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

J R Coll Physicians Lond. 1999 Nov-Dec;33(6):549-52.

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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Ethics Committees* / organization & administration
  • Humans
  • Multicenter Studies as Topic*
  • Prospective Studies
  • Scotland