Volume 25, Issue 2, February 2025, Page 80-82.

Critical Qualitative Health Research seeks to deepen understandings of the philosophies, politics and practices shaping contemporary qualitative health related research. This accessible, lively, controversial introduction draws on current empirical examples and critical discussion to show how qualitative research undertaken in neoliberal healthcare contexts emerges and the complex issues qualitative researchers confront. This book provides readers with a critical, interrogative discussion of the histories and the legacies of qualitative research, as well as of the more (...) recent calls for renewed criticality in research to respond to global health concerns. Contributions further showcase a range of contemporary work engaging with these issues and the complex encounters with philosophies, politics and practices this involves; from seeking explicit engagements with posthuman ideas or detailed explorations of deeply engaged humanist approaches, to critical discussions of the politics and practices of emerging novel, digital and creative methods. This book offers postgraduate researchers, health researchers and students alike opportunities to engage more deeply with the emergent, complex and messy terrain of qualitative health related research. (shrink)

This timely book examines the interaction of health research and regulation with law through empirical analysis and the application of key anthropological concepts to reveal the inner workings of human health research. Through ground-breaking empirical inquiry, Regulatory Stewardship of Health Research explores how research ethics committees (RECs) work in practice to both protect research participants and promote ethical research.This thought-provoking book provides new perspectives on the regulation of health research (...) by demonstrating how RECs and other regulatory actors seek to fulfil these two functions by performing a role of 'regulatory stewardship'. This involves guiding researchers through stages of research approval, as well as seeking to maximise benefits for participants and society while minimising risks. Arguing that participant protection and research promotion should rightly be treated as twin objectives for health research regulators, this book asserts that there is a need for more overt recognition of the importance and function of the deliberative space in which RECs can negotiate the risks relevant to a research application.This book is a key resource for academics and students interested in health research and regulation, and the dynamic interaction of ethics and the law. Regulators and policy-makers will also find it to be an insightful and illuminating text for the practical insights that it reveals about research governance in action. (shrink)

To address the ethical challenges in big data health research we propose the concept of systemic oversight. This approach is based on six defining features and aims at creating a common ground across the oversight pipeline of biomedical big data research. Current trends towards enhancing granularity of informed consent and specifying legal provisions to address informational privacy and discrimination concerns in data-driven health research are laudable. However, these solutions alone cannot have the desired impact unless (...) oversight activities by different stakeholders acquire a common substantive orientation. (shrink)

Health researchers working in low-resource settings routinely encounter serious unmet health needs for which research participants have, at best, limited treatment options through the local health system (Taylor, Merritt, and Mullany 2011). A recent case discussion features a study conducted in Bamako, Mali (Dickert and Wendler 2009). The study objective was to see whether children with severe malaria develop pulmonary hypertension in order to improve the general understanding of morbidity and mortality associated with malaria. In the (...) study team's interactions with participating children, they encountered not only malaria but also "eye infections, upper respiratory tract illnesses, rashes, pericardial effusions," .. (shrink)

Public funders of health research have been widely criticized on the grounds that their allocations of funding for disease-specific research do not reflect the relative burdens imposed by different diseases. For example, the US National Institutes of Health spends a much greater fraction of its budget on HIV/AIDS research and a much smaller fraction on migraine research than their relative contribution to the US burden of disease would suggest. Implicit in this criticism is a (...) normative claim: Insofar as the scientific opportunities are equal, each patient merits research into their condition proportional to the burden of disease for which that condition is responsible. This claim—the proportional view—is widely accepted but has never been fully specified or defended. In this paper, I explain what is required to specify the view, attempt to do so in the most charitable way, and then critically evaluate its normative underpinnings. I conclude that a severity-weighted proportional view is defensible. I close by drawing out five key lessons of my analysis for health research priority-setting. (shrink)

Most public and non-profit organisations that fund health research provide the majority of their funding in the form of grants. The calls for grant applications are often untargeted, such that a wide variety of applications may compete for the same funding. The grant review process therefore plays a critical role in determining how limited research resources are allocated. Despite this, little attention has been paid to whether grant review criteria align with widely endorsed ethical criteria for allocating (...) health research resources. Here, we analyse the criteria and processes that ten of the largest public and non-profit research funders use to choose between competing grant applications. Our data suggest that research funders rarely instruct reviewers to consider disease burden or to prioritise research for sicker or more disadvantaged populations, and typically only include scientists in the review processes. This is liable to undermine efforts to link research funding to health needs. (shrink)

Uncertainty is a necessary condition for the sound moral and scientific conduct of research involving human subjects. If the expert scientific communities, medical or otherwise, lacked uncertainty about the interventions under investigation, it would be unethical to knowingly subject individuals to inferior or harmful treatment. Moreover, if the relative merits of the interventions were previously established, as indicated by the lack of uncertainty within the relevant expert community, the results of the trial would be of little, if any, scientific (...) value. Despite the important role that uncertainty plays in the formulation and conduct of research involving human subjects, the concept has received inadequate treatment in the research ethics literature. To the limited extent that uncertainty is addressed, much of the emphasis remains on the ethical, not epistemic, aspects of uncertainty. What is left insufficiently examined is the nature and scope of the uncertainty. Often, uncertainty is glossed as agnosticism, indifference, and conflict. Yet these terms represent distinct types of uncertainty, and the type that obtains impacts the epistemic and ethical justifications for a proposed trial. A failure to recognize and clearly articulate the parameters of uncertainty in particular situations compromises our ability to respond to important moral and scientific concerns in the development and conduct of research. This problem is particularly pronounced in public health research that investigates problems resulting not only from uncertainties in scientific knowledge but from institutional failures, economic and social constraints, and lack of political will. Indeed, the role of research in public health is tied to its capacities to successfully navigate such complex questions. The way in which a study is designed and carried out, as well as ethically and scientifically justified, must reflect a robust and systematic characterization of the uncertainties present. Using an example from a study examining the efficacy of using treated sewage sludgeto remediate lead-contaminated soil, I explore and analyze the aforementioned deficiencies in understanding uncertainty among researchers and ethicists. The case study serves as a vehicle through which to illustrate (1) important considerations in characterizing and addressing uncertainty; (2) the influence of the uncertainty characterization on the formulation of parameters used to evaluate the ethical permissibility of the research; and (3) ways in which these parameters might be operationalized in the context of a particular study. (shrink)

Community engagement is gaining prominence in global health research. So far, a philosophical rationale for why researchers should perform community engagement during such research has not been provided by ethics scholars. Its absence means that conducting community engagement is still often viewed as no more than a ‘good idea’ or ‘good practice’ rather than ethically required. In this article, we argue that shared health governance can establish grounds for requiring the engagement of low‐ and middle‐income country (...) (LMIC) community members in global health research, where such research aims to help reduce health disparities. This philosophical basis has important implications for the ethical goals ascribed to engagement and the approach adopted to undertake it. We suggest the ethical goals of engagement in equity‐oriented global health research should include: (a) generating research topics and questions that reflect the key problems disadvantaged groups face in accessing healthcare, services and broader social determinants of health and (b) promoting the translation of research findings into policy and practice in ways that benefit the health of disadvantaged groups. We propose engagement practice should have the following features: deliberation with LMIC community members to make a range of project decisions, beginning with setting research topics and questions; inclusion of members of disadvantaged groups and those with the power to change policy and practice to benefit them; and purposeful structuring of deliberations to minimize the impact of power disparities between LMIC community members. Finally, we reflect on how these features differ from those typical of much current community engagement practice in LMICs. (shrink)

Background: Exposomics, the study of the exposome, is flourishing, but the field is not well defined. The term “exposome” refers to all environmental influences and associated biological responses throughout the lifespan. However, this definition is very similar to that of the term “environment”—the external elements and conditions that surround and affect the life and development of an organism. Consequently, the exposome seems to be nothing more than a synonym for the environment, and exposomics a synonym for environmental research. As (...) a result, some have rebranded their “standard” environmental health research with the neologistic exposome term, whereas others ignore or seek to abandon the seemingly redundant concept of the exposome. -/- Objectives: We argue that exposomics needs to sharpen its mission focus to counteract this apparent redundancy. Exposomics should be defined as a research program in environmental health aimed at enabling a comprehensive and discovery-driven approach to identifying environmental determinants of human health. Similar to the aim of the Human Genome Project, exposomics aims to analyze the complete complexity of exposures and their corresponding biological responses. Exposomics’ primary premise is that the existence of undiscovered, potentially interconnected, nongenetic (environmental) risk factors for health necessitates a comprehensive discovery-driven analysis approach. -/- Discussion: We argue that exposomics researchers should adopt our reconceptualization of exposomics and focus on the productiveness and integrity of their research program: its purpose and principles. We suggest that exposomics researchers should coordinate the writing of reviews that assess the program’s productiveness and integrity, as well as provide a platform for exposomics researchers to define their vision for the field. (shrink)

Guidelines for health research focus on protecting individual research subjects. It is also vital to protect the communities involved in health research. In particular, a number of studies have been criticized on the grounds that they exploited host communities. The present paper attempts to address these concerns by providing an analysis of community exploitation and, based on this analysis, determining what safeguards are needed to protect communities in health research against exploitation. (edited).

When environmental health researchers study hazards in the home, they often discover information that may be relevant to protecting the health and safety of the research subjects and occupants. This article describes the ethical and legal basis for a duty to warn research subjects and occupants about hazards in the home and explores the extent of this duty. Investigators should inform research subjects and occupants about the results of tests conducted as part of the (...) class='Hi'>research protocol only if the information is likely to be accurate, reliable, and medically useful. Investigators should warn subjects and occupants about hazards they happen to discover while they are in the home, if a reasonable person would warn the subjects and occupants about those hazards. Investigators should not report illegal hazards discovered in the home to the authorities, unless those hazards constitute abuse or neglect of children or mentally disabled people living in the home. When investigators decide to warn research subjects and occupants about hazards in the home, they should take some steps to help them make effective use of this information, such as providing additional counselling or making a referral for remediation or medical treatment. Investigators should discuss these issues with research subjects during the informed consent process. (shrink)

This study explores how qualitative health researchers navigate the demands of medical research ethics committees in Germany where qualitative research is subject to approval only when it is conducted in medical contexts. We present the results of a grounded theory study to investigate qualitative health researchers’ experiences with procedural ethics and the strategies they adopt to navigate its demands. Our analysis revealed six dimensions of experience and three strategies adopted by researchers to navigate the demands of (...) medical research ethics committees. All participants agreed that research ethics is of high importance in qualitative health research, but strategies to navigate the demands of medical research ethics committees ranged from avoiding, and adapting, to transforming the procedures of ethics review. Based on our findings, we provide recommendations for improving the ethics review of qualitative health research. (shrink)

This book is a collection of fictionalized case studies of everyday ethical dilemmas and challenges, encountered in the process of conducting global health research in places where the effects of political and economic inequality are particularly evident. It is a training tool to fill the gap between research ethics guidelines and their implementation "on the ground." The cases focus on "relational" ethics: ethical actions and ideas that continuously emerge through relations with others, rather than being determined by (...) bioethics regulation. They are based on stories and experiences collected by a group of social anthropologists who have worked with leading transnational medical research organizations across Africa in the past decade. Accompanied by guidelines, discussion questions and selected further readings, the book provides a flexible resource for training and self-study for people engaged in health research with, universities, international collaborative sites and NGOs and for everyone interested in the realities of global health research today.". (shrink)

Over the past two decades, the promotion of collaborative partnerships involving researchers from low and middle income countries with those from high income countries has been a major development in global health research. Ideally, these partnerships would lead to more equitable collaboration including the sharing of research responsibilities and rewards. While collaborative partnership initiatives have shown promise and attracted growing interest, there has been little scholarly debate regarding the fair distribution of authorship credit within these partnerships.

Mobile devices with health apps, direct-to-consumer genetic testing, crowd-sourced information, and other data sources have enabled research by new classes of researchers. Independent researchers, citizen scientists, patient-directed researchers, self-experimenters, and others are not covered by federal research regulations because they are not recipients of federal financial assistance or conducting research in anticipation of a submission to the FDA for approval of a new drug or medical device. This article addresses the difficult policy challenge of promoting the (...) welfare and interests of research participants, as well as the public, in the absence of regulatory requirements and without discouraging independent, innovative scientific inquiry. The article recommends a series of measures, including education, consultation, transparency, self-governance, and regulation to strike the appropriate balance. (shrink)

In this article we argue that the social value of health research should be conceptualized as a function of both the expected benefits of the research and the priority that the beneficiaries deserve. People deserve greater priority the worse off they are. This conception of social value can be applied for at least two important purposes: in health research priority setting when research funders, policy-makers, or researchers decide between alternative research projects; and in (...) evaluating the ethics of proposed research proposals when research ethics committees assess whether the social value of the research is sufficient to justify the risks and burdens to research participants and others. In assessing how far a proposed research project will advance the interests of people who are more disadvantaged, research priority setters and RECs should examine the diseases that the research targets and the type of research. Just as certain diseases impose a greater burden on people who are more disadvantaged, so certain types of intervention and forms of research are more likely to benefit people who are more disadvantaged. We outline which populations are likely to be representative of the global worst off and identify what types of health research, and which disease categories, are priorities for these populations. (shrink)

Human immunodeficiency virus and other sexually transmitted infections significantly burden youth 13–24 years of age in the United States. Directly engaging youth in sexual health research is a public health priority and urgently needed to develop targeted, youth-friendly, and culturally relevant HIV/sti prevention interventions. Controversies arise, however, regarding informed assent and consent, parental permission or consent, and the definition of “child”/“minor” as it relates to medical, legal, and ethical issues. In this article, we describe challenges in the (...) human subjects review processes that were undertaken before beginning an HIV/sti prevention research project with sexually active youth in an urban setting. These findings provide important contextual information to facilitate youth sexual health research and care, and Institutional Review Board approval processes with fewer delays. (shrink)

Background Despite the growth of biomedical research in South Africa, there are few insights into the operation of Research Ethics Committees (RECs) in this setting. We investigated the composition, operations and training needs of health RECs in South Africa against the backdrop of national and international guidelines. Methods The 12 major health RECs in South Africa were surveyed using semi-structured questionnaires that investigated the composition and functions of each REC as well as the operational issues facing (...) committees. Results Health RECs in SA have an average of 16 members and REC members are predominantly male and white. Overall, there was a large discrepancy in findings between under-resourced RECs and well resourced RECs. The majority of members (56%) are scientists or clinicians who are typically affiliated to the same institution as the health REC. Community representatives account for only 8% of membership. Training needs for health REC members varied widely. Conclusion Most major health RECs in South Africa are well organized given the resource constraints that exist in relation to research ethics in developing countries. However, the gender, racial and occupational diversity of most of these RECs is suboptimal, and most RECs are not constituted in accordance with South African guidelines. Variability in the operations and training needs of RECs is a reflection of apartheid-entrenched influences in tertiary education in SA. While legislation now exists to enforce standardization of research ethics review systems, no provision has been made for resources or capacity development, especially to support historically-disadvantaged institutions. Perpetuation of this legacy of apartheid represents a violation of the principles of justice and equity. (shrink)

Objectives The study uses a qualitative empirical method to define Health Research for Development. This project explores the perspectives of stakeholders in an international health research partnership operating in Ghana and Tanzania. Methods We conducted 52 key informant interviews with major stakeholders in an international multicenter partnership between GlaxoSmithKline and the global health nonprofit organisation PATH and its Malaria Vaccine Initiative program,. The respondents included teams from four clinical research centres and various collaborating partners. (...) This paper analyses responses to the question: What is Health Research for Development? Results Based on the stakeholders’ experience the respondents offered many ways of defining Health Research for Development. The responses fell into four broad themes: i) Equitable Partnerships; ii) System Sustainability; iii) Addressing Local Health Targets, and iv) Regional Commitment to Benefit Sharing. Conclusion Through defining Health Research for Development six key learning points were generated from the four result themes: 1) Ensure there is local research leadership working with the collaborative partnership, and local healthcare system, to align the project agenda and activities with local research and health priorities; 2) Know the country-specific context - map the social, health, legislative and political setting; 3) Define an explicit development component and plan of action in a research project; 4) Address the barriers and opportunities to sustain system capacity. 5) Support decentralised health system decision-making to facilitate the translation pathway; 6) Govern, monitor and evaluate the development components of health research partnerships. Overall, equity and unity between partners are required to deliver health research for development. (shrink)

BackgroundThe health sector aims to improve health outcomes and access to healthcare. At the same time, the sector relies on unsustainable environmental practices that are increasingly recognised to be catastrophic threats to human health and health inequities. As such, a moral imperative exists for the sector to address these practices. While strides are currently underway to mitigate the environmental impacts of healthcare, less is known about how health researchers are addressing these issues, if at all.MethodsThis (...) paper uses an interview methodology to explore the attitudes of UK health researchers using data-intensive methodologies about the adverse environmental impacts of their practices, and how they view the importance of these considerations within wider health goals.ResultsInterviews with 26 researchers showed that participants wanted to address the environmental and related health harms associated with their research and they reflected on how they could do so in alignment with their own research goals. However, when tensions emerged, their own research was prioritised. This was related to their own desires as researchers and driven by the broader socio-political context of their research endeavours.ConclusionTo help mitigate the environmental and health harms associated with data-intensive health research, the socio-political context of research culture must be addressed. (shrink)

England and Wales are moving toward a model of ‘opt out’ for use of personal confidential data in health research. Existing research does not make clear how acceptable this move is to the public. While people are typically supportive of health research, when asked to describe the ideal level of control there is a marked lack of consensus over the preferred model of consent. This study sought to investigate a relatively unexplored difference between the consent (...) model that people prefer and that which they are willing to accept. It also sought to explore any reasons for such acceptance. (shrink)

The European Union Data Protection Regulation will have profound implications for public health, health services research and statistics in Europe. The EU Commission's Proposal was a breakthrough in balancing privacy rights and rights to health and healthcare. The European Parliament, however, has proposed extensive amendments. This paper reviews the amendments proposed by the European Parliament Committee on Civil Liberties, Justice and Home Affairs and their implications for health research and statistics. The amendments eliminate most (...) innovations brought by the Proposal. Notably, derogation to the general prohibition of processing sensitive data shall be allowed for public interests such as the management of healthcare services, but not health research, monitoring, surveillance and governance. The processing of personal health data for historical, statistical or scientific purposes shall be allowed only with the consent of the data subject or if the processing serves an exceptionally high public interest, cannot be performed otherwise and is legally authorised. Research, be it academic, government, corporate or market research, falls under the same rule. The proposed amendments will make difficult or render impossible research and statistics involving the linkage and analysis of the wealth of data from clinical, administrative, insurance and survey sources, which have contributed to improving health outcomes and health systems performance and governance; and may illegitimise efforts that have been made in some European countries to enable privacy-respectful data use for research and statistical purposes. If the amendments stand as written, the right to privacy is likely to override the right to health and healthcare in Europe. (shrink)

This article talks about both clinical research ethics and public health research ethics. Clinical research ethics are defined as set of relevant ethics considered necessary for the conduct of clinical trials in field of the clinical research. While public health research ethics is mainly aimed at finding out what is best for the communities and the populations rather than the individuals. Research ethics is mainly focused on the protection of individual participants and (...) some of the research norms and accepted principles may be challenging when applying in some of the research contexts. (shrink)

Despite the growing importance of ‘social value’ as a central feature of research ethics, the term remains both conceptually vague and to a certain extent operationally rigid. And yet, perhaps because the rhetorical appeal of social value appears immediate and self-evident, the concept has not been put to rigorous investigation in terms of its definition, strength, function, and scope. In this article, we discuss how the anthropological concept of liminality can illuminate social value and differentiate and reconfigure its variegated (...) approaches. Employing liminality as a heuristic encourages a reassessment of how we understand the mobilization of ‘social value’ in bioethics. We argue that social value as seen through the lens of liminality can provide greater clarity of its function and scope for health research. Building on calls to understand social value as a dynamic, rather than a static, concept, we emphasize the need to appraise social value iteratively throughout the entire research as something that transforms over multiple times and across multiple spaces occupied by a range of actors. (shrink)

Engagement in health research is increasingly practised worldwide. Yet many questions remain under debate in the ethics field about its contribution to health research and these debates have largely not been informed by those who have been engaged in health research. This paper addresses the following key questions: what should the ethical goals of engagement in health research be and how should it be performed? Qualitative data were generated by interviewing 22 people (...) with lived experience, members of the public, and engagement managers about power sharing in health research. Thematic analysis of study data identified the following five themes: the value of engagement in research, ideal engagement, tokenistic engagement, terms to describe those engaged, and engagement roles in research. The paper presents that data and then considers what insights it offers for what engagement should look like—its ethical goals and approach—according to those being engaged. (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)

This article draws attention to the limited amount of scholarship on what constitutes fairness and equity in resource allocation to health research by individual funders. It identifies three key decisions of ethical significance about resource allocation that research funders make regularly and calls for prioritizing scholarship on those topics – namely, how health resources should be fairly apportioned amongst public health and health care delivery versus health research, how health research (...) resources should be fairly allocated between health problems experienced domestically versus other health problems typically experienced by disadvantaged populations outside the funder's country, and how domestic and non-domestic health research funding should be further apportioned to different areas, e.g. types of research and recipients. These three topics should be priorities for bioethics research because their outcomes have a substantial bearing on the achievement of health justice. The proposed agenda aims to move discussion on the ethics of health research funding beyond its current focus on the mismatch between worldwide basic and clinical research investment and the global burden of disease. Individual funders’ decision-making on whether and to what extent to allocate resources to non-domestic health research, health systems research, research on the social determinants of health, capacity development, and recipients in certain countries should also be the focus of ethical scrutiny. (shrink)

The biopsychosocial (BPS) model has been of considerable utility to those researching health and illness. This has been particularly the case for critical realists and those with a systemic orientation to their work. Whilst the strengths of the model are conceded in this article, its limitations are also examined. These relate to its ontological sophistication being compromised by its proneness to epistemological naivety. It is a model to explain the emergence of disease and disability, not a reflexive theory applicable (...) to the whole field of health research. This tension is linked to the emergence of a re-orientation of medical knowledge away from bio-medical reductionism. From the outset the model was not about a general critique, or a grand theory, of health and illness. Instead it was a useful intervention, on the part of medical practitioners, like George Engel and Adolf Meyer, to create a reformed medical model on behalf of their profession. Case studies of the problematics of diagnosis and medicalization are offered to illuminate the limitations of the BPS model for health researchers. (shrink)

In this paper we examine ethical issues relevant to conducting mental health research with refugees and immigrant communities that have cultural orientations and social organisation that are substantially different to those of the broader Australian community, and we relate these issues to NH&MRC Guidelines. We describe the development and conduct of a mental health research project carried out recently in Melbourne with the Somali community, focusing on ethical principles involved, and relating these to the NH&MRC National (...) Statement on Ethical Conduct in Research Involving Humans, and the NH&MRC document Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research.The experience of conducting mental health research with the Somali community highlights the fact that the principles of inclusion and benefit enunciated in the NH&MRC document Values and Ethics are particularly pertinent when conducting research with refugees and immigrant communities that are culturally distant to those of the broader Australian community. These principles inform issues of research design and consent, as well as guiding respectful engagement with the participating community and communication of the research findings. (shrink)

Global health research partnerships are increasingly taking the form of consortia of institutions from high-income countries and low- and middle-income countries that undertake programs of research. These partnerships differ from collaborations that carry out single projects in the multiplicity of their goals, scope of their activities, and nature of their management. Although such consortia typically aim to reduce health disparities between and within countries, what is required for them to do so has not been clearly defined. (...) This article takes a conceptual approach to explore how the governance of transnational global health research consortia should be structured to advance health equity. To do so, it applies an account called shared health governance to derive procedural and substantive guidance. A checklist based on this guidance is proposed to assist research consortia determine where their governance practices strongly promote equity and where they may fall short. (shrink)

Massive amounts of data are collected and stored on a routine basis in virtually all domains of human activities. Such data are potentially useful to biomedicine. Yet, access to data for research purposes is hindered by the fact that different kinds of individual-patient data reside in disparate, unlinked silos. We propose that data cooperatives can promote much needed data aggregation and consequently accelerate research and its clinical translation. Data cooperatives enable direct control over personal data, as well as (...) more democratic governance of data pools. This model can realize a specific kind of data economy whereby citizens and communities are empowered to steer data use according to their motivations, preferences, and concerns. Policy makers can promote this model by recognizing citizens’ rights to access and to obtain a copy of their own data, and by funding distributed data infrastructures piloting new data aggregation models. (shrink)

Many are calling for concrete mechanisms of oversight for health research involving artificial intelligence (AI). In response, institutional review boards (IRBs) are being turned to as a familiar model of governance. Here, we examine the IRB model as a form of ethics oversight for health research that uses AI. We consider the model's origins, analyze the challenges IRBs are facing in the contexts of both industry and academia, and offer concrete recommendations for how these committees might (...) be adapted in order to provide an effective mechanism of oversight for health‐related AI research. (shrink)

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)

Engaging citizens is vital to achieving people‐centred health research. This paper aims to put attention to dynamics of power and dynamics of difference back at the centre of citizen engagement in health research priority‐setting. Without attention to power and difference, engagement can lead to presence without voice and voice without influence, particularly for disadvantaged and marginalised groups. By analysing six key bodies of literature, the paper first identifies the different components of engagement—who initiates, for what purpose, (...) who participates, and how they participate—and the dynamics of power and dynamics of difference relevant to them. For each component of engagement, the ethical considerations relating to those dimensions of power and dimensions of difference are characterised for the research priority‐setting context and preliminary guidance on how they might be addressed is provided. An initial framework comprised of a series of questions reflecting these ethical considerations has been developed for use by researchers and citizens when designing engagement processes for research projects. Where researchers and citizens attend to the framework's questions and then revise their priority‐setting processes’ design to better represent diversity and mitigate power disparities, more inclusive citizen engagement is promoted. Disadvantaged and marginalised groups are more likely to be present and heard, which, in turn, will help generate research projects with topics and questions that encompass and more accurately reflect their health needs. (shrink)

The introduction of the National Health and Medical Research Council guidelines for the ethical conduct of Indigenous health research: Values and Ethics: guidelines for ethical conduct in Aboriginal and Torres Strait Islander health research (NHMRC, 2003), has prompted renewed debate about the ethical assessment of Indigenous health research in Australia. Concern has been expressed that these guidelines provide inadequate protection of Indigenous interests and that their introduction will result in a rolling back (...) of important Indigenous research reform gains of the past three decades. Another view is that the participatory focus of the Guidelines will help ensure that key Indigenous values are positioned as central to the development of research involving Indigenous interests. In this article we provide an overview of recent commentary on the Guidelines, and canvass practical proposals for their implementation into practice. In particular, we present a case for applying the Values and Ethics Guidelines as a foundation for establishing negotiated research agreements between Indigenous peoples and professional researchers at the local community level. The intention of this proposal is to give voice to the concerns and perspectives of Indigenous peoples through research, and to provide a framework for monitoring research after ethics approval has been granted. (shrink)

With more than half of individuals incarcerated having serious mental health concerns, correctional settings offer excellent opportunities for epidemiological, prevention, and intervention research. However, due to unique ethical and structural challenges, these settings create risks and vulnerabilities for participants not typically encountered in research populations. We surveyed 1,224 researchers, Institutional Review Board members, and IRB prisoner representatives to assess their perceptions of risks and vulnerabilities associated with mental health research conducted in correctional settings. Highest ranked (...) risks were related to privacy, stigma, and confidentiality; lowest ranked risks were related to prisoners’ loss of privileges or becoming targets of violence due to having participated in research. Cognitive impairment, mental illness, lack of autonomy, and limited access to services emerged as the greatest sources of vulnerability; being male, being female, being older than age 60, being a minority, and being pregnant were the lowest ranked sources of vulnerability. Researchers with corrections experience perceived lower risks and vulnerabilities than all other groups, raising the question whether these researchers accurately appraise risk and vulnerability based on experience, or if their lower risk and vulnerability perceptions reflect potential bias due to their vested interests. By identifying areas of particular risk and vulnerability, this study provides important information for researchers and research reviewers alike. (shrink)

Background: Increasing collaboration between industrialised and developing countries in human research studies has led to concerns regarding the potential exploitation of resource deprived countries. This study, commissioned by the former National Bioethics Advisory Commission of the United States, surveyed developing country researchers about their concerns and opinions regarding ethical review processes and the performance of developing country and US international review boards .Methods: Contact lists from four international organisations were used to identify and survey 670 health researchers in (...) developing countries. A questionnaire with 169 questions explored issues of IRB review, informed consent, and recommendations.Results: The majority of the developing country researchers were middle aged males who were physicians and were employed by educational institutions, carrying out research on part time basis. Forty four percent of the respondents reported that their studies were not reviewed by a developing country IRB or Ministry of Health and one third of these studies were funded by the US. During the review process issues such as the need for local language consent forms and letters for approval, and confidentiality protection of participants were raised by US IRBs in significantly higher proportions than by host country IRBs.Conclusion: This survey indicates the need for the ethical review of collaborative research in both US and host countries. It also reflects a desire for focused capacity development in supporting ethical review of research. (shrink)