Ethical decision-making frameworks assist in identifying the issues at stake in a particular setting and thinking through, in a methodical manner, the ethical issues that require consideration as well as the values that need to be considered and promoted. Decisions made about the use, sharing, and re-use of big data are complex and laden with values. This paper sets out an Ethics Framework for Big Data in Health and Research developed by a working group convened by the Science, Health and (...) Policy-relevant Ethics in Singapore Initiative. It presents the aim and rationale for this framework supported by the underlying ethical concerns that relate to all health and research contexts. It also describes a set of substantive and procedural values that can be weighed up in addressing these concerns, and a step-by-step process for identifying, considering, and resolving the ethical issues arising from big data uses in health and research. This Framework is subsequently applied in the papers published in this Special Issue. These papers each address one of six domains where big data is currently employed: openness in big data and data repositories, precision medicine and big data, real-world data to generate evidence about healthcare interventions, AI-assisted decision-making in healthcare, public-private partnerships in healthcare and research, and cross-sectoral big data. (shrink)

This paper explores early Australasian philosophy in some detail. Two approaches have dominated Western philosophy in Australia: idealism and materialism. Idealism was prevalent between the 1880s and the 1930s, but dissipated thereafter. Idealism in Australia often reflected Kantian themes, but it also reflected the revival of interest in Hegel through the work of ‘absolute idealists’ such as T. H. Green, F. H. Bradley, and Henry Jones. A number of the early New Zealand philosophers were also educated in the idealist tradition (...) and were influential in their communities, but produced relatively little. In Australia, materialism gained prominence through the work of John Anderson, who arrived in Australia in 1927, and continues to be influential. John Anderson had been a student of Henry Jones, who might therefore be said to have influenced both main strands of Australian philosophical thought. (shrink)

Concerns about exploitation pervade the literature on commercial cross-border reproductive care, particularly egg selling and surrogacy. But what constitutes exploitation, and what moral weight does it have? I consider the relationship between vulnerability, limited choice, consent, and mutually advantageous exploitation. To elucidate the difference between limited choice and consent, I draw on an account of relational autonomy. In the absence of a normative principle of fair distribution, it is unclear whether the providers of reproductive goods and services are treated fairly (...) in such contracts, and therefore whether they have been exploited. I finish with some pragmatic recommendations for minimizing risks and empowering egg sellers and surrogates. (shrink)

Traditional accounts of vulnerability tend to label entire populations as vulnerable. This approach is of limited utility. Instead, this article utilizes a layered approach to vulnerability, identifying multiple vulnerabilities that older people experience. It focuses on distinguishing the different layers of vulnerability that may be experienced by the elderly in middle-income countries of Latin America. In doing so, I show how the layered approach to vulnerability functions, and demonstrate why it is more interesting and useful than the traditional approach. The (...) article achieves three things. First, it unwraps the different potential layers of vulnerability that develop in old age and the multidimensionality aspects of aging. Second, it reestablishes the usefulness of the concept of vulnerability and explains its functioning. Finally, it shows how different policies can be designed in order to address each vulnerability layer. The layered account promotes a multifaceted approach to public policy analyses and design. In this sense, the layered concept of vulnerability is an appealing concept to consider in public health ethics. (shrink)

In this paper, I discuss the bioethical principle of justice and the bioethical key concept of vulnerability, in a queer feminist posthuman framework. I situate these contemplations, philosophical by nature, in the context of antimicrobial resistance (AMR), one the most vicious moral problems of our time. Further, I discuss how gender and sexual variance, vulnerability and justice manifest in AMR. I conclude by considering my queer feminist posthuman framework for vulnerability and justice in relation to the notion of antibiotic vulnerabilities, (...) suggesting a lacuna for further AMR research. (shrink)

Refugees and asylum seekers may experience challenges related to pre-arrival experiences, structural disadvantage after migration and during resettlement requiring the need for special protection when participating in research. The aim was to review if and how people with refugee and asylum seeker backgrounds have had their need for special protection addressed in national and international research ethics guidelines. A systematic search of grey literature was undertaken. The search yielded 2187 documents of which fourteen met the inclusion criteria. Few guidelines addressed (...) specific ethical considerations for vulnerable groups much less people with refugee and asylum seeker backgrounds. One guideline explicitly addressed vulnerability for refugees and asylums seekers. To ensure members of ethics committees and researchers consider the potential challenges of conducting research with these groups, guidelines may need to be supplemented with a refugee and asylum seeker specific research ethics framework. Such a framework may be necessary to optimally protect people with refugee and asylum seeker backgrounds in research. (shrink)

The conduct of prior ethics review of human research projects helps to protect vulnerable groups or populations from potential negative impacts of research. Contemporary considerations in human research considers the concept of vulnerability in terms of access to research opportunities, impacts on the consenting process, selection bias, and the generalisability of results. Recent work questions the validity of using enumerated lists as a check box approach to protect research participants from exploitation. Through the use of broad categories to treat cohorts (...) of human research participants as homogenous classes and label some participants as vulnerable merely because they are members of a particular class, some ethics reviewers have used the National Statement on Ethical Conduct in Human Research to strip individuals of their “ethical equality”. Labelling people as vulnerable does not help researchers or human research ethics committee members develop an understanding of the complexities of applying the principles of respect and of justice in ethical decision-making. Conversely, defining specific cohorts of research participants as needing nuanced ethical consideration, due to their vulnerable nature, may imply that other population groups need not be considered vulnerable. We contend that this assumption is erroneous. This paper explores the way that human research ethics guidance documents treat vulnerability within the Australian context and draws on contemporary discussion to focus an alternative perspective based on the principles in the National Statement on Ethical Conduct in Human Research for researchers and human research ethics committee members to consider. (shrink)

University research ethics boards, although well established in North American since the 1980s, sometimes still have a poor reputation among researchers. They may be seen by members of the academic community as a bureaucratic system designed to prevent or slow down research, and one that does not understand the reality of researchers. This negative view is often the result of misunderstanding by 1) researchers and 2) some REBs about what an REB’s mandate is and how it should work. Based on (...) the experience of an REB President and a bioethicist, this series of Frequently Asked Questions aims to demystify research ethics so that researchers and REBs can collaborate in the advancement of knowledge, while ensuring the ethical and responsible conduct of research. (shrink)

Background Notwithstanding the need to produce evidence-based knowledge on medications for pregnant women, they remain underrepresented in clinical research. Sometimes they are excluded because of their supposed vulnerability, but there are no universally accepted criteria for considering pregnant women as vulnerable. Our aim was to explore whether and if so to what extent pregnant women are vulnerable as research subjects. Method We performed a conceptual and empirical analysis of vulnerability applied to pregnant women. Analysis A conceptual analysis supports Hurst's definition (...) of vulnerability. Consequently, we argue that pregnant women are vulnerable if they encounter an identifiably increased likelihood of incurring additional or greater wrong. According to the literature, this increased likelihood could exist of four alleged features for pregnant women's vulnerability: informed consent, susceptibility to coercion, higher exposure to risk due to lack of knowledge, vulnerability of the fetus. Discussion Testing the features against Hurst's definition demonstrates that they all concern the same issue: pregnant women are only vulnerable because a higher exposure to risk due to lack of scientific knowledge comprises an increased wrong. Research Ethics Committees have a responsibility to protect the vulnerable, but a higher exposure to risk due to lack of scientific knowledge is a much broader issue and also needs to be addressed by other stakeholders. Conclusions The only reason why pregnant women are potentially vulnerable is to the extent that they are increasingly exposed to higher risks due to a lack of scientific knowledge. Accordingly, the discussion can advance to the development of practical strategies to promote fair inclusion of pregnant women in clinical research. (shrink)

This paper examines the institutional mechanisms supporting the ethical oversight of human participant research conducted by the United Nations (UN). The UN has served an instrumental role in shaping international standards on research ethics, which invariably require ethical oversight of all research studies with human participants. The authors’ experiences of conducting research collaboratively with UN agencies, in contrast, have led to concern that the UN frequently sponsors, or participates in, studies with human participants that have not received appropriate ethical oversight. (...) It is argued that the institutional mechanisms in place to prevent research with human participants from being undertaken by the UN without ethical oversight do not, at present, extend substantively beyond the provision of guidelines and online training offered by a minority of UN bodies. The WHO and UNICEF are identified as notable exceptions, having implemented various measures to prevent health research with human participants from being undertaken without ethical oversight. Yet, it is highlighted that the WHO and UNICEF are not the only UN bodies that undertake health research with human participants and there are countless actors under the umbrella of the UN system that are regularly involved in non-health research with human participants. Arguments for the pursuit of the highest standard of ethical oversight by UN bodies are presented. Moving forward, the paper asks the question: is it time for the UN to set the standards for the oversight of ethical oversight? (shrink)

Zusammenfassung Lebensweltliche Bedingungen können sich als Barrieren in Hinblick auf die Durchführung einer von den Patient*innen gewählten – beispielsweise onkologischen – Therapie erweisen und den Therapieerfolg gefährden. Solche lebensweltlichen Herausforderungen lassen sich als Schichten sozialer Vulnerabilität begreifen. In dieser Arbeit wird untersucht, ob es geboten ist, herausfordernde soziale Lebensbedingungen von Patient*innen systematisch bei Therapieentscheidungen zu berücksichtigen. Hierfür wird der Befähigungsansatz nach Martha Nussbaum herangezogen, der die Achtung der Patient*innenautonomie mit der Möglichkeit der Unterstützung durch Dritte zusammenbringt. Anschließend werden anhand des (...) Schichten-Konzeptes von Florencia Luna Vorschläge dafür formuliert, wie soziale Vulnerabilitäten in der Praxis erfasst werden könnten. Obwohl die Überlegungen zum vorliegenden Text aus Beobachtungen der onkologischen Behandlungssituation heraus entstanden sind, lassen sie sich auch auf andere Therapiefelder, die lange Behandlungsdauern mit regelmäßigen Anwesenheiten verlangen, übertragen. Die vorliegende Untersuchung kommt zu dem Ergebnis, dass die ethische Pflicht besteht, lebensweltliche Faktoren in gemeinsame Therapieentscheidungen miteinzubeziehen und den Patient*innen ggf. Unterstützung anzubieten, um den Zugang zu der von ihnen gewählten Therapie zu ermöglichen. (shrink)

Background Research is crucial to improve treatment, survival and quality of life for children with cancer. However, recruitment of children for research raises ethical challenges. The aim of this study was to explore and describe ethical values and challenges related to the recruitment of children with cancer for research, from the perspectives and experiences of healthcare professionals in the Swedish context. Another aim was to explore their perceptions of research ethics competence in recruiting children for research. Methods An explorative qualitative (...) study using semi-structured interviews with key informants. Seven physicians and ten nurses were interviewed. Interviews were analysed using inductive qualitative content analysis. Results The respondents’ ethical challenges and values in recruitment mainly concerned establishing relationships and trust, meeting informational needs, acknowledging vulnerability, and balancing roles and interests. Ensuring ethical competence was raised as important, and interpersonal and communicative skills were highlighted. Conclusion This study provides empirical insight into recruitment of children with cancer, from the perspectives of healthcare professionals. It also contributes to the understanding of recruitment as a relational process, where aspects of vulnerability, trust and relationship building are important, alongside meeting informational needs. The results provide knowledge on the complexities raised by paediatric research and underpin the importance of building research ethics competence to ensure that the rights and interests of children with cancer are protected in research. (shrink)

In order to continue to maintain public trust and confidence in human research, participants must be treated with respect. Researchers and Human Research Ethics Committee members need to be aware that modern considerations of this value include: the need for a valid consenting process, the protection of participants who have their capacity for consent compromised; the promotion of dignity for participants; and the effects that human research may have on cultures and communities. This paper explains the prominence of respect as (...) a value when considering the ethics of human research and provides practical advice for both researchers and Human Research Ethics Committee members in developing respectful research practices. (shrink)

Placebo-controlled surgical trials can provide important information about the efficacy of surgical interventions. However, they are ethically contentious as placebo surgery entails the risk of harms to recipients, such as pain, scarring or anaesthetic misadventure. This has led to claims that placebo-controlled surgical trials are inherently unethical. On the other hand, without placebo-controlled surgical trials, it may be impossible to know whether an apparent benefit from surgery is due to the intervention itself or to the placebo effect.

This paper attempts to philosophically articulate empirical evidence on the positive effects of illness within the wider context of a discussion of the positive aspects of vulnerability. The conventional understanding holds that to be vulnerable is to be open to harms and wrongs; it is to be fragile, defenseless, and of compromised autonomy. In this paper, we challenge the assumption that vulnerability consists of nothing but powerlessness and dependence on others. This paper attempts to: (1) outline the theoretical conceptualisation of (...) the positive aspects of coping with illness, while simultaneously showing how these findings provide empirical support for some classical philosophical ideas; (2) influence a change in the manners in which the ill are usually perceived (as weak, dependent, robbed of a good life) and (3) point to the importance of modernising the prevalent biomedical conception of illness with the subjective dimension of health. Biomedical understanding of illness focuses on the vulnerable experience of the sufferer, suggesting the importance of philosophical additions. (shrink)

Human rights have increasingly been put forward as an important framework for bioethics. In this paper, it is argued that human rights offer a potentially fruitful approach to understanding the notion of Respect for Persons in bioethics. The idea that we are owed a certain kind of respect as persons is relatively common, but also quite often understood in terms of respecting people’s autonomous choices. Such accounts do however risk being too narrow, reducing some human beings to a second-class moral (...) status. This paper puts forward a political approach to our standing as persons and a strongly pluralistic account of human rights that lays the ground for a more broadly applicable conception of Respect for Persons. It is further argued that this model also provides an example of a more general approach to philosophical ethics, an approach which is here called taxonomical pluralism. When it comes to Respect for Persons specifically, this principle is developed in terms of five distinct core concerns. (shrink)

This paper examines the concept of vulnerability in the context of social research ethics. An ambiguity is noted in use of this term: it may refer to an incapacity to provide informed consent to participate in a research project, or it may imply heightened susceptibility to the risk of harm. It is pointed out that vulnerability is a matter of degree, and that there are different sources and types of harm, which must be taken into account in any judgment about (...) whether additional precautions are required to protect particular categories of research participants. Furthermore, such judgments must be sensitive to the particular context in which research is taking place. This is one of several considerations that raise questions about the desirability of the sort of pre-emptive ethical regulation that has become institutionalized in many countries over the past few decades, a form that is more appropriate to medical rather than to social research. However, this is not to deny that a concern with the vulnerability of research participants is necessary on the part of social researchers. Furthermore, it must be recognized that researchers themselves may be vulnerable to harm in the research process. Finally, some discussion is provided of the way in which a concern with vulnerability can conflict with other considerations that researchers need to take into account in doing their work. The key point is that vulnerability is a complex and controversial concept, and it requires careful handling in thinking about social research ethics. (shrink)

Ethical guidelines protecting medical research participants have been criticized for stripping the sociocultural contexts of research. This critique is urgent considering ongoing calls to account for participant diversity in recruitment and inclusion procedures. Our intersectional analysis of illness narratives explores how sociostructural factors might play a role in participants’ exposure to research-related harm in clinical trials. Although widening participation does respond to generalizability concerns, we argue that gendered, classed, and ableist processes of self-silencing could simultaneously enhance risk of harm for (...) participants with multiple oppressed identities. To prevent this, researchers might actively involve participants when designing trials. (shrink)

People with dementia have commonly been excluded from research. The adverse impacts of this exclusion are now being recognized and research literature, position statements, and ethics guidelines increasingly call for inclusion of people with dementia in research. However, few published studies investigate the views of potential participants on taking part in research should they experience dementia-related cognitive impairment. This cross-sectional survey examined the views of people aged sixty and older attending hospital outpatient clinics about clinical research participation if they had (...) dementia and impaired decision-making ability. Over 90 percent of respondents were agreeable to participating in a wide range of research activities, such as cognitive testing, physical measurements, imaging procedures, and blood draws. For drug studies, however, agreement dropped to 60 percent. Altruism was a strong motivator for research participation. In regard to who should be involved in decisions about their participation in research during periods of incapacity, respondents mostly preferred the person they appoint as their substitute decision-maker for healthcare matters or a doctor or health professional on the research team. Over three-quarters expressed interest in making an advance research directive. The study findings are discussed in relation to law reforms in Australia that aim to strengthen respect and inclusion for people with impaired decision-making capacity, especially by providing frameworks for advance planning for research participation. (shrink)

At healthcare facilities worldwide, women during childbirth undergo medical procedures they haven’t consented to and experience mistreatment and disrespect. This phenomenon is recognized as obstetric violence (OV), a distinct form of gender violence. The resulting trauma carries both immediate and long-term implications, making it vital to address for promoting women’s health. OV is partly shaped by a narrow, paternalistic conception of vulnerability. A flawed conception of the vulnerability of pregnant women and fetuses has opened the door to medical control and (...) coercion during childbirth. In this paper we examine what role notions of vulnerability play in perpetuating OV and consider recent attitudinal shifts in research ethics as a model for addressing it. (shrink)

In conceptualizing vulnerability, it is common for researchers to assume that some participants are more vulnerable on the basis of their membership of a particular group or because they exhibit particular characteristics. Older people are often viewed as inherently more vulnerable by ethics committees and the ethical guidelines committees construct. Because age alone does not confer or cause vulnerability, risk of harm to older research participants is not purely associated with their intrinsic connection to a vulnerable group, and classifying older (...) research participants as vulnerable may not necessarily protect them from harm. Drawing on the preliminary findings of a qualitative study of older people who had survived a suicide attempt, we reflect on how the specific context of our study had the potential of framing older people as vulnerable, and describe ways in which these were managed and resolved. Specifically, we discuss potential for harm through the ethical principles of coercion and distress. (shrink)

“Ethics in practice” are the ethical dilemmas that arise during the conduct of research. In this article, we describe the ethical issues we faced when conducting an exploration of the experiences of 19 potential living kidney donors, and demonstrate how reflexivity can guide the ethical decision-making throughout the research process. We discuss how we addressed issues of risk of potential psychological discomfort and distress to participants; autonomy and consent; and power imbalance, disclosure and reciprocity. We also address the practical implications (...) of our decisions. Through this discussion of the “ethically important” moments we faced, we aim to spark debate about the ethical and practical challenges facing qualitative health researchers today, and demonstrate how reflexivity can contribute to navigating the “ethical labyrinth” of qualitative health research. (shrink)

Patient-centered care is now recognized as a clinical method and ideal model for patient – health professional relationships, and many definitions have influenced its evolution. Overall the patient-centered care literature has provided relatively little to define patient-centered care at the level of the patient-professional relationship. Additionally, patient-centered care lacks grounding in ethical theory. This thesis asserts that theoretical concepts from the ethics of care can provide a stronger conceptual basis for patient-centered care.This thesis begins with a critical interpretive review of (...) the patient-centered care literature, yielding 12 articles that previously introduced new theoretical and definitional work on patient-centered care and patient-centered communication. Six common themes and ideas were discovered, and include Engaging the Patient as a Whole Person, Recognizing and Responding to Emotions, Fostering a Therapeutic Alliance, Promoting an Exchange of Information, Sharing Decision Making, and Enabling Self-Management and Patient Navigation. These elements were then compared to key elements of the ethics of care. This thesis argues that feminists have good reason to consider care as a type of moral duty, and it describes how this duty functions. This thesis also argues that a duty to care is triggered when caregivers are presented with particular substantive forms of vulnerability. Specifically, this thesis argues that vulnerable subjects whose constitutive needs are at risk require particular moral obligations. The links between the ethics of care and patient-centered care are discussed, including how an ethics of care response ought to function in the health care context. Finally, the cases of J.J. and Makayla Sault, two aboriginal girls who refused chemotherapy in favour of traditional aboriginal healing practices, are analyzed. This thesis offers a short scoping review of the bioethics discourse surrounding these cases. A review of this discourse revealed several common themes, which included the peripheral importance of culture and history, the equating of best interests with survival, the supremacy of science-based medicine, and the impartial application of ethical principles. This thesis recommends that health care professionals apply an ethics of care approach to similar ethical dilemmas in the future, which involves shifting one's ethical focus to the central relationships of the case, understanding the unique perspective of the patient's narrative, and promoting a care-based rather than a justice-based approach to problem-solving. (shrink)