HRA

What HRA does

The Health Research Authority (HRA) is a UK executive non-departmental public body established under the Care Act 2014 that protects and promotes the interests of patients and the public in health and social care research while streamlining the regulation of that research. It operates across all four UK nations (England, Northern Ireland, Scotland, and Wales) in coordination with the Devolved Administrations, and is sponsored by the UK Department of Health and Social Care. Headquartered at 2 Redman Place, Stratford, London, with additional offices in Manchester, Nottingham, Newcastle, and Bristol, the organisation employs 101–250 staff and is governed under the UK Policy Framework for Health and Social Care Research (currently version 3.4, April 2026), which set out 19 principles of good practice.

HRA's core offerings are the centralised HRA Approval service, Research Ethics Committees (65+ across the UK) that deliver ethical opinions, and the Confidentiality Advisory Group (CAG) that provides Section 251 advice under the NHS Act 2006 for access to confidential patient information without consent. The supporting technology stack includes the Integrated Research Application System (IRAS) — a single UK-wide online submission gateway — the HRA Assessment Review Portal (HARP) for processing applications, the Over-Volunteering Prevention System (TOPS) for managing volunteer records across trials, and the NIHR-hosted Learning Management System (NIHR Learn) used by staff, committee members, and researchers. Together these platforms collapse what were previously multiple national approval pathways into a single proportionate, risk-based review.

HRA is funded through government appropriations under the Care Act 2014 and provides regulatory services at no direct cost to researchers. It has no commercial revenue, no shareholders, and no disclosed funding rounds. Its primary customer segments are health and social care researchers (academic and clinical), NHS and Health and Social Care providers in Northern Ireland acting as research sites, the four UK Health Departments and Devolved Administrations, and patients/service users and the public. Key strategic partners include MHRA, NIHR, HTA, HFEA, ARSAC, and the ISRCTN Registry (for automatic CTIMP registration from January 2022).

Name

HRA

Legal name

Health Research Authority

Website

https://hra.nhs.uk

Company type

Private

Founded year

2015

Operating status

Operating

Headcount range

101–250 employees

Short description

The Health Research Authority (HRA) is a UK statutory non-departmental public body, established under the Care Act 2014, that regulates health and social care research across England, Northern Ireland, Scotland, and Wales — providing ethics review, HRA Approval, CAG Section 251 advice, and the IRAS/HARP digital platforms, funded through government appropriations.

Ownership category

akta.pro rank

Product category

Healthcare Research Regulation

NAICS

Administration of Public Health Programs (923120)

SIC

Services-Health Services (8000), Services-Misc Health & Allied Services, Nec (8090)

akta.pro primary industry

Clinical Research Ethics & Human Subjects Protection Authorities (IRB/REC Oversight) (HLAJACAG)

akta.pro secondary industries

Consent, Authorization & Data Sharing Governance (opt-in/opt-out, DS4P) (HLACABAG), Health Technology Assessment (HTA) & Reimbursement Policy Bodies (HLAJACAF)

Keywords

• Health research regulation
• Research ethics review
• Clinical trial approvals
• Research governance
• Health data protection

Headquarters

HQ city

London

HQ country

United Kingdom

HQ region

Europe

Offices5 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Infrastructure, Others

Distribution channels5 records

Marketing channels6 records

Core offering

The Health Research Authority (HRA) provides a unified regulatory framework for health and social care research across the UK. Its core services include HRA Approval (a centralised research approval combining multiple reviews into a single assessment), Research Ethics Committees (independent ethics review for research involving humans), the Confidentiality Advisory Group (advice on accessing confidential patient information without consent under Section 251 of the NHS Act 2006), and the Integrated Research Application System (IRAS) — a single UK-wide online platform for submitting applications for permissions and approvals across multiple regulatory bodies.

Product overview

The Health Research Authority (HRA) is a UK regulatory body, not a commercial product company. HRA offers a unified portfolio of regulatory services and platforms for health and social care research approval and governance. The core offerings include HRA Approval (centralised approval service), Research Ethics Committees (REC) for ethical review, and the Confidentiality Advisory Group (CAG) for advice on accessing confidential patient data. Supporting digital platforms include the Integrated Research Application System (IRAS) for submitting applications, HARP for application processing, and NIHR Learn for training. The UK Policy Framework for Health and Social Care Research provides the overarching principles and responsibilities governing all UK health research. These services work together to enable researchers to navigate the regulatory pathway from application through to approval and ongoing compliance.

Differentiator

Problem solved

Functional benefit

Products and services

• HRA Approval Central approval service combining approvals from various review bodies for NHS project-based health and social care research, enabling researchers to submit a single application rather than multiple separate approvals for their studies.
• Research Ethics Committees (REC) Independent committees across the UK that review research proposals involving humans to ensure ethical standards are met, participant safety is protected, and research is conducted with integrity. More than 65 RECs operate as part of the HRA system.
• Confidentiality Advisory Group (CAG) Advisory body that provides advice on accessing confidential patient information without consent under Section 251 of the NHS Act 2006, for research and non-research purposes requiring lawful basis for patient data use.
• Integrated Research Application System (IRAS) Single UK-wide online system for applying for the permissions and approvals required for health and social care research, streamlining the application process across multiple regulatory bodies.
• HRA Assessment Review Portal (HARP) Portal system used by HRA to process and approve research applications, supporting the assessment and review workflow for HRA Approval and ethics processes.
• Research Registration and Reporting Services Services supporting transparency in health research including registration of clinical trials (such as via the ISRCTN Registry partnership for CTIMPs) and reporting of research outcomes through published application summaries.
• NIHR Learn (Learning Management System) Learning Management System hosted by NIHR Learn providing e-learning modules, learning events, and additional learning materials for HRA staff, Research Ethics Committee members, and researchers across the UK research community.
• UK Policy Framework for Health and Social Care Research Statutory guidance (version 3.4, April 2026) setting out 19 principles of good practice in the management and conduct of health and social care research across the UK, replacing the separate Research Governance Frameworks in each UK country with a single set of principles.

Quantifiable outcome

• UK clinical trials reaching 150-day set-up milestone

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Seven partnerships are on record, tiered core.

• UK Health Departments (Devolved Administrations)coreStrategic or Co-development PartnerHRA works in partnership with Department of Health (England), Department of Health (Northern Ireland), Scottish Government Health and Social Care Directorates, and Welsh Government to develop and maintain the UK Policy Framework for Health and Social Care Research, ensuring compatible standards across the UK.
• NHS OrganizationscoreStrategic or Co-development PartnerNHS trusts, NHS foundation trusts, and Health and Social Care (HSC) organizations in Northern Ireland are key research sites and partners in the HRA approval process.
• Medicines and Healthcare Products Regulatory Agency (MHRA)coreStrategic or Co-development PartnerCooperation agreement to improve and simplify the regulatory environment for clinical trials. MHRA handles clinical trial authorizations while HRA handles ethics review.
• National Institute for Health and Care Research (NIHR)coreStrategic or Co-development PartnerNIHR funds health and social care research and works with HRA on research approvals and the Learning Management System (NIHR Learn).
• Human Tissue Authority (HTA)coreStrategic or Co-development PartnerHTA licenses storage of tissue for research. HRA and HTA cooperate on regulatory processes for research involving human tissue.
• Administration of Radioactive Substances Advisory Committee (ARSAC)coreStrategic or Co-development PartnerARSAC advises on administration of radioactive substances. Listed as a partner in research approvals alongside HRA.
• Human Fertilisation and Embryology Authority (HFEA)coreStrategic or Co-development PartnerHFEA regulates fertility treatment and research involving embryos. Cooperates with HRA on research approvals.

Scale indicators3 records

Recent moves6 records

Expansion highlights5 records

Regional players

• Canadian Tri-Council Policy Statement (TCPS) / Panel on Research Ethics: Canada's national policy framework (TCPS) and oversight body for research with humans. Comparable to HRA's UK Policy Framework and REC system, serving an analogous function in a different national jurisdiction.
• U.S. Office for Human Research Protections (OHRP): U.S. federal body that oversees human research subject protections under the Common Rule. OHRP is the closest international analog to HRA's REC oversight function, operating in a different jurisdiction with a comparable mission to protect research participants.

Direct peers

• Administration of Radioactive Substances Advisory Committee (ARSAC): UK advisory committee on administration of radioactive substances, with HRA cooperation on research approvals. ARSAC is a small, structurally related UK health research advisory body with a comparable NDPB-style governance model.
• Medicines and Healthcare products Regulatory Agency (MHRA): UK's regulator for clinical trial authorizations and medicines/medical devices. MHRA and HRA jointly handle clinical trial approvals (MHRA = authorization, HRA = ethics review) under a formal cooperation agreement, making them the most directly comparable sister regulatory body.
• Human Fertilisation and Embryology Authority (HFEA): UK regulator for fertility treatment and embryo research. HFEA cooperates with HRA on research approvals and shares a similar statutory NDPB structure, making it a directly comparable UK health research regulator with overlapping research ethics remit.
• Human Tissue Authority (HTA): UK statutory regulator licensing storage of human tissue for research. HTA and HRA cooperate on regulatory processes for tissue-related research, making HTA a structurally parallel UK health research regulator with comparable statutory footing.

Broad incumbents

• National Institute for Health and Care Research (NIHR): UK's primary funder of health and social care research. NIHR funds research while HRA regulates it; they cooperate on the LMS (NIHR Learn) and approvals, making NIHR a deeply interrelated UK health research body rather than a direct competitor.
• U.S. Food and Drug Administration (FDA): U.S. regulator with overlapping jurisdiction over clinical trial authorization and broader medical product oversight. FDA is a much larger, broader incumbent whose clinical trial review functions partially overlap with HRA + MHRA's combined role.
• European Medicines Agency (EMA): EU-level regulator for clinical trial authorization and medicinal products. EMA shares clinical trial regulatory scope with HRA/MHRA and represents a relevant international peer for cross-border research framework design.
• Australian National Health and Medical Research Council (NHMRC): Australia's primary public health and medical research funder and ethics standard-setter. NHMRC's national research ethics framework (National Statement on Ethical Conduct in Human Research) is the closest Australian analog to HRA's UK Policy Framework.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks5 records

Key highlights7 records

Customer concentration

• Xx.com/HRA_Latest
• LinkedInlinkedin.com/company/health-research-authority
• Facebookfacebook.com/HealthResearchAuthority

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds

Investors

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M&A

Investments

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Frequently asked questions about HRA