- What Is the UK Policy Framework for Health and Social Care Research?
- The 19 Principles: Structure and Scope
- Sponsor Responsibilities for Grant-Funded Studies
- REC Review and NHS/HRA Approval
- Governance Across the Four UK Nations
- Frequently Asked Questions
- Implications for Research Administrators
- What This Means Going Forward
What Is the UK Policy Framework for Health and Social Care Research?
The UK Policy Framework for Health and Social Care Research is the single set of standards that governs how health and social care research is designed, sponsored, approved, and reported across England, Northern Ireland, Scotland, and Wales. It was published by the Health Research Authority (HRA) and the four UK health departments in October 2017, replacing the separate national Research Governance Frameworks that each country had previously maintained since the early 2000s.
For research administrators, the practical significance is that a single rulebook now applies wherever the study touches NHS or Health and Social Care (HSC) patients, service users, data, or tissue — regardless of whether the funder is a UK research council, a charity, a university, or a life sciences company. Any study that falls within scope requires a designated sponsor, appropriate ethical and regulatory approval, and proportionate ongoing oversight before, during, and after delivery.
The 19 Principles: Structure and Scope
The framework is built around 19 principles of good practice, split into two tiers. The first 15 apply to all health and social care research; the final four apply only to interventional research, where treatment, care, or service delivery is changed for research purposes.
- Principles 1–15 (all research): Safety, Competence, Scientific and Ethical Conduct, Patient/Service User/Public Involvement, Integrity/Quality/Transparency, Protocol, Legality, Benefits and Risks, Approval, Information about the Research, Accessible Findings, Choice, Insurance and Indemnity, Respect for Privacy, and Compliance.
- Principles 16–19 (interventional research only): Justified Intervention, Ongoing Provision of Treatment, Integrity of the Care Record, and Duty of Care.
Principle 9 (Approval) and Principle 10 (Information about the Research) are the two most operationally significant for grant-funded studies: no study may start until it has a favourable Research Ethics Committee (REC) opinion where required, and every study — bar limited waivers — must be registered publicly before recruitment begins to avoid research waste.
Sponsor Responsibilities for Grant-Funded Studies
Every study in scope must have a sponsor: the individual, organisation, or partnership that takes overall responsibility for proportionate, effective arrangements to set up, run, and report the research. For non-commercial, grant-funded studies the sponsor is normally the employer of the chief investigator; for commercial studies it is normally the funder. Crucially, an employer or funder does not become the sponsor automatically — the role must be explicitly accepted and documented.
Under the framework, the sponsor’s overall responsibility includes:
- Identifying and addressing poorly designed research and ensuring proposals are scientifically sound, safe, ethical, legal, and feasible for the duration of the study.
- Satisfying itself that investigators, the research team, and research sites are suitable.
- Documenting agreed roles, responsibilities, and any delegation of sponsor tasks.
- Ensuring adequate insurance or indemnity is in place to cover liabilities arising from the research.
- Ensuring public registration before the study starts and accessible reporting of data, tissue, and findings afterwards.
- Confirming REC and any other required regulatory approvals are secured before the research begins.
- Maintaining adequate finance, risk management, and data management arrangements throughout delivery.
- Keeping effective monitoring, progress-reporting, and safety-reporting procedures in place.
Sponsors of clinical trials of investigational medicinal products (CTIMPs) carry additional statutory duties under the Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031, as amended). Universities and colleges are expected to accept the sponsor role for educational research conducted by their own students, unless the student’s NHS or social care employer prefers to take it on.
REC Review and NHS/HRA Approval
Research Ethics Committee review is the framework’s central quality gate. No study may start unless a REC — and, where applicable, another approval body such as the Medicines and Healthcare products Regulatory Agency (MHRA), the Human Fertilisation and Embryology Authority (HFEA), or the Administration of Radioactive Substances Advisory Committee (ARSAC) — has issued a favourable opinion on the protocol and supporting documentation.
In England, REC review is bundled with the confirmation of capacity and capability at NHS organisations through the HRA Approval process, which replaced separate local Research and Development (R&D) sign-off across NHS trusts in 2016. Applications are submitted and tracked through the Integrated Research Application System (IRAS). This single-approval model is one of the framework’s clearest efficiency gains over the pre-2017 regime, in which sponsors could face duplicated ethics and governance review at every participating site.
The following table summarises the approval routes that sit alongside REC review, depending on study type.
| Study type | Additional approval body | Legal basis |
|---|---|---|
| Clinical trials of investigational medicinal products (CTIMPs) | MHRA | Medicines for Human Use (Clinical Trials) Regulations 2004 |
| Studies using ionising radiation | ARSAC | Ionising Radiation (Medical Exposure) Regulations |
| Research involving human embryos or gametes | HFEA | Human Fertilisation and Embryology Act 1990 |
| Research using confidential patient information without consent | Confidentiality Advisory Group (CAG) | Health Service (Control of Patient Information) Regulations 2002 |
Governance Across the Four UK Nations
Because health and social care are devolved matters, the framework is implemented by a different lead body in each nation, though the 19 principles and sponsor duties remain constant UK-wide.
- England: Health Research Authority (HRA) — covers health and adult social care research.
- Northern Ireland: Department of Health (Northern Ireland) — covers health and social care.
- Scotland: Scottish Government Health and Social Care Directorates — covers health and adult social care.
- Wales: Department for Health, Social Care and Early Years, operationalised through Health and Care Research Wales.
Underlying legislation also varies by nation. Common UK-wide law includes the Data Protection Act 2018, UK GDPR, and the Human Tissue Act, while instruments such as the Adults with Incapacity (Scotland) Act 2000 and the Mental Capacity Act 2005 (England and Wales) apply only where the relevant nation’s remit covers them — a detail sponsors running multi-nation studies frequently miss.
Frequently Asked Questions
What is a policy framework?
A policy framework is a structured set of principles, standards, and accountabilities that organisations must follow within a defined area of activity. In health and social care research, the UK Policy Framework sets 19 such principles covering safety, ethics, transparency, and sponsor accountability, replacing what were previously separate national governance documents.
What are the ethical frameworks for health research?
Health research ethics in the UK draws on established principles — autonomy, beneficence, non-maleficence, and justice — operationalised through REC review under the UK Policy Framework. Principles 3, 4, and 12 of the framework specifically require scientifically sound, ethically conducted studies with informed participant choice.
What are some policies in health and social care?
Alongside the UK Policy Framework, relevant policies include data protection and confidentiality rules (UK GDPR, Data Protection Act 2018), safeguarding policies, consent and capacity policies, and organisation-specific research governance procedures that translate the framework’s sponsor and REC approval requirements into local practice.
What are frameworks in healthcare?
In healthcare, a framework is a formally published document that sets shared expectations for practice across organisations. The UK Policy Framework for Health and Social Care Research is one such framework: a single, UK-wide reference that sponsors, investigators, and NHS/HSC organisations must follow when managing research involving patients or service users.
Implications for Research Administrators
For institutional research offices, the framework’s practical weight falls on three activities: confirming sponsorship arrangements before a grant is accepted, tracking REC and HRA/NHS approval milestones against funder timelines, and maintaining the documentation trail — protocols, risk assessments, monitoring reports — that demonstrates ongoing compliance with the 19 principles.
Bodies such as the Association of Research Managers and Administrators (ARMA) in the UK, and international counterparts including INORMS and NCURA, treat sponsor-duty literacy as a core competency for research administration staff, precisely because sponsor obligations under this framework sit outside the funder’s own grant terms and conditions — a distinction that is frequently misunderstood by newly grant-funded principal investigators.
A common failure mode is treating “sponsor” and “funder” as synonymous. They are not: a funder can decline the sponsor role entirely, leaving the chief investigator’s employer to accept it, with all the attendant obligations around insurance, monitoring, and public registration described above.
What This Means Going Forward
The UK Policy Framework for Health and Social Care Research remains the definitive reference for governance obligations across NHS and HSC research, and its principle-based, proportionate design has held up well against a decade of regulatory change, including UK GDPR and post-Brexit clinical trials reform. For institutions managing grant-funded clinical or social care studies, the operational priority is unchanged: confirm sponsorship early, sequence REC and NHS approval realistically against funder milestones, and keep documentation aligned to the framework’s principles rather than treating it as a one-off compliance checkbox.
Research administrators seeking to embed these obligations into wider institutional practice may find it useful to review CASRAI’s broader coverage of research administration standards and terminology in the CASRAI Dictionary.
