Ethics and research governance in a multicentre study: add 150 days to your study protocol

doi:10.1136/bmj.330.7495.847

BMJ 2005;330:847 (9 April), doi:10.1136/bmj.330.7495.847

Letter

Ethics and research governance in a multicentre study: add 150 days to your study protocol

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

EDITOR—Concern is growing that health service researchwill be impeded by "research governance" procedures, in additionto the difficulties of gaining ethical approval.^1-3 We describethe problems experienced by an evaluation study team (fundedby the Service Delivery and Organisation Research Programme)that wanted to assess the impact of modernising endoscopy servicesin 20 NHS Trusts in England. Ethical approval was given by amulticentre research ethics committee in 47 working days. Achievingresearch governance approval was more difficult.

The study used postal surveys of patients to assess the impactof endoscopy service innovations on waiting times and otheroutcomes, using validated quality of life, patient satisfactioninstruments, and health economic data. A qualitative componentused interviews with clinicians, change agents, and patients.No experimental intervention was undertaken.

The range of familiarity with research governance "approval"procedures in NHS trusts was wide, from full awareness to totalignorance, . . . [Full text of this article]

Glyn Elwyn, professor

glyn.elwyn@btinternet.com, University of Wales, Swansea SA2 8PP

Anne Seagrove, researcher, Kym Thorne, researcher, Wai Yee Cheung, senior lecturer

University of Wales, Swansea SA2 8PP

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