Published 10 December 2008, doi:10.1136/bmj.a2914
Cite this as: BMJ 2008;337:a2914

Letters

Regulation’s threat to research

Can anyone beat my delays?

The first 100% of the full text of this article appears below.

Stewart and colleagues report their problems in applying for research approval.¹ I easily trump their delay of one year.

For a randomised trial of general versus regional anaesthesia for hip fracture surgery, we first sought the approval of the Medicines and Healthcare products Regulatory Agency (MHRA). We applied in November 2004, and in October 2005 received a reply stating that MHRA approval was not necessary. Ethics approval was sought in October 2005 and granted in February 2007. The research and development application was made in February 2007 and approved in June 2007. The study started in June 2007. Total time for regulatory approval two years eight months.

Cite this as: BMJ 2008;337:a2914

¹ Orthopaedic Department, Peterborough District Hospital, Peterborough PE3 6DA

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Competing interests: None declared.

1. Stewart PM, Stears A, Tomlinson JW, Brown MJ. Regulation—the real threat to clinical research. BMJ 2008;337:a1732. (16 October.)[Free Full Text]

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