NHS Approval

NHS Approval

Approval must be gained from an NHS REC for any research involving:

  • NHS patients/service users (including potential participants recruited by their past or present treatment and NHS patients treated under contracts with private sector institutions)
  • Potential participants identified because of their status as relatives/carers of patients and users of the NHS
  • Access to data, organs or other bodily material of past and present NHS patients
  • Foetal material and IVF involving NHS patients
  • Recently dead in NHS premises
  • Use of/access to NHS premises or facilities
  • Healthy volunteers, where a drug or device is being tested within the NHS

Research involving NHS staff recruited as research participants by virtue of their professional role no longer requires approval by an NHS REC.  It should be noted that audits and service evaluations do not require approval through an NHS REC.  Some guidance as to the distinction between research, audit and evaluation can be found here or you can email an A4 summary (one side only) outlining your proposal to the Chair of a REC or the NRES Queries Line.

You will also normally require approval from the R&D of the NHS Trust(s) involved.

Further information on approval requirements ca be found at:  http://www.nres.nhs.uk/applications/approval-requirements/

A REC must give an opinion on a project within 60 days of receiving a valid application as required in law for CTIMPs and the Research Governance Framework for all other research in the NHS (unless it is a trial of a medicinal product for somatic cell therapy or the product contains a genetically modified organism, in which case the time limit is 90 days).

A single ethical opinion will be given for a project, regardless of the number of sites at which it is to be conducted. A 'main REC' will be responsible for all aspects of the ethical review.

All applications for ethical approval from the NHS must be made using the IRAS online application form. If you are a first time user, you will need to register for an account online, which is activated immediately.

You will need to identify a sponsor for the research.  This may be the University.  Please contact Dr John-Paul Wilson for further information.

When you have completed the application form, you will need to book an agenda slot at the next meeting of an appropriate REC.

Bookings should either be made direct with a local REC in the NHS domain through the Local Allocation System (LAS) or via the Central Allocation System (CAS) depending on the nature of your project.