Health Research Authority (HRA)

The Health Research Authority (HRA) is the UK’s national body for protecting and promoting the interests of patients and the public in health and social care research. It is an executive non-departmental public body (NDPB) sponsored by the Department of Health and Social Care, established on 1 January 2015 under Part 3, Chapter 2 of the Care Act 2014. In practice, most researchers encounter the HRA through two functions: it oversees the network of NHS Research Ethics Committees (RECs) that review the ethics of a study, and it grants HRA Approval, the combined decision that brings ethical review and NHS permissions together into a single national process for most NHS-related research in England.

What the HRA actually does

The HRA’s own stated mission is to make the UK ‘a great place to do health research’ while building public confidence and participation in it. Concretely, that mission is delivered through a small number of core statutory and operational functions:

• Running the Research Ethics Service. The HRA coordinates the national network of RECs that provide the independent ethical opinion a study needs before it can proceed — a favourable opinion from a REC is a distinct decision from HRA Approval itself, though both are usually sought through the same application.
• Granting HRA Approval. For most project-based NHS research in England, HRA Approval is the single decision that combines the REC’s ethical opinion with an assessment of the study’s legal and regulatory compliance nationally, replacing the need for separate local NHS permission checks at every site.
• Coordinating Combined Review for CTIMPs. For clinical trials of investigational medicinal products, the HRA coordinates Combined Review — a single application, submitted once, that goes simultaneously to the Medicines and Healthcare products Regulatory Agency (MHRA) for regulatory assessment and to a REC for ethical review, producing one combined decision rather than two.
• Supporting research transparency. The HRA sets registration and reporting expectations for studies it approves, and maintains public-facing information about approved research as part of its transparency remit.
• Advising on data and confidentiality. The HRA hosts the Confidentiality Advisory Group (CAG), which advises on applications to use confidential patient information without consent under Section 251 of the NHS Act 2006.

Where HRA remit stops: MHRA, NIHR, and local ethics committees

The HRA is easy to conflate with several adjacent bodies that share overlapping subject matter but have genuinely different functions:

• HRA vs MHRA. The HRA covers the ethics and NHS-permissions side of health and social-care research broadly, across every study type. The Medicines and Healthcare products Regulatory Agency (MHRA) is a separate regulator whose remit is the regulatory side specifically for medicines and medical devices — authorising clinical trials of investigational medicinal products, running its own Good Clinical Practice inspectorate, and licensing medicines. For CTIMPs the two now work through one Combined Review application, but they remain two separate statutory bodies making two separate assessments that happen to be coordinated.
• HRA vs NIHR. The National Institute for Health and Care Research (NIHR, formerly the National Institute for Health Research) is the UK’s principal funder and infrastructure body for health and care research — it funds studies, funds researcher fellowships, and runs the clinical research delivery infrastructure that helps studies recruit. NIHR funding a study is a funding decision; it does not substitute for HRA Approval, and NIHR-funded studies still need to go through the HRA’s approval process on their own track.
• HRA vs a local/institutional ethics committee. A university’s or company’s own internal ethics committee reviews research that falls outside HRA/REC scope (e.g. no NHS, HSC, or social-care-research involvement). Where a study genuinely needs the HRA’s Research Ethics Service, an institution’s internal sign-off does not replace that review.
• HRA vs Health and Care Research Wales (HCRW), NHS Research Scotland, and HSC research permissions (Northern Ireland). HRA Approval is specifically an England/Wales mechanism, coordinated with HCRW for Wales-based elements of a study. Scotland and Northern Ireland run their own national coordinating arrangements rather than HRA Approval itself, though the underlying REC review is still coordinated through the HRA’s UK-wide Research Ethics Service.

How to actually apply

Applications for REC review, HRA Approval, and Combined Review are submitted through the Integrated Research Application System (IRAS), which the HRA is in the process of replacing with a new service, Plan and Manage Health and Care Research — see CASRAI’s full walkthrough of UK Health Research Approvals: HRA, IRAS, and What Replaced Them for the current migration timeline, the HRA’s decision tool for whether a project counts as research, and what a compliant Participant Information Sheet needs to contain.

Frequently Asked Questions

What does the Health Research Authority do?

It protects and promotes the interests of patients and the public in health and social care research, mainly by coordinating the Research Ethics Service (NHS RECs) and by granting HRA Approval — the combined ethics-and-permissions decision most NHS-related research in England needs before it can start.

Does the Health Research Authority still exist?

Yes. It has operated continuously as a statutory NDPB since 1 January 2015 under the Care Act 2014, and it remains the body responsible for HRA Approval, REC coordination, and Combined Review today. Confusion sometimes arises because the HRA absorbed and replaced several predecessor arrangements (including the National Research Ethics Service) when it was established, so older references to those predecessor names can read as if the function no longer exists — it does, under the HRA.

What is the difference between the MHRA and the HRA?

The MHRA is the medicines and medical-devices regulator; it authorises clinical trials of investigational medicinal products and runs Good Clinical Practice inspections. The HRA is the ethics-and-permissions body for health and social care research generally. For clinical trials of medicines, the two now coordinate through a single Combined Review application, but they are separate bodies with separate statutory remits.

Is the NIHR part of the NHS?

No — the National Institute for Health and Care Research (NIHR) is the UK’s funder and delivery-infrastructure body for health and care research, part of the Department of Health and Social Care family and working closely with the NHS, but it is a distinct organisation from the NHS itself and from the HRA.

Related CASRAI Resources

• UK Health Research Approvals: HRA, IRAS, and What Replaced Them — the full HRA Approval / IRAS / Participant Information Sheet walkthrough
• MHRA GCP Inspection
• Favourable Opinion (NHS REC)
• Confidentiality Advisory Group (CAG, Section 251)
• Data Protection Act 2018, Section 19 (Research Safeguards)
• Ethical Approval
• NIHR Funding Opportunities
• Clinical Research Administration — cluster hub

References

• Health Research Authority, About us (hra.nhs.uk)
• GOV.UK, Health Research Authority (organisation page)
• Care Act 2014, Part 3, Chapter 2 (legislation.gov.uk)