International research, sponsored by for-profit companies, is regularly criticised as unethical on the grounds that it exploits research subjects in developing countries. Many commentators agree that exploitation occurs when the benefits of cooperative activity are unfairly distributed between the parties. To determine whether international research is exploitative we therefore need an account of fair distribution. Procedural accounts of fair bargaining have been popular solutions to this problem, but I argue that they are insufficient to protect against exploitation. I argue instead (...) that a maximin principle of fair distribution provides a more compelling normative account of fairness in relationships characterised by extreme vulnerability and inequality of bargaining potential between the parties. A global tax on international research would provide a mechanism for implementing the maximin account of fair benefits. This model has the capacity to ensure fair benefits and thereby prevent exploitation in international research. (shrink)

(2010). Response to Open Peer Commentaries on “How to Do Research Fairly in an Unjust World”. The American Journal of Bioethics: Vol. 10, No. 6, pp. W4-W6.

Background We aimed to examine the ethical concerns Singaporeans have about sharing health-data for precision medicine and identify suggestions for governance strategies. Just as Asian genomes are under-represented in PM, the views of Asian populations about the risks and benefits of data sharing are under-represented in prior attitudinal research. Methods We conducted seven focus groups with 62 participants in Singapore from May to July 2019. They were conducted in three languages and analysed with qualitative content and thematic analysis. Results Four (...) key themes emerged: nuanced understandings of data security and data sensitivity; trade-offs between data protection and research benefits; trust in the public and private sectors; and governance and control options. Participants were aware of the inherent risks associated with data sharing for research. Participants expressed conditional support for data sharing, including genomic sequence data and information contained within electronic medical records. This support included sharing data with researchers from universities and healthcare institutions, both in Singapore and overseas. Support was conditional on the perceived social value of the research and appropriate de-identification and data security processes. Participants suggested that a data sharing oversight body would help strengthen public trust and comfort in data research for PM in Singapore. Conclusion Maintenance of public trust in data security systems and governance regimes can enhance participation in PM and data sharing for research. Contrary to themes in much prior research, participants demonstrated a sophisticated understanding of the inherent risks of data sharing, analysed trade-offs between risks and potential benefits of PM, and often adopted an international perspective. (shrink)

In this essay, we suggest practical ways to shift the framing of crisis standards of care toward disability justice. We elaborate on the vision statement provided in the 2010 Institute of Medicine (National Academy of Medicine) “Summary of Guidance for Establishing Crisis Standards of Care for Use in Disaster Situations,” which emphasizes fairness; equitable processes; community and provider engagement, education, and communication; and the rule of law. We argue that interpreting these elements through disability justice entails a commitment to both (...) distributive and recognitive justice. The disability rights movement's demand “Nothing about us, without us” requires substantive inclusion of disabled people in decision‐making related to their interests, including in crisis planning before, during, and after a pandemic like Covid‐19. (shrink)

Precision medicine is an emerging approach to treatment and disease prevention that relies on linkages between very large datasets of health information that is shared amongst researchers and health professionals. While studies suggest broad support for sharing precision medicine data with researchers at publicly funded institutions, there is reluctance to share health information with private industry for research and development. As the private sector is likely to play an important role in generating public benefits from precision medicine initiatives, it is (...) important to understand what the concerns are and how they might be mitigated. This study reports outcomes of a deliberative method of citizen engagement in Singapore that asked whether sharing precision medicine data with private industry would be permissible, and if so, under what circumstances. Findings from this citizens’ jury suggest sharing with industry would be permissible under certain conditions that are set out in nine recommendations. Implications of the recommendations and their underlying assumptions for policy decision makers are discussed. This study aligns with prior international studies which found conditional acceptance for data sharing with private industry, a public benefit requirement, specific reluctance to share with insurance companies and an emphasis on accountability and transparency to demonstrate trustworthiness. However, our results differ from prior studies in that opt-in consent did not dominate the deliberations as jurors were able to set it aside as an assumed prerequisite for participation in a precision medicine programme. (shrink)

Using data collected at two phases, this study examines why and how ethical leadership behavior influences employees’ evaluations of organization-focused justice, i.e., procedural justice and distributive justice. By proposing ethical leaders as moral agents of the organization, we build up the linkage between ethical leadership behavior and the above two types of organization-focused justice. We further suggest trust in organization as a key mediating mechanism in the linkage. Our findings indicate that ethical leadership behavior engenders employees’ trust in their employing (...) organization, which in turn promotes their justice perceptions toward the organization. The theoretical and practical implications of these findings are discussed, and some directions for future research are suggested. (shrink)

(2001). Fruits, Apples, and Category Mistakes: On Sport, Games, and Play. Journal of the Philosophy of Sport: Vol. 28, No. 2, pp. 151-159. doi: 10.1080/00948705.2001.9714610.

(1993). Why Olympic Athletes Should Avoid the Use and Seek the Elimination of Performance-Enhancing Substances and Practices From the Olympic Games. Journal of the Philosophy of Sport: Vol. 20, No. 1, pp. 64-81. doi: 10.1080/00948705.1993.9714504.

In this article, I develop a framework for re-imagining gender-based violence not as an outgrowth of patriarchy but as a response to the threat of gender integration and the inversion of the gendered hierarchy. I argue that this reconceptualization is critical to re-envisioning not just research but also prevention and intervention strategies. I begin by identifying two reasons for the stalled revolution in reducing rates of gender-based violence: the focus on intimate partner violence and sexual violence as distinct rather than (...) as similar tools that are simply deployed in different spaces, and the de-centering of Black feminist voices and the obscuring of the similarities between gender-based violence and racialized violence. Finally, I conclude with recommendations to transform policies and hegemonic ideologies that limit the impact of gender-based violence—including by holding perpetrators accountable—and render it socially unacceptable, thus creating the foundation for building social institutions that are diverse, inclusive, and equitable. (shrink)

The assumption that commonsense psychological explanations of behavior are causal underlies current debate between simulation theory and theory theory regarding the nature of cognitive mechanism responsible for our folk psychological practices. Theory theorists claim that these explanations are subsumed by the covering law model of causal explanation. Simulationists are not explicit about the nature of the explanations produced by simulation. In what follows, I propose a set of plausible conditions that a correct causal simulation-produced folk psychological explanation will satisfy and (...) point out two prima facie problems. In discussing a possible solution, I discover that the latter incurs the need for some sort of causal law. An examination of two likely candidates for these laws reveals that neither is capable of playing the role required. I then suggest alternative routes that simulationists might explore in order to provide simulation theory with a sorely-needed account of the nature of the explanations produced by simulation. (shrink)

Underlying the current debate between simulation theory and theory theory is the assumption that folk psychological explanations of behavior are causal. Simulationists Martin Davies, Tony Stone, and Jane Heal claim that folk psychological explanations are explanations that make sense of another person by citing the thoughts important to the determination of his behavior on a given occasion. I argue that it is unlikely these explanations will be causal. Davis et al. base their claim on the assumption that a certain isomorphism (...) obtains between the cognitive mechanisms of human beings. Investigation into the nature of the isomorphism required reveals that it is of a sort that is unlikely to obtain. I suggest that in order to maintain their challenge to theory theory, simulationists must either motivate and describe a non-causal simulation-based account of folk psychological explanation or else delineate a causal account that attributes a nonessential, heuristic role to simulation. (shrink)

In the following article, it will be argued that there are at least four clusters of arguments generally proposed to justify banning doping in sport and that Simon’s contribution has been of a seminal nature to at least two of the clusters.

Grounded in Bandura’s social cognitive theory of moral thought and action, we develop a conceptual model linking supervisors’ perceptions of organizational injustice and abusive supervision with moral disengagement mechanisms acting as the underlying process. Specifically, we elaborate why and how supervisors’ experiences of each type of injustice would trigger their adoption of distinctive moral disengagement mechanisms, which in turn lead to their abusive supervisory conduct. The present conceptual model sheds new light on linking organizational injustice to abusive supervision from a (...) moral perspective. In addition, it also provides important theoretical and managerial implications to our current understanding of why and how abusive supervision happens. (shrink)

Research on mental health of non-professional caregivers has focused on caregivers of people with specific diseases, especially dementia. Less is known about caregivers of people with other diseases. The aims of this study were (a) to determine the caregivers’ emotional state in a random sample of caregivers of people in situations of dependency, (b) to analyze the association between each disease of the care-recipient (a variety of 23 diseases included in the International Classification of Diseases) and the emotional state of (...) the caregiver, and (c) based on the theoretical model, to analyze the relationship of the different study variables in the appearance of the emotional distress of the caregiver. A sample of 491 non-professional caregivers was selected randomly (89.0% women, average age 55.3 years). Trained psychologists collected sociodemographic and care-related characteristics and evaluated the global emotional distress, somatic symptoms, anxiety-insomnia, social dysfunction, depression, probable mental disorder case, self-esteem and social support. It was found that (a) the caregivers showed moderate emotional distress, and 33.8% presented a probable mental disorder. (b) Caring for a care-recipient with cat's cry syndrome or epilepsy was related to suffering from social dysfunction, and caring for a care-recipient with autism was related to having a probable mental health case. (c) Social support mediated the relationship between social class, daily hours of care, monthly family income, self-esteem and global emotional distress. There is an important impact on the emotional state of the caregivers. This impact was similar in caregivers of care-recipients with different diseases, except in caregivers caring for a care-recipient with cat's cry syndrome or epilepsy (related to social dysfunction), and in caregivers caring for a care-recipient with autism (related to having a probable mental health case). (shrink)

It is increasingly argued that polymathy—vocational and avocational pursuits in multiple domains—is deeply associated with creativity and innovation, and that its development enables the creation of important bridges between otherwise fragmented, dispersed sets of knowledge. Nevertheless, the dominant culture in both industry and academia is still that of narrow specialization. In this paper, we argue that in the context of COVID-19 crisis, with its wicked and transdisciplinary nature, the disciplinary approach of specialization is ill-suited to solve our increasingly complex problems, (...) and that polymathic thinking can be a crucial asset in this regard. Drawing on different literature strands, we first examine the interplay between polymathy and other well-developed constructs in personality and temperament research. We then advance theoretical predictions regarding the relationship between trait polymathy and resilience in the COVID-19 crisis. After that, we discuss learnable strategies that can be used in complex, uncertain and adverse situations, which are associated with development of a more polymathic set of knowledge. Later, we discuss how it may be possible to better capitalize on the key features of polymathic thinking at the societal level. Finally, we conclude with a reflection on the adequacy of our current institutions for dealing with complex problems, and we underscore the crucial role of polymathic thinking in an increasingly complex and interrelated world. (shrink)

Two theses are central to recent work on the epistemology of disagreement: Conciliationism:?In a revealed peer disagreement over P, each thinker should give at least some weight to her peer's attitude. Uniqueness:?For any given proposition and total body of evidence, the evidence fully justifies exactly one level of confidence in the proposition. 1This paper is the product of full and equal collaboration between its authors. Does Conciliationism commit one to Uniqueness? Thomas Kelly 2010 has argued that it does. After some (...) scene-setting (?1), in ?2 we explain and criticize Kelly's argument, thereby defeating his larger argument that Conciliationism deserves no dialectical special treatment. But we argue further that Conciliationists are committed to a disjunction, one of whose disjuncts is Uniqueness, that amounts to an ?extremely strong and unobvious position? (??3?4). If we are correct, theorists should not treat Conciliationism as a default position in debates about the epistemic significance of disagreement. (shrink)

There is growing interest in contact tracing apps for pandemic management. It is crucial to consider ethical requirements before, while, and after implementing such apps. In this paper, we illustrate the complexity and multiplicity of the ethical considerations by presenting an ethical framework for a responsible design and implementation of CT apps. Using this framework as a starting point, we briefly highlight the interconnection of social and political contexts, available measures of pandemic management, and a multi-layer assessment of CT apps. (...) We will discuss some trade-offs that arise from this perspective. We then suggest that public trust is of major importance for population uptake of contact tracing apps. Hasty, ill-prepared or badly communicated implementations of CT apps will likely undermine public trust, and as such, risk impeding general effectiveness. (shrink)

The predominant view is that a study using health data is observational research and should require individual consent unless it can be shown that gaining consent is impractical. But recent arguments have been made that citizens have an ethical obligation to share their health information for research purposes. In our view, this obligation is sufficient ground to expand the circumstances where secondary use research with identifiable health information is permitted without explicit subject consent. As such, for some studies the Institutional (...) Review Board/Research Ethics Committee review process should not assess the practicality of gaining consent for data use. Instead the review process should focus on assessing the public good of the research, public engagement and transparency. (shrink)

The future of health research will be characterised by three continuing trends: rising demand for health data; increasing impracticability of obtaining specific consent for secondary research; and decreasing capacity to effectively anonymise data. In this context, governments, clinicians and the research community must demonstrate that they can be responsible stewards of health data. IRBs and RECs sit at heart of this process because in many jurisdictions they have the capacity to grant consent waivers when research is judged to be of (...) particular value. However, several different terms are used to refer to this value, indicating a lack of conceptual clarity regarding the appropriate test for access to health data for research without consent. In this paper we do three things. First we describe the current confusion and instability in terminology relating to public interest in the context of consent waivers. Second we argue for harmonisation of terminology on the grounds of clarity, transparency and consistency. Third we argue that the term ‘public interest’ best reflects the normative work required to justify consent waivers because it is the broadest of the competing terms. ‘Public interest’ contains within its scope positive and negative implications of a study, as well as welfare, justice and rights considerations. In making this argument, we explain the normative basis for consent waivers, and provide a starting place for further discussion about the precise conditions in which a given study can be said to advance the public interest. Ipsos MORI study found that: … the public would be broadly happy with administrative data linking for research projects provided Those projects have social value, broadly defined. Data are de-identified. Data are kept secure. Businesses are not able to access the data for profit. (shrink)

Public-private partnerships are established to specifically harness the potential of Big Data in healthcare and can include partners working across the data chain—producing health data, analysing data, using research results or creating value from data. This domain paper will illustrate the challenges that arise when partners from the public and private sector collaborate to share, analyse and use biomedical Big Data. We discuss three specific challenges for PPPs: working within the social licence, public antipathy to the commercialisation of public sector (...) health data, and questions of ownership, both of the data and any resulting intellectual property or products. As a specific example we consider the case of the UK National Health Service providing patient data to Google’s DeepMind AI program to develop a diagnostic app for kidney disease. This article is an application of the framework presented in this issue of ABR. Please refer to that article for more information on how this framework is to be used, including a full explanation of the key values involved and the balancing approach used in the case study at the end. We use four specific values to help analysis these issues: public benefit, stewardship, transparency and engagement. We demonstrate how the Deliberative Framework can support ethical governance of PPPs involving biomedical big data. (shrink)

This paper contends that a research ethics approach to the regulation of health data research is unhelpful in the era of population‐level research and big data because it results in a primary focus on consent (meta‐, broad, dynamic and/or specific consent). Two recent guidelines – the 2016 WMA Declaration of Taipei on ethical considerations regarding health databases and biobanks and the revised CIOMS International ethical guidelines for health‐related research involving humans – both focus on the growing reliance on health data (...) for research. But as research ethics documents, they remain (to varying degrees) focused on consent and individual control of data use. Many current and future uses of health data make individual consent impractical, if not impossible. Many of the risks of secondary data use apply to communities and stakeholders rather than individual data subjects. Shifting from a research ethics perspective to a public health lens brings a different set of issues into view: how are the benefits and burdens of data use distributed, how can data research empower communities, who has legitimate decision‐making capacity? I propose that a public health ethics framework – based on public benefit, proportionality, equity, trust and accountability – provides more appropriate tools for assessing the ethical uses of health data. The main advantage of a public health approach for data research is that it is more likely to foster debate about power, justice and equity and to highlight the complexity of deciding when data use is in the public interest. (shrink)

The concept of ‘ownership’ is increasingly central to debates, in the media, health policy and bioethics, about the appropriate management of clinical data. I argue that the language of ownership acts as a metaphor and reflects multiple concerns about current data use and the disenfranchisement of citizens and collectives in the existing data ecosystem. But exactly which core interests and concerns ownership claims allude to remains opaque. Too often, we jump straight from ‘ownership’ to ‘private property’ and conclude ‘the data (...) belongs to the patient’. I will argue here that private property is only one type of relevant relationship between people, communities and data. There are several reasons to doubt that conceptualising data as private property presents a compelling response to concerns about clinical data ownership. In particular I argue that clinical data are co-constructed, so a property account would fail to confer exclusive rights to the patient. A non-property account of ownership acknowledges that the data are ‘about the patient’, and therefore the patient has relevant interests, without jumping to the conclusion that the data ‘belongs to the patient’. On this broader account of ownership, the relevant harm is the severing of the connection between the patient and their data, and the solution is to re-engage and re-connect patients to the data research enterprise. (shrink)

The success of digital COVID-19 contact tracing requires a strategy that successfully addresses the digital divide—inequitable access to technology such as smartphones. Lack of access both undermines the degree of social benefit achieved by the use of tracing apps, and exacerbates existing social and health inequities because those who lack access are likely to already be disadvantaged. Recently, Singapore has introduced portable tracing wearables (with the same functionality as a contact tracing app) to address the equity gap and promote public (...) health. We argue that governments have an ethical obligation to ensure fair access to the protective benefits of contract tracing during the pandemic and that wearables are an effective way of addressing some important equity issues. The most contentious issues about contact tracing apps have been the potential infringements of privacy and individual liberty, especially where the use of apps or other technology (such as wearables or QR codes) is required for access to certain spaces. Here we argue that wearables, as opposed to apps alone, will make a digital contact tracing mandate more practical and explain some conditions under which such a mandate would be justified. We focus on Singapore as a case study that has recently deployed contact tracing wearables nationally, but also reference debate about wearables in Australia and New Zealand. Our analysis will be relevant to counties trialling similar portable tracing wearables. (shrink)

We give anecdotal accounts from our own experience of scientific theories which have been generally accepted as the ruling opinion long after sufficient evidence has been collected for their disproof. This has led us to the opinion that the normal scientific process, of working hypothesis followed by experimental test aimed at disproof, is being replaced by the ruling opinion followed by experiment aimed at confirmation. The apparently widespread adoption of this procedure may be postulated to arise in part from the (...) need for workers entering a new field of study to obtain grants and to get their results published. (shrink)

This book discusses 'how' to respectfully and responsibly include pregnant women in clinical research. In sharp contrast, the existing literature predominantly focuses on the reasons 'why' the inclusion of pregnant women in clinical research is necessary - viz., to develop effective treatments for women during pregnancy, to promote fetal safety, to reduce harm to women and fetuses from suboptimal care, and to allow access to the benefits of research participation. This book supports the shift to a new default position, whereby (...) pregnant women are included in clinical research unless researchers argue convincingly for their exclusion. This shift raises many as yet unexplored ethical and policy questions about existing barriers to the equitable inclusion of pregnant women in research. This book is original in three key ways. First, it presents an unparalleled depth of analysis of the ethics of research with pregnant women, bringing together many of the key authors in this field as well as experts in research ethics and in vulnerability who have not previously applied their work to pregnant women. Second, it includes innovative theoretical work in ethics and disease specific case studies that highlight the current complexity and future challenges of research involving pregnant women. Third, the book brings together authors who argue both for and against including more pregnant women in formal clinical trials. (shrink)

Psychotherapy clients read two consumer-oriented brochures: a general brochure on psychology and a brochure on the topic of client-therapist intimacy. Half of the participants read the general brochure first and the brochure on client-therapist intimacy second, and half the participants did the reverse. Participants reported favorable reactions to the brochures, indicating they thought both should be made available to psychotherapy clients; that neither were too long, too sensitive, or too difficult to read; and that the brochures should be made available (...) early during the therapeutic process. After reading the client-therapist intimacy brochure, participants also showed some changes in Likert-type scores measuring attitudes regarding intimate contact between clients and therapists. Although participants were more negative about issues of sexual misconduct after reading the client-therapist intimacy brochure, they did not indicate a decrease in trust of therapists, nor did they indicate a greater likelihood of filing a false complaint. We concluded that therapists' reservations about presenting clients with factual information regarding therapist sexual exploitation of clients are not empirically founded. (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)

In 2004 Emanuel et al. published an influential account of exploitation in international research, which has become known as the 'fair benefits account'. In this paper I argue that the thin definition of fairness presented by Emanuel et al, and subsequently endorsed by Gbadegesin and Wendler, does not provide a notion of fairness that is adequately robust to support a fair benefits account of exploitation. The authors present a procedural notion of fairness – the fair distribution of the benefits of (...) research is to be determined on a case-by-case basis by the parties involved in each study. The fairness of the distribution of benefits is not assessed against an independent normative standard. Emanuel et al.'s account of fairness provides a framework for objecting only to transactions that occur without the fully informed consent of the weaker party. As a result, a debate about exploitation collapses into a debate about consent. This is problematic because, as the proponents of the fair benefits framework acknowledge, neither the trial participants' consent nor the host community's consent preclude exploitation. Attempts to stipulate normative standards of fairness to protect research subjects in developing countries have been controversial and divisive, and it is therefore understandable that bioethicists would be tempted to develop accounts of exploitation that are independent of such prescriptive principles. I conclude, however, that the utility of the fair benefits model of exploitation as a policy tool will ultimately depend on whether a substantive principle of fairness can be developed to underpin it. (shrink)

Throughout March and April 2020, debate raged about how best to allocate limited intensive care unit resources in the face of a growing COVID-19 pandemic. The debate was dominated by utility-based arguments for saving the most lives or life-years. These arguments were tempered by equity-based concerns that triage based solely on prognosis would exacerbate existing health inequities, leaving disadvantaged patients worse off. Central to this debate was the assumption that ICU admission is a valuable but scarce resource in the pandemic (...) context.In this paper, we argue that the concern about achieving equity in ICU triage is problematic for two reasons. First, ICU can be futile and prolong or exacerbate suffering rather than ameliorate it. This may be especially true in patients with COVID-19 with emerging data showing that most who receive access to a ventilator will still die. There is no value in admitting patients with poor prognostic indicators to ICU to meet an equity target when intensive critical care is contrary to their best interests. Second, the focus on ICU admission shifts focus away from important aspects of COVID-19 care where there is greater opportunity for mitigating suffering and enhancing equitable care.We propose that the focus on equity concerns during the pandemic should broaden to include providing all people who need it with access to the highest possible standard of end-of-life care. This requires attention to culturally safe care in the following interlinked areas: palliative care, communication and decision support and advanced care planning. (shrink)

This paper aims to show that to reduce the level of exploitation present in (some) international clinical trials, research sponsors must aim to provide both an ex-ante expected gain in utility and a fair ex-post distribution of benefits for research subjects. I suggest the following principles of fair risk distribution in international research as the basis of a normative definition of fairness: (a) Persons should not be forced (by circumstance) to gamble in order to achieve or protect basic goods; (b) (...) In cases where one party is gambling with basic goods and the other party is not, the distribution of benefits and burdens must be arranged so that they are of greatest benefit to the worst off; (c) In relationships where one party is gambling for basic goods and the other party is not, the party gambling for basic goods must be assured of some guaranteed benefits in addition to the chance of gaining some potential benefits.These principles are applied to the case of HIV international research. I conclude that the research (as described) is mutually advantageous but still exploitative because the distribution of surplus benefits is unfair. It is unfair because research subjects are gambling with and for basic goods but they are not assured of a fair ex-post distribution of benefits. Principles (b) and (c) are not satisfied. Research participants are not accorded enough guaranteed benefits to outweigh the risks they undertake. (shrink)

The revision of the Council of International Organizations of Medical Sciences (CIOMS) International ethical guidelines for health‐related research (2016) heralds a paradigm shift from the ‘protectionist’ policies that emerged following historical research atrocities of the 20th century, towards a more nuanced and inclusive approach to research participation. Adopting this modified approach will enable countries to secure the benefits of research for individuals and for society as a whole, while at the same time minimizing the potential for exploitation and research‐related harms. (...) This article considers the potential impact of Guideline 16 of the CIOMS 2016 from a New Zealand perspective, with respect to research involving adults with impaired capacity and who are incapable of giving informed consent. While the CIOMS 2016 apply a ‘minimal risk’ threshold to guide research involving adults who lack capacity to consent, New Zealand law currently adopts a ‘best interests’ standard which significantly restricts the scope of permissible research that may be performed in this context. This article argues that the CIOMS 2016 should influence change to New Zealand’s legal framework for ethical review of research. CIOMS 2016 provides useful guidance for the necessary standards and processes to enable the responsible and ethical inclusion of adults with impaired capacity in research. (shrink)

This target article considers the ethical implications of providing prenatal diagnosis (PND) and antenatal screening services to detect fetal abnormalities in jurisdictions that prohibit abortion for these conditions. This unusual health policy context is common in the Latin American region. Congenital conditions are often untreated or under-treated in developing countries due to limited health resources, leading many women/couples to prefer termination of affected pregnancies. Three potential harms derive from the provision of PND in the absence of legal and safe abortion (...) for these conditions: psychological distress, unjust distribution of burdens between socio-economic classes, and financial burdens for families and society. We present Iran as a comparative case study where recognition of these ethical issues has led to the liberalization of abortion laws for fetuses with thalassemia. We argue that physicians, geneticists and policymakers have an ethical and professional duty of care to advocate for change in order to ameliorate these harms. (shrink)

Trust is taken to be one of the foundational values in the doctor-patient relationship, facilitating access to the benefits of health care and providing a guarantee against possible harms. Despite this foundational role, some doctors betray the trust of their patients. Trusting involves granting discretionary powers and makes the truster vulnerable to the trustee. Patients trust medical practitioners to act with goodwill and to act competently. Some patients carry pre-existing vulnerabilities, for reasons such as gender, poverty, age, ethnicity, or disability, (...) and these vulnerabilities can be exacerbated when such patients extend their trust to a doctor. Gender stereotypes reduce women's ability to challenge and thereby assess their doctor's competency. In addition, women are more likely to be distrusted by their doctors and have their experiences of medical symptoms discounted. In this paper, we analyze two extreme examples of breaches of medical trust that exploited the vulnerability of women in the health care system: the "unfortunate experiment" at the National Women's Hospital in New Zealand and the Harold Shipman murders of elderly patients in the United Kingdom, examining the potential role of gender in the outcomes with regard to trust. Major breaches of medical trust such as these typically lead to government inquiries, revisions of ethical guidelines, and substantive policy change in an effort to re-establish public and patient trust. We argue that the medical profession has an ethical obligation to put mechanisms in place to protect vulnerable patients from abuses of trust, to monitor colleagues' competence, and to be prepared to blow the whistle to protect patients who are not in a position to recognize misplaced trust. Such mechanisms will act disprosportionately to reduce harm to women as patients. (shrink)

Governments are investing in precision medicine with the aim of improving healthcare through the use of genomic analyses and data analytics to develop tailored treatment approaches for individual patients. The success of PM is contingent upon clear public communications that engender trust and secure the social licence to collect and share large population-wide data sets because specific consent for each data re-use is impractical. Variation in the terminology used by different programmes used to describe PM may hinder clear communication and (...) threaten trust. Language is used to create common understanding and expectations regarding precision medicine between researchers, clinicians and the volunteers. There is a need to better understand public interpretations of PM-related terminology. This paper reports on a qualitative study involving 24 focus group participants in the multi-lingual context of Singapore. The study explored how Singaporeans interpret and understand the terms ‘precision medicine’ and ‘personalised medicine’, and which term they felt more aptly communicates the concept and goals of PM. Results suggest that participants were unable to readily link the terms with this area of medicine and initially displayed preferences for the more familiar term of ‘personalised’. The use of visual aids to convey key concepts resonated with participants, some of whom then indicated preferences for the term ‘precision’ as being a more accurate description of PM research. These aids helped to facilitate dialogue around the ethical and social value, as well as the risks, of PM. Implications for programme developers and policy makers are discussed. (shrink)

In their response to ‘Public interest in health data research: laying out the conceptual groundwork’, Grewal and Newson critique us for inattention to the law and putting forward an impracticably broad conceptual understanding of public interest. While we agree more work is needed to generate a workable framework for Institutional Review Boards/Research Ethics Committees, we would contend that this should be grounded on a broad conception of public interest. This broadness facilitates regulatory agility, and is already reflected by some current (...) frameworks such as that found in the guidelines approved under Australia’s Privacy Act. It remains unclear which elements of our broad account Grewal and Newson would reject, or indeed where the substantive disagreement with our position lies. (shrink)