HRA Approval

HRA Approval

Health Research Authority Approval is a new process for research approval in England. The HRA will undertake a new review process for research studies taking place in England in the NHS and will issue an approval on behalf of the NHS. This will provide 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

This will be a major change to the approvals process, which will make the system similar to that in some other countries, without the perceived ‘extra’ NHS review process that researchers and companies have struggled with. Research will benefit from a streamlined approvals process.

The HRA has compatibility arrangements in place with the national NHS permissions coordinating functions in Scotland, Northern Ireland and Wales meaning that the HRA can share information with those national coordinating functions to benefit study set up in participating NHS/HSC organisations across the UK where applicable.

Refer to the documents below for details on HRA approval for Scotland and the UK.