Letter: Ethics and research governance in a multicentre study: add 150 days to your study protocol BMJ Volume 330 p 847
Approval procedures for UK research will "accelerate the migration of clinical studies to other parts of the world," warn researchers in a letter to this week's BMJ.
They describe the problems experienced by a research team that wanted to assess the impact of modernising endoscopy services in 20 NHS trusts in England.
Substantial variation occurred in the application procedures. Some trusts gave approval authority to one person while others relied on research and development committees, which typically sat monthly, resulting in delays. Documentation was "lost" in two trusts.
Obtaining research governance approval for all 20 trusts required 103 days. With the addition of the 47 days taken to obtain ethical approval, this resulted in a total delay of 150 days.
Research studies requiring multiple NHS sites should build in substantial lag times before research processes can be initiated, say the authors.
"We anticipate that failure to address this new obstacle to health service research will block evaluation work and accelerate the migration of clinical studies to other parts of the world," they conclude.
Source: Eurekalert & othersLast reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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