Abstract
In the May 2009 edition of JRSM your headline article was ‘Research governance delays for a non-interventional study’ a sentiment which many researchers may share. 1 The authors put the reasons for delay clearly in the arms of research and development departments (RDD) where significant variation in processes leads to variation in delay. While we do not defend the over-bureaucratic system for research approval in the UK our findings suggest that the reason for delay must be shared among those involved in the study. In 2006 we published an article which examined the delays in a similar multicentre observational study which involved 178 sites across the UK, of which 159 were hospital trusts. 2 We examined the reason for delay at all sites taking more than 60 days for approval (i.e. more than the legally specified time currently required for ethics committee review). 3 We found that the mean approval time was 82 days with a range of 0–259 days, thus supporting the wide variation identified by Mallick and O’Callaghan. In our analysis more than half the hospital sites took longer than 60 days (n=86, mean 126 days) to obtain local approval. We examined the source of the delay and found that of those cases taking more than 60 days, 25 (29%) were delayed at the RDD while 22 (26%) were delayed while awaiting investigators to respond to queries and 11 (13%) delayed at the trust level awaiting sign off. The remaining 28 had mixed reasons for delay beyond 60 days.
We therefore support the call for an improved approval system but would suggest that all parties involved in the approval process must be prepared to support change and act in a timely manner.
Footnotes