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It’s time to change how Europe regulates research

BMJ 2008; 337 doi: (Published 11 December 2008) Cite this as: BMJ 2008;337:a2986

This article has a correction. Please see:

  1. Fiona Godlee, editor, BMJ
  1. fgodlee{at}

    So were they right, the UK academics who six weeks ago wrote that regulation was “the real threat to research”? (BMJ 2008:337:a1732, doi:10.1136/bmj.a1732). If the BMJ’s rapid responses are a reliable guide, yes they were. This week’s letters pages host a selection of these responses, each vying with the next to show, in the words of surgical trainee David Samuel, “how prohibitive, laborious, and bureaucratic attempting to conduct research has become” (doi:10.1136/bmj.a2917). Can anyone beat my delays? asks Martyn Parker, whose randomised trial was eventually approved after a delay of over two and a half years (doi:10.1136/bmj.a2914). Further responses are welcome if anyone wants to try.

    It’s not only researchers who suffer the consequences, says patient representative Christine Gratus. “The pursuit of patient confidentiality, often by patient representatives, is almost obsessive and can be in no one’s interests, particularly patients,” she writes (doi:10.1136/bmja2915). Bonnie Sibbald from the NHS research network in Manchester reports idiocies that would be funny if they weren’t so costly in terms of researchers’ and administrators’ time (doi:10.1136/bmj.a2916). Richard Holt, a senior academic in Southampton, worries that young researchers are being put off research as a career (doi:10.1136/bmj.a2918). “My last three grants have taken more than a year from award to full approval,” he writes, “leading to the embarrassing situation of the first year’s annual report in which our achievements are listed as ‘ethics and R&D approval obtained.’”

    Hugh Davies from the UK’s National Research Ethics Service lists several initiatives that may or may not impress frustrated researchers and patients (doi:10.1136/bmj.a2920). The most substantial is the integrated research application system (IRAS), which when fully operational will be a one stop shop for applications to funders and regulatory bodies, including the Medicines and Healthcare Products Regulatory Agency. However, these bodies will need to raise their game if things are to improve substantially. At a gathering of UK research ethics committees last week, Iain Chalmers, one of the founders of the Cochrane Collaboration, said (not for the first time) that ethics committees and other regulators had failed patients on a massive scale by acquiescing in unnecessary research, obstructing necessary research, failing to require public registration of clinical trials, and not pressing for full publication of research results.

    The EU Clinical Trials Directive must take some blame. Set up in 2004 to improve the quality and safety of trials and to harmonise and simplify application processes across Europe, it has been heavily criticised by industry and academics alike. In their letter, Cascorbi and colleagues report that, although long delays are mainly a UK phenomenon, approval times are generally longer in countries that follow the directive than in those that don’t.

    The European Commission is listening, writes BMJ deputy editor Trish Groves in her blog from a meeting in Brussels earlier this month ( One proposal is to simplify the directive and make it mandatory. As a first step, regulators have agreed to pilot a single Europe-wide application process. But things will need to move fast. While we dally, careers are being blighted, patients’ lives are being wasted, and important research that could be done in the UK and Europe is moving elsewhere.


    Cite this as: BMJ 2008;337:a2986