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Regulatory burden in research

Psychopharmacology Unit, Bristol Royal Infirmary, Bristol BS2 8HW, email: Lindsey.sinclair{at}bristol.org.uk

I would like to highlight difficulties we have experienced, in the hope that this will help others. We are taking part in a multicentre study which was approved by the multicentre research ethics committee in August 2005. In Bristol we are studying patients attending hospital clinics and a group from primary care.

Both site-specific assessments and R&D approval resulted in months of delays. Advice that we could not quote the primary care trust as a site (i.e. we needed to list surgeries that had agreed to take part) later turned out to be wrong. It was also unclear from guidance from the Central Office for Research Ethics Committees (COREC) that site-specific applications are not considered by the main ethics committee, but by subcommittees which meet more frequently.

Both R&D departments involved advised that an honorary contract was required prior to any patient contact, in addition to my NHS contract with the local mental health trust. An honorary contract with one was not acceptable to the other, in contravention of Department of Health guidance: ‘where a researcher works across many NHS organisations they should not have to obtain multiple contracts’ (http://www.bartsandthelondon.org.uk/research/honorary_contracts.asp). Both departments required separate Criminal Records Bureau checks and occupational health clearance, causing significant delays.

As an aspiring young academic psychiatrist this has been a discouraging start to my research career. There has been much debate about the regulatory and bureaucratic burden in research and the need to find a balance with safety so that research in the UK is not stifled. Sadly this does not seem to have been put into practice yet.

This Article Full Text (PDF) Submit an eLetter Alert me when this article is cited Alert me when eLetters are posted Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Sinclair, L. Search for Related Content PubMed Articles by Sinclair, L.