BackgroundEthics review is the process of assessing the ethics of research involving humans. The Ethics Review Committee (ERC) is the key oversight mechanism designated to ensure ethics review. Whether or not this governance mechanism is still fit for purpose in the data-driven research context remains a debated issue among research ethics experts.Main textIn this article, we seek to address this issue in a twofold manner. First, we review the strengths and weaknesses of ERCs in ensuring ethical oversight. Second, we map (...) these strengths and weaknesses onto specific challenges raised by big data research. We distinguish two categories of potential weakness. The first category concerns persistent weaknesses, i.e., those which are not specific to big data research, but may be exacerbated by it. The second category concerns novel weaknesses, i.e., those which are created by and inherent to big data projects. Within this second category, we further distinguish between purview weaknesses related to the ERC’s scope (e.g., how big data projects may evade ERC review) and functional weaknesses, related to the ERC’s way of operating. Based on this analysis, we propose reforms aimed at improving the oversight capacity of ERCs in the era of big data science.ConclusionsWe believe the oversight mechanism could benefit from these reforms because they will help to overcome data-intensive research challenges and consequently benefit research at large. (shrink)

The dominant, individualistic understanding of autonomy that features in clinical practice and research is underpinned by the idea that people are, in their ideal form, independent, self-interested and rational gain-maximising decision-makers. In recent decades, this paradigm has been challenged from various disciplinary and intellectual directions. Proponents of ‘relational autonomy’ in particular have argued that people’s identities, needs, interests – and indeed autonomy – are always also shaped by their relations to others. Yet, despite the pronounced and nuanced critique directed at (...) an individualistic understanding of autonomy, this critique has had very little effect on ethical and legal instruments in clinical practice and research so far. In this article, we use four case studies to explore to what extent, if at all, relational autonomy can provide solutions to ethical and practical problems in clinical practice and research. We conclude that certain forms of relational autonomy can have a tangibl... (shrink)

In their proof-of-concept, Meier and colleagues describe the purpose and programming decisions underpinning Medical Ethics Advisor, an automated decision support system used t...

This article investigates a high-profile and ongoing dilemma for healthcare professionals, namely whether the existence of a duty of care to genetic relatives of a patient is a help or a hindrance in deciding what to do in cases where a patient’s genetic information may have relevance to the health of the patient’s family members. The English case ABC v St George’s Healthcare NHS Trust and others considered if a duty of confidentiality owed to the patient and a putative duty (...) of care to the patient’s close relatives could coexist in this context. This article examines whether embracing the concept of coexisting duties could enable HCPs to respect duties in line with their clinical judgement, thereby providing legal support and clarity to professionals to allow them to provide the best possible genetics service to both the patient and their family. We argue that these dual duties, framed as a novel, composite duty to consider the interests of genetic relatives, could allow HCPs to exercise and act on their professional judgements about the relative value of information to family members, without fears of liability for negligence or breach of confidence. (shrink)

Spurred by a confluence of factors, most notably the decreasing cost of high-throughput technologies and advances in information technologies, a number of population research initiatives have emerged in recent years. These include large-scale, internationally collaborative genomic projects and biobanks, the latter of which can be defined as an organized collection of human biological material and associated data stored for one or more research purposes. Biobanks are a key emerging research infrastructure, and those established as prospective research resources comprising biospecimens and (...) data from many participants are viewed as particularly promising drivers of biomedical progress. Such biobanks, particularly those publicly funded and set up to promote the public interest, have expanded across the globe in recent years. (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)

Life sciences research is increasingly international and data-intensive. Researchers work in multi-jurisdictional teams or formally established research consortia to exchange data and conduct research using computation of multiple sources and volumes of data at multiple sites and through multiple pathways. Despite the internationalization and data intensification of research, the same ethics review process as applies to single-site studies in one country tends to apply to multi-site studies in multiple countries. Because of the standard requirement for multi-jurisdictional or multi-site ethics review, (...) international research projects are subjected to multiple ethics reviews of the same research protocol. Consequently, the reviews may be redundant and resource-consuming, whilst the opinions delivered by ethics committees may be inconsistent both within and across jurisdictions. In this article, we present findings based on interviews conducted with international experts in research ethics on the topic of et... (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)

The collapse of confidence in anonymization as a robust approach for preserving the privacy of personal data has incited an outpouring of new approaches that aim to fill the resulting trifecta of technical, organizational, and regulatory privacy gaps left in its wake. In the latter category, and in large part due to the growth of Big Data–driven biomedical research, falls a growing chorus of calls for criminal and penal offences to sanction wrongful re-identification of “anonymized” data. This chorus cuts across (...) the fault lines of polarized privacy law scholarship that at times seems to advocate privacy protection at the expense of Big Data research or vice versa. Focusing on Big Data in the context of biomedicine, this article surveys the approaches that criminal or penal law might take toward wrongful re-identification of health data. It contextualizes the strategies within their respective legal regimes as well as in relation to emerging privacy debates focusing on personal data use and data linkage and assesses the relative merit of criminalization. We conclude that this approach suffers from several flaws and that alternative social and legal strategies to deter wrongful re-identification may be preferable. (shrink)

As the sustained and devastating extent of the coronavirus disease 2019 pandemic becomes apparent, a key focus of public scrutiny in the UK has centred on the novel legal and regulatory measures introduced in response to the virus. When those measures were first implemented in March 2020 by the UK Government, it was thought that human rights obligations would limit excesses of governmental action and that the public had more to fear from unwarranted intrusion into civil liberties. However, within the (...) first year of the pandemic’s devastation in the UK, a different picture has emerged: rather than through action, it is governmentalinactionthat has given rise to greater human rights concerns. The UK Government has been roundly criticized for its inadequate response, including missteps in decision-making, delayed implementation and poor enforcement of lockdown measures, abandonment of testing, shortages of critical resources and inadequate test and trace methods. In this article, we analyse the UK Government’s missteps and compare them with published international guidance; we also contrast the UK’s decisions with those taken by several other countries to understand how its actions and inactions have contributed to unfavourable outcomes. Using an analytical perspective that demonstrates how human rights are both a protection from the power of the state and a requirement that governmental powers are used to protect the lives, health and wellbeing of citizens, we argue that the UK Government’s failure to exercise their powers competently allowed the virus to spread without ensuring the country had the means to manage a high case load. This abject failure has led to one of the highest rates of deaths per capita worldwide. We offer several lessons that can be learnt from this unfortunate, but preventable, situation. (shrink)

While ethical norms for conducting academic research in the United Kingdom are relatively clear, there is little empirical understanding of how university research ethics committees (RECs) themselves operate and whether they are seen to operate well. In this article, we offer insights from a project focused on the Scottish university context. We deployed a three-sided qualitative approach: (i) document analysis; (ii) interviews with REC members, administrators, and managers; and (iii) direct observation of REC meetings. We found that RECs have diverse (...) operation and vary in terms of what members understand to be the remit of their REC and what should constitute the content of ethics review. Overall, though, most participants perceive university RECs as operating well. When asked what they consider to be areas for further improvement, most commented on: implementation of an online system; more experience with how to evaluate various kinds of research projects; best practice exchange and training opportunities; more accurate reflection of the REC role as part of the university’s workload allocation model; and greater recognition of the importance of research ethics governance in the university’s research environment, and, for the members themselves, their career advancement. Based on our findings and subsequent discussions during an end-of-project roundtable with stakeholders, we propose a model of collaboration that can address some of the identified areas that could benefit from further improvement. This model would facilitate a heightened awareness of the importance of supporting REC members in their own effort in assisting students and staff alike in undertaking as ethically robust research as possible. (shrink)

This article argues in general support of the sIRB rule, but also draws on recent empirical research to highlight several residual weaknesses in the US regulatory structure for research ethics review, and suggests ways in which these weaknesses might be addressed in future regulatory reforms to improve upon the sIRB rule.

In this article, we consider the possible application of the European General Data Protection Regulation to “citizen scientist”-led health research with mobile devices. We argue that the GDPR likely does cover this activity, depending on the specific context and the territorial scope. Remaining open questions that result from our analysis lead us to call for lex specialis that would provide greater clarity and certainty regarding the processing of health data by for research purposes, including these non-traditional researchers.

European and international regulation of human health research is typified by a morass of interconnecting laws, diverse and divergent ethical frameworks, and national and transnational standards. There is also a tendency for legislators to regulate in silos—that is, in discrete fields of scientific activity without due regard to the need to make new knowledge as generalisable as possible. There are myriad challenges for the stakeholders—researchers and regulators alike—who attempt to navigate these landscapes. This Delphi study was undertaken in order to (...) provide the first interdisciplinary and crosscutting analysis of health research regulation, as it is experienced by such stakeholders in the UK context. As well as reinforcing existing understandings of the regulatory environment, Delphi participants called for greater collaboration, and even co-production, of processes involved in health research regulation. On the basis of this research, we offer insights about how health research regulation can become a matter with which a wider range of stakeholders—including researchers, regulators, publics and research sponsors—can engage. The evidence supports the normative claim that health research regulation should continue to move away from strict, prescriptive rules-based approaches, and towards flexible principle-based regimes that allow researchers, regulators and publics to co-produce regulatory systems serving core principles. By unpacking thorny concepts and practices at the heart of health research regulation—including the public interest and public engagement—our results have the potential to situate and breathe life into them. The results also demonstrate that while proportionality is well-recognised as a crucial element of flexible regulatory systems, more must be done to operationalise this as an ethical assessment of the values and risks at stake at multiple junctures in the research trajectory. This is required if we are to move beyond proportionality as a mere risk-management tool. Compliance culture no longer accurately reflects the needs and expectations of researchers or regulators, nor does it necessarily produce the best research. Embracing uncertainty—both as a human practice and a regulatory objective—may represent the brighter future for health research. (shrink)

In the United States, final amendments to the Federal Policy for the Protection of Human Subjects (“the Common Rule”) were published on January 19, 2017, and they will take effect on January 21, 2019. One of the most widely discussed provisions is that for the first time, federal regulations governing research with humans authorize the use of broad consent for future, unspecified research on individually identifiable biospecimens and associated data. Many questions have been raised about broad consent, including what effect (...) it will have on research and whether it adequately protects the interests of research participants.There are lessons to be learned for the U.S. and other countries by looking to countries that already have experience with broad consent for biobank collection and with the storage and subsequent use of the biospecimens and data. This article describes how broad consent works in five countries—Canada (in Quebec), Israel, Nigeria, Taiwan, and the United Kingdom—and with different types of biobanks: national biobanks, federated biobanks, and regional biobanks. Evaluating the provisions and challenges of the broad consent approaches in these countries can inform policies for this increasingly used approach to biobank regulation. (shrink)

The aim of UK-REACH (“The United Kingdom Research study into Ethnicity And COVID-19 outcomes in Healthcare workers”) is to understand if, how, and why healthcare workers (HCWs) in the United Kingdom (UK) from ethnic minority groups are at increased risk of poor outcomes from COVID-19. In this article, we present findings from the ethical and legal stream of the study, which undertook qualitative research seeking to understand and address legal, ethical, and social acceptability issues around data protection, privacy, and information (...) governance associated with the linkage of HCWs’ registration data and healthcare data. We interviewed 22 key opinion leaders in healthcare and health research from across the UK in two-to-one semi-structured interviews. Transcripts were coded using qualitative thematic analysis. Participants told us that a significant aspect of Big Data research in public health is varying drivers of mistrust—of the research itself, research staff and funders, and broader concerns of mistrust within participant communities, particularly in the context of COVID-19 and those situated in more marginalised community settings. However, despite the challenges, participants also identified ways in which legally compliant and ethically informed approaches to research can be crafted to mitigate or overcome mistrust and establish greater confidence in Big Data public health research. Overall, our research indicates that a “Big Data Ethics by Design” approach to research in this area can help assure (1) that meaningful community and participant engagement is taking place and that extant challenges are addressed, and (2) that any new challenges or hitherto unknown unknowns can be rapidly and properly considered to ensure potential (but material) harms are identified and minimised where necessary. Our findings indicate such an approach, in turn, will help drive better scientific breakthroughs that translate into medical innovations and effective public health interventions, which benefit the publics studied, including those who are often marginalised in research. (shrink)

The second of two commentaries on “Respecting Donors to Biobank Research,” from the January‐February 2013 issue.

The American Journal of Bioethics, Volume 12, Issue 1, Page 13-15, January 2012.

Data access committees (DAC) gatekeep access to secured genomic and related health datasets yet are challenged to keep pace with the rising volume and complexity of data generation. Automated decision support (ADS) systems have been shown to support consistency, compliance, and coordination of data access review decisions. However, we lack understanding of how DAC members perceive the value add of ADS, if any, on the quality and effectiveness of their reviews. In this qualitative study, we report findings from 13 semi-structured (...) interviews with DAC members from around the world to identify relevant barriers and facilitators to implementing ADS for genomic data access management. Participants generally supported pilot studies that test ADS performance, for example in cataloging data types, verifying user credentials and tagging datasets for use terms. Concerns related to over-automation, lack of human oversight, low prioritization, and misalignment with institutional missions tempered enthusiasm for ADS among the DAC members we engaged. Tensions for change in institutional settings within which DACs operated was a powerful motivator for why DAC members considered the implementation of ADS into their access workflows, as well as perceptions of the relative advantage of ADS over the status quo. Future research is needed to build the evidence base around the comparative effectiveness and decisional outcomes of institutions that do/not use ADS into their workflows. (shrink)

BackgroundObtaining a research participant’s voluntary and informed consent is the bedrock of sound ethics practice. Greater inclusion of children in research has led to questions about how paediatric consent operates in practice to accord with current and emerging legal and socio-ethical issues, norms, and requirements.MethodsEmploying a qualitative thematic content analysis, we examined paediatric consent forms from major academic centres and public organisations across Canada dated from 2008–2011, which were purposively selected to reflect different types of research ethics boards, participants, and (...) studies. The studies included biobanking, longitudinal studies, and gene-environment studies. Our purpose was to explore the following six emerging issues: (1) whether the scope of parental consent allows for a child’s assent, dissent, or future consent; (2) whether the concepts of risk and benefit incorporate the child’s psychological and social perspective; (3) whether a child’s ability to withdraw is respected and to what extent withdrawal is permitted; (4) whether the return of research results includes individual results and/or incidental findings and the processes involved therein; (5) whether privacy and confidentiality concerns adequately address the child’s perspective and whether standard data and/or sample identifiability nomenclature is used; and (6) whether retention of and access to paediatric biological samples and associated medical data are addressed.ResultsThe review suggests gaps and variability in the consent forms with respect to addressing each of the six issues. Many forms did not discuss the possibility of returning research results, be they individual or general/aggregate results. Forms were also divided in terms of the scope of parental consent (specific versus broad), and none discussed a process for resolving disputes that can arise when either the parents or the child wishes to withdraw from the study.ConclusionsThe analysis provides valuable insight and evidence into how consent forms address current ethical issues. While we do not thoroughly explore the contexts and reasons behind consent form gaps and variability, we do advocate and formulate the development of best practices for drafting paediatric health research consent forms. This can greatly ameliorate current gaps and facilitate harmonised and yet contextualised approaches to paediatric health research ethics. (shrink)