BMJ 2000;320:1182-1183 ( 29 April )

Papers

Responses of local research ethics committees to a study with approval from a multicentre research ethics committee

Editorial by Alberti, pp   1179 , 1217

Andrew L Lux, clinical research fellow Stuart W Edwards, research coordinator John P Osborne, professor of paediatrics and child health

Children's Centre, Royal United Hospital, Combe Park, Bath BA1 3NG

Correspondence to: A L Lux andrew.lux@ruh-bath.swest.nhs.uk

The first 150 words of the full text of this article appear below.

Studies approved by multicentre research ethics committees in the United Kingdom are submitted to a local research ethics committee in each health district. Guidelines on handling such submissions were issued in September 1998.1 The United Kingdom infantile spasm study was approved that same month: as members of the steering committee we attempted to assess the impact of the guidelines on the practice of local research ethics committees.

    Participants, methods, and results

We made 113 submissions on behalf of local investigators to 99 local research ethics committees between September 1998 and September 1999. We analysed the committees' responses to the first submission. A committee was classified as "fast track" if the administrator stated that the submission would be reviewed by an executive subcommittee, as recommended by the guidelines. Our main outcome measure was response time, defined as the number of days between arrival of the submission and the date on which written confirmation of the committee's decision was typed. . . . [Full text of this article]


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