Health Research Authority (HRA) and Health and Care Research Wales (HCRW) Approval is the review process for research studies taking place in the NHS in England and Wales.
HRA/HCRW Approval replaces the need for local checks of legal compliance and related matters by each participating organisation in England and Wales - the review brings together a governance and legal compliance assessment undertaken by dedicated HRA/HCRW staff, with an independent ethical opinion by a Research Ethics Committee (REC) and provides assurance that:
● the study has a favourable ethical opinion AND
● the study protocol and arrangements are compliant with relevant legal and regulatory requirements AND
● the study documents are compliant with nationally agreed standards
The HRA has compatibility arrangements in place with the national NHS permissions coordinating functions in Scotland and Northern Ireland meaning that the HRA can share information with those national coordinating functions to benefit study set up in participating NHS organisations across the UK.
If your project is led from Scotland or Northern Ireland and involves English or Welsh NHS sites, you should apply through the national NHS permissions coordinating function of the lead nation, who will share information with the HRA and HCRW approval teams to issue approval for English and Welsh sites.
Refer to the NHS Research Scotland site for details on on obtaining HRA approval for research led from Scotland.