N A Maskell1, E L Jones, R J O Davies. 1. Oxford Centre for Respiratory Medicine, Churchill Hospital, John Radcliffe NHS Trust, Headington, Oxford, UK. nickmaskell@doctors.org.uk
Abstract
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. AIM: 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. DISCUSSION: The guidelines do not seem to have been implemented by all LREC committees, leading to wide variation in local experience.
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. AIM: 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. DISCUSSION: The guidelines do not seem to have been implemented by all LREC committees, leading to wide variation in local experience.