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.
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.
Competing interests: None declared.
Read the full text or download the PDF:
Other content recommended for you
- Determining the need for ethical review: a three-stage Delphi study
- Reporting of ethical requirements in phase III surgical trials
- Research ethics committees in Europe: implementing the directive, respecting diversity
- Research made simple: ethics committee approval
- Lest we forget… research ethics in children: perhaps onerous, yet absolutely necessary
- Should research ethics committees be told how to think?
- Do we really know how many clinical trials are conducted ethically? Why research ethics committee review practices need to be strengthened and initial steps we could take to strengthen them
- Reforming research ethics committees
- Non-commercial clinical trials of a medicinal product: can they survive the current process of research approvals in the UK?
- Another threat to research in the United Kingdom