair beyond those derived directly from the study's findings. This paper explores a third benefit model consistent with the writings of the Human Hereditary and Health in Africa research initiative. The H3Africa—a North-South collaborative initiative predicated by U.S. National Institutes of Health, the Wellcome Trust and the African Society of Human Genetics upholds a benefit model that endorses capacity building as the primary obligation of its research agenda. This is evident by the endorsement of mechanisms to strengthen capacity building in its research projects. While capacity building remains a plausible means of improving the expertise, quality and independence of research in Africa, sustainable measures are needed to realizing the full potential for African-led research on the continent. (shrink)

The purpose of this article is to discuss whether a person can be discriminated against by means of an action intended to benefit him or her. The discussion is triggered by a recent court decision according to which women may be entitled to compensation for a policy that made them better off in some respect because of its assumed effect on the perpetuation of harmful stereotypes about women. I reject this view, arguing that such effects are neither necessary nor sufficient (...) for an act to be discriminatory. If people stand to directly benefit from some act, they cannot claim discrimination on the basis of such benefit. (shrink)

Institutional review boards and investigators are used to talking about risks of harm. Both low risks of great harm and high risks of small harm must be disclosed to prospective subjects and should be explained and categorized in ways that help potential subjects to understand and weigh them appropriately. Everyone on an IRB has probably spent time at meetings arguing over whether a three-page bulleted list of risk description is helpful or overkill for prospective subjects. Yet only a small fraction (...) of all the time and attention lavished on risk disclosure has been devoted to discussing whether and when potential benefit to subjects can reasonably be claimed and, if so, how it should be described in the consent form and process.Traditionally, IRBs and regulators have worked to ensure that clear lines can be drawn between research that, by definition, carries no potential for direct benefit — because it uses healthy volunteers or because it is not foreseeably focused on the development of treatments — and research that does have the development of effective treatments as its goal. (shrink)

Short food supply chains have become the focus of considerable research in the last two decades. However, studies so far remain highly localized, and claims about the economic and social advantages of such channels for farmers are not backed by large-scale empirical evidence. Using a web survey of 613 direct-market farmers across Canada, this article explores the potential economic and social benefits that farmers derive from participating in short food supply chains. We used multivariate analysis to test whether (...) a farmer’s degree of involvement in direct food channels is positively correlated with levels of work enjoyment, social satisfaction, and economic satisfaction. The results indicate that, overall, direct-market farmers report high levels of occupational satisfaction, although work-related challenges persist, such as stress, excessive workloads, and competition. Farmer participation in short food chains was also a positive predictor of work enjoyment and economic satisfaction, but not of social satisfaction, as measured by the share of total farm sales attributable to direct selling. Net annual farm revenue, the share of direct food sales involving a middleman, age, and gender also correlated with one or more dimensions of occupational satisfaction. (shrink)

Mitochondrial replacement therapy (MRT) utilises nuclear transfer technology to replace defective mitochondria with healthy ones and thereby minimise the risk of a mitochondrial disease passing from a mother to her child. It promises much but comes with ethical controversy, significant risk of harm and many unknowns. Forming a position on MRT requires accurate information about the current state of knowledge, and an appreciation of the ethical issues at stake. Ethical deliberations will vary depending on the framework used. There are in (...) principle objections to MRT on the grounds of direct harm to human embryos and germline genetic modification. But even without these objections MRT can be weighed in terms of the balance between risks and benefits, alternatives and uncertainties. This paper explores the evidence and lays out the relevant issues to assist such a deliberation. (shrink)

Benefit/cost analysis is a technique for evaluating programs, procedures, and actions; it is not a moral theory. There is significant controversy over the moral justification of benefit/cost analysis. When a procedure for evaluating social policy is challenged on moral grounds, defenders frequently seek a justification by construing the procedure as the practical embodiment of a correct moral theory. This has the apparent advantage of avoiding difficult empirical questions concerning such matters as the consequences of using the procedure. So, for example, (...) defenders of benefit/cost analysis (BCA) are frequently tempted to argue that this procedurejust isthe calculation of moral Tightness – perhaps that what itmeansfor an action to be morally right is just for it to have the best benefit-to-cost ratio given the accounts of “benefit” and “cost” that BCA employs. They suggest, in defense of BCA, that they have found the moral calculus – Bentham's “unabashed arithmetic of morals.” To defend BCA in this manner is to commit oneself to one member of a family of moral theories (let us call thembenefit/cost moral theoriesorB/C moral theories) and, also, to the view that if a procedure is (so to speak) the direct implementation of a correct moral theory, then it is a justified procedure. Neither of these commitments is desirable, and so the temptation to justify BCA by direct appeal to a B/C moral theory should be resisted; it constitutes an unwarranted short cut to moral foundations – in this case, an unsound foundation. Critics of BCA are quick to point out the flaws of B/C moral theories, and to conclude that these undermine the justification of BCA. But the failure to justify BCA by a direct appeal to B/C moral theory does not show that the technique is unjustified. There is hope for BCA, even if it does not lie with B/C moral theory. (shrink)

In this paper I will first bring out some linguistic difficulties which suggest that the notions of benefit and harm are not as straightforwardly univocal as one might have thought, and then go on to make some distinctions within these notions which will bring to light their complexities, and help to clarify the relation between the good and the beneficial. The notion of the good and of the bene- ficial that are being used here are tied to human happiness. There (...) are other conceptions of the good of man, and I may be mistaken in connecting it exclusively with human happiness, but the logical points concerning the concepts of benefit and harm will not be directly affected by this. (shrink)

Next SectionThere has been considerable debate surrounding the ethics of sham-controlled trials of procedures and interventions. Critics argue that these trials are unethical because participants assigned to the control group have no prospect of benefit from the trial, yet they are exposed to all the risks of the sham intervention. However, the placebo effect associated with sham procedures can often be substantial and has been well documented in the scientific literature. We argue that, in light of the scientific evidence supporting (...) the benefits of sham interventions for pain and Parkinson's disease that stem from the placebo effect, these sham-controlled trials should be considered as offering potential direct benefit to participants. If scientific evidence demonstrates the positive effect of placebo from sham interventions on other conditions, sham-controlled trials of interventions for the treatment of these conditions should be considered to have prospects of benefit as well. This potential benefit should be taken into account by research ethics committees in risk-benefit analyses, and be included in informed consent documents. (shrink)

In 1986 David Gauthier proposed an arbitration scheme for two player cardinal bargaining games based on interpersonal comparisons of players’ relative concessions. In Gauthier’s original arbitration scheme, players’ relative concessions are defined in terms of Raiffa-normalized cardinal utility gains, and so it cannot be directly applied to ordinal bargaining problems. In this paper I propose a relative benefit equilibrating bargaining solution for two and n-player ordinal and quasiconvex ordinal bargaining problems with finite sets of feasible basic agreements based on the (...) measure of players’ ordinal relative individual advantage gains. I provide an axiomatic characterization of this bargaining solution and discuss the conceptual relationship between RBEBS and ordinal egalitarian bargaining solution proposed by Conley and Wilkie. I show the relationship between the measurement procedure for ordinal relative individual advantage gains and the measurement procedure for players’ ordinal relative concessions, and argue that the proposed arbitration scheme for ordinal games can be interpreted as an ordinal version of Gauthier’s arbitration scheme. (shrink)

Morality seems to require us to attend to the good of others, but does not require that we assign any importance to our own good. Standard forms of consequentialism thus appear vulnerable to the compulsory self-benefit objection: they require agents to benefit themselves when doing so is entailed by the requirement of maximizing overall impersonal good. Attempts to address this objection by appealing to ideally motivated consequentialist agents; by rejecting maximization; by leveraging consequentialist responses to the more familiar special relationships (...) and demandingness objections; or by appealing to dual rankings of moral and all-things-considered reasons fall short of adequately answering this objection. A satisfactory response to the compulsory self-benefit objection is elusive because of consequentialism struggles to account for directed options (in this case, an option not to maximize one’s own good but not that of others) and for moral considerations that do not rest on the value of outcomes or states of affairs. (shrink)

Definition of the problemAdvance directives involve evaluative assumptions about the further course of one’s life that can be more or less appropriate and thus call for ethical reflection. This contribution focuses on the basis and criteria of such assumptions. We argue that considerations regarding the temporal structure of a good life constitute a particularly relevant perspective in this context.ArgumentsEmpirical studies on the individual composition of advance directives point to the important role of personal values and life plans that can change (...) over time. Therefore, we first contextualize advance directives from the perspective of an ethics of the good life and then discuss their implications with regard to different levels of temporality, comprising fundamental parameters of human existence in time, cultural models of the life course, as well as narratives of the individual trajectory of life.ConclusionConceptions of a good life and its temporal structure represent an important perspective for drafting and interpreting advance directives. Their consideration provides a more nuanced understanding of the evaluative implications of advance care planning. This can benefit individual patients, service providers, as well as policy makers. (shrink)

The recent successful conversion of adult cells into induced pluripotent stem (iPS) cells through direct reprogramming opens a new chapter in the study of disease and the development of regenerative medicine. It also provides a historic opportunity to turn away from the ethically problematic use of embryonic stem cells isolated through the destruction of human embryos. Moreover, because iPS cells are patient specific, they render therapeutic cloning unnecessary. To maximize therapeutic benefit, adult stem cell research will need to be (...) pursued in parallel with studies using iPS cells. Among the four alternative methods presented by the President’s Council on Bioethics, direct reprogram- ming is the most ethically acceptable. Nonetheless, iPS cells are tainted by their association with the human embryonic stem cell lines, derived in the past, which will be required for their validation. This concern is one that can be resolved. Human iPS cells will serve to stem the tide of human embryonic stem cell research, changing it and diverting stem cell research in a more ethical direction. (shrink)

The dominant approach to the subjectivity of the clinician in psychiatry is a negative one. Based on the idea of objectivity as "a view from nowhere", contemporary psychiatry stipulates that the psychiatrist's impressions and emotions may only interfere with the results of the psychiatric examination. Even the person-centered approach in psychiatry fails to address this issue directly because it focuses almost exclusively on the person of the patient. A positive approach to the psychiatrist's subjective experience has not achieved wide recognition (...) and has only been adopted in psychotherapy and in particular in psychoanalysis and psychodynamic psychotherapy. Psychoanalysts were, indeed, the first to... (shrink)

Arguments against directed altruistic living organ donation are too weak to justify a ban. Potential donors who want to specify the non-related person or group of persons to receive their donated kidney should be accepted. The arguments against, based on considerations of motivation, fairness and (non-)anonymity (e.g. those recently cited by an advisory report of the Dutch Health Council), are presented and discussed, as well as the Dutch Governments response. Whereas the Government argues that individuals have authority with regard to (...) the allocation of their organs, partial considerations have not been sufficiently explored. In addition, it is argued that partial relationships govern human life, are significant and should be valued highly. These relationships are at the core of accepted living kidney donation between relatives (family members, partners, friends). Respecting the particular act of living donation goes beyond respect for autonomy; it touches upon our personal and social identity. Donation, e.g. of a kidney, is not undertaken strictly for the benefit of the recipient, but also to meet the moral standards we wish to set for ourselves. This consideration, rooted in a view of moral identity, provides the basis for many forms of directed donation that are both partial and justified. If the importance of this is not recognized, social policies can be neither adequate nor effective. (shrink)

Complexes of two or more proteins form many, if not most, of the intracellular “machines” that execute physical and chemical work, and transmit information. Complexes can form from stochastic post‐translational interactions of fully formed proteins, but recent attention has shifted to co‐translational interactions in which the most common mechanism involves binding of a mature constituent to an incomplete polypeptide emerging from a translating ribosome. Studies in yeast have revealed co‐translational interactions during formation of multiple major complexes, and together with recent (...) mammalian cell studies, suggest widespread utilization of the mechanism. These translation‐dependent interactions can involve a single or multiple mRNA templates, can be uni‐ or bi‐directional, and can use multi‐protein sub‐complexes as a binding component. Here, we discuss benefits of co‐translational complex assembly including accuracy and efficiency, overcoming hidden interfaces, localized and hierarchical assembly, and reduction of orphan protein degradation, toxicity, and dominant‐negative pathogenesis, all serving to improve cell fitness. (shrink)

Health policy is only one part of social policy. Although spending administered by the health sector constitutes a sizeable fraction of total state spending in most countries, other sectors such as education and transportation also represent major portions of national budgets. Additionally, though health is one important aspect of economic and social activity, people pursue many other goals in their social and economic lives. Similarly, direct benefits—those that are immediate results of health policy choices—are only a small portion (...) of the overall impact of health policy. This chapter considers what weight health policy should give to its “spill-over effects,” namely non-health and indirect benefits. (shrink)

: This paper examines the nature of the harm-benefit tradeoff in early clinical research for interventions that involve remote possibility of direct benefit and likelihood of direct harms to research participants with fatal prognoses, by drawing on the example of gene transfer trials for glioblastoma multiforme. We argue that the appeal made by the component approach to clinical equipoise fails to account fully for the nature of the harm-benefit tradeoff—individual harm for social benefit—that would be required to justify (...) such research. An analysis of what we label "collateral affective benefits," such as the experience of hope or exercise of altruism, shows that the existence of these motivations reinforces rather than mitigates the necessity of justification by reference to social benefit. Evaluations of social benefit must be taken seriously in the research ethics review process to avoid the exploitation of research participants' motivations of hope or altruism and to avoid the possibility of inadvertent exploitation of high-risk research participants and the harms that would associate with such exploitation. (shrink)

Modern medicine has put a new twist on one of our most fundamental values: self-determination. Although advance directives may be used to request treatment, this volume limits its focus to their more common function--the refusal of treatment. Timely and comprehensive, it provides a stimulating overview of this relevant topic, addressing such questions as: What are the individual and societal benefits of advance directives? Does an advance directive tamper with the sanctity of life? Will normalizing directives have an adverse effect (...) on the practice of medicine? Should a patient specify treatments to be withheld within a directive? What legal sanctions should apply against those who ignore directives? and What is a physician's role in helping his patient formulate an appropriate directive? (shrink)

Recent reports and papers on chimeric research highlight the promise of chimeric models of human neuropsychiatric disorders to ameliorate human suffering due to autism spectrum disorders, depression, and schizophrenia. These calls, however, typically do not acknowledge, much less address, criticisms of model creation and validation, or concerns about scientific conduct more generally. The ethical justification for the use of nonhuman animals in research depends on the production of benefits to humans based on such research. But the assessment and production (...) of benefits are highly uncertain and rife with both practical and conceptual challenges. This essay provides a general framework for classifying the benefits of biomedical research and then focuses on two factors that directly impact—and threaten—the production of knowledge in research that models neuropsychiatric disorders. (shrink)

It is widely agreed that foreign sponsors of research in low- and middle-income countries (LMICs) are morally required to ensure that their research benefits the broader host community. There is no agreement, however, about how much benefit or what type of benefit research sponsors must provide, nor is there agreement about what group of people is entitled to benefit. To settle these questions, it is necessary to examine why research sponsors have an obligation to benefit the broader host community, (...) not only their subjects. Justifying this claim is not straightforward. There are three justifications for an obligation to benefit host communities that each apply to some research, but not to all. Each requires a different amount of benefit, and each requires benefit to be directed toward a different group. If research involves significant net risk to LMIC subjects, research must provide adequate benefit to people in LMICs to avoid an unjustified appeal to subjects’ altruism. If research places significant burdens on public resources, research must provide fair compensation to the community whose public resources are burdened. If research is for profit, research sponsors must contribute adequately to the upkeep of public goods from which they benefit in order to avoid the wrong of free-riding, even if their use of these public goods is not burdensome. (shrink)

Pictures are principally descriptive. Advertising images highlight features of potential purchases; cartoons open portals to scenes in fictional worlds; snapshots in the family photo album remind us of our past selves and landmark events in our personal histories; works of pictorial art express thoughts or feelings about depicted scenes. In addition, pictures serve a directive or action-guiding function that, though not taken into account by theorists, deserves no less attention than their descriptive one. Theories of depiction and the appreciation of (...) pictures stand to benefit by taking "directive pictures" into account, as do theories of representation in general and mental representation in particular. (shrink)

In research involving pregnant women and fetuses, a number of questions arise concerning the balancing of risks and benefits. In research that holds out a prospect of direct benefit for the woman, how much risk to the fetus is permissible? How should the principle of minimizing risks be applied when there are two subjects—pregnant woman and fetus? Should risks for each of them be minimized? What if minimizing risks for one increases risks for the other? These and other (...) questions are not addressed in the current federal regulations for the protection of human subjects. This paper reviews the current regulations, attempts to identify issues that need to be addressed, considers alternative viewpoints concerning those issues, and argues for particular views. It concludes with a set of proposed guidelines for balancing risks and benefits in research involving pregnant women and fetuses. (shrink)

Research on incompetent humans raises ethical challenges, especially when there is no direct benefit to these research subjects. Contemporary codes of research ethics typically require that such research must specifically serve to benefit the population to which the research subjects belong. The article critically examines this “same-population condition”, raising issues of both interpretation and moral justification. Of particular concern is the risk that the way in which the condition is articulated and rationalized in effect disguises or downplays the instrumentalization (...) of incompetent individuals. (shrink)

In this paper, I show how Thomas Aquinas's account of sensory cognition is undergirded by a strong commitment to direct realism. According to the specific form of direct realism I articulate and defend here, which I claim emerges from a proper study of Aquinas's account of sensory cognition, it is only by having sense experiences that possess definitive content--content that is isomorphic or formally identical with the sensible features of mind-independent reality--that we can be credited with occupying world-intending (...) sensory states, in which we see, hear, taste, touch, and smell objective aspects or features of the world itself. Thus, it is by virtue of possessing the requisite content that the veridical sensations or perceptions we enjoy and possess bear directly on the world, and thereby unite us to the world. In defending this claim, I exposit what I take to be the most important features of Aquinas's account of sensory cognition: most notably, the operation of the external senses, and secondarily, the role of the common sense and phantasms. Interpreting Aquinas in the right light allows us better to understand and appreciate his account of sensory cognition as well as the nature and benefits of direct realism itself. (shrink)

abstract Numerous measures have been proposed to change the collection procedure in order to increase the supply of organ donations. One such proposal is to give the candidate donors the right to direct their organs to groups of recipients characterised by specific features like sex, age, disease and geographic location. Four possible justifications for directed donation of organs are considered: the utilitarian benefit, the egalitarian principle of justice, the maximin principle of justice and the autonomy principle. It is concluded (...) that none of these principles justifies the acceptance of designated donations. When potentially life‐saving resources are distributed, only a pure egalitarian distribution is in agreement with the principle of justice.s. (shrink)

The Cameron government has recently negotiated a deal with the EU which permits the UK to restrict access to in-work benefits for recent EU migrants in the first four years of residence. Withdrawing access to in-work benefits will lead to significant inequalities in pay between British workers and their EU equivalents working at the same job, in the same general situation. The proposal has been widely decried as discriminatory. Is it? I do not, in this article, ask the (...) legal question: Does it violate anti-discrimination norms implicit in the treaties? Rather, I will ask the moral question underlying the legal one: Would, say, Polish citizens denied in-work benefits that British citizens receive be victims of wrongful discrimination? This question deserves consideration not simply because it will help us to evaluate some of the central concerns at stake in the Brexit debates but also because it will allow us to explore the role of norms against discrimination according to nationality within the EU, to address the nature of the European commitment to freedom of movement, and, in the reverse direction, to better understand our own moral commitment to anti-discrimination norms. (shrink)

Marine and coastal ecosystems are crucial in maintaining human livelihood, facilitating social development, and reducing climate change impacts. Studies have examined how the benefit perception of aquatic ecosystems, knowledge, and emotion about climate change affect peoples’ support for marine protection. However, their interaction effects remain understudied. The current study explores the intricate interaction effect of the benefit perception of aquatic ecosystems, knowledge, and worry about climate change on marine protection support. Bayesian Mindsponge Framework (BMF) analytics was employed on a dataset (...) of 709 stakeholders from 42 countries generated by MaCoBioS—a research project funded by the European Commission Horizon 2020. The statistical analysis shows that the impacts of benefit perception of ocean ecosystems, knowledge, and worry about climate change on marine protection support vary due to their interactions. Specifically, when stakeholders perceive ocean ecosystems to have little utility in mitigating climate change, greater climate change knowledge and concern are associated with a higher level of marine protection support. Nevertheless, in the scenarios where stakeholders perceive the benefits of ocean ecosystems, the effect of climate change knowledge becomes conditional on the worry level. If stakeholders are concerned about climate change, those with a greater level of climate change knowledge will associate with a higher level of marine protection support. Otherwise, greater climate change knowledge will result in lower support. These findings highlight emotion’s importance in directing climate change knowledge’s effect on marine protection support. Linking people’s “objects of care” to the consequences of climate change can help improve climate change communication effectiveness. (shrink)

The UCLA Medical Center has initiated a “voucher program” under which a person who donated a kidney would receive a voucher that she could provide to someone of her choosing who could then use it to move to the top of the renal transplantation waiting list. If the use of such vouchers as incentives for donors is morally permissible, then cash payments for kidneys are also morally permissible. But, that argument faces five objections. First, there are some goods whose nature (...) allows them to be exchanged for similar goods but renders them monetarily inalienable. Hence, kidneys might be exchanged for kidneys but not sold for cash. Second, voucher programs respect donor autonomy, whereas the offer of cash payments does not. Third, the burden of proof lies with the advocates of cash payments for kidneys to show that their benefits would outweigh the costs of their legalization. Fourth, allowing cash payments for kidneys would stifle medical innovation. Fifth, allowing cash payments for kidneys would result in these organs being used as collateral to secure loans—and that this would disadvantage potential borrowers who did not want to risk their kidneys in this way. This paper will rebut all these objections. (shrink)

This article illustrates some of the difficulties of defining discrimination and briefly sketches the benefits and desiderata of doing so. It then examines and defines generic direct discrimination as an agent treating two groups differently because of the property that defines one of the groups as a group, in a way that is worse for that group, clarifying each of these three conditions in turn. It considers two arguments for further conditions: that an act must target one among (...) a particular set of groups to constitute discrimination, and that an act must be in some sense morally wrong to constitute discrimination. It concludes that while these objections are forceful it may be the case that they illustrate that we employ multiple, partly overlapping concepts of discrimination, and that it may be more important to recognize this heterogeneity than it is to attempt to establish a dominant or unitary definition. (shrink)

Uterus transplantation (UTx) is highly anticipated for the benefits that it might bring to individuals wanting to carry a pregnancy in order to reproduce who do not have a functioning uterus. The surgery—now having been performed successfully in several countries around the world—remains experimental. However, UTx is at some point expected to become a routine treatment for people without a uterus and considering themselves in need of one: women with absolute uterine factor infertility; transgender women; and even cisgender men (...) who wish to gestate. Given the unique benefits UTx offers, uteri are likely to be ‘in demand’, and such demand, we suggest, will feasibly outstrip supply. Therefore, allocation of those uteri available for transplant may become a pressing issue. In this paper, we consider one aspect of organ allocation—the preferences of donors in making a directed or conditional donation of their uterus. To what extent, in the context of uterus donation, would such donations be ethically permissible? (shrink)