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.