Charting Regulatory Stewardship in Health Research: Making the Invisible Visible

Laurie, Graeme; Ganguli‐Mitra, Agomoni; Fletcher, Isabel; McMillan, Catriona; Sethi, Nayha; Sorbie, Annie

doi:10.1017/s0963180117000664

Cited by 27 publications

(17 citation statements)

References 13 publications

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“…Whilst having a proportionate outlook' (27, clinician). This has resonance with our own argument for an increased role for regulatory stewardship to help guide researchers through regulatory landscapes [19]. Others called for 'networked governance' whereby, among other things, '…regulatory agencies in health (broadly understood) would need to engage more with academics and charities, and to look to utilise a broader range of expertise in designing and implementing governance strategies and mechanisms' (5, researcher).…”

Section: Proportionalitymentioning

confidence: 99%

Co-production and Managing Uncertainty in Health Research Regulation: A Delphi Study

et al. 2019

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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 coproduce 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.

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Section: Proportionalitymentioning

confidence: 99%

Co-production and Managing Uncertainty in Health Research Regulation: A Delphi Study

et al. 2019

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“…It is argued that best practice remains invaluable nonetheless in a wide-array of settings where pre-established best practice does exist, but where it has not yet been captured alongside guidelines. Further, there is an important role to be played by third party actors in supporting researchers ( Laurie et al , 2018 ), which, it is argued here, also includes a responsibility to identify possible instances of best practice across a range of settings, even perhaps where connections across different contexts may not be immediately apparent. Indeed, the GHE context gives rise to numerous opportunities for sharing best practice as cooperation between different actors becomes more prolific, particularly by virtue of the number of collaborative frameworks and networks which appear to be increasing.…”

Section: Best Practice: Learning From the Ground Up?mentioning

confidence: 99%

Research and Global Health Emergencies: On the Essential Role of Best Practice

Sethi

2018

Public Health Ethics

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This article addresses an important, overlooked regulatory challenge during global health emergencies (GHEs). It provides novel insights into how, and why, best practice can support decision makers in interpreting and implementing key guidance on conducting research during GHEs. The ability to conduct research before, during and after such events is crucial. The recent West-African Ebola outbreaks and the Zika virus have highlighted considerable room for improvement in meeting the imperative to research and rapidly develop effective therapies. A means of effectively capturing these experiences and folding them into future decision-making is lacking; the need for effective practical translational measures remains. The challenge for the research community lies in extracting meaningful action-guiding content from pre-existing guidelines—which draw upon practical examples of guidelines ‘in action’—that assist in determining how to act in a particular (future) situation. Insights are provided into the role of best practice as a means to do so; such examples can provide invaluable support to decision makers in interpreting high-level guidance; overarching guidelines retain their necessary level of generality and flexibility, whilst corresponding best practice examples—which incorporate important lessons learned—illustrate how such guidelines can be interpreted at a practical level.

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“…Ethics+ involves a range of actors and stakeholders, and perhaps most importantly, it requires engagement of those actors in the deliberative and reflective processes -mere compliance is no longer king; 5. Ethics+ probably requires stewardship of these processes, that is, trained actors who can support and facilitate the deliberative and reflective processes (for a fuller argument on the importance of regulatory stewardship, see: Laurie et al 2017).…”

Section: )mentioning

confidence: 99%

What Does It Mean to Take an Ethics+ Approach to Global Biobank Governance?

Laurie

2017

ABR

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This article reexamines and fundamentally reassesses the symbiotic relationship between law and ethics in the governance and regulation of biobanks as a global phenomenon. Set against the two decades of experience of setup , management, and most recently granting access to biobanks to promote advances in human health, it is argued that the boundaries-and so the legitimacy-of the respective roles of ethics and law have become blurred and, potentially, blunted. The caricature of law as a tool of command and control-resulting in compliance culture-is well-recognised in regulation studies, but parallels with this can now also be seen within certain ethical regimes pertaining to biobanks, and human health research more generally. At the same time, the ethical content of certain legal responses to biobanks can be lacking, as some legal systems seek to regulate biobanking in inflexible and unreflective ways that potentially undermine the entire enterprise. This can result in a net failure to capture adequately particular features of biobanking that make this field so potentially rich in terms of ultimate social value and human benefit. The argument is made that the interconnected, yet distinct, nature of the contributions of law and ethics must be better understood in this setting. The central message is unapologetically sceptical about the role of law in regulating biobanking, except when we see law as process. Rather, the position is advanced that more work is required to develop governance regimes that are "Ethics+", that is, rooted in the core values and principles at stake while able to adapt and accommodate the inevitable changing landscape of biobank research and practice. While ethics are always a necessary component of a robust and defensible regimes of health research, the notion of Ethics+ directs our attention to processes in which ethical discourse and engagement can be optimised to respond to particular features of biobanks and their operation.

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Charting Regulatory Stewardship in Health Research: Making the Invisible Visible

Abstract: This section focuses on the ethical, legal, social, and policy questions arising from research involving human and animal subjects.

Cited by 27 publications

References 13 publications

Co-production and Managing Uncertainty in Health Research Regulation: A Delphi Study

Co-production and Managing Uncertainty in Health Research Regulation: A Delphi Study

Research and Global Health Emergencies: On the Essential Role of Best Practice

What Does It Mean to Take an Ethics+ Approach to Global Biobank Governance?

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