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Brighton & Sussex Medical School

Approvals for  NHS-Related Research

BSMS > Research > Support and governance > RGEC hub > Approvals for NHS-Related Research

Approvals for NHS-Related Research

This page provides information regarding obtaining ethics and governance approvals for projects conducted in the NHS. All health and social care research undertaken in the NHS is regulated by the Health Research Authority (HRA) UK Policy Framework for Health and Social Care Research. The policy framework applies to clinical health and social care research projects undertaken in the UK which involve:

  • NHS patients or service users (including NHS patients treated under contracts with private sector institutions)
  • Potential participants identified because of their status as relatives and/or carers of patients or service users of the NHS
  • Identifiable NHS patient biomaterial; organs or other bodily material of past and present NHS patients. Foetal material and IVF involving NHS patients
  • Identifiable NHS patient data (related to past or present patient medical records)
  • Use of or access to NHS premises or facilities
  • NHS staff

Quick links

HRA approval >
What is the process for university sponsorship of applications to the HRA? >
What documents do the university and HRA require? >
Is my study research? Do i need to apply for NHS ethics approval? >


HRA approval

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* 


What is the process for University Sponsorship of applications to the HRA?

All research conducted in the NHS requires a research Sponsor. If you are a member of BSMS Staff or a PGR student, before you can apply for HRA Approval University of Sussex Sponsorship must be obtained. Applicants will need to: 

  • Apply for University of Sussex Sponsorship, before proceeding to the HRA’s review processes. 
  • Submit your application to the Pre-Sponsorship Review Panel (PSRP) prior to onward submission to the University of Sussex Sponsorship Sub-Committee. The order of application is: PSRP, University Sponsorship Sub-Committee, HRA.
  • A schedule Pre-Sponsorship Review Panel of meeting dates can be found via the website below.

View the website here >

  • Information on University Sponsorship can be found on the website below. 

View the website here > 

What documents do the University and HRA require?

  • Applications for University Sponsorship and for HRA Approval (including solely for the assessment of regulatory and study-wide research governance compliance) are made using IRAS. View the website here. If you are using IRAS for the first time, you will need to register your details, and start completing the IRAS project filter form for your project. Projects require completion of an IRAS Form and supporting study documents for both University Sponsorship approval and HRA Approval. The application will need to be sufficiently robust (and cannot be rushed due to limited time constraints).
  • All applications to the HRA must enclose: Signed IRAS application; Research protocol; Summary CV for the Chief Investigator; Participant information sheets and consent forms; Evidence of insurance or indemnity (for non-NHS sponsors only). Other documents may also be necessary and will be outlined in the IRAS checklist. The IRAS application and checklist are downloaded from IRAS.
  • Guidance on completing the IRAS application form and supporting documentation is available on the IRAS website – when completing IRAS forms online green ‘i’ symbols appear next to some sections providing extra information about how to answer a question.

It can take time to obtain NHS ethics approval. Your application may be returned with a request for further amendments. The average time for approval is between 2-3 months but can be longer. Please note: the HRA introduced new eligibility criteria for standalone student research projects conducted in the NHS. The policy came into force on 1 September 2021. Please refer to The Health Research Authority's (HRA) New Eligibility Criteria for Standalone Student Research for further guidance on the implications for taught student research. 

View the eligibility criteria here >


Is my study research? Do I need to apply for NHS Ethics approval?

Is NHS ethics approval required? Please ensure that you use the HRA’s decision tool to establish this: 

  • The HRA provides an online decision tool to assist researchers in determining whether a project is deemed research. View the HRA website here. Results may be saved and printed/emailed by way of confirmation of the outcome. Following confirmation, an HRA decision tool can be used to determine whether your study requires NHS Ethics approval. View the decision tool here.

However, some activities are exempt from requiring approval from an NHS REC or NHS governance review assessment. HRA Approval is not normally required from the HRA, for example, if: 

  • Your project falls under the category of Clinical Audit, Service Evaluation, or Quality Improvement. While Service Evaluations and Clinical Audits involving NHS patients do not usually need HRA Approval, they require registration at the NHS Trust at which they are conducted. The Trust will usually require confirmation of the data required and likely sources and information governance solutions on how data will be transferred and stored and who will have access to it. *Clinical projects run in NHS settings require registration and approval via the respective NHS Trust* Refer to the guidance on clinical audit versus research below.

View the guidance on clinical audit versus research here >

Please Note: If work is not classed as ‘research’ or falls under specific exemption criteria such as that defined by the Health Research Authority (HRA), be aware that in the vast majority of cases research with human participants requires appropriate consent. Formal ethics review may still be required through the Universities of Brighton and Sussex research governance procedures. Please note, if your study qualifies for ethics exemption but you intend to publish the results of your research, you may still be asked for proof of institutional ethics review by a journal or funder. Please ensure that you find out if this will be a requirement by speaking with the journal/funder and contacting the BSMS Research Governance and Ethics Committee ahead of time. *Ethics approval cannot be granted retrospectively*