R al-Shahi1, C P Warlow. 1. Department of Clinical Neurosciences, Western General Hospital, Edinburgh.
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 required. RESULTS: The median delay to review of an application at an LREC meeting was 28 days (range 14-97), the median delay from application to the time of LREC 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 multicentre research, elimination of unnecessary delay, cost and variation in LREC operating procedures is still necessary.
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 required. RESULTS: The median delay to review of an application at an LREC meeting was 28 days (range 14-97), the median delay from application to the time of LREC 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 multicentre research, elimination of unnecessary delay, cost and variation in LREC operating procedures is still necessary.
Keywords:
Bioethics and Professional Ethics; Biomedical and Behavioral Research; Empirical Approach