A change of process means sponsors will now be responsible for informing NHS organisations when the HRA has made the decision that no formal confirmation of capacity and capability is required.
The judgement is made by the HRA on a per study basis as part of our proportionate arrangements for study set-up.
Previously, the HRA has contacted NHS organisations in England directly to inform them of that decision.
But now, sponsors whose studies do not require formal confirmation will inform NHS organisations of the HRA’s decision directly.
We have made this change to reduce duplication and waste, as sponsors should already be communicating with sites about their studies, as well as release internal resource.
There is no change for NHS organisations – they will simply receive this information directly from the sponsor rather than the HRA.
We have set up a system to enable sponsors to access up-to-date email contacts and information, access to which is provided in the letter.
Trusts are advised to continue to keep accurate contact details on the R&D Forum organisation list to ensure they receive all relevant information. This is the same contact list previously used by the HRA to contact trusts.
Further information on collaborative working between sponsors and NHS organisations in England for HRA Approval studies, where no formal confirmation of capacity and capability is required can be found in this document.