The research governance framework for health and social care is the UK-wide system of principles, defined roles and formal approvals that govern how health and social care research is designed, sponsored, hosted and conducted. The original Department of Health document of that name (2001, second edition 2005) was withdrawn on 7 November 2017 and replaced by the UK Policy Framework for Health and Social Care Research, published by the Health Research Authority (HRA). This guide sets out what the current framework actually requires of sponsors, host organisations and investigators.
The UK Policy Framework for Health and Social Care Research is the Health Research Authority’s single, UK-wide set of principles — replacing the four separate national Research Governance Frameworks — that defines proportionate, assurance-based management of health and social care research involving patients, service users, carers or their data.
- What is the research governance framework for health and social care?
- Why was the original framework withdrawn — and what replaced it?
- What does the current framework require of sponsors?
- What does it require of host organisations?
- What does it require of investigators?
- Common questions about research governance
- What this means for research teams today
- The bottom line
What is the research governance framework for health and social care?
The Research Governance Framework for Health and Social Care was first published by the Department of Health in 2001, with a second edition on 24 April 2005. It set out principles, requirements and standards that applied to research falling within the responsibilities of the Secretary of State for Health.
It formalised three roles that still anchor governance today: a sponsor taking overall responsibility for a study, an NHS or care organisation granting local research-and-development (R&D) permission, and a Chief Investigator leading the research. Most searches for “research governance framework” still refer to this historic document, even though it no longer governs live research.
Why was the original framework withdrawn — and what replaced it?
GOV.UK’s official record confirms the Research Governance Framework for Health and Social Care “was withdrawn on 7 November 2017”. It was superseded by the UK Policy Framework for Health and Social Care Research, published in October 2017 by the HRA together with the health departments of Northern Ireland, Scotland and Wales, following public consultation.
The change replaced four separate country-level research governance frameworks with one UK-wide document. According to the HRA, the policy framework “replaces the separate Research Governance Frameworks in each UK country with a single, modern set of principles for the whole UK.” The framework was itself informed by earlier standards, including ICH Good Clinical Practice (ICH GCP) and the pan-European RESPECT ethical guidelines, rather than being written from scratch.
Practically, the core accountability structure — sponsor, host, investigator — carried over. What changed was terminology, scope (a single UK document instead of four) and the mechanics of local sign-off, discussed below.
| Aspect | Research Governance Framework (2001; 2nd ed. 2005) | UK Policy Framework for Health and Social Care Research (2017–present) |
|---|---|---|
| Status | Withdrawn 7 November 2017 | Current governing document |
| Publisher | Department of Health | Health Research Authority, with health departments of Northern Ireland, Scotland and Wales |
| Geographic scope | Separate framework per UK nation | Single set of principles across England, Northern Ireland, Scotland and Wales |
| Local sign-off | “R&D approval/permission” issued by individual NHS trusts | “Capacity and capability” confirmation by host organisations |
| Core roles | Sponsor, R&D-approving organisation, Chief Investigator | Sponsor, host organisation, Chief Investigator, Principal Investigator (per site) |
What does the current framework require of sponsors?
Every study within scope must have a named sponsor — an individual, organisation or partnership that takes overall responsibility for setting up, running and reporting the research. For non-commercial studies, the sponsor is typically the employer of the Chief Investigator (often a university or NHS trust); for commercial studies, the funding company usually sponsors directly.
- Ensuring the protocol is scientifically sound before the study starts
- Securing a favourable opinion from a Research Ethics Committee (REC) and any other required regulatory approvals
- Putting proportionate quality, risk-management and monitoring systems in place
- Arranging adequate insurance or indemnity to cover potential liabilities
- Taking responsibility for accurate reporting, registration and dissemination of findings
Sponsorship is a formal role that must be explicitly accepted in writing — it is never assumed by default.
What does it require of host organisations?
The framework does not use the word “host” as a defined technical term, but the obligations fall on the research site or employing organisation — an NHS trust, university, or social care provider where the research actually takes place. Under HRA Approval, hosts confirm capacity and capability rather than issuing the older-style “R&D permission”.
- Confirming the site has the resources, facilities and capability to deliver the research safely
- Completing local capacity and capability checks before recruitment begins at that site
- Ensuring staff involved are appropriately qualified, trained and supervised
- Safeguarding the dignity, rights, safety and wellbeing of participants at that site
- Working collaboratively with the sponsor and Chief Investigator throughout the study
What does it require of investigators?
The Chief Investigator (CI) is the overall lead researcher and, for clinical trials, must be a healthcare professional. In multi-site studies, a Principal Investigator (PI) holds equivalent responsibility for conduct at each individual site.
- Conducting the research to the approved protocol and to high scientific and ethical standards
- Obtaining valid informed consent from every participant before they take part
- Protecting participant dignity, rights, safety and wellbeing throughout the study
- Reporting adverse events and unexpected issues to the sponsor and REC promptly
- Collecting, recording and storing data accurately and securely
Common questions about research governance
What is a research governance framework?
A research governance framework is the set of regulations, principles and standards that govern how health and social care research is designed, approved, conducted and reported. It defines who holds responsibility — the sponsor, host organisation and investigator — and sets the assurance and oversight arrangements that protect participants and data.
What is the UK Policy Framework for Health and Social Care Research?
The UK Policy Framework for Health and Social Care Research is the document that has governed UK health and social care research since October 2017, when the Health Research Authority and the health departments of Northern Ireland, Scotland and Wales replaced the country-specific research governance frameworks with one UK-wide set of principles.
What is research governance in the NHS?
In the NHS, research governance means every study has a designated sponsor who takes overall responsibility, a host organisation that confirms capacity and capability, and an investigator who leads day-to-day conduct — with a favourable Research Ethics Committee opinion required before recruitment can begin under HRA approval.
What are the 7 pillars of clinical governance, and how does that differ from research governance?
Clinical governance covers seven pillars — education and training, clinical audit, clinical effectiveness, staffing, patient involvement, risk management and information governance — and concerns everyday care quality. Research governance is a distinct system specific to research projects, covering sponsorship, ethical approval and investigator accountability rather than routine service delivery.
What this means for research teams today
Any protocol, SOP or training material that still cites the “Research Governance Framework for Health and Social Care” as live guidance is referencing a document withdrawn in 2017. Institutions relying on legacy templates risk misaligning their sponsor and host obligations with current HRA Approval processes, particularly around capacity-and-capability sign-off rather than the older R&D permission route.
The HRA’s guidance page on the current framework shows a last-reviewed date of 10 January 2025, indicating the 2017 principles remain the active, maintained standard rather than a static one-off publication. Research administrators and R&D offices should audit internal documents against the current text on the HRA website, not archived Department of Health PDFs.
The bottom line
The research governance framework that many searches still name no longer governs UK health and social care research: the UK Policy Framework for Health and Social Care Research has done so since 2017. Its sponsor, host and investigator obligations are more precisely defined than the 2005 document they replaced, and they are the requirements institutions must demonstrate compliance with today. As research becomes more decentralised and data-driven, these role definitions — rooted in accountability, capability and consent — remain the reference point for governance across England, Northern Ireland, Scotland and Wales.
For related definitions and role frameworks, see CASRAI’s research administration resources and the research administration dictionary.
