United Kingdom research governance strategy

BMJ 2004; 328 doi: http://dx.doi.org/10.1136/bmj.328.7430.50 (Published 01 January 2004) Cite this as: BMJ 2004;328:50

Authors' reply

  1. Susan Kerrison, assistant director, research governance,
  2. Nick McNally, assistant director, research and development (nick.mcnally{at}uclh.org),
  3. Allyson M Pollock, director, research and development
  1. University College London Hospitals NHS Trust, London NW1 2LT

    EDITOR—Sullivan is correct that partnerships with industry such as the new networks will need careful scrutiny. Subsequent to the influential Baker report in 1999,1 every government report on research and development and higher education has emphasised the role of industry in NHS research, the most recent being the Bioscience Innovation and Growth Team's report.2

    New networks and other bodies have been created to “form a platform to bring in other players from industry and the science base on a collaborative basis to maximise opportunities for innovation and research.”3 For example, the National Cancer Research Institute, established to take a strategic oversight of cancer research in the United Kingdom, also has industry represented on its board. The overall policy goals of the institute—namely, the drive to increase subject recruitment to clinical trials and to translate new products more quickly to trials—are consistent across the Pharmaceutical Industry Competitiveness Taskforce, National Cancer Research Network, and National Translational Cancer Research Network. Others have noted that these increased collaborative relationships with industry will alter the strategic direction of research.4 5 Like Sullivan, we too have concerns over the current organisational change in the NHS.

    In our second paper we show how the Department of Health's draft research governance strategy is a response to increasing legislation, such as the Data Protection Act, Human Rights Act, Human Tissue Bill, and EU Clinical Trials Directive. Studies falling under these regulations must be conducted according to the rules laid down by the regulator, not to the investigators' own rules. By April 2004 our trust will have to have in place framework agreements with over 200 organisations with which it has collaborative research relationships.

    Irrespective of whether it is the government's intent to formalise research, implementation of the research governance framework will have the effect of transferring the control of research from individual clinical researchers to institutions.


    • Competing interests None declared.


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