Background: Research Ethics Committees (RECs) or their equivalent review applications for prospective research with human participants. Reviewers use universally agreed principles i to make decisions about whether prospective health and social care research is ethical. Close attention to understanding how reviewers go about their decision-making work and consider principles in practice is limited. Objective: The study aimed to understand how reviewers made decisions in the contexts of meetings and to understand more about how reviewers approach their work. The purpose of (...) this article is to draw on data and findings and to show how reflective equilibrium as a theoretical frame can (1) deepen understanding of ethics review and (2) permit a reflexive examination of the habitual processes of review. Design and participants: Methods captured the day-to-day work of the RECs. Seventeen applications were heard during eight observations. There were 12 formal interviews with reviewers (n = 12) and with researchers (n = 8) which are not reported on in this article. Ethical considerations: Organisational permission for the study was given by the National Research Ethics Service (NRES) whose functions became part of the Health Research Authority (HRA) during the study. The study was given favourable opinion by the University of Salford's REC (Reference HSCR11/17). Findings: Data were analysed using constructed grounded theory resulting in eight themes which revealed attention to procedure and engagement with applications. Reflective equilibrium was used as a qualitative frame to interpret themes distilling them into three processes at work in review: emotion and intuition; imagination and creative thinking; and intuition and trust. Discussion: Reviewers went back and forth between universal principles and considered these in the contexts of each application using the above processes. Conclusions: Reflective equilibrium offers a coherent and grounded account of review work. Reflexivity in training for reviewers is essential for improving practices. The challenges reflexivity presents can be assisted by using reflective equilibrium as a tool to illuminate tacit review processes. (shrink)

This article argues in general support of the sIRB rule, but also draws on recent empirical research to highlight several residual weaknesses in the US regulatory structure for research ethics review, and suggests ways in which these weaknesses might be addressed in future regulatory reforms to improve upon the sIRB rule.