Since 1 March 2004 anyone who wishes to set up clinical trials in the United Kingdom has to go through an extensive application process to gain ethical approval. The Central Office for Research Ethics Committees (COREC) was set up by the government both to standardise and centralise the process and to address concerns regarding patient care, safety and confidentiality. We are encouraged to complete this online (http://www.corec.org.uk/). Here awaits a 60-page form, which although not all its pages are applicable, is time-consuming. There is also a research and development (RD) form (http://www.rdform.org.uk/) to complete, which deals with cost issues and a Caldicott form dealing with patient confidentiality. On top of all that there may be other local forms to complete. There is already evidence that applications to local research ethics committees are down by around 40% in the years 2003–2004.
Heterogeneity of Human Research Ethics Committees and Research Governance Offices across Australia: An observational study
