Variations in experience in obtaining local ethical approval for participation in a multi-centre study.
BACKGROUND
The Department of Health recently issued guidance on how Local Research Ethics Committees (LRECs) should handle an Multi-centre Research Ethics Committee (MREC)-approved application. This process is intended as a rapid standardized approval process, facilitating the execution of clinical trials.


OBJECTIVE
To evaluate if this guidance had led to an efficient process for obtaining local ethical approval.


METHODS
Questionnaires were sent by post to Local Investigators of the 56 centres who had obtained LREC approval for the Multi-centre Intrapleural Streptokinase Trial.


RESULTS
Replies were received from 51 centres (91%). A total of 25 296 pieces of paper and 62 h of photocopying time were required to meet the 51 LRECs' requirements. LREC meetings ranged from weekly to bimonthly, with only 24 (47%) having a 'fast track' system in place. Applications took a median of 27 (1-90) days from submission to first being considered, with local investigators spending 3.27 (0.5-15) h on each submission. Nineteen (37%) of the local investigators felt the LREC/MREC interface did not work well and 17 (33%) were at least partly deterred from participating in future trials.


CONCLUSIONS
The guidelines do not seem to have been implemented by all LREC committees, leading to wide variation in local experience.
Maskell
N A
NA
Oxford Centre for Respiratory Medicine, Churchill Hospital, John Radcliffe NHS Trust, Headington, Oxford, UK. nickmaskell@doctors.org.uk
Jones
E L
EL
Davies
R J O
RJ
D026724:Ethical Review / Q000592:standards*; D028744:Ethics Committees, Research; D032984:Ethics, Research; D006801:Humans; D015337:Multicenter Studies as Topic / Q000941:ethics*; D017410:Practice Guidelines as Topic; D006113:United Kingdom