Conceptual framework—setting the scene for ‘protection’ and ‘promotion’

Abstract

Human health research, which can be defined as research into matters relating to people’s physical or mental health, is a formalized, institutionalized, and regulated activity, replete with actors, rules, tools, policies, and diffuse sets of social constraints. Researchers who wish to gather data, investigate questions, test hypotheses, and build new generalizable knowledge on topics that involve human participants confront at the earliest stages of their project design the application of abstract ethical principles such as respect for persons, social value, beneficence, and justice, not to mention rules regarding informed consent and confidentiality. Additionally, researchers confront a panoply of law and regulation. When it comes to health research involving humans, determination of its ethical acceptability has taken a particularly regulated, technocratic, and structured form, with specific groups of individuals wielding power to decide whether a research project may proceed on ethical grounds. This group is known as a research ethics committee (REC), which is also known as an institutional review board (IRB) and research ethics board (REB). This book will explore the mandate and operation of one particular type of REC in the UK, the NHS REC, drawing on both governance instruments and policies and original empirical research. This chapter begins the process by querying whether the practices of these RECs align with their recently established regulatory mandate—as set out in instruments promulgated by the UK government, devolved administrations, and regulatory bodies—which has modified the regulatory environment involving human health research. In particular, it explores a shift from a protectionist model that has been seen by some as paternalistic, with regulators disproportionately focusing on research risks in comparison to research benefits and inexplicably road-blocking otherwise ethical research, to a more broadly facilitative model, undergirded by law, that