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Research Governance by NHS Bodies from April 2004

  • Last modified date:
    8 February 2007

This note provides an update for the NHS on research governance: Regulations were published on 1 April to transpose Directive 2001/20/EC on clinical trials of medicines into UK law; A controls assurance statement (see CE Bulletin 11 March 2004) replaces reporting on local implementation plans.

New Regulations on clinical trials with medicines

See the link to the Medicines and Healthcare products Regulatory Agency's website for the Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031).  The MHRA are issuing guidance on procedures and on the interpretation of the Regulations and the EU Clinical Trials Directive.  A Medical Research Council / Department of Health Joint Project is working on identifying and documenting current best practice in the areas to be regulated and to provide advice on systems and approaches based on best practice that will comply with the law.

Sponsorship implementation

The Research Governance Implementation Plan (DH 2001) included a target that no research with human participants, their organs, tissue or data, may begin or continue in the NHS until a research sponsor has confirmed it accepts responsibility; the target date was April 2004.  The Directive comes into force on 1 May 2004.  Because of the delay in finalising the Regulations, and the practicality of making immediate agreements about sponsorship between organisations and investigators now that the legal requirements are clear, there may be some concern about existing research projects.

DH does not wish to see projects concluded prematurely where there is a good prospect for early arrangements to cover the sponsor's role.  Premature closure of research without due cause can be considered to run counter to ethical principles.  It would subject participants to investigations which do not contribute to an advancement of knowledge.  A pragmatic approach to considering ongoing research was set out in an annex to the guidance on local implementation plans for research governance, and this remains relevant.

Sponsors list

A list of sponsors was instituted to support research governance implementation in the NHS in England, and this was maintained on the DH website.  With the expected implementation of Directive 2001/20/EC, organisations on the list were given the opportunity to reconsider their position in the light of the Directive's requirements.

The list of sponsors will now be reconstituted.  If they have not already done so, NHS organisations are invited to confirm whether or not they are willing and able to take on the role of sponsor.  In declaring that they can be sponsors, it would be helpful if they can indicate whether there are any limitations on the type of research they would sponsor (eg clinical trials of medicines).  Declarations may be sent to Mr Marc Taylor, Head of Research Policy and Governance, Department of Health, Quarry House, Quarry Hill, Leeds LS2 7UE (email Marc.Taylor@doh.gsi.gov.uk).  This declaration says that an organisation has systems allowing it to consider, case by case, whether to sponsor individual studies.

Research Governance Framework revision

The draft second edition of the Research Governance Framework for Health and Social Care remains available for information on the DH website.  This will be revised to ensure consistency with the new clinical trials Regulations with a view to publication as soon as possible after 1 May, and there will be consequential changes to other guidance notes.

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