Background: Expenditure on industry products (mostly drugs and devices) has spiraled over the last 15 years and accounts for substantial part of healthcare expenditure. The enormous financial interests involved in the development and marketing of drugs and devices may have given excessive power to these industries to influence medical research, policy, and practice.Material and methods: Review of the literature and analysis of the multiple pathways through which the industry has directly or indirectly infiltrated the broader healthcare systems. We present (...) the analysis of the industry influences at the following levels: (i) evidence base production, (ii) evidence synthesis, (iii) understanding of safety and harms issues, (iv) cost-effectiveness evaluation, (v) clinical practice guidelines formation, (vi) healthcare professional education, (vii) healthcare practice, (viii) healthcare consumer’s decisions.Results: We located abundance of consistent evidence demonstrating that the industry has created means to intervene in all steps of the processes that determine healthcare research, strategy, expenditure, practice and education. As a result of these interferences, the benefits of drugs and other products are often exaggerated and their potential harms are downplayed, and clinical guidelines, medical practice, and healthcare expenditure decisions are biased. Conclusion: To serve its interests, the industry masterfully influences evidence base production, evidence synthesis, understanding of harms issues, cost-effectiveness evaluations, clinical practice guidelines and Healthcare professional education and also exerts direct influences on professional decisions and health consumers. There is an urgent need for regulation and other action towards redefining the mission of medicine towards a more objective and patient-, population- and society-benefit direction that is free from conflict of interests. (shrink)

Payment to recruit research subjects is a common practice but raises ethical concerns relating to the potential for coercion or undue influence. We conducted the first national study of IRB members and human subjects protection professionals to explore attitudes as to whether and why payment of research participants constitutes coercion or undue influence. Upon critical evaluation of the cogency of ethical concerns regarding payment, as reflected in our survey results, we found expansive or inconsistent views about (...) coercion and undue influence that may interfere with valuable research. In particular, respondents appear to believe that coercion and undue influence lie on a continuum; by contrast, we argue that they are wholly distinct: whereas undue influence is a cognitive distortion relating to assessment of risks and benefits, coercion is a threat of harm. Because payment is an offer, rather than a threat, payment is never coercive. (shrink)

This paper examines a patient with borderline mental capacity, where the healthcare team is conflicted about how to proceed. This case demonstrates the complicated intersection between undue influence and mental capacity, allowing us to explore how the law is applied in clinical practice. Patients have the right to decline or accept medical treatments offered to them. In Singapore, family members perceive a right to be involved in the decision-making process for sick and elderly patients. Elderly patients, dependent on (...) mainly family members for care and support, sometimes submit to their overbearing influence resulting in decisions that fail to protect the patients’ own best interests. However, the clinicians’ own well-intentioned influence, driven by a desire for the best medical outcome can also be undue, and neither influence should seek to be a substitution for the patient’s decision. Following Re BKR [2015] SGCA 26, we are now obliged to examine how mental capacity can be affected by undue influence. A lack of capacity can be found when a patient fails to appreciate the presence of undue influence or is susceptible to undue influence due to their mental impairment causing their will to be overborne. This then paves the way for the health care team to decide based on best interests, because the patient is determined to be lacking in mental capacity. (shrink)

Forensic psychologists face a variety of ethical issues in conducting evaluations. One such issue is attorney presence during a forensic evaluation. In forensic evaluations, it is necessary to use standardized procedures while also attending to the rights of the individuals being assessed. This article examines the neuropsychological literature on extraneous influences in evaluations including effects of attorney presence. Then the article discusses the limited knowledge about attorney presence during forensic evaluations, addresses attorney motivations for being present during an evaluation, and (...) considers attorney presence in the context of ethical mandates. Finally, suggestions are offered for forensic clinicians confronted with attorneys who wish to be present during assessments. (shrink)

The American Journal of Bioethics, Volume 11, Issue 8, Page 19-20, August 2011.

Advances in psychology and neuroscience have elucidated the social aspects of human agency, leading to a broad shift in our thinking about fundamental concepts such as autonomy and responsibility. Here, we address a critical aspect of this inquiry by investigating how people consider the socio-relational nature of their own agency, particularly the influence of others on their perceived control over their decisions and actions. Specifically, in a series of studies using contrastive vignettes, we examine public attitudes about when external (...) influences on everyday decisions are perceived as " undue " – that is, as undermining the control conditions for these decisions to be considered autonomous – vs. when they are perceived as appropriate and even supportive of autonomous decision-making. We found that the influence of preauthorized agents – individuals and institutions with whom we share a worldview – was judged to be less undue than non-preauthorized agents, even after controlling for the familiarity of the agent. These effects persisted irrespective of the extent to which respondents identified as communitarian or individualistic, and were consistent across two distinct scenarios. We also found that external influences that were rational were perceived as less undue than those that were arational. Our study opens new avenues of inquiry into the " folk conception " of autonomy, and we discuss the implications of our findings for the ethics of public policies designed to influence decisions and for information sharing in social networks. (shrink)

A major appellate court decision from the United States seriously questions the legal sufficiency of prevailing medical criteria for the determination of death by neurological criteria. There may be a mismatch between legal and medical standards for brain death, requiring the amendment of either or both. In South Australia, a Bill seeks to establish a legal right for a defined category of persons suffering unbearably to request voluntary euthanasia. However, an essential criterion of a voluntary decision is that it is (...) not tainted by undue influence, and this Bill falls short of providing adequate guidance to assess for undue influence. (shrink)

Introduction Scholars have debated how to define coercion and undue influence, but how institutional review boards (IRBs) view and make decisions about these issues in actual cases has not been explored. Methods I contacted the leadership of 60 US IRBs (every fourth one in the list of the top 240 institutions by National Institutes of Health funding), and interviewed 39 IRB leaders or administrators from 34 of these institutions (response rate=55%), and 7 members. Results IRBs wrestled with defining (...) of ‘coercion’ and ‘undue inducement’, most notably in deciding about participant compensation. IRBs often use these terms synonymously and define undue inducement in varying ways, often wrestling with these issues, relying on ‘gut feelings’, and seeking compromises. Ambiguities arose, partly reflecting underlying tensions: whether subjects should ‘get paid’ versus ‘volunteer’ (ie, whether subjects should be motivated by compensation vs altruism), and whether subjects should be paid differently based on income, given possible resultant selection bias. Lack of consistent standards emerged between and even on single IRBs. Questions arose concerning certain aspects and types of studies; for example, how to view and weigh providing free care in research, whether and how recruitment flyers should mention compensation, and how to avoid coercion in paediatric, developing world, or students research. Conclusions These data, the first to probe qualitatively how IRBs view and approach questions about coercion, undue influence and participant compensation, and to examine how IRBs have reviewed actual cases, reveal several critical ambiguities and dilemmas, and have vital implications for future practice, education, policy and research. (shrink)

Clinical investigators must engage in just subject recruitment and selection and avoid unduly influencing research participation. There may be tension between the practice of keeping payments to participants low to avoid undue influence and the requirements of justice when recruiting normal healthy volunteers for phase 1 drug studies. By intentionally keeping payments low to avoid unduly influenced participation, investigators, on the recommendation or insistence of institutional review boards, may be targeting or systematically recruiting healthy adult members of lower (...) socio-economic groups for participation in phase 1 studies. Investigators are at risk of routinely failing to fulfill the obligation of justice, which prohibits the systematic targeting and recruiting of subjects for reasons unrelated to the nature of the study. Insofar as we take seriously the obligation to engage in just subject recruitment and selection, I argue that we must acknowledge the implications low payments might have for subject recruitment and selection and examine the effect of low payments. If low payments de facto target the less well-off for phase 1 studies, we must defend the priority ranking of the obligation to avoid undue influence over the obligation of justice or adopt an alternative recruitment approach. This paper identifies a number of alternatives to the current system of low-value payments to research participants. (shrink)

In Barclay's Bank v. O'Brien(1993) the House of Lords extended the undue influence rules to heterosexual and homosexual cohabitees, a move that was widely welcomed and has been endorsed in Royal Bank of Scotland v. Etridge (No. 2) (2001). The paper argues that the extension to homosexual couples is inappropriate, since undue influence is largely a problem of heterosexuality. It is not accidental that there have been no reported cases of undue influence between lesbian (...) or gay partners, not because abuses of power do not occur within such relationships, but because they are free of the central causal factor of undue influence: not intimacy per se but the gendered power dynamic within heterosexual intimacy that has characterised almost all reported cases. The first part of the paper examines the courts' treatment of gay and lesbian couples in other areas of equity and concludes that the absence of gender role assumptions leads courts to treat lesbian and gay claimants more equitably than they do heterosexual women. The second part focuses on the potential for gay and, especially, lesbian relationships to act as models of more egalitarian relationships than heterosexual ones. The dominant discourse of inclusion within the gay and lesbian legal lobby is problematised, and the paper concludes that what is needed is social and judicial recognition of what is different, not what is the same, about our relationships. (shrink)

In a compelling article, Peterson, Karlawish and Largent argue that supported decision-making is preferable to substitute decision-making for people with dynamic impairments. We fully...

Presently, the pharmaceutical industry funds about half of the costs of continuing medical education programs in the U.S. This contributes to the ethical problems that pervade the relationship between medicine and the pharmaceutical industry: trustworthiness and conflicts of interest. The problems are exacerbated by rationalizations prevalent on both sides that deny the ethical concerns. Commercialism and commercial bias are highly visible at large CME gatherings, and available data, while scanty, back up the view that physician attendees' subsequent prescribing practices are (...) influenced by the commercial message. The industry believes that it will recoup $3.56 in increased sales for every dollar that it invests in CME. New guidelines instituted by the Accreditation Council for Continuing Medical Education in 2004 may succeed in reducing excessive commercial influence, especially since the Department of Health and Human Services has also warned the industry of possible anti-kickback violations if firewalls are not erected between CME funding and marketing of drugs. Critics counter that early indicators of improvement are lacking. (shrink)

As early as the 1960s and 1970s, astute commentators began to call into question the degree of influence that the pharmaceutical industry was exercising over all aspects of medical research, education, and practice in the U.S. More recently, a spate of books and articles demonstrates that the issue has only become more serious in the last decade or two.My focus in this paper will be on the industry’s influence on medical education. The influence that the industry exerts (...) on undergraduate and graduate medical education often occurs through the system of pharmaceutical sales representatives, who also “detail” drugs to practitioners; or through the influence that the industry exerts over medical research. I will therefore devote my attention here primarily to the system of continuing medical education by which practitioners receive information about medical advances. The pharmaceutical industry currently supports about one-half of the costs of CME in the U.S., so it seems appropriate to question the degree of industry influence over the content of CME. (shrink)

This paper argues that despite pressures to conform to the research methodology of the social sciences, African philosophers must diligently work for the preservation of the distinct character of philosophy as a discipline. To do this, they will have to move away from the debate on the existence and nature of African philosophy, and focus their efforts on the quest for a criterion by which to distinguish philosophical works from non-philosophical ones, regardless of where the works hail from. They will (...) also have to be busy engaging in other aspects of philosophical reflection, so that their discipline may grow in an all-rounded manner, and so that the research methodology of philosophy may be manifest to scholars from other disciplines. Only then will philosophy make its unique contribution to interdisciplinary research in Africa and beyond. (shrink)

Busy physicians and scientists tend to be willfully naive about politics. Physics, chemistry, and biology are clean—that is, subject to relatively consistent and identifiable laws or at least trends and, certainly in the case of medicine, beneficial when properly applied. Politics, on the other hand, tend to be unpredictable, murky, and dirty—that is, too often all about self-serving power and, ultimately, money.

Using payment to recruit research subjects is a common practice, but it raises ethical concerns that coercion or undue inducement could potentially compromise participants’ informed consent. This is the first national study to explore the attitudes of IRB members and other human subjects protection professionals concerning whether payment of research participants constitutes coercion or undue influence, and if so, why. The majority of respondents expressed concern that payment of any amount might influence a participant’s decisions or (...) behaviors regarding research participation. Respondents expressed greater acceptance of payment as reimbursement or compensation than as an incentive to participate in research, and most agreed that subjects are coerced if the offer of payment makes them participate when they otherwise would not or when the offer of payment causes them to feel that they have no reasonable alternative but to participate . Views about undue influence were similar. We conclude that human subjects protection professionals hold expansive and inconsistent views about coercion and undue influence that may interfere with the recruitment of research participants and impede valuable research. (shrink)

There is an alleged tension between undue inducement and exploitation in research trials. This paper considers claims that increasing the benefits to research subjects enrolled in international, externally-sponsored clinical trials should be avoided on the grounds that it may result in the undue inducement of research subjects. This article contributes to the debate about exploitation versus undue inducement by introducing an analysis of the available empirical research into research participants' motivations and the influence of payments on (...) research subjects' behaviour and risk assessment. Admittedly, the available research in this field is limited, but the research that has been conducted suggests that financial rewards do not distort research subjects' behaviour or blind them to the risks involved with research. Therefore, I conclude that research sponsors should prioritise the prevention of exploitation in international research by providing greater benefits to research participants. (edited). (shrink)

This essay considers how we are to understand the decision to end one’s life under medical aid-in-dying (MAID) statutes and the role of influencing others. Bioethical concerns about the potential for abuse in MAID have focused predominantly on the risk of coercion and other forms of undue influence. Most bioethical analyses of relational influences in MAID have been made by opponents of MAID, who argue that MAID is unethical, in part, because it cannot cleanly accommodate relational influences. In (...) contrast, proponents of MAID have downplayed the role of relational influences because they may threaten the pillars of autonomy and voluntariness on which the ethics of MAID rest. Drawing on a case study collected as part of an ethnographic study of MAID in Vermont, we show how relations of care are central to MAID decision-making. Such relations may muddle motives for assisted death, exposing the limits of conventional bioethics thinking on MAID and relational influence. Here, we argue that ethical frameworks for MAID should account for the role of relational influences in decision-making, and acknowledge that relational influences may support, as well as undermine, a decision for MAID. We then outline an evaluative framework for determining whether relational influences are undue that identifies six key domains for consideration: mental competence, authenticity, relationship context, having an adequate range options, financial considerations and irremediability. We conclude by suggesting that social relationships may constitute an important source of value in end-of-life decision-making and not only a liability. (shrink)

John Tillson argues, on grounds of children’s well-being, that it is impermissible to teach them religious views. I defend a practice of pluralistically advocating religious views to children. As long as there are no monopolies of influence over children, and as long as advocates do not use coercion, deceit, or manipulation, children can greatly benefit without having their rational abilities subverted, or incurring undue risk to form false beliefs. This solution should counter, to some extent, both perfectionist and (...) antiperfectionist reasons against initiating children into religions. (shrink)

The practice of paying prisoners to for their participation in research has long been debated, and the controversy is reflected in the differing policies in the U.S. prison systems. Empirical study of financial payments to inmates who enroll in research has focused on whether this practice is coercive. In this study, we examined whether monetary incentives have the potential to be unduly influential among fifty HIV‐positive prisoners. The majority of prisoners surveyed believed that inmates should receive some compensation for their (...) involvement in research and disagreed with statements suggesting that the offer of payment constitutes undue influence. However, a sense of potentially being susceptible to undue influence was significantly higher among participants who had spent a longer time in prison and had less education. Overall, our findings suggest that most prisoners feel that they would be able to make a decision about research enrollment that is not solely based on an offer of monetary payment. (shrink)

Some are concerned about the possibility that offering money for research participation can constitute coercion or undue influence capable of distorting the judgment of potential research subjects and compromising the voluntariness of their informed consent. The author recognizes that more often than not there are multiple influences leading to decisions, including decisions about research participation. The concept of undue influence is explored, as well as the question of whether or not there is something uniquely distorting about (...) money as opposed to a chance for treatment or medical care. An amount of money that is not excessive and is calculated on the basis of time or contribution may, rather than constitute an undue inducement, be an indication of respect for the time and contribution that research subjects make. (shrink)

Consent, in terms of voluntary choice, is - or, at least, appears to be or purports to be - at the essence of contract law. Contract law, both in principle and in practice, is about allowing parties to enter arrangements on terms they choose - each party imposing obligations on itself in return for obligations another party has placed upon itself. This freedom of contract- an ideal by which there are obligations to the extent, but only to the extent, freely (...) chosen by the parties - is contrasted to the duties of criminal law and tort law, which bind all parties regardless of consent. At the same time, consent, in the robust sense expressed by the ideal of freedom of contract, is arguably absent in the vast majority of the contracts we enter these days, but its absence does little to affect the enforceability of those agreements. Consent to contractual terms often looks like consent to government: present, if at all, only under a fictional (as if) or attenuated rubric. This article explores a variety of topics relating to consent, and the role it plays in contract law doctrine and theory. The article begins by a brief examination of the nature of consent, then turns to contract doctrines that turn on the alleged absence of consent (e.g., duress and undue influence); contract rules and principles (e.g., implied terms) that turn on hypothetical consent; the challenges to consent that arise from electronic contracting and bounded rationality, and theories of contract law that emphasize consent. (shrink)

There is considerable confusion regarding the ethical appropriateness of using incentives in research with human subjects. Previous work on determining whether incentives are unethical considers them as a form of undue influence or coercive offer. We understand the ethical issue of undue influence as an issue, not of coercion, but of corruption of judgment. By doing so we find that, for the most part, the use of incentives to recruit and retain research subjects is innocuous. But (...) there are some instances where it is not. Specifically, incentives become problematic when conjoined with the following factors, singly or in combination with one another: where the subject is in a dependency relationship with the researcher, where the risks are particularly high, where the research is degrading, where the participant will only consent if the incentive is relatively large because the participant's aversion to the study is strong, and where the aversion is a principled one. The factors we have identified and the kinds of judgments they require differ substantially from those considered crucial in most previous discussions of the ethics of employing incentives in research with human subjects. (shrink)

In order to accommodate for the present shortage of oocyte donors, oocyte-donation programs place ads in college newspapers and provide large monetary compensation to encourage participation. Large compensation acts as a strong incentive for young women to undergo the potentially risky procedure of donation. In this enticing situation, it is particularly important for programs to fully inform prospective donors of the risks of the procedure so that they can accurately weigh the costs and benefits of donating. However, because oocyte-donor programs (...) must alleviate the shortage of donors if they wish to maintain a financially viable business, there is reason to fear that they may minimize or misrepresent risks when recruiting egg donors. In this pilot study, the risk information provided by programs (n=19) to prospective oocyte donors in a preliminary phone call inquiry was investigated. The majority of the programs provided incomplete and/or inaccurate risk information. Policy changes are recommended to reduce the potential for undue influence and to standardize and regulate the risk information provided to prospective egg donors. (shrink)

This article concerns two themes in Bart Schultz's recent biography of Henry Sidgwick, Henry Sidgwick: Eye of the Universe. The first is the importance of Sidgwick's conflict over his religious beliefs to the development of his thinking in The Methods of Ethics. I suggest that, in addition to the characteristics of Methods that Schulz highlights, the work's epistemology, specifically, Sidgwick's program of presenting ethics as an axiomatic system on the traditional understanding of such systems, is due to the conflict. The (...) second is the relative neglect into which Methods fell in the first part of the twentieth century, neglect Schultz attributes to changes in philosophical fashions and to the undue influence of the Bloomsbury literati on British intellectual culture. I suggest that there is a deeper explanation, which lies in Sidgwick's program of presenting ethics as an axiomatic system on the traditional understanding of such systems. Such programs, I argue, became obsolete in analytic philosophy owing to changes in how axiomatization in mathematics was understood that resulted initially from the rise of non-Euclidean geometries and ultimately from the collapse of Frege's and Russell's logicism. (shrink)

BackgroundAn increasing number of studies utilize intracranial electrophysiology in human subjects to advance basic neuroscience knowledge. However, the use of neurosurgical patients as human research subjects raises important ethical considerations, particularly regarding informed consent and undue influence, as well as subjects’ motivations for participation. Yet a thorough empirical examination of these issues in a participant population has been lacking. The present study therefore aimed to empirically investigate ethical concerns regarding informed consent and voluntariness in Parkinson’s disease patients undergoing (...) deep brain stimulator (DBS) placement who participated in an intraoperative neuroscience study.MethodsTwo semi-structured 30-minute interviews were conducted preoperatively and postoperatively via telephone. Interviews assessed participants’ motivations for participation in the parent intraoperative study, recall of information presented during the informed consent process, and participants’ postoperative reflections on the research study.ResultsTwenty-two participants (mean age = 60.9) completed preoperative interviews at a mean of 7.8 days following informed consent and a mean of 5.2 days prior to DBS surgery. Twenty participants completed postoperative interviews at a mean of 5 weeks following surgery. All participants cited altruism or advancing medical science as “very important” or “important” in their decision to participate in the study. Only 22.7% (n = 5) correctly recalled one of the two risks of the study. Correct recall of other aspects of the informed consent was poor (36.4% for study purpose; 50.0% for study protocol; 36.4% for study benefits). All correctly understood that the study would not confer a direct therapeutic benefit to them.ConclusionEven though research coordinators were properly trained and the informed consent was administered according to protocol, participants demonstrated poor retention of study information. While intraoperative studies that aim to advance neuroscience knowledge represent a unique opportunity to gain fundamental scientific knowledge, improved standards for the informed consent process can help facilitate their ethical implementation. (shrink)

American bioethics has served as a safety net for the rich and powerful, often failing to protect minorities and the economically disadvantaged. For example, minorities and the economically disadvantaged are often unduly influenced into participating in clinical trials that promise monetary gain or access to health care. This is a violation of the bioethical principle of “respect for persons,” which requires that informed consent for participation in clinical trials is voluntary and free of undue influence. Promises of access (...) to health care invalidate the voluntariness of informed consent not only because it unduly induces minorities and the economically disadvantaged to participate in clinical trials to obtain access to potentially life saving health care, but it is also manipulative because some times the clinical trial is conducted by the very institutions that are denying minorities and the economically disadvantaged access to health care. To measure whether consent is voluntary and free of undue influence, federal agencies should require researchers to use the Vulnerability and Equity Impact Assessment tool, which I have created based on the Health Equity Impact Assessment tool, to determine whether minorities and the economically disadvantaged are being unduly influenced into participating in clinical trials in violation of the “respect for persons” principle. (shrink)

Since children are considered incapable ofgiving informed consent to participate inresearch, regulations require that bothparental permission and the assent of thepotential child subject be obtained. Assent andpermission are uniquely bound together, eachserving a different purpose. Parentalpermission protects the child from assumingunreasonable risks. Assent demonstrates respectfor the child and his developing autonomy. Inorder to give meaningful assent, the child mustunderstand that procedures will be performed,voluntarily choose to undergo the procedures,and communicate this choice. Understanding theelements of informed consent has been theparadigm for (...) assessing capacity to give assent.This method leaves the youngest, leastcognitively mature children vulnerable towaiver of assent and forced researchparticipation. Voluntariness can also becompromised by the influence of authorityfigures who can exert undue influence andcoerce children to participate in research. This paper discusses factors that may influencethe decision to give assent/permission,potential parent-child conflict in theassent/permission process and how it isresolved, and potential parental undueinfluence on research participation. Theseissues are illustrated with quotations drawnfrom a larger qualitative study of parentalpermission and child assent (data notpresented). We suggest a developmentalapproach, viewing assent as a continuum rangingfrom mere affirmation in the youngest childrento the equivalent of the informed consentprocess in the mature adolescent. (shrink)

Obtaining consent for medical treatment in older adults raises a number of complex challenges. Despite being required by ethics and the law, consent for medical treatment is not always validly sought in this population. The dynamic nature of capacity, particularly in individuals who have dementia or other cognitive impairments, adds complexity to obtaining consent. Further challenges arise in ensuring that older people comprehend the medical treatment information provided and that consent is not vitiated by coercion or undue influence. (...) Existing mechanisms to address issues surrounding consent for older adults only address incapacity and raise further challenges. As the ageing population increases, these issues are likely to become more profound, thus action is required to address these challenges. Raising awareness, more education, engaging with people with dementia, and conducting further research would assist in beginning to overcome these challenges. (shrink)

The possibility that industry is exerting an undue influence on the culture of medicine has profound implications for the profession's public health mission. Policy analysts, investigative journalists, researchers, and clinicians have questioned whether academic-industry relationships have had a corrupting effect on evidence-based medicine. Psychiatry has been at the heart of this epistemic and ethical crisis in medicine. This article examines how commercial entities, such as pharmaceutical companies, influence psychiatric taxonomy and treatment guidelines. Using the conceptual framework of (...) institutional corruption, we show that organized psychiatry's dependence on drug firms has led to a distortion of science. We describe the current dependency corruption and argue that transparency alone is not a solution. We conclude by taking the position that the corruption of the evidence base in diagnostic and practice guidelines has compromised the informed consent process, and we suggest strategies to address this problem. (shrink)

This study examines the tensions between the western concept of professional independence and accountants’ commitment to significant others under the care perspective of guanxi. The principle of professional independence is founded on arm’s-length transactions to avoid undue influence on professional and ethical judgement. However, in the relational society of China, social interactions based on Confucianism elicit a duty of care and concern towards significant others in important relationships. For a professional accountant, the commitment to persons with whom they (...) have guanxi is potentially at odds with their commitment to professional independence. Data collected from interviews with Chinese accounting professionals, accounting academics and expatriate accountants working in China provide insight on how Chinese accounting professionals discharge their obligations under guanxi. Notions of guanxi and the rules of exchange identified in Hwang’s (Knowledge and action: A social psychological interpretation of Chinese cultural traditions, Sin-Li, Taipei, 1995) model of “Confucian ethics for ordinary people” provide the lens to explain the ethical dilemmas facing Chinese accountants. The findings suggest that accounting professionals prioritise the interests of their superiors and clients over the users of financial reports. Despite accountants’ moral obligation to protect the public interest, personal and professional obligations in China struggle to extend beyond client or employer interests mostly because of the absence of a formal relationship or connection with the public. This contrasts sharply with the notion of professional independence practised in western societies, where accounting professionals must be independent of their clients and superiors and commit to a duty to protect the public interest. The outcome of this study demonstrates the impediments to transplanting western concepts to different cultures. (shrink)

Beneficence is usually regarded as adequate when it results in an actual benefit for a beneficiary and satisfies her self-chosen end. However, beneficence that satisfies these conditions can harm beneficiaries' free agency, particularly when they are robustly dependent on benefactors. First, the means that benefactors choose can have undesirable side-effects on resources that beneficiaries need for future free action. Second, benefactors may undermine beneficiaries' ability to freely deliberate and choose. It is therefore insufficient to satisfy someone's self-chosen ends. Instead, good (...) beneficence depends on whether the benefactor avoids undue influence over a beneficiary's deliberation and whether the choice of means is compatible with the beneficiary's conception of her good. Consequently, benefactors must have substantial respect for a beneficiary's free agency and the practical competence to choose means that take into account the beneficiary's conception of her good and the wider set of circumstances that influence her life. (shrink)

There is a growing resurgence in the study of psychedelic medicines for the treatment of mental health and substance use disorders. However, certain early investigations are marred by questionable research methods, abuses against research participants, and covert Central Intelligence Agency financial involvement. The purpose of this study was to understand how and to what extent people of colour and other vulnerable populations, specifically, individuals who were incarcerated or incapacitated due to mental health issues, were exploited during the first wave of (...) psychedelic research in the USA. To do so, we reviewed available empirical publications according to current ethical standards. Variables of interest included race and ethnicity of participants, population vulnerability, drug administration conditions, informed consent and undue influence. Our findings draw attention to the history of research abuses against people of colour in Western psychedelic research. In light of these findings, we urge a call-to-action to current psychedelic researchers to prioritise culturally inclusive and socially responsible research methods in current and future studies. All data relevant to the study are included in the article. (shrink)

In this article, I present some worries about the possible impact of global efforts to aid the needy in some of the world’s most desperate regions. Among the worries I address are possible unintended negative consequences that may occur elsewhere in a society when aid agencies hire highly qualified local people to promote their agendas; the possibility that foreign interests and priorities may have undue influence on a country’s direction and priorities, negatively impacting local authority and autonomy; and (...) the related problem of outside interventions undermining the responsiveness of local and national governments to their citizens. -/- Another issue I discuss is the possibility that efforts to aid the needy may involve an Each-We Dilemma, in which case conflicts may arise between what is individually rational or moral, and what is collectively rational or moral. Unfortunately, it is possible that if each of us does what we have most reason to do, morally, in aiding the needy, we together will bring about an outcome which is worse, morally, in terms of its overall impact on the global needy. -/- The article ends by briefly noting a number of claims and arguments that I made in my 2017 Uehiro Lectures regarding how good people should respond in a world of need. As I have long argued, I have no doubt that those who are well off are open to serious moral criticism if they ignore the plight of the needy. Unfortunately, however, for a host of both empirical and philosophical reasons, what one should do in light of that truth is much more complex, and murky, than most people have realized. (shrink)

Ethical oversight of clinical research is one of the primary means of ensuring that human subjects are protected from the natural bias of researchers and research institutions in favor of experimentation. At a minimum, effective oversight should ensure that risks are minimized and reasonable in relation to anticipated benefits, protect vulnerable subjects from potential coercion or undue influence, ensure full and informed consent, and promote the equitable distribution of the risks and benefits of research. Because these assessments often (...) involve value judgments for which there are no agreed-upon objective standards, we rely on deliberative procedures thought to have the greatest likelihood of producing the right or best outcomes. Concerns about the potential for improperly functioning IRBs to waste scarce human and institutional resources and impede biomedical progress have motivated a surge in empirical research assessing their procedures and outcomes. Yet within this literature, there has been minimal attention paid to the social scientific evidence regarding how individuals and deliberating groups make decisions, nor how those data might inform IRB practice. This essay seeks to fill that gap, locating recent empirical data on IRB composition and process within the context of data regarding what I call “deliberative pathologies,” or instances when deliberation fails to live up to one or more aspect of the deliberative ideal because of systematic biases in the ways participants interact. The paper goes on to make evidence-based recommendations to reduce the vulnerability of IRB deliberations to the kinds of pathologies discussed and indicate directions for future research. (shrink)

The main aim of this paper is to revisit the curve fitting problem using the reliability of inductive inference as a primary criterion for the ‘fittest' curve. Viewed from this perspective, it is argued that a crucial concern with the current framework for addressing the curve fitting problem is, on the one hand, the undue influence of the mathematical approximation perspective, and on the other, the insufficient attention paid to the statistical modeling aspects of the problem. Using goodness-of-fit (...) as the primary criterion for ‘best', the mathematical approximation perspective undermines the reliability of inference objective by giving rise to selection rules which pay insufficient attention to ‘accounting for the regularities in the data'. A more appropriate framework is offered by the error-statistical approach, where (i) statistical adequacy provides the criterion for assessing when a curve captures the regularities in the data adequately, and (ii) the relevant error probabilities can be used to assess the reliability of inductive inference. Broadly speaking, the fittest curve (statistically adequate) is not determined by the smallness if its residuals, tempered by simplicity or other pragmatic criteria, but by the nonsystematic (e.g. white noise) nature of its residuals. The advocated error-statistical arguments are illustrated by comparing the Kepler and Ptolemaic models on empirical grounds. ‡I am grateful to Deborah Mayo and Clark Glymour for many valuable suggestions and comments on an earlier draft of the paper; estimating the Ptolemaic model was the result of Glymour's prompting and encouragement. †To contact the author, please write to: Department of Economics, Virginia Tech 3019 Pamplin Hall (0316), Blacksburg, VA 24061; e-mail: [email protected]. (shrink)

My aim is to extend and complement the arguments that others have already made for the claim that women who are citizens of economically disadvantaged states and who have been trafficked into sex work in economically advantaged states should be considered candidates for asylum. Familiar arguments cite the sexual violence and forced labor that trafficked women are subjected to along with their well-founded fear of persecution if they’re repatriated. What hasn’t been considered is that reproductive rights are also at stake. (...) I explain how reproductive rights are implicated in sex trafficking. Moreover, I contend that sex traffickers’ abuse of women’s reproductive rights is persecutory and that that this persecutory abuse obliges destination states to offer asylum to transnational sex trafficking victims. I start by sketching reproductive human rights doctrine. I then examine studies of women who are in post-trafficking recovery programs in order to ascertain the impact of their past experience of forced sex work on their reproductive freedom and health. On the basis of these findings, I maintain that, among other outrages, sex trafficking systematically violates victims’ reproductive human rights. In view of this abuse, women trafficked into sex work might seem to be prime candidates for asylum in destination states. Yet, economically well-off destination states are not particularly receptive to this idea, and international law provides some justification for their chilliness. Preliminary to challenging them, I explicate four ways in which international anti-trafficking law and international refugee law interfere with viewing women trafficked into sex work as refugees and approving their applications for asylum. The second half of my paper aims to overcome those legal obstacles. In the interest of parsimony and because there are many continuities between U.S. refugee law and anti-trafficking law and the policies of similar destination states, I focus mainly on the U.S. in this part of the paper. To anchor my argument, I spotlight two precedents in refugee law for taking reproductive human rights seriously and several precedents for treating trafficked women as members of a distinct social group as required by refugee law. I then urge that a law enforcement gestalt has gained undue influence over U.S. legal practices where anti-trafficking law intersects with refugee protection law. A human rights gestalt is needed as a counterweight, for otherwise victims of sex trafficking and the reproductive abuse they’ve suffered are erased. Taking up a human rights perspective and mobilizing the precedents I’ve identified, I show that respecting the reproductive human rights of women who have been trafficked into sex work entails that affluent destination states must recognize their right to asylum. (shrink)

In 2008 pharmaceutical companies spent over $12 billion on product promotion and detailing aimed at U.S. health care practitioners. Drug and device manufacturers rely on a workforce of detailers and physician speakers to reach health care practitioners and nudge their prescribing habits. To prevent undue influence and protect the public fisc, a number of states began regulating these marketing practices, requiring companies to disclose all gifts to practitioners, prohibiting the commercialized sale of prescription data, and prohibiting certain gifts (...) altogether. The 2010 enactment of the Physician Payment Sunshine Act marks the first Congressional involvement in the regulation of disclosure related to pharmaceutical marketing. Overall, the Act improves transparency in pharmaceutical marketing to physicians and expands the regulation of disclosure of pharmaceutical marketing activities in important substantive ways. (shrink)

Stricter policies regarding conflicts of interest policies will increase transparency but have limitations and unintended adverse consequences. Physicians and the medical profession should take the lead in developing policies, rather than responding to external regulations. The goal is to reduce significant risks of undue influence, while keeping the burdens and opportunity costs of policies acceptable.

Lowering compensation to research subjects to protect them from “undue inducement” is a misguided attempt to shoehorn a concern about exploitation into the framework of autonomy. We suggest that oversight bodies should be less concerned about undue influence than about exploitation of subjects. Avoiding exploitation in human subjects research requires not only increasing compensation, but enhancing the dignity of research participation.

All major journalism ethical codes explicitly state that journalists should protect editorial copy from undue influence by outside sources. However, much of the previous research on agricultural information has concentrated on what information various media communicate (gatekeeping studies) or communication's role in increasing innovation adoption (diffusion studies). Few studies have concentrated specifically on organizational and structural constraints that might adversely affect agricultural journalists' ethical standards; those that have, focus largely on farm magazines. A study of newspaper reporters who (...) cover agricultural news found that the most pressing ethical concern is the effect of advertiser (agri-business) pressure on editorial copy, and that their concerns in general parallel those of farm magazine writers and editors. The majority reported being in situations in which they might be exposed to advertiser pressure, including pressures to change or withhold editorial copy. Large minorities suggested that advertising pressures affect the overall environment in which agricultural journalists work, and more than one in ten said they allow advertiser pressures to influence editorial decisions. The newspaper reporters who cover agricultural beats showed slightly more resistance to advertiser pressure than did farm magazine editors in a parallel study. (shrink)

BackgroundOne of the next frontiers in HIV research is focused on finding a cure. A new priority includes people with HIV (PWH) with non-AIDS terminal illnesses who are willing to donate their bodies at the end-of-life (EOL) to advance the search towards an HIV cure. We endeavored to understand perceptions of this research and to identify ethical and practical considerations relevant to implementing it.MethodsWe conducted 20 in-depth interviews and 3 virtual focus groups among four types of key stakeholders in the (...) United States (PWH, biomedical HIV cure researchers, HIV clinicians, and bioethicists) to obtain triangulated viewpoints because little was known about the ethics of this topic. Each group was queried as to ethical considerations, safeguards, and protections for conducting HIV cure-related research at the EOL to ensure this research remains acceptable.ResultsAll four key stakeholder groups generally supported HIV cure-related research conducted at the EOL because of the history of altruism within the PWH community and the potential for substantial scientific knowledge to be gained. Our informants expressed that: (1) Strong stakeholder and community involvement are integral to the ethical and effective implementation, as well as the social acceptability of this research; (2) PWH approaching the EOL should not inherently be considered a vulnerable class and their autonomy must be respected when choosing to participate in HIV cure-related research at the EOL; (3) Greater diversity among study participants, as well as multi-disciplinary research teams, is necessitated by HIV cure-related research at the EOL; (4) The sensitive nature of this research warrants robust oversight to ensure a favorable risk/benefit balance and to minimize the possibility of therapeutic misconception or undue influence; and (5) Research protocols should remain flexible to accommodate participants’ comfort and needs at the EOL.ConclusionBecause of the ethical issues presented by HIV cure-related research at the EOL, robust ethical safeguards are of utmost importance. The proposed ethical and practical considerations presented herein is a first step in determining the best way to maximize this research’s impact and social value. More much inquiry will need to be directed towards understanding context-specific and cultural considerations for implementing EOL HIV cure research in diverse settings. (shrink)

Community Engagement (CE) has been presented by bio-ethicists and scientists as a straightforward and unequivocal good which can minimize the risks of exploitation and ensure a fair distribution of research benefits in developing countries. By means of ethnographic fieldwork undertaken in Kenya between 2007 and 2009 we explored how CE is understood and enacted in paediatric vaccine trials conducted by the Kenyan Medical Research Institute and the US Centers for Disease Control (KEMRI/CDC). In this paper we focus on the role (...) of paid volunteers who act as an interface between villagers KEMRI/CDC. Village Reporters’ (VRs) position of being both with the community and with KEMRI/CDC is advantageous for the conduct of trials. However it is also problematic in terms of exercising trust, balancing allegiances and representing community views. VRs role is shaped by ambiguities related to their employment status and their dual accountability to researchers and their villages. VRs are understandably careful to stress their commitment to self-less community service since it augments their respectability at community level and opens up opportunities for financial gain and self-development. Simultaneously VRs association with KEMRI/CDC and proximity to trial participants requires them to negotiate implicit and explicit expectations for material and medical assistance in a cultural setting in which much importance is placed on sharing and mutuality. To ensure continuity of productive interactions between VRs, and similar community intermediaries, and researchers, open discussion is needed about the problematic aspects of relational ethics, issues concerning undue influence, power relations and negotiating expectations. (shrink)

We identify three distinct ethical problems that can arise with risk displacement. Risk displacement is the shifting of extant risk from one or more individuals to other individual(s) such that the reduction of risk to the first group is causally implicated in increasing risk to the second group. These problems are: concentration of risk in inequitable ways; transfer of risk to already vulnerable or disadvantaged populations; and exercise of undue influence over potential research participants. The first two arise (...) in both public policy and research initiatives, whereas the third is a special concern that only applies to research initiatives. We argue that when one or more of these is of high magnitude, then the study or policy intervention may be ethically wrong. Finally, we conclude that although some risk displacement is ethically permissible, researchers and policymakers still have ethical reasons to reduce the magnitude of these problems. (shrink)