Where to submit for ethics approval

Ethics review applications for clinical research

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Ethics approval process chartResearch ethicsSponsorshipNHS RESCURECHRACAGMRHAtrust

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Check the definition of research.

All research involving human participants, human tissue and/or personal data1 requires ethics review. 

If the research involves only previously collected, anonymised, non-NHS data3 that cannot be traced back to an individual by the researcher and collaborators, ethics approval is not required. 

  • clinical trial (CTIMP) or administration of a drug that is not licensed in the UK
  • ionising radiation
  • human biological samples (containing cells) that cannot be stored under an HTA licence, or that will be collected from participants recruited by virtue of being UK National Health Service (NHS) patients
  • use of certain medical devices
  • participants recruited by virtue of being UK National Health Service (NHS) patients
  • NHS staff2 or NHS data3
  • Secondary data obtained directly from an NHS care-giving organisation (e.g. clinical notes)
  • class A invasive procedure (defined in CUREC glossary)

Applications should route through:

  1. Sponsorship group of RGEA for University sponsorship
  2. NHS Research Ethics Service
  3. HRA approval (if required)
  4. CAG approval (if required)
  5. MHRA approval (if required)
  6. Local NHS trust confirmation (if required)

  • NHS staff1 
  • NHS data2

Apply via:

  1. Sponsorship group of RGEA for University sponsorship
  2. Ethics group of RGEA for Central University Research Ethics Committee (CUREC) review and approval
  3. HRA approval (if required)
  4. Local NHS trust confirmation (if required)

Definitions

 

1 Personal data are data that relate to a living individual who can be identified either from those data or from those data and other information that is in the possession of, or is likely to come into the possession of, the data controller (for example through the use of a code devised by, or accessible to, the researchers). 

2 NHS staff are considered people recruited to research by virtue of their status as current or former employees of the NHS.

3 NHS data means data generated by an NHS clinical service, or held in NHS databases or behind NHS firewalls, or owned by the NHS in any other capacity. It does not matter whether the data contain identifying personal information or whether they are anonymised.

Confidential patient information: Confidentiality Advisory Group (CAG)

If your research involves the use of patient-identifiable information without consent, you will need to apply to the HRA Confidentiality Advisory Group (CAG). Applications can be made via the Integrated Research Application System (IRAS) application process.

CAG expects to see evidence of public involvement that specifically tests the public acceptability of using confidential patient information without consent for the purpose of your application. What this means in practice is providing a public group with a plain language summary of your project that includes the purpose of the project, how confidential patient information is used without consent and the safeguards that will be in place. Read more about CAG-specific public involvement requirements on their website: Public Involvement for CAG applicants.

Applicants seeking Section 251 support for use of confidential patient data without consent will be expected to attend the CAG meeting at which their application is being discussed.

Contacts

RGEA TEAM  

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