The ethical review process should both protect participants and facilitate good quality research. We are constantly working to improve our service to better meet these aims.
One of our main programmes for improvement is our strategic implementation plan ‘Building on Improvement’. It is linked to the Department of Health five-year strategy, Best Research for Best Health, published in 2006.
‘Building on Improvement’ resulted from the work of an ad hoc advisory group, set up by Lord Warner in November 2004. The group was asked to report on the operation of NHS Research Ethics Committees (RECs) and on the interface with other research approval processes, and to report by April 2005. We then consulted on the report with our stakeholders.
We then wrote ‘Building on Improvement’ as a plan to deliver the ideas set out in the report.
Two of the areas identified in the report have undergone pilot screening studies: early provision of advice and proportionate review (previously known as 'fast track' review).
Proportionate Review has now been rolled-out at six REC Centres in England and also in Scotland and Wales.
Screening pilots for these took place between April 2007 and March 2008, where we carried out a review of applications made to RECs and of the general enquiries that we received.
Early provision of advice
This screening pilot aimed to provide guidance to researchers before their study went to the REC. It included identifying:
studies submitted inappropriately (that is, outside our remit);
studies for which RECs may require further expert review; or
any further ethical questions or advice requested.
Research applicants would be advised of the areas where the submission could be improved prior to the REC considering the application. This would allow them to address the issues and reshape their application. Importantly, the REC would then make an independent decision on the application.
Further work is being undertaken to determine how early provision of advice should be incorporated into the NRES Standard Operating Procedures (SOPs). It is planned to introduce the process into the SOPs in 2010. In the meantime, the results of the pilot have been disseminated to RECs in order to promote dialogue between researchers and to facilitate ethical research.