Unlike other countries in South Asia, in Nepal research in the health sector has a relatively recent history. Most health research activities in the country are sponsored by international collaborative assemblages of aid agencies and universities. Data from Nepal Health Research Council shows that, officially, 1,212 health research activities have been carried out between 1991 and 2014. These range from addressing immediate health problems at the country level through operational research, (...) to evaluations and programmatic interventions that are aimed at generating evidence, to more systematic research activities that inform global scientific and policy debates. Established in 1991, the Ethical Review Board of the Nepal Health Research Council is the central body that has the formal regulating authority of all the health research activities in country, granted through an act of parliament. Based on research conducted between 2010 and 2013, and a workshop on research ethics that the authors conducted in July 2012 in Nepal as a part of the on-going research, this article highlights the emerging regulatory and ethical fields in this low-income country that has witnessed these increased health research activities. Issues arising reflect this particular political economy of research and includes questions to emerging regulatory and ethical frameworks. (shrink)

In this paper the author argues that the Academy of Medical Sciences's ‘Review of the regulation and governance of medical research’ has produced a set of muddled recommendations that could increase complexity and uncertainty in research governance rather than reduce it. Issues discussed in the paper include the additional legal burden placed upon the newly proposed Health Research Agency by the plan for a National Research Governance Service and its system of centralized permissions, the (...) consequences that this may have for the research ethics committees in the discharge of their legal duty, and the unanswered questions surrounding the TGN1412 incident. (shrink)

On October 6, 2015, in Schrems v. Data Protection Commissioner, the European Court of Justice, the European Union's highest court, held that the fifteen-year-old Safe Harbor Framework Agreement with the United States was invalid. Under the agreement, about forty-five hundred American companies each year self-certified to the U.S. Department of Commerce that they were in compliance with the essential privacy protections of the European Union, and therefore it was permissible for entities in the European Union to send personal data to (...) these American companies. According to the court, because some American companies were making the personal data of E.U. citizens available to U.S. government agencies, such as the National Security Agency, the fundamental privacy interests of E.U. citizens were not being protected. As a result of this court decision there has been considerable speculation about what, if any, effect the case has on international collaboration in health research, in particular, the sharing of personal data by E.U. researchers with their U.S. colleagues. (shrink)

The focus of this paper is the moral and scientific value of ‘expertise by experience’, that is, knowledge based on personal experience of ill mental health as a form of expertise in mental health research. In contrast to individualistic theories of personal autonomy and the first-person in bioethics, my account of shared decision-making is focussed on how a relational approach to the ‘person’ and ‘patient values’ can throw new light on our understanding of ‘voice’ in mental (...) class='Hi'>health research. The mistake, I argue, is to think that a commitment to listening to the patient voice in the process of perspective taking implies a threat to ‘objectivity’ in clinical practice and the very concept of evidence in the philosophy of science more generally. Instead, I use Helen Longino's account of epistemic validity in philosophy of science to argue that narrative experience and ‘patient perspective’ should be understood as an ongoing dynamic partnership working between the different stakeholders’ knowledge perspectives. I also address the connection between expertise by experience and the psychiatric significance of the personal self for the entrenched topics of agency, self-hood, personal identity, and self-knowledge in psychiatric diagnosis. In contrast to identity politics, my model of shared decision-making preserves a critical distance between perspective-taking and value itself in self/other appraisal as the gold standard for good clinical practice. (shrink)

BackgroundAs Canadian global health researchers who conducted a qualitative study with adults with and without disabilities in Uganda, we obtained ethics approval from four institutional research ethics boards (two in Canada and two in Uganda). In Canada, research ethics boards and researchers follow the research ethics norms of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2), and the National Guidelines for Research Involving Humans as Research Participants of Uganda (NGRU) in (...) Uganda. The preparation and implementation of this qualitative research raised specific ethical issues related to research participant privacy and the importance of availability and management of financial resources.Main bodyOur field experience highlights three main issues for reflection. First, we demonstrate that, in a global health research context, methodological and logistic adjustments were necessary throughout the research implementation process to ensure the protection of study participants’ privacy, especially that of people with disabilities, despite having followed the prescribed Canadian and Ugandan ethics norms. Data collection and management plans were adapted iteratively based on local realities. Second, securing financial support as a key aspect of financial management was critical to ensure privacy through disability-sensitive data collection strategies. Without adequate funding, the recruitment of research participants based on disability type, sex, and region or the hiring of local sign language interpreters would not have been possible. Third, although the TCPS2 and NGRU underscore the significance of participants’ privacy, none of these normative documents clearly express this issue in the context of global health research and disability, nor broadly discuss the ethical issue related to financial availability and management.ConclusionsConducting research in resource limited settings and with study participants with different needs calls for a nuanced and respectful implementation of research ethics in a global health context. We recommend a greater integration in both the TCPS2 and NGRU of global health research, disability, and responsible conduct of research. This integration should also be accompanied by adequate training which can further guide researchers, be they senior, junior, or students, and funding agencies. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Women and Health Research:A Report from the Institute of MedicineAnna C. Mastroianni (bio), Ruth Faden (bio), and Daniel Federman (bio)In recent years, claims have been made by segments of the research community and by women's health advocacy groups that clinical research practices and policies have not benefitted women's health to the same extent as men's health. Central to these claims has been (...) an assertion that women have been inadequately represented as subjects of clinical studies and that as a result neither health conditions unique to women—e.g., menopause—nor women's manifestations of health problems affecting both sexes—e.g., heart disease—have been investigated sufficiently.The scientific community, including federal agencies that sponsor and regulate clinical studies, is increasingly responsive to these claims and is taking steps to raise the level of women's participation in clinical studies. Controversy and concern have surrounded these actions, however. Two of the claims that have been made are: (1) that women are more difficult to study than men because of their cyclical hormonal changes; and (2) that conducting gender-specific subgroup analyses would increase the size of study populations, raise the cost of studies, and thereby reduce the number of studies that could be performed with the limited resources available. In addition, controversy over the inclusion of women of childbearing potential and pregnant women has been particularly salient. Concerns have been expressed about avoiding potential harm to existing or potential fetuses and about the possible legal and financial ramifications of such harm. A further concern involves the perceived difficulties in enrolling women in studies and retaining them for the duration of the studies.Against this backdrop, the Office of Research on Women's Health at the National Institutes of Health (NIH) asked the Institute of Medicine (IOM) in October 1992 to establish the Committee on the Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies. The Committee's charge was to: (1) consider the ethical and legal implications of including women, particularly pregnant women and women of childbearing potential, in clinical studies; (2) examine known instances of litigation regarding injuries to research subjects [End Page 55] and describe existing legal liabilities and protections; and (3) provide practical advice on these issues for consideration by NIH, institutional review boards (IRBs), and clinical investigators.The 16 Committee members came from diverse backgrounds: bioethics, law, epidemiology and biostatistics, public health policy, obstetrics and gynecology, clinical research, pharmaceutical development, social and behavioral sciences, and clinical evaluative sciences.1 Chaired by two of the authors of this article, Ruth Faden and Daniel Federman, and coordinated by the third, IOM Study Director Anna Mastroianni, the Committee met five times over a fourteen-month period, convened a one-and-one-half day invitational workshop, and commissioned several background papers. The Committee's deliberations were complicated by the announcement of new federal policies late in its term. Specifically, the Food and Drug Administration (FDA) issued guidelines (FDA 1993) to replace its 1977 guidelines, which prohibited the inclusion of women of childbearing potential in early phases of most clinical drug trials. In addition, Congress passed the NIH Revitalization Act of 1993 (P.L. 103-43), which contains provisions mandating the inclusion of women and racial and ethnic minorities in NIH-sponsored clinical research. In February 1994, the IOM Committee publicly issued its final report and recommendations, Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, publishing the workshop presentations and commissioned papers in a separate volume.Deliberations of the CommitteeA number of issues arose at the outset as the Committee considered its charge. A few members initially believed that verification of the underrepresentation of women relative to men in clinical studies as a whole was a prerequisite to providing policy recommendations. Others believed that such an examination would be an important contribution to the knowledge base, but that it was not necessary for addressing the Committee's charge. As summarized in the Committee's report, the Committee's research indicated that firm conclusions about the relative underrepresentation of women could not be drawn from the available data because of the lack of systematic information... (shrink)

BackgroundUnderstanding sex and gender in health research can improve the quality of scholarship and enhance health outcomes. Funding agencies and academic journals are two key gatekeepers of knowledge production and dissemination, including whether and how sex/gender is incorporated into health research. Though attention has been paid to key issues and practices in accounting for sex/gender in health funding agencies and academic journals, to date, there has been no systematic analysis documenting whether and how agencies (...) and journals require attention to sex/gender, what conceptual explanations and practical guidance are given for such inclusion, and whether existing practices reflect the reality that sex/gender cannot be separated from other axes of inequality.MethodsOur research systematically examines official statements about sex/gender inclusion from 45 national-level funding agencies that fund health research across 36 countries (covering the regions of the EU and associated countries, North America, and Australia) and from ten top-ranking general health (the top five in “science” and the top five in “social science”) and ten sex- and/or gender-related health journals. We explore the extent to which agencies and journals require inclusion of sex/gender considerations and to what extent existing strategies reflect state of the art understandings of sex/gender, including intersectional perspectives.ResultsThe research highlights the following: (a) there is no consistency in whether sex/gender are mentioned in funding and publishing guidelines; (b) there is wide variation in how sex/gender are conceptualized and how researchers are asked to address the inclusion/exclusion of sex/gender in research; (c) funding agencies tend to prioritize male/female equality in research teams and funding outcomes over considerations of sex/gender in research content and knowledge production; and (d) with very few exceptions, agency and journal criteria fail to recognize the complexity of sex/gender, including the intersection of sex/gender with other key factors that shape health.ConclusionsThe conceptualization and integration of sex/gender needs to better capture the interacting and complex factors that shape health—an imperative that can be informed by an intersectional approach. This can strengthen current efforts to advance scientific excellence in the production and reporting of research. We provide recommendations and supporting questions to strengthen consideration of sex/gender in policies and practices of health journals and funding agencies. (shrink)

In October 1993, a survey of health care agency administrators was undertaken shortly after they had experienced two sudden reductions in public funding. The purpose of this investigation was to gain insight into the role of ethics in health administrator decision making. A mail questionnaire was designed for this purpose. Descriptive statistics and content analysis were used to summarize the data. Staff reductions and bed closures were the two most frequently reported mechanisms for addressing the funding reductions. (...) Most administrators did not believe that these changes would have a negative public impact. In contrast, the majority indicated that future changes in reaction to additional funding reductions would have a negative public impact. Approximately one-third of the administrators reported ethics to be an element of recent administrative decision making, and one-half could foresee that ethics would be important in the future if reductions continued. These findings are discussed in relation to ethics. Issues for additional research are outlined. (shrink)

Funding agencies in Canada are attempting to break down the organizational boundaries between disciplines to promote interdisciplinary research and foster the integration of the social sciences into the health research field. This paper explores the extent to which biomedical and clinician scientists’ perceptions of social science research operate as a cultural boundary to the inclusion of social scientists into this field. Results indicated that cultural boundaries may impede social scientists’ entry into the health research (...) field through three modalities: (1) biomedical and clinician scientists’ unfavourable and ambivalent posture towards social science research; (2) their opposition to a resource increase for the social sciences; and (3) clinician scientists procedural assessment criteria for social science. The paper also discusses the merits and limitations of Tom Gieryn’s concept of boundary-work for studying social dynamics within the field of science. (shrink)

Research funders, regulatory agencies, and journals are increasingly expecting that individual-level data from health research will be shared. Broad consent to such sharing is considered appropriate, feasible and acceptable in low- and middle-income settings, but to date limited empirical research has been conducted to inform the design of such processes. We examined stakeholder perspectives about how best to seek broad consent to sharing data from the Mahidol Oxford Tropical Medicine Research Unit, which implemented a data (...) sharing policy and broad consent to data sharing in January 2016. Between February and August 2017 qualitative data were collected at two sites, Bangkok and the Thai-Myanmar border town of Mae Sot. We conducted eighteen semi-structured interviews. We also conducted four focus group discussions with a total of nineteen people. Descriptive and thematic coding informed analysis of aspects of data sharing that are considered most important to inform participants about, and the best ways to explain complex and abstract topics relating to data sharing. The findings demonstrated that clinical trial participants prioritise information about the potential benefits and harms of data sharing. Stakeholders made multiple suggestions for clarifying information provided about data sharing on such topics. There was significant variation amongst stakeholders’ perspectives about how much information should be provided about data sharing, and it was clear that effective information provision should be responsive to the study, the study population, the individual research participant and the research context. Effectively communicating about data sharing with research participants is challenging in practice, highlighting the importance of robust and effective data sharing governance in this context. Broad consent should incorporate effective and efficient explanations of data sharing to promote informed decision-making, without impeding research participants’ understandings of key aspects of the research from which data will be shared. Further work is required to refine both the development of core information about data sharing to be provided to all research participants, and appropriate solutions for context specific-challenges arising when explaining data sharing. (shrink)

Online resources offer a uniquely efficient way of sharing health research with scientists and the public. Using web portals to make results and study information available to diverse audiences could work to accelerate research translation and empower patients to play a more active role in their care. But using online tools to broadly share health information raises several challenging ethical and regulatory questions. Issues such as equity, privacy, and patient empowerment may create challenges for regulators, portal (...) developers, as well as researchers. It is additionally unclear whether web portals designed to facilitate access to research results and general health information will be regulated as medical devices under emerging regimes that control software with medical purposes. This paper aims to comparatively address whether online therapeutic portals for sharing health research are likely to be regulated in Canada, the United States, the United Kingdom, and France. We find that though these jurisdictions have each taken recent steps to regulate software as medical devices, the applicable regimes will generally not capture online portals for sharing health research. Though online portals for sharing health research are probably unregulated in many (if not most) jurisdictions, agencies have nevertheless signalled their concerns regarding several important ethical considerations (such as equity, transparency, and safety), to which portal developers and researchers should be attentive and respond. We describe here one set of issues highlighted by regulators – that is, efficiency, equity, transparency, confidentiality, communication, empowerment, training, and safety & efficacy – and consider how to best guide the design of online portals in a context of regulatory uncertainty. (shrink)

In the field of bioethics, scholars have begun to consider carefully the impact of structural issues on global population health, including socioeconomic and political factors influencing the disproportionate burden of disease throughout the world. Human rights and social justice are key considerations for both population health and biomedical research. In this paper, I will briefly explore approaches to human rights in bioethics and review guidelines for ethical conduct in international health research, focusing specifically on (...) class='Hi'>health research conducted in resource-poor settings. I will demonstrate the potential for addressing human rights considerations in international health research with special attention to the importance of collaborative partnerships, capacity building, and respect for cultural traditions. Strengthening professional knowledge about international research ethics increases awareness of ethical concerns associated with study design and informed consent among researchers working in resource-poor settings. But this is not enough. Technological and financial resources are also necessary to build capacity for local communities to ensure that research results are integrated into existing health systems. Problematic issues surrounding the application of ethical guidelines in resource-poor settings are embedded in social history, cultural context, and the global political economy. Resolving the moral complexities requires a commitment to engaged dialogue and action among investigators, funding agencies, policy makers, governmental institutions, and private industry. (shrink)

Priorities in Medical Research was published in 1988 by a select committee of the House of Lords. The report ushered in an era of NHS research and development that lasted from 2001 to 2006. The inquiry's origins lay in concerns about academic medicine in the United Kingdom, yet PMR gave relatively little attention to this subject. Instead the report focused critically on the disconnect between the Department of Health and the NHS in R & D. This, the (...) committee argued, had led to the neglect of research into health services and public health. To sidestep the report's unwelcome proposal for a National Health Research Agency, the department eventually grafted R & D management onto structures created as part of wider NHS reforms. The Medical Research Council successfully pursued a strategy of keeping the committee's attention away from sensitive aspects of its own programme. The final focus of PMR was shaped by an alignment between committee members with an industrial view of research and champions of health services research. The actions of the various actors involved are interpreted using elite models of the state, and the applicability of these models is critically examined. (shrink)

“Public health practice” consists of activities and Programs managed by public health agencies to promote health and prevent disease, injury, and disability. Some of these activities might be deemed to fit within the broad definition of “research” under federal regulations, known as the Common Rule, designed to protect human research subjects. The Common Rule defines research as “a systeniatic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” (...) Public health activities that might under some circumstances be considered research include disease reporting, review of medical records, surveys, interviews, focus groups, specimen collection, and laboratory testing.There are questions about the extent to which the Common Rule applies or was intended to apply to public health practice: and it has been suggested in any case that Common Rule regulation of public health practice may not be socially optimal for both practical and principled reasons. (shrink)

Social justice has been identified as a foundational moral commitment for global health research ethics. Yet what a commitment to social justice means for community engagement in such research has not been critically examined. This paper draws on the rich social justice literature from political philosophy to explore the normative question: What should the ethical goals of community engagement be if it is to help connect global health research to social justice? Five ethical goals for (...) community engagement are proposed that promote well-being, agency, and self-development, particularly for those considered disadvantaged and marginalized. The paper also considers how key terms used in the proposed goals should be defined using existing theories of health and social justice. This analysis is done to give global health researchers and their partners a better idea of what the ethical goals mean. Patterns of convergence amongst different theories are identified that support relying on particular definitions of key terms. (shrink)

International research is an essential means of reducing health disparities between and within countries and should do so as a matter of global justice. Research funders from high-income countries have an obligation of justice to support health research in low and middle-income countries that furthers such objectives. This paper investigates how their current funding schemes are designed to incentivise health systems research in LMICs that promotes health equity. Semi-structured in-depth interviews were performed (...) with 16 grants officers working for 11 funders and organisations that support health systems research: the Alliance for Health Policy and Systems Research, Comic Relief, Doris Duke Foundation, European Commission, International Development Research Centre, Norwegian Agency for Development Cooperation, Research Council of Norway, Rockefeller Foundation, UK Department of International Development, UK Medical Research Council, and Wellcome Trust. Thematic analysis of the data demonstrates their funding schemes promote health systems research with five key features that advance health equity: being conducted with worst-off populations, focusing on research topics that advance equitable health systems, having LMIC ownership of the research agenda, strengthening LMIC research capacity, and having an impact on health disparities. The different types of incentives that encouraged proposed projects to have these features are identified and classified by their strength. It is suggested that research funders ought to create and maintain funding schemes with strong incentives for the features identified above in order to more effectively help reduce global health disparities. (shrink)

Little research has explored the possible effects of government institutions in emerging economies on ethical reviews of multinational research. We conducted semi-structured, in-depth telephone interviews with 15 researchers, Research Ethics Committees personnel, and a government agency member involved in multinational HIV Prevention Trials Network research in emerging economies. Ministries of Health or other government agencies often play pivotal roles as facilitators or barriers in the research ethics approval process. Government agency RECs reviewing (...) protocols may face particular challenges, as they can lack resources, be poorly organized, have inconsistent review processes and limited expertise, and use differing definitions of national interests, including upholding national reputation and avoiding potential exploitation and stigma of the country's population. The MOH/governmental review body may be affected by power dynamics and politics in study reviews; may consider issues both related and unrelated to research ethics as understood elsewhere; and may prioritize particular diseases, treatments, or interventions over other topics/types of research. Poor communication and deeply-rooted tensions may exist between sponsor and host countries, impeding optimal interactions and reviews. Investigators must understand and plan for the potential effects of governmental agencies on multinational collaborative research, including preserving adequate time for agency review, and contacting these agencies beforehand to address issues that may arise. Better understanding of these issues can aid and advance appropriate global scientific collaboration. (shrink)

Taking debates about the roles of structure and agency in health as a lens, this essay asks how Critical Realist and Feminist Intersectional approaches might inform health interventions research. Despite recognition of multiple determinants of health, health problems are often thought of as individual and interventions, in turn, target risky individual behaviours. Such approaches are rooted in a liberal model of personhood. This paper critiques enduring individualist assumptions linked to Western liberal underpinnings embedded in (...) health interventions. It posits the need to include a robust conception of the social world in which change depends on shifting power relations, and individual agency is shaped by power as well as individual will. We propose preliminary steps for undertaking critical realist intersectional interventions research. (shrink)

No one questions the importance of protecting human subjects of research, but over the past few years dissatisfaction has surfaced with the manner in which the protection is conferred by the federal regulatory system referred to as “The Common Rule. ” Some of the criticism surfaces in print. Some bubbles out anecdotally in conversations among researchers, with complaints about the review process being virtually inevitable whenever the topic arises. Like those in other disciplines that differ more or less dramatically (...) from the world of clinical medical research around which the Common Rule was conceptualized, public health researchers, particularly those working in official public health agencies, have experienced some tension and difficulty in adapting to the rules. The Centers For Disease Control and Prevention has adopted guidelines that require Common Rule review for “research” but not “practice” activities. (shrink)

This article argues that the movement of dogs from pounds to medical laboratories played a critically important role in debates over the use of animals in science and medicine in the United States in the twentieth century, not least by drawing the scientific community into every greater engagement with bureaucratic political governance. If we are to understand the unique characteristics of the American federal legislation that emerges in the 1960s, we need to understand the long and protracted debate over the (...) use of pound animals at the local municipal and state level between antivivisectionists, humane activists, and scientific and medical researchers. We argue that the Laboratory Animal Care Act of 1966 reflects the slow evolution of a strategy that proved most successful in local conflicts, and which would characterize a “new humanitarianism”: not the regulation of experimental practices but of the care and transportation of the animals being provided to the laboratory. Our analysis is consistent with, and draws upon, scholarship which has established the productive power of public agencies and civil society on the periphery of the American state. (shrink)

Background Community involvement in research has been advocated by researchers, communities, regulatory agencies, and funders with the aim of reinforcing subjects’ protection and improving research efficiency. Community involvement also has the potential to improve dissemination, uptake, and implementation of research findings. The fields of community based participatory research conducted with indigenous populations and of participatory action research offer a large base of experience in community involvement in research. Rules on involving the population affected when (...) conducting research have been established in these fields. But what is the role of community engagement in clinical research and observational studies conducted in biomedical research outside of these specific areas? Main body of the abstract More than 20 years ago, in the field of HIV medicine, regulatory bodies and funding agencies recommended the constitution of a formal organism, the Community Advisory Board, as part of the study requirements for HIV trials. More recently, CABs have been adopted and used in other fields of medical research, such as malaria. CABs are not without limitations, however, and there is little research on the effectiveness of their use in achieving community protection and participation. Nevertheless, CABs could be a model to import into clinical trials and observational research where no alternative model of community representation is currently being used. Conclusions Allocating more resources to training and shifting more power to community representatives could be part of the solution to current CAB limitations. However, for researchers to be able to apply these recommendations on community involvement, certain conditions need to be met. In particular, funding agencies need to recognize the human and financial resources required for serious community involvement, and the academic environment needs to take community involvement into account when appraising, mentoring, and training researchers. (shrink)

Making research data readily accessible during a public health emergency can have profound effects on our response capabilities. The moral milieu of this data sharing has not yet been adequately explored. This article explores the foundation and nature of a duty, if any, that researchers have to share data, specifically in the context of public health emergencies. There are three notable reasons that stand in opposition to a duty to share one’s data, relating to: (i) data property (...) and ownership, (ii) just distribution of benefits and burdens and (iii) the contemporary ethos of science. We argue each reason can be successfully met with corresponding rationale in favour of data sharing. Further support for data sharing has been echoed in policies of health agencies, funding bodies and academic institutions; in documents on the ethical conduct of biomedical research; and in discussions on the nature of public health. From this, we ascertain that sharing data is the morally sound default position. This article then highlights the key roles reciprocity and solidarity play in supporting the practice of data sharing. We conclude with recommendations to regard public health research data as a common-pool resource in order to build a framework for stable data sharing management. (shrink)

Understanding the relationship between obesity and fast food consumption encompasses a broad range of individual level and environmental factors. One theoretical approach, the health capability framework, focuses on the complex set of conditions allowing individuals to be healthy. This qualitative study aimed to identify factors that influence individual level health agency with respect to healthy eating choices in uniformly constrained environments. We used an inductive qualitative research design to develop an interview guide, conduct open-ended interviews with (...) a purposive sample of 14 student fast food workers, and analyze the data. Data analysis was conducted iteratively during the study with multiple coders to identify themes. Emergent themes included environmental influences on eating behaviors and internal psychological factors. A localized, embedded approach to analyzing the factors driving the obesity epidemic is needed. Addressing contextual interactions between internal psychological and external environmental factors responds to social justice and public health concerns, and may yield more relevant and effective interventions for vulnerable communities. (shrink)

BackgroundThe Health Research Council of New Zealand is the first major government funding agency to use a lottery to allocate research funding for their Explorer Grant scheme. This is a somewhat controversial approach because, despite the documented problems of peer review, many researchers believe that funding should be allocated solely using peer review, and peer review is used almost ubiquitously by funding agencies around the world. Given the rarity of alternative funding schemes, there is interest in (...) hearing from the first cohort of researchers to ever experience a lottery. Additionally, the Health Research Council of New Zealand wanted to hear from applicants about the acceptability of the randomisation process and anonymity of applicants.MethodsThis paper presents the results of a survey of Health Research Council applicants from 2013 to 2019. The survey asked about the acceptability of using a lottery and if the lottery meant researchers took a different approach to their application.ResultsThe overall response rate was 39%, with 30% from applicants in the years 2013 to 2018, and 68% for those in the year 2019 who were not aware of the funding result. There was agreement that randomisation is an acceptable method for allocating Explorer Grant funds with 63% in favour and 25% against. There was less support for allocating funds randomly for other grant types with only 40% in favour and 37% against. Support for a lottery was higher amongst those that had won funding. Multiple respondents stated that they supported a lottery when ineligible applications had been excluded and outstanding applications funded, so that the remaining applications were truly equal. Most applicants reported that the lottery did not change the time they spent preparing their application.ConclusionsThe Health Research Council’s experience through the Explorer Grant scheme supports further uptake of a modified lottery. (shrink)

Justin Biddle and Quill Kukla have introduced the concept of phronetic risk to refer to epistemic risks emerging in activities that either are conditions for empirical reasoning or included in empirical reasoning and that have to be weighted according to different values and interests. In this paper, I show how a phronetic risk arises in research agenda setting. Given the prevalence of noncommunicable diseases associated with diet, there is a need for science-based nutritional public health interventions. However, how (...) the relation between nutrition and health should be studied is a contested matter. I argue that the choice between different approaches of studying nutrition-related disease causation involves considerable phronetic risks that cannot be managed by researchers alone. Funding agencies, non-governmental organisations and science policy decision makers should be considered epistemically relevant actors. (shrink)

BackgroundAdvances in healthcare artificial intelligence (AI) are occurring rapidly and there is a growing discussion about managing its development. Many AI technologies end up owned and controlled by private entities. The nature of the implementation of AI could mean such corporations, clinics and public bodies will have a greater than typical role in obtaining, utilizing and protecting patient health information. This raises privacy issues relating to implementation and data security. Main bodyThe first set of concerns includes access, use and (...) control of patient data in private hands. Some recent public–private partnerships for implementing AI have resulted in poor protection of privacy. As such, there have been calls for greater systemic oversight of big data health research. Appropriate safeguards must be in place to maintain privacy and patient agency. Private custodians of data can be impacted by competing goals and should be structurally encouraged to ensure data protection and to deter alternative use thereof. Another set of concerns relates to the external risk of privacy breaches through AI-driven methods. The ability to deidentify or anonymize patient health data may be compromised or even nullified in light of new algorithms that have successfully reidentified such data. This could increase the risk to patient data under private custodianship.ConclusionsWe are currently in a familiar situation in which regulation and oversight risk falling behind the technologies they govern. Regulation should emphasize patient agency and consent, and should encourage increasingly sophisticated methods of data anonymization and protection. (shrink)

What are the Differences between Public Health Practice and Research? This perplexing question constantly arises in the planning and performance of public health activities involving the acquisition and use of identifiable health information. Public health agencies collect and analyze significant identifiable health data from health care providers, insurers, other agencies, or individuals to perform an array of public health activities. These activities include surveillance, epidemiological investigations, and evaluation and monitoring. Few debate that (...) these essential public health activities, often specifically authorized by law, are classifiable as public health practice.Other public health activities in which identifiable health data are acquired or used, however, can resemble, include, or constitute human subjects research. “Human subjects research” is legally defined as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” that involves living human subjects. (shrink)

This chapter provides a critical reflection on an ethnographic approach led by a non-Indigenous researcher in partnership with an Indigenous community-controlled health organization, and a team of Indigenous and non-Indigenous supervisors, advisors, critical friends, and mentors. The chapter explores the way the three interrelated principles of Indigenist research informed the study, as a critical reflection of the methodology’s achievement of a decolonizing research agenda. The flow of Maiwah provides a metaphor for the chapter’s diverse authorship. Maiwah’s tributaries, (...) inlets, and banks represent author voices at different points while the one River flowing represents coming together to form a broader collective story of the research that still respects the authors’ individual positioning. Maiwah’s flow also signifies the dialogical approach of the research – “tricky ground” for non-Indigenous researchers seeking to privilege Indigenous voices while remaining accountable to their own White privilege, particularly given that at its most basic level, research requires the “extraction of ideas” from participants. Yet, the flow of Maiwah also shows us the possibilities of research, where in this case, researcher and participants together cocreated new knowledge in support of their agendas. This process enabled both research outcomes and increased research capacity and confidence in the host agency and researcher. On this account, decolonizing research is perhaps more about relationship and devolving control over the process than it is about particular methods, and the respectful negotiation of epistemological meanings and representation of particular knowledges that can result. (shrink)

Moral distress has been covered extensively in the nursing literature and increasingly in the literature of other health professions. Cases that cause nurses’ moral distress that are mentioned most frequently are those concerned with prolonging the dying process. Given the standard of aggressive treatment that is typical in intensive care units (ICUs), much of the existing moral distress research focuses on the experiences of critical care nurses. However, moral distress does not automatically occur in all end-of-life circumstances, nor (...) does every critical care nurse suffer its damaging effects. What are the practices of these nurses? What specifically do they do to navigate around or through the distressing situations? The nursing literature is lacking an answer to these questions. This article reports a study that used narrative analysis to explore the reported practices of experienced critical care nurses who are skilled at and comfortable working with families and physicians regarding the withdrawal of aggressive treatment. A major finding was that these nurses did not report experiencing the dam-Moral Agency, Moral Imagination, and Moral Community: Antidotes to Moral Distress Terri Traudt, Joan Liaschenko, and Cynthia Peden-McAlpine Terri Traudt, MBC, MA, is a Communications Consultant specializing in bioethics at the Center for Bioethics at the University of Minnesota, in Minneapolis. [email protected] Joan Liaschenko, PhD, RN, FAAN, is a Professor at the Center for Bioethics and Nursing at the University of Minnesota. Cynthia Peden-McAlpine, PhD, ACNS, BC, is an Associate Professor in the School of Nursing at the University of Minnesota. © 2016 by The Journal of Clinical Ethics. All rights reserved. aging effects of moral distress as described in the nursing literature. The verbal communication and stated practices relevant to this finding are organized under three major themes: (1) moral agency, (2) moral imagination, and (3) moral community. Further, a total of eight subthemes are identified. The practices that constitute these themes and subthemes are further detailed and discussed in this article. Understanding these practices can help mitigate critical care nurses’ moral distress. (shrink)

In recent years, genetically engineered (GE) mosquitoes have been proposed as a public health measure against the high incidence of mosquito-borne diseases among the poor in regions of the global South. While uncertainties as well as risks for humans and ecosystems are entailed by the open-release of GE mosquitoes, a powerful global health governance non-state organization is funding the development of and advocating the use of those bio-technologies as public health tools. In August 2016, the US Food (...) and Drug Agency (FDA) approved the uncaged field trial of a GE Aedes aegypti mosquito in Key Haven, Florida. The FDA’s decision was based on its assessment of the risks of the proposed experimental public health research project. The FDA is considered a global regulatory standard setter. So, its approval of the uncaged field trial could be used by proponents of GE mosquitoes to urge countries in the global South to permit the use of those bio-technologies. -/- From a public health ethics perspective, this paper evaluates the FDA’s 2016 risk assessment of the proposed uncaged field trial of the GE mosquito to determine whether it qualified as a realistic risk evaluation. -/- The FDA’s risk assessment of the proposed uncaged field trial did not proximate the conditions under which the GE mosquitoes would be used in regions of the global South where there is a high prevalence of mosquito-borne diseases. -/- Given that health and disease have political-economic determinants, whether a risk assessment of a product is realistic or not particularly matters with respect to interventions meant for public health problems that disproportionately impact socio-economically marginalized populations. If ineffective public health interventions are adopted based on risk evaluations that do not closely mirror the conditions under which those products would actually be used, there could be public health and ethical costs for those populations. (shrink)

Covid‐19 has infected thousands and killed hundreds in prisons, jails, and immigration detention facilities across the United States. Responding to this crisis, leading medical researchers have called for expanding opportunities for people in prison to participate in vaccine trials. These calls, like current regulations, focus on individualized risk assessments around consent, coercion, and harm, while ignoring the unnaturalness of deprivation conditions in U.S. prisons. We need new frameworks of analysis that refocus on structural, rather than individual, risk assessments. Integrating structural (...) perspectives—including skepticism of claims of scarcity, avoidance of representational distortions, and attention to institutional agency—into our existing, overly individualistic frameworks might permit the design of more ethical research projects involving people who are incarcerated. Still, the unnatural deprivations of incarceration might be so great that research subjects might need to be removed from prison entirely in order to ethically participate in research. (shrink)

Data-sharing is a desired default in the field of public health and a source of much ethical deliberation. Sharing data potentially contributes the largest, most efficient source of scientific data, but is fraught with contextual challenges which make stakeholders, particularly those in under-resourced contexts hesitant or slow to share. Relatively little empirical research has engaged stakeholders in discussing the issue. This study sought to explore relevant experiences, contextual, and subjective explanations around the topic to provide a rich and (...) detailed presentation of what it means to different stakeholders and contexts to share data and how that can guide practice and ethical guidance. A qualitative design involving interviews was undertaken with professionals working in public health institutions endowed with data, ethics committees, and advisory agencies which help shape health research in Africa. A descriptive form of thematic analysis was used to summarize results into six key themes: The role of HDSSs in research using public health data and data-sharing; Ownership and funding are critical factors influencing data-sharing; Other factors discourage data-sharing; Promoting and sustaining data-sharing; Ethical guidance structures; and Establishing effective guidance. The themes reveal factors regarding the willingness or not to share and an intricate ethical system that current discourse could reflect. Many of the concerns resonate with the literature, but a whole other gamut of people and process issues; commitments, investments, careers, and the right ethical guidance are needed to realize a sustainable goal of reaching ‘share’ as a default. (shrink)

Stereotype threat is a psychological phenomenon that occurs when individuals become aware that their behavior could potentially confirm a negative stereotype. Though stereotype threat is a widely studied phenomenon in social psychology, there has been relatively little scholarship on it in philosophy, despite its relevance to issues such as implicit cognition, epistemic injustice, and diversity in philosophy. However, most psychological research on stereotype threat discusses the phenomenon by using an overly narrow picture of it, which focuses on one of (...) its effects: the ability to hinder performance. As a result, almost all philosophical work on stereotype threat is solely focused on issues of performance too. -/- Social psychologists know that stereotype threat has additional effects, such as negatively impacting individuals’ motivation, interests, long-term health, and even their sense of self, but these other effects are often downplayed, or even forgotten about. Therefore, the “standard picture” of stereotype threat needs to be expanded, in order to better understand the theoretical aspects of the phenomenon, and to develop broader, more effective interventions. This dissertation develops such an “expanded picture” of stereotype threat, which emphasizes how the phenomenon can negatively impact both self-identity and epistemic agency. In doing so, I explore the nature of stereotypes more generally and argue that they undermine groups’ moral status and contribute to what is called “ontic injustice.” I also show how stereotype threat harms members of socially subordinated groups by way of coercing their self-identity and undermining their epistemic agency, which I argue is a form of epistemic injustice. Lastly, I analyze the expanded picture’s implications for addressing the low proportion of women in professional philosophy. I critically engage recent arguments that these low numbers simply reflect different interests women have, which if innate or benign, would require no intervention. My expanded picture shows the mistakes in this sort of reasoning, which is also present in discussions on the underrepresentation of women in science. The expanded picture of stereotype threat that this dissertation develops is not only practically important, but also advances key philosophical debates in social epistemology, applied ethics, and social metaphysics. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 15.2 (2005) 199-210 [Access article in PDF] Conflict-of-Interest Policy at the National Institutes of Health: The Pendulum Swings Wildly* Evan G. DeRenzo **This article addresses the National Institutes of Health (NIH) employee conflict-of-interest (COI) policy that went into effect February 2005. It is not, however, merely an account of another poorly crafted government policy that cries out for revision. Instead, it is (...) also a story about one of our nation's most important and prestigious institutions and its struggles to navigate the crosscurrents of scientific aspirations, power politics, public ambivalence toward capitalist economics in the biosciences, and the media's inclination to exaggerate problems and under report complicated facts. It is also a tale of greed, politics, purgatory, and redemption. The dramatic and abrupt change in the NIH COI policy demonstrates the difficulty of balancing the production of cutting-edge science with the demands for transparency resulting from work performed in the public interest on the public tab. It is an unhappy chapter in the life of a government agency that is also a national treasure. And, one hopes, it will be an example of how harmful and ill-conceived law can be revised and amended to advance national health and well-being. What is the New NIH COI Policy? The new NIH COI employee policy, more accurately referred to as the Interim Final Rule (Federal Register 2005), is a sweeping set of prohibitions on activities and holdings to reduce the possibility that NIH employees will have any actual [End Page 199] or apparent conflicts of interest. For the most part, the prohibitions are applied across-the-board—i.e., without distinction to employee category or function. The new policy includes prohibitions on outside activities, stock holdings, and awards. It prohibits all NIH employees from engaging in any compensated or uncompensated employment, including consulting, serving on advisory or other such boards, and compensated teaching, speaking, writing, or editing with certain kinds of entities. The first class of such entities is referred to as substantially affected organizations, defined as biotechnology, pharmaceutical, medical device companies, and others with similar interests. But these are not the only entities included in the prohibitions. Other organizations from which NIH employees now are cut off are hospitals, clinics, and other health care institutions; health, science, or health research-related professional associations and consumer and advocacy groups. Included also are educational institutions and not-for-profit independent research institutes that are, or were, recent NIH funding applicants, grantees, contractors, or cooperative research and development agreement (CRADA) partners. The only exemptions appear to be for health care institutions at which NIH employees provide clinical care and some forms of writing—e.g., an NIH physician who moonlights at her/his local hospital's emergency room or submits a manuscript to a peer-reviewed journal that receives only unrestricted funding from a prohibited entity. Prohibited and/or restricted holdings include stock in biotechnology, pharmaceutical, and medical device companies and others in research, development, or manufacture of medical devices, equipment, preparations, treatments, or products. The prohibitions apply to senior NIH employees; restrictions in the amount of such holdings apply to all remaining employees. Both apply to the spouses and minor children of NIH employees. If an NIH employee wins an award, the monetary allowance in most cases is limited to $200. In sum, the scope of this policy is vast, too vast to be reasonable. Too many employees are restricted in too many ways. Where appropriate restrictions have been placed on senior NIH employees, even these constructive aspects of the policy are overshadowed by the unfairness and destructiveness of other aspects. This policy far exceeds anything that could be considered sound. Fortunately, the policy has a built-in assessment process to begin at the end of the policy's first year of implementation. One can only hope that a fair and open evaluation will be conducted, the results of which surely must result in major revisions to what is now bad regulation. Why the Policy... (shrink)

The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans was first developed to establish a standard of practice in research ethics by the three federal agencies responsible for funding institutional research in Canada: Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council, and Social Sciences and Humanities Research Council. In 2010, a second edition of the policy, known as the TCPS 2, was released with updated information and expanded coverage of (...) research ethics issues. According to the TCPS 2, the Agencies’ mandate is “to promote research that is conducted according to the highest ethical standards,” and the TCPS 2 serves as a benchmark for this with respect for human dignity as its underlying value. Research institutions receiving Agency funding are to comply with this policy statement by forming Research Ethics Boards to review all research involving human participants. The intention behind this review requirement is to provide a proportionate assessment of the benefit-to-risk ratio of the research, and in that process, to safeguard “respect for persons”, express a “concern for welfare”, and uphold “justice”. Research may not proceed until ethics approval is granted by an institution’s REB. The current study evaluates REB members’ perspectives on their knowledge of research ethics, and juxtaposes these perceptions with those of researchers. Specifically, we are interested in the extent to which REB members with less experience read the TCPS 2, and whether those with less experience have decreased confidence in their ethics knowledge. (shrink)

The Health Protection Agency has recently attempted to create a postmortem tissue archive to determine the prevalence of abnormal prion protein. The success of this archive was prevented because the Health Protection Agency could not convince coroners to support the study’s methodology and participate on that basis. The findings of this paper detail and support the view that the Coroners’ Society of England and Wales’s refusal to participate was misguided and failed to appreciate that coroners have (...) a moral obligation to protect public health. Measures to assist coroners in fulfilling this role are proposed. (shrink)

Health research for progress in the control and conquest of disease afflicting man is unquestionable. Concerns arise when motives other than the advancement of scientific knowledge and benefit for individuals and society are the driving force behind clinical trials. These conflicts of interests become even more pronounced when dealing with populations rendered vulnerable by virtue of poverty and ignorance. South Asia with its teeming millions represents one such region. This essay examines the reasons that make this population vulnerable (...) to exploitation. Informed consent in the process of research is an area where such conflicts are prone to arise. In order to ensure that conflicting interests of researchers and funding agencies are kept in check, the processes of informed consent and ethical review of research need to be strengthened. Suggestions are put forward to modify the consent process to match the needs of South Asia and to strengthen the ethical review process for safeguarding the rights of the study subjects. But perhaps the most important safeguard against exploitation is the virtuous researcher himself with noble intentions. (shrink)

Health professionals are involved in humanitarian assistance and development work in many regions of the world. They participate in primary health care, immunization campaigns, clinic- and hospital-based care, rehabilitation and feeding programs. In the course of this work, clinicians are frequently exposed to complex ethical issues. This paper examines how health workers experience ethics in the course of humanitarian assistance and development work. A qualitative study was conducted to consider this question. Five core themes emerged from the (...) data, including: tension between respecting local customs and imposing values; obstacles to providing adequate care; differing understandings of health and illness; questions of identity for health workers; and issues of trust and distrust. Recommendations are made for organizational strategies that could help aid agencies support and equip their staff as they respond to ethical issues. (shrink)

BackgroundCarefully planned research is critical to developing policies and interventions that counter physical, psychological and social challenges faced by young people living with HIV/aids, without increasing burdens. Such studies, however, must navigate a ‘vulnerability paradox’, since including potentially vulnerable groups also risks unintentionally worsening their situation. Through embedded social science research, linked to a cohort study involving Adolescents Living with HIV/aids (ALH) in Kenya, we develop an account of researchers’ responsibilities towards young people, incorporating concepts of vulnerability, resilience, (...) and agency as ‘interacting layers’.MethodsUsing a qualitative, iterative approach across three linked data collection phases including interviews, group discussions, observations and a participatory workshop, we explored stakeholders’ perspectives on vulnerability and resilience of young people living with HIV/aids, in relation to home and community, school, health care and health research participation. A total of 62 policy, provider, research, and community-based stakeholders were involved, including 27 ALH participating in a longitudinal cohort study. Data analysis drew on a Framework Analysis approach; ethical analysis adapts Luna’s layered account of vulnerability.ResultsALH experienced forms of vulnerability and resilience in their daily lives in which socioeconomic context, institutional policies, organisational systems and interpersonal relations were key, interrelated influences. Anticipated and experienced forms of stigma and discrimination in schools, health clinics and communities were linked to actions undermining ART adherence, worsening physical and mental health, and poor educational outcomes, indicating cascading forms of vulnerability, resulting in worsened vulnerabilities. Positive inputs within and across sectors could build resilience, improve outcomes, and support positive research experiences.ConclusionsThe most serious forms of vulnerability faced by ALH in the cohort study were related to structural, inter-sectoral influences, unrelated to study participation and underscored by constraints to their agency. Vulnerabilities, including cascading forms, were potentially responsive to policy-based and interpersonal actions. Stakeholder engagement supported cohort design and implementation, building privacy, stakeholder understanding, interpersonal relations and ancillary care policies. Structural forms of vulnerability underscore researchers’ responsibilities to work within multi-sectoral partnerships to plan and implement studies involving ALH, share findings in a timely way and contribute to policies addressing known causes of vulnerabilities. (shrink)

This paper describes the interventions by the International Committee of the Red Cross to support a hospital in Afghanistan during the mid 1990s. We present elements of the interventions introduced in Ghazni, Afghanistan, and consider a number of ethical issues stimulated by this analysis. Ethical challenges arise whenever humanitarian interventions to deal with complex political emergencies are undertaken: among those related to the case study presented are questions concerning: a) whether humanitarian support runs the risk of propping up repressive and (...) irresponsible governments; b) whether humanitarian relief activities can legitimately focus on a narrow range of interventions, or need to broaden to address the range of challenges facing the health system; and c) whether sustainability and quality of care should be routinely considered in such settings. The paper concludes by highlighting the value of case studies, suggesting mechanisms for extending transparency and accountability in humanitarian health interventions, and highlighting the need of contextualising humanitarian work if the interventions are to be successful. (shrink)

Despite changes to research and practice, that, to some degree, acknowledge that people are shaped by their contexts, the treatment of mental illness remains largely focused on interventions that take place at the level of the individual. Conceptualizing mental illness as something that resides in individuals can lead to reliance on neurobiological and psychotherapeutic solutions, and away from conversations about not only contextual causes of mental distress, but also sociopolitical solutions to mental distress. Further, it can lead to the (...) use of mental health interventions that focus on the biology of an individual without a consideration for how those interventions themselves may have psychological, social, or political consequences that act to shape an individual's identity, agency, and relationship to their community. This paper examines one medicolegal intervention, the community treatment order, using the philosophical work of Grosz and Foucault to consider how this intervention affects the experience and construction of identity, and the impact of this on an individual's sense of agential membership in a community. This discussion aims to increase understanding of the individual and social implications of interventions for mental illness, and provide a conceptualization of the relationship between identity, agency, and ethics which can inform critical research and nursing practice more broadly. (shrink)

Black youths experience poor mental health especially due to anti‐Black racism. Research related to Black youths have been conducted on Black youths with little or no participation or engagement rather than with Black youths. This paper presents information from a dialogue on decolonizing nursing research. I draw on interviews and conversation cafes with around 120 Black youths in Canada to identify strategies for decolonizing research with Black youths. First, I reflect on my relations with the Indigenous (...) land in which the study was conducted as well as my positionality as a Black woman. In this paper, I discuss how community based participatory action research can integrate capacity building component, amplify youth's voices and capitalize on the agency of youths as fruitful actors. I also reflect on the opportunities and benefits of decolonizing nursing research. (shrink)

There is substantial literature on fetal alcohol spectrum disorder research involving Aboriginal children, but little related literature on other common neurodevelopmental conditions such as autism spectrum disorder or cerebral palsy for this population. As part of our work in cross-cultural neuroethics, we examined this phenomenon as a case study in Canada. We conducted semi-structured interviews with health researchers working on the frontline with First Nation communities to obtain perspectives about: reasons for the lack of ASD and CP (...) class='Hi'>research within the Aboriginal context, the potential ethical and social implications of this disparity, and recommendations for change. Participants reported that the major barriers to engage in ASD or CP research are under-reporting and under-diagnosis of these conditions in Aboriginal communities, difficulties in establishing trust between community members and researchers, challenges in accessing children living under the care of child welfare services, and lack of support from universities and funding agencies to encourage community partnerships. They further perceived threats to justice as the population is denied the benefits of ASD and CP research, and stigma related to the possible over-representation of FASD in the population. The adoption of strength- and community-based practices to improve engagement and address disparities, and to create health databases with prevalence rates that are representative of all forms of disability in both Aboriginal and non-Aboriginal populations are critical steps to close these gaps. (shrink)

During a pandemic, where there is widespread human infection, various and varying measures are taken that are targeted at public health objectives. During the early stages of a pandemic, these objectives may focus on containing the disease and minimizing its spread, but they may switch to mitigation as the emergent infectious disease takes hold in a population. There has been considerable debate and elucidation of the ethical principles and framework for the various responses including the need to fast track (...) research and vaccine development. However, the measures imposed during a pandemic would have unintended and untoward effect on ongoing clinical research. For example, precautionary measures, such as social distancing, may hamper ongoing clinical research, because recruitment and participation of patients and healthy volunteers is a potential source of virus spread. In this paper, we argue that a framework is needed to ensure the continuity of such research. Such a framework that considers the pertinent issues would need the ‘buy in’ of the key stakeholders (policy makers, funding agencies, institutional authorities, researchers and subjects) to ensure that the issues that are ethically relevant to pandemic planning would not be neglected or overlooked. (shrink)

Once a term used primarily by moral philosophers, “moral distress” is increasingly used by health professionals to name experiences of frustration and failure in fulfilling moral obligations inherent to their fiduciary relationship with the public. Although such challenges have always been present, as has discord regarding the right thing to do in particular situations, there is a radical change in the degree and intensity of moral distress being expressed. Has the plight of professionals in healthcare practice changed? “Plight” encompasses (...) not only the act of pledging, but that of predicament and peril. The author claims that health professionals are increasingly put in peril by healthcare reform that undermines their efficacy and jeopardizes ethical engagement with those in their care. The re-engineering of healthcare to give precedence to corporate and commercial values and strategies of commodification, service rationing, streamlining, and measuring of “efficiency,” is literally demoralizing health professionals. Healthcare practice needs to be grounded in a capacity for compassion and empathy, as is evident in standards of practice and codes of ethics, and in the understanding of what it means to be a professional. Such grounding allows for humane response to the availability of unprecedented advances in biotechnological treatments, for genuine dialogue and the raising of difficult, necessary ethical questions, and for the mutual support of health professionals themselves. If healthcare environments are not understood as moral communities but rather as simulated marketplaces, then health professionals’ moral agency is diminished and their vulnerability to moral distress is exacerbated. Research in moral distress and relational ethics is used to support this claim. (shrink)

A large part of the explainable AI literature focuses on what explanations are in general, what algorithmic explainability is more specifically, and how to code these principles of explainability into AI systems. Much less attention has been devoted to the question of why algorithmic decisions and systems should be explainable and whether there ought to be a right to explanation and why. We therefore explore the normative landscape of the need for AI to be explainable and individuals having a right (...) to such explanation. This exploration is particularly relevant to the medical domain where the (im)possibility of explainable AI is high on both the research and practitioners’ agenda. The dominant intuition overall is that explainability has and should play a key role in the health context. Notwithstanding the strong normative intuition for having a right to explanation, intuitions can be wrong. So, we need more than an appeal to intuitions when it comes to explaining the normative significance of having a right to explanation when being subject to AI-based decision-making. The aim of the paper is therefore to provide an account of what might underlie the normative intuition. We defend the ‘symmetry thesis’ according to which there is no special normative reason to have a right to explanation when ‘machines’ in the broad sense, make decisions, recommend treatment, discover tumors, and so on. Instead, we argue that we have a right to explanation in cases that involve automated processing that significantly affect our core deliberative agency and which we do not understand, because we have a general moral right to explanation when choices are made which significantly affect us but which we do not understand. (shrink)

The governance structures of state public health systems vary as much as the states themselves, including the existence and role of state boards of health. Understanding these differences is essential to a complete understanding of the governmental public health enterprise. State boards of health are obvious vehicles for public health policy development in some states, where they work closely with or oversee state health agencies. In other states they do not exist or serve only (...) in a non-binding advisory capacity.In this article, we distinguish and identify state boards of health and state public health advisory boards, examine state boards of health in practice, and discuss their role in advocacy and policy development in the context of state politics. We used a set of mixed qualitative methods, including a literature review, online research of state statutes establishing state board of health authorities, and key informant interviews. Informants were five current and former state board of health members, four current and former state health officers, and nine state health agency senior policy staff, spanning 13 states. (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)

Building on decades of rich discussions of why 'nothing about us without us' matters in the field of psychiatry, this paper aims to illuminate the justifications underlying participatory research in psychiatry, and how these justifications might shape participatory methodologies. This is accomplished through the examination of several epistemic and ethical features of psychiatry that underlie the importance of engaging in participatory research in the field, unpacking their connection to participatory research, and offering suggestions related to their implications (...) for research methodologies. The epistemic features include: the irreducible value of patient experience, the extent of disagreement and uncertainty in the field, and the value-laden nature of knowledge in psychiatry. The ethical features include: the preponderance of harm, denials of agency and epistemic injustice, and the constant struggle for power. These features offer useful touchpoints for thinking through why participation matters in mental health research. (shrink)

In calling for the transformation of military medical education and training, the 2005 Base Realignment and Closure Commission recommended relocating basic and specialty enlisted medical training to a single site to take advantage of economies of scale and the opportunity for joint training. As a result, a joint medical education and training campus (METC) has been established at Fort Sam Houston, Texas. Two of METC's primary long-term goals are to become a high-performing learning organization and to seek accreditation as a (...) community college. Such goals require a clear model of organizational improvement with well-defined metrics for measuring its performance and using research and evaluation to assess and improve that performance. Lessons learned from a review of practices at institutions with similar missions -- such as community colleges, corporate universities, the UK's Defence Medical Education and Training Agency, and other federal agencies, such as the Veterans Health Administration -- establish a clear need for an office of institutional research to help METC attain its organizational goals. They also provide useful recommendations regarding the METC office's structure, scope, and governance. (shrink)