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

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

Author information

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.

PMID:
10633333
[Indexed for MEDLINE]

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