CASRAI Dictionary

Tag: research governance framework

  • Research Governance Framework Explained: What UK Institutions Must Comply With

    Search “research governance framework” today and you land on documents that are, technically, retired. The Research Governance Framework for Health and Social Care — first issued in 2001 and revised in April 2005 by the Department of Health — was superseded across the UK by October 2017. Yet the phrase persists in job titles, standard operating procedures, contracts and search queries, because the underlying obligations never went away; they were consolidated, not abolished. This explainer sets out what the term still refers to in practice, what replaced it, and the concrete checklist a UK research office needs to satisfy compliance today.

    What was the Research Governance Framework?

    The Research Governance Framework (RGF) was the Department of Health’s statement of principles, requirements and standards applying to health research within the responsibilities of the Secretary of State for Health in England. Scotland, Wales and Northern Ireland each issued their own, broadly parallel versions, so a multi-site UK trial could in practice be answering to four separate documents.

    The RGF organised obligations around five domains:

    • Ethics and patient information — protecting participants’ rights, dignity, safety and informed consent
    • Science — ensuring research design is valid and methodologically sound
    • Information — confidentiality, data handling and transparent reporting of findings
    • Health and safety, and employment — competence, training and safe working environments for researchers
    • Finance and intellectual property — transparent management of funds and fair attribution

    One point of genuine confusion: “Research Governance Framework” was never a protected or exclusive title. Non-health public bodies still publish their own documents under exactly this name for research that touches their own remit rather than the NHS — the Gambling Commission maintains a current “Research governance framework” for its evidence programme, and several local authorities (Manchester City Council, Tower Hamlets among them) use the same title for research governance approval processes involving council data or vulnerable residents. These are legitimate, separate documents; they are not the health and social care framework this article addresses, and conflating the two is a common source of misdirected compliance effort.

    What replaced it: the UK Policy Framework for Health and Social Care Research

    The Health Research Authority (HRA) became a non-departmental public body on 1 January 2015 and took on responsibility for research governance guidance in England. Working with the health departments of Northern Ireland, Scotland and Wales, the HRA then issued the UK Policy Framework for Health and Social Care Research in October 2017, replacing the four devolved Research Governance Frameworks with a single, UK-wide document. The HRA has since kept it under active revision — the version in force was last updated in January 2025.

    The structural change matters more than a rename. The RGF was organised as five fixed domains; the UK Policy Framework is organised around defined roles across the research lifecycle — funders, sponsors, researchers and their employers, research sites and care providers — with each role carrying explicit duties, rather than a single institution being expected to satisfy five generic principles.

    Aspect Research Governance Framework (2001/2005–2017) UK Policy Framework for Health and Social Care Research (2017–present)
    Geographic scope England only; Scotland, Wales and Northern Ireland each had separate equivalent documents Single framework covering all four UK nations
    Issuing body Department of Health (England) Health Research Authority, with the devolved health departments
    Structure Five fixed domains (ethics, science, information, safety/employment, finance/IP) Role-based duties across funders, sponsors, researchers, employers and sites
    Sponsor concept Introduced but loosely defined Central and explicit: every study must have an identified sponsor accepting overall responsibility
    Last major update Second edition, April 2005 Updated January 2025

    Institutions applying for MRC/UKRI clinical research funding must now nominate a sponsor as a condition of the grant, and directors of MRC institutes are required to keep systematic documentation of every project for which sponsorship responsibility has been accepted — a direct operational consequence of the framework’s sponsor-centred structure. Read more about how these governance obligations sit alongside institutional research administration functions more broadly.

    Answer-first: common research governance questions

    What is an example of a governance framework?

    The clearest current UK example is the UK Policy Framework for Health and Social Care Research, issued by the Health Research Authority and the devolved health departments. Sector-specific equivalents also exist outside health, such as the Gambling Commission’s own research governance framework, which governs a different remit entirely.

    What are the 7 Nolan principles of good governance?

    The Nolan Principles — selflessness, integrity, objectivity, accountability, openness, honesty and leadership — were set out by the Committee on Standards in Public Life in 1995. They underpin conduct expected of anyone working in or for UK public bodies, including NHS research staff and research ethics committee members.

    What are the 7 key ethical principles in research?

    Widely cited principles include social/scientific value, informed consent, favourable risk-benefit balance, independent review, respect for participants, fairness in selection and confidentiality. UK Research Ethics Committees, coordinated by the HRA, apply equivalent tests when reviewing health and social care research proposals.

    What are the 8 elements of good governance?

    A commonly cited international model (UN ESCAP) lists participation, rule of law, transparency, responsiveness, consensus orientation, equity/inclusiveness, effectiveness/efficiency and accountability. UK research governance instruments draw on the same underlying accountability and transparency principles, adapted for research-specific risk.

    The compliance checklist: what research offices must have in place

    Whichever term staff still use internally, a UK research office running health or social care studies needs the following in place to satisfy the current framework:

    • A named sponsor — an organisation or individual formally accepting overall responsibility for each study
    • Applications and approvals managed through the Integrated Research Application System (IRAS) and, where applicable, a Research Ethics Committee (REC) opinion
    • Local NHS Research and Development (R&D) permissions confirmed at every participating site before recruitment begins
    • Documented risk assessment covering ethics, scientific validity, data protection, finance and health and safety
    • A named Principal Investigator per project with defined accountability
    • Data handling compliant with UK GDPR and the Data Protection Act 2018
    • Insurance and indemnity arrangements appropriate to the research type
    • Evidence of Good Clinical Practice (GCP) training and up-to-date competency records for research staff
    • Adverse event and complaints reporting procedures, escalating to the sponsor and, where relevant, the REC
    • Records retention and archiving arrangements consistent with sponsor and funder requirements

    Institutions can cross-check specific terminology — sponsor, REC, IRAS and related definitions — against a standards-aligned research governance terminology dictionary when drafting internal SOPs.

    Implications for institutions still using RGF language

    Institutions that still reference “the Research Governance Framework” in SOPs, job descriptions or supplier contracts are not automatically non-compliant, but they are working from superseded terminology that can create real gaps. A research governance officer hired against a job description written around the five 2005 domains may miss role-based duties the UK Policy Framework assigns specifically to sponsors or funders. Auditors and REC reviewers now expect documentation mapped to the current framework’s roles, not the old domain structure, so internal policy documents drafted before 2017 — and never revisited since the January 2025 update — are a genuine compliance risk worth flagging in the next governance review cycle.

    The practical fix is straightforward: retitle internal documents to reference the UK Policy Framework for Health and Social Care Research explicitly, re-map existing SOPs from the five domains to the current role-based duties, and confirm sponsorship arrangements are documented per project rather than assumed at institutional level.

    Looking ahead

    The Health Research Authority continues to revise the UK Policy Framework rather than replace it outright — the January 2025 update is evidence of an iterative model rather than another wholesale rewrite. For research offices, that means the practical task is not tracking down a new document every few years, but keeping local SOPs, sponsorship records and R&D permissions current against a single framework that evolves incrementally. Institutions that treat “Research Governance Framework” purely as historical vocabulary, while keeping their compliance architecture mapped to the UK Policy Framework’s role-based duties, are the ones best placed to pass audit and REC scrutiny without disruption.

  • UK Policy Framework for Health and Social Care Research: A Governance Primer

    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.

    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:

    1. Identifying and addressing poorly designed research and ensuring proposals are scientifically sound, safe, ethical, legal, and feasible for the duration of the study.
    2. Satisfying itself that investigators, the research team, and research sites are suitable.
    3. Documenting agreed roles, responsibilities, and any delegation of sponsor tasks.
    4. Ensuring adequate insurance or indemnity is in place to cover liabilities arising from the research.
    5. Ensuring public registration before the study starts and accessible reporting of data, tissue, and findings afterwards.
    6. Confirming REC and any other required regulatory approvals are secured before the research begins.
    7. Maintaining adequate finance, risk management, and data management arrangements throughout delivery.
    8. 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.