Status of healthcare studies submitted to UK research ethics committees for approval in 2004-5.

BACKGROUND

In view of the increasing complexity of research ethics committee (REC) applications and thus the time and expense involved in completing the forms, continual monitoring of outcome of clinical research studies for which ethics applications have been submitted is essential in determining whether resources are being effectively used, or alternatively whether significant numbers of research proposals are abandoned because of lack of funding or manpower. Previously published surveys for which data are available examined outcome of studies receiving REC approval 10 or more years ago.

METHODS

A prospective questionnaire-based survey sent out in July 2006 to all 506 principal investigators who submitted research ethics applications to nine Greater Manchester RECs between April 2004 and March 2005. Data on the outcome of REC applications, and the status of the research study were collected and analysed.

RESULTS

288 of the 506 (57%) questionnaires were returned. 97% of REC applications were approved, and 87% of studies were in progress or had been completed 1-2 years after approval had been granted. Researchers employed by universities (51%), healthcare (43%) and the pharmaceutical industry (6%) had similar rates of success in initiating research studies.

CONCLUSIONS

This survey suggests that most research studies submitted to RECs in Manchester, UK are approved and initiated.