Such studies (described above) require ‘HRA Approval’ from the Health Research Authority (HRA), the review process required for research conducted in the NHS in England. HRA Approval comprises an independent ethics review opinion from an NHS Research Ethics Committee (REC) (where required) in addition to the assessment of regulatory compliance, and study-wide research governance checks undertaken by HRA staff. Applications for HRA Approval are made through the Integrated Research Application System (IRAS):
View the website here >
Additionally, specialist NHS RECs operate for specific activities:
- HRA Confidentiality Advisory Group (CAG) reviews research requiring access to confidential patient information without patient consent.
- HRA Social Care Research Ethics Committee reviews research involving individuals under the care of social or community care professionals, their families, or NHS Staff.
Studies involving the NHS that require HRA approval but fall outside the scope of NHS REC review include:
- Research involving NHS staff recruited due to their professional role: NHS REC review is not normally required for research recruiting NHS or social care staff as participants by virtue of their professional role. These studies require submission to the Health Research Authority solely for the NHS governance review assessment portion of HRA Approval (and not NHS Ethics review). Please note studies that involve a cohort of NHS staff in addition to healthy volunteers must be submitted for HRA Approval. See the approval pathway for BSMS research studies (led by staff or students) recruiting NHS staff as participants for further guidance.
View the approval pathway guidance here >
*No research activity, including any data collection or recruitment activities, can commence until HRA Approval (NHS ethics and/or NHS governance and legal assessment approval) has first been secured from the HRA*