Research sites & HRA Approval
The review of site-specific issues is the responsibility of the NHS R&D Office and is confirmed through assessing and arranging capacity and capability. The favourable opinion from the REC is given on condition of the confirmation by the R&D Office.
Management permission at NHS sites
The review of site-specific issues is the responsibility of the NHS R&D Office and is an integral part of the organisation’s oversight of the set-up of studies. The favourable opinion from the REC is given on condition that the organisation has confirmed its permission for the study to proceed.
SSA at non-NHS sites
This is the responsibility of the REC system.
The REC undertaking the review of the main application will undertake the SSA(s) for non-NHS site(s), generally at the same time as the review of the main application. Alternatively, an SSA can be reviewed separately by a Sub-Committee of the REC. For more information see the documents below:
- Phase 1 trials in healthy volunteers – site specific assessment – guidance for applicants version 3.2 dated 8 April 2013. [pdf, 195KB]
- Site Specific Assessment for non-NHS sites version 1 dated 30 October 2013 [pdf, 235KB]
Where a SSA application(s) is submitted at the same time as the main application, the REC will review the documentation when undertaking the ethical review. Therefore there will no longer be a timeframe for reviewing the SSA application in these cases.
Where a SSI form is submitted after a favourable ethical opinion, the REC has 14 days (for a Phase 1 trial where there is no intended therapeutic benefit for subjects) or 25 days (for other studies) from receipt of a Site Specific Assessment application to notify the Chief Investigator for the study of the decision for the SSA.
Exemption from the requirement for SSA at non-NHS sites – RECs have discretion to waive the requirement for SSA in some instances, as set out in Section 4 of the Standard Operating Procedures.