Reconciling fragmented sectors of health research regulation: toward an ecosystem of processual regulation

Abstract The delivery of good outcomes from human health research is entirely dependent on the proper functioning attendant regulatory systems. This article focuses processes regulation themselves, and how these might be better understood, so that regulators other stakeholders have a strong normative basis upon which to pursue objective achieving with maximum social value. argument made concept ‘processual regulation’—which promotes whole systems approach regulation—can assist greatly in design, implementation, review research. moves beyond current often-fragmented towards joined-up, reflective, responsive system has fitness-for-purpose at its core.