title: Ethics review of research: in pursuit of proportionality.
abstract: The ethics review system of research is now well-established, at least in the developed world, although there are many differences in how countries view it and go about managing it. The UK specifically is now seeking to revise its system by speeding up the process of ethics approval but only for some studies. It is proposed that only those studies which pose "no material ethical issues" should be "fast-tracked". However, it is unclear what this means, who should decide and what should be included in this category. In this paper, we go some way towards answering these questions. While we are certain that the debate is only just beginning, we are equally certain that it will continue to run long after the system has been reformed. To stimulate this conversation and to inform a pilot project of the new system directly, we review two candidates to help give some substance to the notion of "material" ethical issues. Firstly, material could mean a certain type or degree of risk. Second, material could mean how physically invasive the research is. We conclude that there is still much work to be done on making the system of governing health and social care consistent and practicable.
authors.affiliation: University College London First Floor Maple House, Rosenheim Wing, Ground Floor, 25 Grafton Way, London WC1E5DB, UK. sarah.edwards1@uclh.org
authors.forename: S J L
authors.initials: SJ
authors.lastname: Edwards
authors.forename: R
authors.initials: R
authors.lastname: Omar
mesh_terms: D026724:Ethical Review / Q000592:standards*; D028744:Ethics Committees, Research / Q000639:trends; D006291:Health Policy; D006302:Health Services Research / Q000941:ethics*; D006801:Humans; D008485:Medical Audit / Q000592:standards*; D010865:Pilot Projects; D011320:Primary Health Care / Q000941:ethics*; D015397:Program Evaluation; D006113:United Kingdom