Jump to comment:

• Lay REC members: patient and public
  Joan Kirkbride
  Published on: 29 July 2013

• Published on: 29 July 2013

  Lay REC members: patient and public

  • Joan Kirkbride, Director of Operations
  • Other Contributors:
    • Professor Andrew George (NREAP Chair)

  The Health Research Authority (HRA) is fully supportive of, and strongly encourages, the involvement of patients and the public as active partners in all aspects of the research process. Such involvement produces high quality ethical research consistent with the HRA's mission to 'protect and promote the interests of patients and the public in health research'. The HRA will shortly launch a three-month consultation on its...

  Show More

  The Health Research Authority (HRA) is fully supportive of, and strongly encourages, the involvement of patients and the public as active partners in all aspects of the research process. Such involvement produces high quality ethical research consistent with the HRA's mission to 'protect and promote the interests of patients and the public in health research'. The HRA will shortly launch a three-month consultation on its public involvement strategy which sets out our proposed approach for involving patients and the public in our work, and how we can support and enable the research community to involve patients and the public more in their work.

  The HRA agrees that patient involvement (PI) offers real benefits as described in this article. However, it does take issue with the author's central thesis that the role of lay members on research ethics committees (RECs) is to be understood as primarily providing a "patient perspective" involving "checking the accessibility of written materials" and ensuring that researchers produce "a summary for a lay audience". The HRA is proud of, and is grateful to all its volunteer REC members who give up their valuable time to review health research in the NHS in order to ensure that the rights, safety, dignity and well-being of research participants are protected. Whilst checking written materials and lay summaries are important aspects of that review we do not recognise this somewhat narrow conception of the lay member's contribution put forward in this article.

  Staley correctly states that NRES (a Directorate of the HRA) identifies one aspect of the lay contribution as "taking a balanced view of the likely harms and benefits of a research project by bringing a lay perspective..." but neglects to point out that the Department of Health's 'Governance arrangements for research ethics committees - A harmonised edition' (updated April 2012), states that:

  "4.2.2 RECs are expected to reflect current ethical norms in society as well as their own ethical judgement. REC members may come from groups associated with particular interests but they are not representatives of those groups. REC members are appointed in their own right to participate in the work of a REC as equal individuals of sound judgement, relevant experience and adequate training in research ethics and REC review. 4.2.3 A REC should contain a mixture of people who reflect the currency of public opinion ('lay' members), as well as people who have relevant formal qualifications or professional experience that can help the REC understand particular aspects of research proposals ('expert' members)."

  The important role of lay members as "equal individuals of sound judgement" reflecting "the currency of public opinion" is thus an integral part of an ethics committee's function. Lay members are already charged with taking the very perspective that Staley argues will be necessary as a result of increasing levels of patient involvement, namely the contribution of "their views as a 'member of the public'" as a "general citizen - or reasonable person".

  Staley suggests that "If the patient perspective is incorporated into research projects through early PI, then the quality of these PI processes will need to be assessed as part of the REC review". In fact RECs already assess the level of patient involvement through consideration of the answer given to question (A14-1) of the current Integrated Research Application System (IRAS) application form: "In which aspects of the research process have you actively involved, or will you involve, patients, service users, or members of the public?". This question draws the attention of both researchers and RECs to the importance of patient involvement with researchers being challenged to justify any absence of patient and/or public involvement to the committee.

  The HRA welcomes and actively promotes the involvement of patients and public in the design of health research but this is, unfortunately, a long way from becoming standard practice, with some researchers still taking patient involvement to mean that patients are sufficiently 'involved' by virtue of their simply being research participants. So, whilst REC members do already assess and promote patient involvement in health research, reflect public opinion and ensure transparency and public accountability, the "patient perspective", brought not just by lay members but expert members too (who we should not forget are also patients and members of the public), will continue to play an important part in the ethical review of health research in the UK.

  Joan Kirkbride (Director of Operations, Health Research Authority) & Prof. Andrew George (NREAP Chair)

  Conflict of Interest:

  Joan Kirkbride is the Health Research Authority's Director of Operations with responsibility for the operation of research ethics committees within the National Research Ethics Service. Prof. Andrew George is the Chair of the Health Research Authority's National Research Ethics Advisors' Panel (NREAP) and an expert member of the West London & GTAC REC

  Show Less

  Conflict of Interest:
  None declared.

  • Back to top