Observational study of 353 applications to the London multicentre research ethics committee, 1997–2000

Summary

Objectives

To analyse applications to the London multicentre research ethics committee (MREC) for duration, efficiency and outcome of the ethical review process.

Design and setting

Retrospective review of applications for the period October 1997–November 2000, from discussion at first announced meeting to outcome.

Source data

Completed application forms, minutes of meetings, and correspondence between the MREC and researchers.

Results

Of 353 applications, 14 (4%) were approved, 217 (62%) were conditionally approved, 103 (29%) were deferred, and 19 (5%) were rejected at first meeting. All deferred and rejected applications were reconsidered at up to four other meetings and required more profound changes than conditionally approved applications. Most applications required changes to the patient information leaflet. A total of 330 (93%) applications were approved eventually. The estimated median time from first meeting to approval was 64 days (range 7–386).

Conclusions

The review process was facilitative, rigorous and often protracted. More care and effort in preparing applications, particularly the patient information leaflet, would improve the success rate. When the European Clinical Trials Directive (CTD) is implemented, the MREC will have to either shorten the approval time of some applications or reject more applications.