Abstract
The delivery of good outcomes from human health research is entirely dependent on the proper functioning of the attendant regulatory systems. This article focuses on the processes of regulation themselves, and how these might be better understood, so that regulators and other stakeholders have a strong normative basis upon which to pursue the regulatory objective of achieving outcomes with maximum social value. The argument is made that the concept of ‘processual regulation’—which promotes a whole systems approach to regulation—can assist greatly in the design, implementation, and review of human health research. This moves beyond the current often-fragmented approach to regulation towards a joined-up, reflective, and responsive system that has fitness-for-purpose at its core.
Highlights
Health research has the objective of improving human health by understanding and improving current diagnostics and treatments or developing new ones (Institute of Medicine, 2009)
The argument is made that the concept of ‘processual regulation’—which supports and promotes a whole systems approach to regulation—can assist greatly in the design, implementation, and review of human health research
That some of what is being re-imagined has inevitable economic and transactional costs, e.g. what would regulatory stewardship involve, who would carry this out, and who would fund it? More fundamentally, it is important to appreciate that what is being advocated is a way to look at current systems with fresh eyes: (i) we need not see the roles of consent and anonymisation in an atomistic fashion; (ii) we can promote and support debates about what counts as social value without huge expense, and (iii) training of regulators, researchers, and members of ethics bodies can be re-oriented in light of system-wide learning (Sykes, 2021; Charlebois and Labrecque, 2007)
Summary
Health research has the objective of improving human health by understanding and improving current diagnostics and treatments or developing new ones (Institute of Medicine, 2009). Multiple instances of social value can drive processual regulation as part of a WSA (Ganguli-Mitra et al, 2017) These include (i) pursuit of the ongoing trust and input of research participants, (ii) demonstration to researchers that the regulatory system will support and respond to their needs, (iii) creation of ‘safe spaces’ to capture learning moments when mistakes or missteps do arise and which can be folded back into the ecosystem through feedback loops, and (iv) recognition that social value can arise even if the science does not achieve its intended purpose. It is important to appreciate that what is being advocated is a way to look at current systems with fresh eyes: (i) we need not see the roles of consent and anonymisation in an atomistic fashion; (ii) we can promote and support debates about what counts as social value without huge expense, and (iii) training of regulators, researchers, and members of ethics bodies can be re-oriented in light of system-wide learning (Sykes, 2021; Charlebois and Labrecque, 2007). A processual approach to regulation can embrace a wide array of human practices that make up health research and move towards a means to coproduce regulation without first determining what the outcome might be
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