The regulation of health research provides participants with assurance that the research that they take part in is of high quality, safe and ethical. It also ensures that the results of research can be relied on and used as evidence to inform future decisions about healthcare and treatment.
The UK has a range of bodies which have roles in regulating different aspects of health research in humans. The information below will help you to determine which approvals are relevant to your research.
Unless otherwise stated applications should be made using the Integrated Research Application IRAS account.
The information below lists the various types of approvals and when they are required.
- HRA Approval for the NHS in England
- NHS management permission in Scotland, Wales or Northern Ireland
- Research Ethics Committee (REC)
- Medicines and Healthcare products Regulatory Agency (MHRA) – clinical trial authorisation (Investigational Medicinal Products)
- Medicines and Healthcare products Regulatory Agency (MHRA) – Notice of No Objection (Medical Devices)
- Confidentiality Advisory Group (CAG; previously the National Information Governance Board (NIGB) for Health and Social Care)
- National Offender Management Service (NOMS)
- Administration of Radioactive Substances Advisory Committee (ARSAC)
- Human Fertilisation and Embryology Authority (HFEA)
- Human Tissue Authority (HTA)
HRA Approval is applicable to all types of health research projects (but not infrastructure such as Research Tissue Banks or Databases) taking place in the NHS in England, including those that do not need to seek NHS Research Ethics review, and regardless of their eligibility for the NIHR CRN portfolio.
HRA Approval should be obtained wherever NHS organisations in England have a duty of care to participants in relation to the research activity, either as service users or NHS staff or volunteers, or when the resource required for the study (i.e. data or human biological material) are under the responsibility of the NHS organisation as a healthcare provider.
HRA Approval comprises a review by an NHS Research Ethics Committee (REC) (where required) as well as an assessment of regulatory compliance and related matters on behalf of the participating NHS organisations It replaces the need for NHS permission by each participating organisation in England.
For projects led from England with NHS/HSC sites in Scotland, Wales or Northern Ireland, you should apply for HRA Approval and the HRA will share relevant information with the appropriate national R&D coordinating functions. Please refer to the national arrangements for setting up these sites here.
Where a project is led from outside England but has English NHS sites, the national R&D coordinating function of the lead nation will share information with the HRA Assessment team, who can issue HRA Approval for England. You do not need to submit a separate application for HRA Approval. For more information on projects led from outside England please refer here.
The HRA assessment of regulatory compliance and related matters is conducted against a set of standards. Sponsors are advised to familiarise themselves with the current version of these standards.
HRA Approval provides a standard process for sponsors or Chief Investigators to set up and work with intended participating NHS organisations in England.
Site Specific Information Forms are no longer used in England; a Local Information Pack is used instead. More information can be found here.
This process allows the NHS organisation to confirm that it has the capacity and capability to deliver the study without duplication of R&D approval processes at each site. The set up process can happen in parallel to HRA Approval with organisational capacity and capability confirmed after HRA Approval has been issued.
For more information on applying for HRA Approval please refer to further guidance and links here.
Sponsors are advised to check whether review by other bodies might be required for their study and to determine whether additional applications and approvals are therefore needed (see below).
2. NHS management permission in Scotland, Wales or Northern Ireland
Researchers wishing to conduct research in the NHS in Wales or Scotland, or Health and Social Care (HSC) in Northern Ireland, must obtain ‘NHS (or HSC) management permission’ (also referred to as ‘R&D approval’ or ‘R&D permission’) for each NHS/HSC research site.
Please note that this management permission relates to the role of NHS organisations in hosting research, i.e. recruiting participants or conducting interventions.
Where a project is led from Scotland, Wales or Northern Ireland, you should apply to the national R&D coordinating function of the lead nation. If the project has NHS sites in other UK nations then compatibility arrangements are in place so that the national R&D coordinating function of the lead nation will share information with the national R&D coordinating functions of the other relevant nations, including HRA Approval for sites in England. You do not need to make a separate application to each nation.
To set-up and work with NHS participating organisations in Scotland, Wales and Northern Ireland a Site Specific Information Form for each site is completed in IRAS. If you require further guidance or support when setting up your study at sites in Scotland, Wales or Northern Ireland, you can contact the national R&D coordinating function for that nation. Contact details for each can be found here.
To set up and work with sites in England a Local Information Pack is used: Site Specific Information Forms are no longer accepted. More information can be found here.
3. Research Ethics Committee (REC)
Research Ethics Committees (RECs) review applications for research and give an opinion about the proposed participant involvement and whether the research is ethical. There are several different types of REC.
NHS Research Ethics Committees (NHS RECs):
The requirements for ethical review by NHS RECs are set out in the harmonised UK-wide edition of the Governance Arrangements for Research Ethics Committees (GAfREC), which is published by the UK Health Departments.
Requirement for ethical review of research may be under:
- legislation applying to the UK as a whole or particular countries of the UK
- policy of the UK Health Departments, where research relates to the services for which they are responsible
The HRA establishes the NHS RECs in England within the UK Health Departments’ Research Ethics Service. Some of these RECs are also recognised for the purpose of reviewing clinical trials of investigational medicinal products (CTIMPs).Please refer to further guidance about the types of NHS REC.
NHS RECs safeguard the rights, safety, dignity and well-being of people participating in research in the NHS. They review applications for research and give an opinion about the proposed participant involvement and whether the research is ethical.
Some types of research require NHS REC review by law whether or not they take place within the NHS or involve NHS patients or other service users.
For studies being set up under HRA Approval, NHS REC review is undertaken as part of this process where it is required. A separate application for ethical review is not required.
Gene Therapy Advisory Committee:
If your project is a gene therapy clinical trial you must apply to the Gene Therapy Advisory Committee (GTAC) for ethical review. GTAC is the UK national REC for gene therapy clinical research according to regulation 14(5) of The Medicines for Human Use (Clinical Trials) Regulations 2004.
For studies being set up under HRA Approval, GTAC review is undertaken as part of this process where it is required. A separate GTAC application is not required.
Social Care Research Ethics Committee (REC):
The Social Care REC reviews social care research study proposals involving adults, intergenerational social care studies involving adults and children or families and some proposals for social science studies situated in the NHS. The Social Care REC does not consider any research involving clinical interventions. Such research should be reviewed by another appropriate REC within the UK Health Departments’ Research Ethics Service. Social Care research involving only children is outside the remit of the Secretary of State for Health. Further guidance is provided on the National Social Care REC webpage.
Ministry of Defence Research Ethics Committee (MoDREC):
The ethical review of research funded by or sponsored by the MoD, including research involving the UK Armed Forces, is carried out by MoDREC. MoDREC is recognised by the United Kingdom Ethics Committee Authority (UKECA) to review clinical trials of investigational medicinal products involving subjects who are UK Armed Forces personnel recruited in a military setting, as well as Phase 1 trials in healthy volunteers conducted by the MoD or its agencies or contractors. It is also recognised as an Appropriate Body under the Mental Capacity Act 2005 for review of research involving UK Armed Forces personnel who are unable to consent for themselves.
Higher Education Institution (HEI) Research Ethics Committees:
Researchers in Higher Education Institutions (HEIs) are advised to check whether, under their institution’s policy and internal arrangements, ethical review is required by their HEI research ethics committee.
4. Medicines and Healthcare products Regulatory Agency (MHRA) – clinical trial authorisation (Investigational Medicinal Products)
A Clinical Trial Authorisation (CTA) is required for any clinical trial of an investigational medicinal product (CTIMP) to be conducted in the UK that fall within the scope of the EU Clinical Trials Directive and the Medicines for Human Use (Clinical Trials) Regulations 2004. The application for a CTA is made to MHRA who are responsible for advising on the Regulations and the requirements for CTA. Detailed guidance, including an algorithm to help you decide whether or not your research is a CTIMP is provided by the MHRA. These pages also provide the details of the MHRA’s email helpline for further advice.
5. Medicines and Healthcare products Regulatory Agency (MHRA) – Notice of No Objection (Medical Devices)
An application to MHRA Devices will be required where the study is a clinical investigation of a medical device undertaken by the manufacturer for CE marking purposes. This will be either an investigation of a non-CE marked product, or an investigation of a CE marked product that has been modified or is to be used outside its intended purpose.
MHRA approval is not always required in the case of:
- Medical devices manufactured “in-house” in a healthcare establishment
- Clinician led off-label use of a medical device.
In these cases applicants are advised to contact MHRA Devices to discuss the purpose of the investigation and determine whether MHRA approval is required.
Guidance on whether MHRA approval is required can be found on the MHRA website.
6. Confidentiality Advisory Group (CAG; previously the National Information Governance Board (NIGB) for Health and Social Care)
The HRA’s Confidentiality Advisory Group (CAG) provides independent expert advice to the HRA and the Secretary of State for Health on whether applications to access confidential patient information without consent should or should not be approved. CAGs remit extends England and Wales and to projects that are managed as research and those that are not managed as research in the NHS. The Confidentiality Advisory Group was previously the National Information Governance Board for Health and Social Care (NIGB). You should apply to the CAG if you need to access: Identifiable patient information relating to people living in, or receiving healthcare in, England and Wales without explicit consent, prior to the disclosure of confidential information or Human Fertilisation and Embryology Authority (HFEA) Register Data.
Potential applicants should refer to the guidance provided to identify whether an application to CAG is advised. You should contact the Confidentiality Advice Team if you are uncertain whether an application is needed
Where applicants intend to link to national datasets, such as Hospital Episodes Statistics (HES) and cancer registry data, they will be expected to have contacted the data controllers for the dataset and discussed whether alternative methods which might limit the disclosure of confidential patient information without consent could be used. You will need to provide copies of this correspondence, and any other evidence to show that alternatives to access of confidential patient data without consent have been explored, as part of the supporting information for your application to CAG.
The next section includes guidance on applying to CAG.
7. National Offender Management Service (NOMS)
If the project is with Prisons or Probation Trusts an application to NOMS will be required. Please refer to the NOMS website for more information.
Note that the NOMS approval process extends to research in Young Offenders’ Institutions (YOIs), but excludes research in Secure Training Centres, Secure Children’s Homes or with Youth Offending Teams – applications to conduct research in these areas should be directed to the Youth Justice Board.
8. Administration of Radioactive Substances Advisory Committee (ARSAC)
Under the Medicines (Administration of Radioactive Substances) Regulations 1978 (‘MARS’), administrations of radioactive medicinal products to humans must be conducted under certificates issued by the Health Ministers.
For research studies involving administration of radioactive materials which are additional to normal care, nuclear medicine professionals at each site require a research certificate from the Administration of Radioactive Substances Advisory Committee (ARSAC).
Procedures involving the administration of radioactive materials include:
- Nuclear Medicine Bone Scans
Diagnostic X-rays, CT scans and DXA do not involve the administration of radioactive materials.
For further guidance please refer to:
- Administration of Radioactive Substances guidance
- ARSAC website
- Guidance in IRAS including green “i” button question specific guidance
9. Human Fertilisation and Embryology Authority (HFEA)
Applications to the HFEA are required for:
Research involving human embryos and gametes
Under the Human Fertilisation and Embryology Act 1990, research involving human embryos or gametes requires a licence from the Human Fertilisation and Embryology Authority (HFEA) in addition to ethical review from a NHS REC. Licensing applications are reviewed by the HFEA Research Licence Committee.
Note: the application for this license is not currently part of the Integrated Research Application System (IRAS). Please refer to the HFEA website for details of how to apply.
Disclosure of protected information from the HFEA Register
Under the Human Fertilisation and Embryology (Disclosure of Information for Research Purposes) Regulations 2010 (‘HFE Regulations’), certain protected information held on the register of the Human Fertilisation and Embryology Authority (HFEA) may be processed for research purposes subject to authorisation from the HFEA. For more information please refer to the HFEA website.
Note: The Human Fertilisation and Embryology Regulations apply to the whole of the UK.
10. Human Tissue Authority (HTA)
Under the Human Tissue Act 2004, storage of ‘relevant material’ (material from a human body consisting of or including cells) for scheduled purposes in England, Wales or Northern Ireland requires a licence from the Human Tissue Authority (HTA). The scheduled purposes include research in connection with disorders or the functioning of the human body.
The HTA does not approve individual projects or license research activity itself but the organisations that store human tissue for research, including the following activities:
- Removal of relevant material from the deceased for the scheduled purpose of research.
- Storage of relevant material (from both the living and the deceased) for the scheduled purpose of research.
A licence is not required for storage in connection with a specific research project with approval from a REC. This exemption does not apply to tissue banks storing relevant material for use in future research. Where voluntary application is made to a REC for ethical review of a research tissue bank, a copy of the licence will be required by the REC as a condition of a favourable opinion.