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. (shrink)

Pediatric participation in non-therapeutic research that poses greater than minimal risk has been the subject of considerable thought-provoking debate in the research ethics literature. While the need for more pediatric research has been called morally imperative, and concerted efforts have been made to increase pediatric medical research, the importance of protecting children from undue research risks remains paramount.United States research regulations are derived largely from the deliberations and report of the National Commission for the (...) Protection of Human Subjects of Biomedical and Behavioral Research. The authors of this report specifically designated children as a vulnerable population and suggested additional protections, most of which became U.S. law. One of the more contested sets of regulations surrounds non-therapeutic research, e.g., research that does not offer the potential for direct benefit to participants. Federal regulations allow local Institutional Review Boards to approve non-therapeutic research posing a minor increase above minimal risk when it involves children who have the disease or medical condition that the research addresses. (shrink)

A common reason for giving research participants post-trial access to the trial intervention appeals to reciprocity, the principle, stated most generally, that if one person benefits a second, the second should reciprocate: benefit the first in return. Many authors consider it obvious that reciprocity supports PTA. Yet their reciprocity principles differ, with many authors apparently unaware of alternative versions. This article is the first to gather the range of reciprocity principles. It finds that: most are false. The most (...) plausible principle, which is also problematic, applies only when participants experience significant net risks or burdens. Seldom does reciprocity support PTA for participants or give researchers stronger reason to benefit participants than equally needy non-participants. Reciprocity fails to explain the common view that it is bad when participants in a successful trial have benefited from the trial intervention but lack PTA to it. (shrink)

Experiences of substitute decision-makers with requests for consent to non-therapeutic research participation during the dying process, including to what degree such requests are perceived as burdensome, have not been well described. In this study, we explored the lived experiences of family members who consented to non-therapeutic research participation on behalf of an imminently dying patient. We interviewed 33 family members involved in surrogate research consent decisions for dying patients in intensive care. Non-therapeutic research involved continuous physiological (...) monitoring of dying patients prior to and for 30 min following cessation of circulation. At some study centres participation involved installation of bedside computers. At one centre electroencephalogram monitoring was used with a subset of participants. Aside from additional monitoring, the research protocol did not involve deviations from usual end-of-life care. Thematic analysis of interviews suggests most family members did not perceive this minimal-risk, non-therapeutic study to affect their time with patients during the dying process, nor did they perceive research consent as an additional burden. In our analysis, consenting for participation in perimortem research offered families of the dying an opportunity to affirm the intrinsic value of patients’ lives and contributions. This opportunity may be particularly important for families of patients who consented to organ donation but did not proceed to organ retrieval. Our work supports concerns that traditional models of informed consent fail to account for possible benefits and harms of perimortem research to surviving families. Further research into consent models which integrate patient and family perspectives is needed. All data relevant to the study are included in the article. (shrink)

Non-therapeutic research on children raises ethical concerns. Such research is not only conducted on individuals who are incapable of providing informed consent. It also typically involves some degree of risk or discomfort, without prospects of medically benefiting the participating children. Therefore, these children seem to be instrumentalized. Some ethicists, however, have tried to sidestep this problem by arguing that the children may indirectly benefit from participating in such research, in ways not related to the medical intervention (...) as such. It has been argued, for example, that non-therapeutic pediatric research does not instrumentalize the children enrolled since it has the prospects of furthering their moral development. We argue that this argument is far too undeveloped to be taken seriously. (shrink)

To judge from the rash of recent law review articles, it is a miracle that research with human subjects in the U.S. continues to draw breath under the asphyxiating heel of the rent-seeking, creativity-stifling, jack-booted bureaucrethics that is the current system of research ethics oversight and review. Institutional Review Boards, sometimes called Research Ethics Committees, have been accused of perpetrating “probably the most widespread violation of the First Amendment in our nation's history,” resulting in a “disaster, not (...) only for academics, but for the whole nation.” One member of the President's Council on Bioethics went so far as to assert, “There has been no greater damage to academic freedom in the United States in my lifetime. And my lifetime encompasses McCarthy and it encompasses political correctness, both.” Locked in the bureaucratic “iron cage” of IRB oversight, critics charge that researchers have been transformed into a vulnerable, exposed population, subject to domination, that has been likened in one case to a kind of “Tuskegee in reverse.”. (shrink)

Non-therapeutic research with imminently dying patients in intensive care presents complex ethical issues. The vulnerabilities of the imminently dying, together with societal disquiet around death and dying, contribute to an intuition that such research is beyond the legitimate scope of scientific inquiry. Yet excluding imminently dying patients from research hinders the advancement of medical science to the detriment of future patients. Building on existing ethical guidelines for research, we propose a framework for the ethical design and (...) conduct of research involving the imminently dying. To enable rapid translation to practice, we frame the approach in the form of eight ethical questions that researchers and research ethics committees ought to answer prior to conducting any research with this patient population. (1) Does the study hypothesis require the inclusion of imminently dying patients? (2) Are non-therapeutic risks and burdens minimised consistent with sound scientific design? (3) Are the risks of these procedures no more than minimal risk? (4) Are these non-therapeutic risks justified insofar as they are reasonable in relation to the anticipated benefits of the study? (5) Will valid informed consent be obtained from an authorised surrogate decision maker? (6) How will incidental findings be handled? (7) What additional steps are in place to protect families and significant others of research participants? (8) What additional steps are in place to protect clinical staff and researchers? Several ethical challenges hinder research with imminently dying patients. Nonetheless, provided adequate protections are in place, non-therapeutic research with imminently dying patients is ethically justifiable. Applying our framework to an ongoing study, we demonstrate how our question-driven approach is well suited to guiding investigators and research ethics committees. (shrink)

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)

Part of the standard protection of decisionally incapacitated research subjects is a prohibition against enrolling them unless surrogate decision makers authorize it. A common view is that surrogates primarily ought to make their decisions based on what the decisionally incapacitated subject would have wanted regarding research participation. However, empirical studies indicate that surrogate predictions about such preferences are not very accurate. The focus of this article is the significance of surrogate accuracy in the context of research that (...) is not expected to benefit the research subject. We identify three morally relevant asymmetries between being enrolled and not being enrolled in such non-beneficial research, and conclude that when there is a non-negligible probability that surrogates’ predictions are wrong, it will generally be better to err on the side of not authorizing enrollment. (shrink)

This article was originally published in the Encyclopedia of Language & Linguistics, Second Edition, published by Elsevier, and the attached copy is provided by Elsevier for the author's benefit and for the benefit of the author's institution, for noncommercial research and educational use including without limitation use in instruction at your institution, sending it to specific colleagues who you know, and providing a copy to your institution’s administrator.

The Kennedy Krieger lead paint study received a lot of attention after a US Court of Appeals ruled that a parent cannot consent to the participation of a child in non-therapeutic research. The ruling has raised fears that, if it goes unchallenged, valuable research might not proceed and ultimately all children would be harmed. The author discusses significant aspects of the study that have been neglected, and argues that the study was unethical because it involved injustice and its (...) design meant that the study lacked importance and value. Issues of benefit, risk, and consent are vital, but it is sometimes a mistake to consider these issues before settling questions about justice and the importance and value of a research project. The author concludes by offering a strategy for researchers and reviewers of research to appreciate, in a vivid way, the implications of research participation. (shrink)

Emerging biotechnology may soon allow the creation of genetically human organs inside animals, with non-human primates and pigs being the best candidate species. This prospect raises the question of whether creating organs in primates in order to then transplant them into humans would be more acceptable than using them for research. In this paper, we examine the validity of the purported moral distinction between primates and other animals, and analyze the ethical acceptability of using primates to create organs for (...) human use. (shrink)

This study critically examines the concept of benefit‐sharing in the context of health research involving human participants in South Africa, identifying a significant gap in the precision and application of terminology. It introduces a new terminological framework designed to provide clarity and facilitate standardisation in both national and international discourse on benefit‐sharing. The analysis extends to the complex legal landscape in South Africa, highlighting the nuances of mandated, permitted, and prohibited practices of benefit‐sharing across various statutes. (...) This reveals substantial implications for ethics committees, researchers, and participants, emphasising the need for a legal and ethical recalibration. Furthermore, the manuscript critiques South Africa's main ethics instruments for their inadequate guidance on benefit‐sharing and proposes recommendations for enhancing the Department of Health's ethics guidelines. By advocating for a coherent, legally informed approach to ethical decision‐making, the study underscores the need for integrating the proposed framework and legal insights into ethics guidelines. This comprehensive strategy aims not only to advance ethical practices within South Africa but also to contribute significantly to the global discourse on benefit‐sharing in health research. (shrink)

This paper considers what are the appropriate limits of parental or guardian proxy consent for a child's participation in medical or social science research. Such proxy consent, it is proposed, is invalid in regards “non-therapeutic research.” The latter research may add to scientific knowledge and/or benefit others, but any benefit to the child research participant is but a coincidental theoretical possibility and not a primary objective. Research involving children, without intended and acceptable prospect (...) of beneficial outcome to the individual participant, even if with negligible risk, does not meet the test for “best interests.” Proxy consent for children's involvement in research is justifiable only when given for and on behalf of the child in his or her best interest to enhance the child's well-being. Only in the latter case is the parental proxy consent situation analogous in regards key criteria to a competent individual consenting to research participation. (shrink)

Biomedical research involving human subjects is an arena of conflicts of interests. One of the most important conflicts is between interests of participants and interests of future patients. Legal regulations and ethical guidelines are instruments designed to help find a fair balance between risks and burdens taken by research subjects and development of knowledge and new treatment. There is an universally accepted ethical principle, which states that it is not ethically allowed to sacrifice individual interests for the sake (...) of society and science. This is the principle of precedence of individual. But there is a problem with how to interpret the principle of precedence of individual in the context of research without prospect of future benefit involving children. There are proposals trying to reconcile non-beneficial research involving children with the concept of the best interests. We assert that this reconciliation is flawed and propose an interpretation of the principle of precedence of individual as follows: not all, but only the most important interests of participants, must be guaranteed; this principle should be interpreted as the secure participant standard. In consequence, the issue of permissible risk ceiling becomes ethically crucial in research with incompetent subjects. (shrink)

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 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. (shrink)

Background: Both the Council for International Organization of Medical Sciences and the Helsinki Declaration emphasize that the potential benefits of research should outweigh potential harms; consequently, some work has been conducted on participants' perception of benefits in therapeutic research. However, there appears to be very little work conducted with participants who have joined non-therapeutic research. This work was done to evaluate participants' perception of benefits in a genetic epidemiological study by examining their perception of the potential benefits (...) of enrollment.Methods: In-depth interviews lasting between 45 and 60 minutes were conducted with a convenient sample of 25 ill patients and 25 healthy accompanying relatives enrolled in a genetic epidemiological study of tuberculosis. Recorded interviews were transcribed and analyzed using content analysis.Results: Participants perceived that research was beneficial and some of the benefits included the generation of new knowledge, finding the cause of diseases, as well as the control, eradication and prevention of disease. Some thought that research was risky whilst others thought that the benefits outweighed the risks.Conclusion: Participants perceived research to be beneficial and most of them thought that, though it was risky, the benefits outweighed the risks. It is our view that researchers need to give serious consideration to participant's perception of benefits in designing their consent forms, to see to the fulfillment of achievable goals. (shrink)

Federal efforts beginning in the 1990's have successfully increased pediatric research to improve medical care for all children. Since 1997, the FDA has requested 800 pediatric studies involving 45,000 children. Much of this research is "non-beneficial"; that is, it exposes pediatric subjects to risk even though these children will not benefit from participating in the research. Non-beneficial pediatric research (NBPR) seems, by definition, contrary to the best interests of pediatric subjects, which is why one state (...) supreme court has essentially prohibited it. It also appears that the only plausible rationale for this research is utilitarian, as it risks some children for the good of all. But that rationale is troubling. This Article answers two related questions: (1) What is the appropriate legal relationship between NBPR and the "best interests of the child" standard? (2) What is the ethical justification for this research? I argue that courts should hold that the "best interests" standard governs pediatric research. But, contrary to existing case law, courts must consider the benefits to each child, including pediatric subjects, from a policy that permits NBPR, and not simply consider that a non-beneficial protocol presents more risk than potential benefit to a child. Moreover, I argue that the justification for the practice need not be utilitarian. There is no need to appeal to the greater good to justify the research because each child has reason to endorse a policy permitting NBPR where there is a very low ceiling on acceptable risk, and each child has reason to participate in a practice from which she benefits. More controversially, I argue that each child, like other persons, has reason to help others when she can do so at little to no cost to herself. The Article then highlights practical implications of the offered justifications. (shrink)

Abusive supervision has long been found to have remarkably negative impacts on individual and organizational outcomes. Accordingly, prior studies have explored many organizational and supervisory predictors of abusive supervision and offered several interventions to reduce it. However, extant research lacks the bottom-up perspective to explore how employees can act to reduce abusive supervision, which is an important factor that enriches abusive supervision literature and helps employees protect themselves from being abused. Drawing on self-disclosure theory, we develop a model of (...) whether and how employee boundary blurring behavior may protect them from being abused by their supervisors. Specifically, we conducted two studies to test the theoretical model, including a scenario-based experimental study and a multi-source, multi-wave field study. The results reveal a negative indirect effect of employee boundary blurring behavior on abusive supervision via supervisor liking toward the employee. By uncovering employee boundary blurring behavior as an antecedent of abusive supervision, we enrich the abusive supervision literature with a bottom-up behavioral strategy for employees to proactively protect themselves from being abused. We hope our findings will encourage future studies to identify boundary conditions and other solutions for employees to minimize the risk of being abused. (shrink)

ABSTRACT The 2006 Institute of Medicine (IOM) report, ‘Ethical Considerations for Research Involving Prisoners’, recommended five main changes to current US Common Rule regulations on prisoner research. Their third recommendation was to shift from a category‐based to a risk‐benefit approach to research review, similar to current guidelines on pediatric research. However, prisoners are not children, so risk‐benefit constraints on prisoner research must be justified in a different way from those on pediatric research. (...) In this paper I argue that additional risk‐benefit constraints on prisoner research are unnecessary: the current Common Rule regulations, omitting category‐based restrictions but conjoined with the IOM report's other four main recommendations, ensure that prisoner research is as ethical as non‐prisoner research is. I explain why four problems which which may be more prevalent in prisons and which risk‐benefit constraints may seem to address – coercion, undue inducements, exploitation, and protection from harm – are in fact not solved by adding further risk‐benefit constraints on prisoner research. (shrink)

The idea that research with human participants should benefit society has become firmly entrenched in various regulations, policies, and guidelines, but there has been little in-depth analysis of this ethical principle in the bioethics literature. In this paper, I distinguish between strong and weak versions and the social benefits principle and examine six arguments for it. I argue that while it is always ethically desirable for research with human subjects to offer important benefits to society, the reasonable (...) expectation of substantial public benefit should be a necessary condition for regarding research as ethical only when it imposes more than minimal risks on non-consenting subjects; or it is supported by public resources. (shrink)

In this chapter we outline the need to develop ethical frameworks to guide research on the role of animal-orientated health, therapeutic, and service interventions. We discuss findings from our research on uses of animals in therapeutic settings and benefits of human–canine interactions for human health. These stories from the field reveal that current ethics review processes do not recognise the animal as an equal partner in the potential reciprocal benefits and risks of therapeutic human–animal relationships. We explore how (...) these review processes frame research on the relationships between humans and non-human animals and use the ethical review system of Aotearoa/New Zealand as an example. We propose an ethical framework that goes beyond animal welfare legislation and recognises a range of non-human animal capacities. (shrink)

I offer a principled objection to arguments in favour of legalizing non-voluntary euthanasia on the basis of the principle of beneficence. The objection is that the status of death as a benefit to people who cannot formulate a desire to die is more problematic than pain management care. I ground this objection on epistemic and political arguments. Namely, I argue that death is relatively more unknowable, and the benefits it confers more subjectively debatable, than pain management. I am not (...) primarily referring to the claim that it is difficult to make comparisons between live and post-mortem states, but rather to the fact that it is epistemically and metaphysically problematic to impute a “life-worse-than-death” or a state of “suffering-calling-for-death” to people who cannot subjectively wish to die, as though this kind of suffering were a medically observable fact rather than a belief- and value-laden notion. On the contrary, people enduring similar causes of pain may have different experiences of suffering and views on how it affects the worthwhileness of their existence or the desirability of death or of continuing their lives. The projection of a “suffering-calling-for-death” onto infants or people with severe intellectual disabilities may not be indefensible, but it is more controversial than judging that pain management will improve their well-being from the perspective of beneficence. My argument also relies on our society’s liberal endeavour to avoid endorsing unverifiable beliefs about life and death or controversial conceptions of the good life. My goal is not to suggest we should not attend the suffering of cognitively disabled people. On the contrary, I only cast doubt on too quick an assumption that ending their lives is the best way of caring for them, when robust palliative treatments are available. Moreover, I express the concern that a lack of attention to distinctions between “pain-calling-for-relief” and “suffering-calling-for-death” may be based on ableist projections and assumptions. I conclude that it is imperative to continue research into the nature of pain and suffering experienced by individuals with mental or cognitive impairments preventing them from expressing autonomous wishes about the kind of treatment that would most benefit them. (shrink)

Research studying the effects of non-financial goals on stakeholder relationships remains inconclusive, with scholars disagreeing on which goals increase or decrease a firm’s proactive stakeholder engagement (PSE). Instead of examining which goals act as forces for good or evil, we shift the focus of recent discussions by emphasizing the mechanisms that can explain the positive and negative stakeholder outcomes of non-financial goals under the umbrella of one theoretical lens. We do so by introducing an ethics of care perspective. Specifically, (...) we first show that four of the five most distinctive non-financial goals of family owners jointly stipulate care-based morality, which likely enhances PSE. However, we subsequently argue that one goal, namely, the wish to exert power and influence, interacts with other goals and related care-based morality to lower PSE. Finally, we show how female family directors temper these interactions. Our insights into the additive and interactive effects of non-financial goals on PSE contribute to corporate social responsibility research, to the organizational goal literature, to family business studies and to work drawing on care ethics in management studies. (shrink)

ABSTRACT Benefit sharing aims to achieve an equitable exchange between the granting of access to a genetic resource and the provision of compensation. The Convention on Biological Diversity (CBD), adopted at the 1992 Earth Summit in Rio de Janeiro, is the only international legal instrument setting out obligations for sharing the benefits derived from the use of biodiversity. The CBD excludes human genetic resources from its scope, however, this article considers whether it should be expanded to include those resources, (...) so as to enable research subjects to claim a share of the benefits to be negotiated on a case‐by‐case basis. Our conclusion on this question is: ‘No, the CBD should not be expanded to include human genetic resources.’ There are essential differences between human and non‐human genetic resources, and, in the context of research on humans, an essentially fair exchange model is already available between the health care industry and research subjects. Those who contribute to research should receive benefits in the form of accessible new health care products and services, suitable for local health needs and linked to economic prosperity (e.g. jobs). When this exchange model does not apply, as is often the case in developing countries, individually negotiated benefit sharing agreements between researchers and research subjects should not be used as ‘window dressing’. Instead, national governments should focus their finances on the best economic investment they could make; the investment in population health and health research as outlined by the World Health Organization’s Commission on Macroeconomics and Health; whilst international barriers to such spending need to be removed. (shrink)

With its focus on evidence, psychology has grown into a mature, professional, and scientifically supported practice over the last decades. In general, psychotherapy and psychological counselling have shown to be more efficacious than waiting it out and a staggering 350 specific treatments have been scientifically supported as effective. Although, evidencebased treatments seem to work equally well, not all people benefit from evidence-based treatments, and it often remains unclear why. This raised the field-wide concern of what works for whom and (...) sparked a wealth of research on specific ingredients, common factors, process factors, and intra- and... (shrink)

Non-beneficial paediatric research is vital to improving paediatric healthcare. Nevertheless, it is also ethically controversial. By definition, subjects of such studies are unable to give consent and they are exposed to risks only for the benefit of others, without obtaining any clinical benefits which could compensate those risks. This raises ethical concern that children participating in non-beneficial research are treated instrumentally; that they are reduced to mere instruments for the benefit of science and society. But this (...) would make the research incompatible with the widely endorsed principle of the primacy of the human subject, which stipulates that the interests of the participating individual should prevail over the interests of science and society. This paper deals with this conflict. It analyses solutions to this problem developed in the literature, and shows that they are unsuccessful. Finally, it offers a new idea of how to reconcile the conduct of non-beneficial paediatric research with the PP. The paper argues for a new formula of the PP, and shows that it implies a specific non-comparative definition of the minimal risk threshold. (shrink)

In this paper, the results of a pilot interview study with 19 subjects participating in an EEG-based non-invasive brain–computer interface (BCI) research study on stroke rehabilitation and assistive technology and of a survey among 17 BCI professionals are presented and discussed in the light of ethical, legal, and social issues in research with human subjects. Most of the users were content with study participation and felt well informed. Negative aspects reported include the long and cumbersome preparation procedure, discomfort (...) with the cap and the wet electrodes, problems concerning BCI control, and strains during the training sessions. In addition, some users reflected on issues concerning system security. When asked for morally problematic issues in this field of non-invasive BCI research, the BCI professionals stressed the need for correct information transfer, the obligation to avoid unrealistic expectations in study participants, the selection of study participants, benefits and strains of participation, BCI illiteracy, the possibility of detrimental brain modifications induced by BCI use, and problems that may arise at the end of the trials. Furthermore, privacy issues were raised. Based on the results obtained, psychosocial and ethical aspects of EEG-based non-invasive BCI research are discussed and possible implications for future research addressed. (shrink)

Clinical research is increasingly ‘offshored’ to developing countries, a practice that has generated considerable controversy. It has recently been argued that the prevailing ethical norms governing such research are deeply puzzling. On the one hand, sponsors are not required to offshore trials, even when participants in developing countries would benefit considerably from these trials. On the other hand, if sponsors do offshore, they are required not to exploit participants, even when the latter would benefit from and (...) consent to exploitation. How, it is asked, can it be worse to exploit the global poor than to neglect them when exploitation is voluntary and makes them better off? The present article seeks to respond to this challenge. I argue that mutually beneficial and voluntary exploitation can be worse than neglect when — as is typically true of exploitative international research — it takes advantage of unjust background conditions. This is because, in such cases, exploitation overlaps with another, less familiar wrong: complicity in injustice. Recognising complicity as a distinct wrong should make us judge exchanges arising from background injustice more harshly than we typically do, in research and elsewhere. (shrink)

AbstractOrganizations receive multiple benefits when their members act ethically. Of interest in this study is if the actors receive benefits as well, especially as individuals look to work to fulfill psychological and social needs in addition to economic ones. Specifically, we highlight a series of ongoing ethical practices embodied in professional moral courage and their relationship to actor’s work meaningfulness and life well-being. Drawing on self-determination theory and affective events theory, we explore how exercising professional moral courage in one’s work (...) leads to positive work and life outcomes. Data from 106 administrative staff of non-profit organizations demonstrates the positive benefits of adopting ethical practices at work. Specifically, professional moral courage is found to be significantly related to both work meaningfulness and individual eudaimonic life well-being. Our findings note positive benefits for individuals who incorporate professional moral courage into their daily lives and provide support for organizations seeking to encourage it from their employees; benefits for organizations and employees go beyond just the gains from ethical behavior into other positive psychological processes. Implications for future work that considers both the psychological and normative approaches to meaningful work are discussed. (shrink)

Benefit sharing aims to achieve an equitable exchange between the granting of access to a genetic resource and the provision of compensation. The Convention on Biological Diversity, adopted at the 1992 Earth Summit in Rio de Janeiro, is the only international legal instrument setting out obligations for sharing the benefits derived from the use of biodiversity. The CBD excludes human genetic resources from its scope, however, this article considers whether it should be expanded to include those resources, so as (...) to enable research subjects to claim a share of the benefits to be negotiated on a case-by-case basis. Our conclusion on this question is: 'No, the CBD should not be expanded to include human genetic resources.' There are essential differences between human and non-human genetic resources, and, in the context of research on humans, an essentially fair exchange model is already available between the health care industry and research subjects. Those who contribute to research should receive benefits in the form of accessible new health care products and services, suitable for local health needs and linked to economic prosperity. When this exchange model does not apply, as is often the case in developing countries, individually negotiated benefit sharing agreements between researchers and research subjects should not be used as 'window dressing'. Instead, national governments should focus their finances on the best economic investment they could make; the investment in population health and health research as outlined by the World Health Organization's Commission on Macroeconomics and Health; whilst international barriers to such spending need to be removed. (shrink)

The objective of this study is twofold: to examine the patterns that govern social reporting with reference to an Islamic framework and to identify the moral legitimacy factors that influence them. We select 146 publicly listed Sharia‐compliant companies and classify the disclosures in their annual reports according to an Islamic framework that categorises items as either Required, Expected or Desired to indicate the degree of importance each item carries from an Islamic perspective. Based on this framework, we then analyse moral (...) legitimacy factors, specifically the type of Sharia screening body and the proportion of Muslims in the population, that may influence the prioritisation of the different categories of social reporting. We find that disclosures that fall into the Required category of our framework—especially those that relate to companies’ involvement in “haram” activities (activities not permissible in Islam)—are still few among the companies studied. Our research also reveals that both moral legitimacy factors under investigation influence the three categories of social reporting, although in different ways. This research contributes to the existing literature by empirically examining how organisations prioritise their disclosure of virtues and the moral legitimacy factors that influence that prioritisation. (shrink)

BackgroundLarge-scale, centralized data repositories are playing a critical and unprecedented role in fostering innovative health research, leading to new opportunities as well as dilemmas for the medical sciences. Uncovering the reasons as to why citizens do or do not contribute to such repositories, for example, to population-based biobanks, is therefore crucial. We investigated and compared the views of existing participants and non-participants on contributing to large-scale, centralized health research data repositories with those of ex-participants regarding the decision to (...) end their participation. This comparison could yield new insights into motives of participation and non-participation, in particular the behavioural change of withdrawal.MethodsWe conducted 36 in-depth interviews with ex-participants, participants, and non-participants of a three-generation, population-based biobank in the Netherlands. The interviews focused on the respondents’ decision-making processes relating to their participation in a large-scale, centralized repository for health research data.ResultsThe decision of participants and non-participants to contribute to the biobank was motivated by a desire to help others. Whereas participants perceived only benefits relating to their participation and were unconcerned about potential risks, non-participants and ex-participants raised concerns about the threat of large-scale, centralized public data repositories and public institutes, such as social exclusion or commercialization. Our analysis of ex-participants’ perceptions suggests that intrapersonal characteristics, such as levels of trust in society, participation conceived as a social norm, and basic societal values account for differences between participants and non-participants.ConclusionsOur findings indicate the fluidity of motives centring on helping others in decisions to participate in large-scale, centralized health research data repositories. Efforts to improve participation should focus on enhancing the trustworthiness of such data repositories and developing layered strategies for communication with participants and with the public. Accordingly, personalized approaches for recruiting participants and transmitting information along with appropriate regulatory frameworks are required, which have important implications for current data management and informed consent procedures. (shrink)

The ‘best interests’ decision making standard is used in clinical care to make necessary health decisions for non-capacitated individuals for whom neither explicit nor inferred wishes are known. It has been also widely acknowledged as a basis for enrolling some non-capacitated adults into clinical research such as emergency, critical care, and dementia research. However, the best interests standard requires that choices provide the highest net benefit of available options, and clinical research rarely meets this criterion. In (...) the context of modern norms of bioethics, the best interests standard rarely supports surrogate consent for research and should not be accepted as a routine provision. (shrink)

Researchers have long suspected that grapheme-color synaesthesia is useful, but research on its utility has so far focused primarily on episodic memory and perceptual discrimination. Here we ask whether it can be harnessed during rule-based Category learning. Participants learned through trial and error to classify grapheme pairs that were organized into categories on the basis of their associated synaesthetic colors. The performance of synaesthetes was similar to non-synaesthetes viewing graphemes that were physically colored in the same way. Specifically, synaesthetes (...) learned to categorize stimuli effectively, they were able to transfer this learning to novel stimuli, and they falsely recognized grapheme-pair foils, all like non-synaesthetes viewing colored graphemes. These findings demonstrate that synaesthesia can be exploited when learning the kind of material taught in many classroom settings. (shrink)

:To what extent, if any, should minors have a say about whether they participate in research that offers them no prospect of direct benefit? This article addresses this question as it pertains to minors who cannot understand enough about what their participation would involve to make an autonomous choice, but can comprehend enough to have and express opinions about participating. The first aim is to defend David Wendler and Seema Shah’s claim that minors who meet this description should (...) not be offered a choice about whether they participate. The second aim is to show, contra Wendler and Shah, that the principle of nonmaleficence requires more with respect to giving these minors a say than merely respecting their dissent. Additionally, it requires that investigators obtain affirmation of their non-dissent. This addresses intuitive concerns about denying children a choice, while steering clear of the problems that arise with allowing them one. (shrink)

This paper critically analyses ‘the paradox of autonomy and consent in maternity care’. It argues that maternity care has certain features that increase the need for explicit attention to, and respect for, both autonomy and rigorous informed consent processes. And, moreover, that the resulting need is considerably greater than in almost all other areas of medicine. These features are as follows: (1) maternity care involves particularly socially sensitive body parts that are regularly implicated in consent‐centred procedures, as well as in (...) unconsented interventions, in ordinary, non‐medical life; and (2) much of maternity care (especially intervening in childbirth) is medically unique, in that it harms one patient (the mother) not primarily for the promotion of her own health but for the benefit of another (the baby). The apt comparison, within medicine, is therefore with non‐therapeutic research and transplantation medicine—both of which have elevated consent requirements characterized by very rigorous consent processes. At the same time—and this delivers the titular paradox—the importance of autonomy and consent in maternity care is at particular risk of being denied or disregarded. Jointly, these considerations make a very strong case for change: attention to and respect for autonomy and consent should be (1) core values; (2) key points of practical attention in the years ahead; and (3) central quality indicators in maternity care. (shrink)

The involvement of children in non-beneficial clinical research is extremely important for improving pediatric care, but its ethical acceptability is still disputed. Therefore, various pro-research justifications have been proposed throughout the years. The present essay aims at contributing to the on-going discussion surrounding children’s participation in non-beneficial clinical research. Building on Wendler’s ‘contribution to a valuable project’ justification, but going beyond a risk/benefit analysis, it articulates a pro-research argument which appeals to a phenomenological view on (...) the body and vulnerability. It is claimed that children’s bodies are not mere physical objects, but body-subjects due to which children, as persons, can contribute to research that may hold no direct clinical benefit to them even before they can give informed consent. (shrink)

As a product of globalization and as a fruit of new public diplomacy, digital diplomacy is considered one of the major trends of the twenty-first century in diplomatic communication. Being under the influence of the extraordinary advances in ICT, the internet and social media, the way of realization and presentation of diplomacy has been radically changed and is increasingly removed from the traditional diplomatic elements. The importance of digital diplomacy is based on the usage of ICT, the internet and social (...) media, which at the same time represent its base, for the strengthening of the diplomatic relations. Therefore, knowledge about the role and importance of digital diplomacy is indispensable. This paper will offer information on the definition, goals, evolution and effectiveness of the digital diplomacy. Meanwhile, the main focus of the research lies in the classification of its benefits and risks. For international actors is more than clear how useful is exploitation of digital diplomacy benefits for achieving their goals in the international arena. However, the process of digitization is unseparated from cyber risks, as well as the freedom of the internet and social media is abused for various purposes that state and non-state actors may have. Although coupled with benefits on the one hand and risks on the other hand, the risks of digital diplomacy are still covered by benefits, making digital diplomacy a key element for the realization of diplomatic activities. Based on all the information over the features of the topic, the primary goal of the paper is to provide sufficient arguments for verifying the abovementioned hypothesis, which is also the general hypothesis of the paper. (shrink)

Many drugs used in paediatric medicine are off-label. There is a rising call for the use of adaptive clinical trial designs in responding to the need for safe and effective drugs given their potential to offer efficiency and cost-effective benefits compared with traditional clinical trials. ADs have a strong appeal in paediatric clinical trials given the small number of available participants, limited understanding of age-related variability and the desire to limit exposure to futile or unsafe interventions. Although the ethical value (...) of adaptive trials has increasingly come under scrutiny, there is a paucity of literature on the ethical dilemmas that may be associated with paediatric adaptive designs. This paper highlights some of these ethical concerns around safety, scientific/social value and caregiver/guardian comprehension of the trial design. Against this background, the paper develops a non-static conceptual lens for understanding PADs. It shows that ADs are epistemically open and reduce some of the knowledge-associated uncertainties inherent in clinical trials as well as fast-track the time to draw conclusions about the value of evaluated drugs/treatments. On this note, the authors argue that PADs are ethically justifiable given they have multiple layers of safety, exposing enrolled children to lesser potential risks, create social/scientific value generally and for paediatric populations in particular, specifically foster the flourishing of paediatric populations and can significantly improve paediatric trial efficiency when properly designed and implemented. However, because PADs are relatively new and their regulatory, ethical and logistical characteristics are yet to be clarified in some jurisdictions, the cooperation of various public and private stakeholders is required to ensure that the interests of children, their caregivers and parents/guardians are best served while exposing paediatric research subjects to the most minimal of risks when they are enrolled in paediatric trials that use ADs. Data sharing not applicable as no datasets generated and/or analysed for this study. Not applicable. (shrink)

Review boards responsible for vetting the ethical conduct of research have been criticised for their costliness, unreliability and inappropriate standards when evaluating some non-medical research, but the basic value of mandatory ethical review has not been questioned. When the standards that review boards use to evaluate research proposals are applied to review board practices, it is clear that review boards do not respect researchers or each other, lack merit and integrity, are not just and are not beneficent. (...) The few benefits of mandatory ethical review come at a much greater, but mainly hidden, social cost. It is time that responsibility for the ethical conduct of research is clearly transferred to researchers, except possibly in that small proportion of cases where prospective research participants may be so intrinsically vulnerable that their well-being may need to be overseen. (shrink)

Recent investigations with non‐model species and whole‐genome approaches have challenged several paradigms in animal epigenetics. They revealed that epigenetic variation in populations is not the mere consequence of genetic variation, but is a semi‐independent or independent source of phenotypic variation, depending on mode of reproduction. DNA methylation is not positively correlated with genome size and phylogenetic position as earlier believed, but has evolved differently between and within higher taxa. Epigenetic marks are usually not completely erased in the zygote and germ (...) cells as generalized from mouse, but often persist and can be transgenerationally inherited, making them evolutionarily relevant. Gene body methylation and promoter methylation are similar in vertebrates and invertebrates with well methylated genomes but transposon silencing through methylation is variable. The new data also suggest that animals use epigenetic mechanisms to cope with rapid environmental changes and to adapt to new environments. The main benefiters are asexual populations, invaders, sessile taxa and long‐lived species. (shrink)

There is a growing consensus that the offer of a reasonable compensation for oocyte donation for reproductive treatment is acceptable if it does not compromise voluntary and altruistically motivated donation. However, how to translate this ‘reasonable compensation’ in practice remains unclear as compensation rates offered to oocyte donors between different European Union countries vary significantly. Clinics involved in oocyte donation, as well as those in other medical contexts, might be encouraged in calculating a more consistent and transparent compensation for donors (...) if the elements that constitute a reasonable compensation are explicated. In doing so, lessons can be learnt from living organ donation and medical research participation. Practices in which the elements of a reasonable compensation for the individuals involved have already been more defined in the literature. By means of analogical reasoning, we will outline the different components of a reasonable compensation and subsequently apply these to the context of oocyte donation. We will argue that oocyte donors should first of all be reasonably reimbursed direct expenses related to the donation, without standard remuneration of lost wages. Second, donating oocytes requests a serious time investment, therefore donors are entitled to suitable compensation for their time spent and efforts made. Finally, we will explain that a reasonable compensation consisting of these two components allows for altruism to remain the key value of oocyte donation for reproductive treatment. However, if we acknowledge that donors’ motives are more complex and often include reasons from self-interest, the reasonable compensation may be complemented with modest (non)monetary benefits. (shrink)

American Academy of Pediatrics (AAP) and American College of Medical Genetics (ACMG) recently provided two recommendations about predictive genetic testing of children. The Clinical Sequencing Exploratory Research Consortium's Pediatrics Working Group compared these recommendations, focusing on operational and ethical issues specific to decision making for children. Content analysis of the statements addresses two issues: (1) how these recommendations characterize and analyze locus of decision making, as well as the risks and benefits of testing, and (2) whether the guidelines conflict (...) or come to different but compatible conclusions because they consider different testing scenarios. These statements differ in ethically significant ways. AAP/ACMG analyzes risks and benefits using best interests of the child and recommends that, absent ameliorative interventions available during childhood, clinicians should generally decline to order testing. Parents authorize focused tests. ACMG analyzes risks and benefits using the interests of the child and other family members and recommends that sequencing results be examined for additional variants that can lead to ameliorative interventions, regardless of age, which laboratories should report to clinicians who should contextualize the results. Parents must accept additional analysis. The ethical arguments in these statements appear to be in tension with each other. (shrink)

What proper role should considerations of risk, particularly to research subjects, play when it comes to conducting research on human enhancement in the military context? We introduce the currently visible military enhancement techniques (1) and the standard discussion of risk for these (2), in particular what we refer to as the ‘Assumption’, which states that the demands for risk-avoidance are higher for enhancement than for therapy. We challenge the Assumption through the introduction of three categories of enhancements (3): (...) therapeutic, preventive, and pure enhancements. This demands a revision of the Assumption (4), alongside which we propose some further general principles bearing on how to balance risks and benefits in the context of military enhancement research. We identify a particular type of therapeutic enhancements as providing a more responsible path to human trials of the relevant interventions than pure enhancement applications. Finally, we discuss some possible objections to our line of thought (5). While acknowledging their potential insights, we ultimately find them to be unpersuasive, at least provided that our proposal is understood as fully non-coercive towards the candidates for such therapeutic enhancement trials. (shrink)

Previous research reported that college students' symbolic addition and subtraction fluency improved after training with non-symbolic, approximate addition and subtraction. These findings were widely interpreted as strong support for the hypothesis that the Approximate Number System (ANS) plays a causal role in symbolic mathematics, and that this relation holds into adulthood. Here we report four experiments that fail to find evidence for this causal relation. Experiment 1 examined whether the approximate arithmetic training effect exists within a shorter training period (...) than originally reported (2 vs 6 days of training). Experiment 2 attempted to replicate and compare the approximate arithmetic training effect to a control training condition matched in working memory load. Experiments 3 and 4 replicated the original approximate arithmetic training experiments with a larger sample size. Across all four experiments (N = 318) approximate arithmetic training was no more effective at improving the arithmetic fluency of adults than training with control tasks. Results call into question any causal relationship between approximate, non-symbolic arithmetic and precise symbolic arithmetic. (shrink)

Promoting Farmer Managed Natural Regeneration (FMNR) aims to increase the productive capacities of farmer households. Under FMNR, farmers select and manage natural regeneration on farmlands and keep them under production. While FMNR contributes to the wealth of farming communities, its contribution to household food security has rarely been researched. We, therefore, used a mixed-methods approach to address the research gap by measuring FMNR’s contribution to food security among farmer households in the Talensi district of Ghana. We adopted the Household (...) Dietary Diversity Score (HDDS) and Food Consumption Score (FCS) to estimate food security status among 243 FMNR farmer households and 243 non-FMNR farmer households. Also, we performed a Chi-square test of independence to compare the frequency of each food group (present vs not present) between FMNR adopters and non-FMNR adopters to establish the relationship between adopting FMNR and consuming the FCS and HDDS food groups. Our results reveal that FMNR farmer households are more food secure than non-FMNR farmer households. The HHDS of the FMNR farmer households was 9.6, which is higher than the target value of 9.1. Conversely, the HHDS of the non-FMNR farmer households was 4.3, which is lower than the target value of 9.1. Up to 86% and 37% of the FMNR farmer households and non-FMNR farmer households fell within acceptable FCS; 15% and 17% of FMNR farmer households and non-FMNR farmer households fell within borderline FCS. While none of the FMNR farmer households fell within poor FCS, 46% of non-FMNR farmer households fell within poor FCS. Adopting FMNR is significantly related to consuming all food groups promoted and benefiting from FMNR practices. The paper recommends enabling farmers in semi-arid environments to practice and invest in FMNR for long-term returns to food security. (shrink)