Ethical review of a multicentre study in Scotland: a weighty problem

Citation
R. Al-shahi et Cp. Warlow, Ethical review of a multicentre study in Scotland: a weighty problem, J ROY COL P, 33(6), 1999, pp. 549-552
Citations number
19
Categorie Soggetti
General & Internal Medicine
Journal title
JOURNAL OF THE ROYAL COLLEGE OF PHYSICIANS OF LONDON
ISSN journal
00358819 → ACNP
Volume
33
Issue
6
Year of publication
1999
Pages
549 - 552
Database
ISI
SICI code
0035-8819(199911/12)33:6<549:EROAMS>2.0.ZU;2-6
Abstract
Objective: To assess the current working practices of local research ethics committees (LRECs) in their review of a multicentre study approved by the new multicentre research ethics committee in Scotland. Design: Observational data collected from correspondence with LRECs. Subjects: All LRECs within the geographical area of the study in Scotland. Interventions: None. Outcome measures: Delay from application to calling an LREC meeting, to an initial LREC decision, to final LREC approval, and the number of A4 pages r equired. Results: The median delay to review of an application at an LREC meeting wa s 28 days (range 14-97), the median delay from application to the time of L REC final approval was 39 days (range 21-109) and a total of 5,789 A4 pages (26.9 kg) were required to complete the application process. Conclusions: Despite recent standardisation of ethical review of multicentr e research, elimination of unnecessary delay, cost and variation in LREC op erating procedures is still necessary.