Ethics review of research: in pursuit of proportionality
- 1Centre for Philosphy, Justice and Health, University College London, London, UK
- 2Department of Statistical Science, University College London, London, UK
- Dr S J Edwards, University College London First Floor Maple House, Rosenheim Wing, Ground Floor, 25 Grafton Way London WC1E 5DB, UK;
- Received 23 July 2007
- Revised 27 September 2007
- Accepted 9 October 2007
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.
↵i This piece of legislation was influenced by international guidelines adopted by some US, European and Japanese Pharmaceutical Industries and regulatory authorities. International Conference on Harmonisation of Good Clinical Practice. General Considerations for Clinical Trials. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Tripartite Guideline, 1997. Available at http://www.ifpma.org.
↵ii NHS Research & Development form the difference between research, audit and service evaluation.
Funding: The authors are funded by the UCL/UCLH Comprehensive Biomedical Research Centre, UK Department of Health.
Competing interests: None.