CASRAI Dictionary

Tag: uk policy framework for health and social care research

  • Research Governance Framework for Health and Social Care: What It Requires

    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 The original Department of Health document of that name (2001, second edition 2005) was withdrawn on 7 November 2017 and replaced by the UK Policy Framework for Health and Social Care Research, published by the Health Research Authority (HRA).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?

    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    Why was the original framework withdrawn — and what replaced it?

    GOV.UK’s official record confirms the Research Governance Framework for Health and Social Care “was withdrawn on 7 November 2017”. It was superseded by the UK Policy Framework for Health and Social Care Research, published in October 2017 by the HRA together with the health departments of Northern Ireland,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)

    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.

  • Research Governance Officer: Role and Remit

    A research governance officer is the institutional post responsible for checking that a research project — most often a clinical trial or human-participant study — has the approvals, contracts, insurance and regulatory sign-offs before it starts, and for monitoring compliance throughout. The role differs from the research integrity officer, who investigates misconduct after the fact.

    Research governance is the framework of regulations, principles and standards of good practice through which the quality, safety and accountability of research involving human participants, data or tissue is monitored and assured. This explainer sets out what the role covers day to day, how it differs from research integrity, and where it typically reports.

    What Does a Research Governance Officer Do?

    A research governance officer reviews study documentation — protocols, participant information sheets, indemnity and insurance arrangements, data-sharing agreements, and contracts with sponsors or CROs — before a project is authorised to open at a site. Once a study is live, they monitor amendments, adverse-event reporting and ongoing compliance against the approvals granted.

    Core duties typically include:

    • Reviewing feasibility and capacity before a site accepts a study
    • Checking regulatory and ethical approvals are in place and current
    • Negotiating and countersigning research contracts and costing agreements
    • Conducting site-specific or local authorisation checks
    • Monitoring protocol amendments, deviations and adverse events
    • Advising investigators, sponsors and ethics committees on governance requirements
    • Logging and triaging complaints or concerns about the conduct of a study

    The role is administrative and risk-based rather than investigative: a research governance officer exists to stop non-compliant studies from starting, and to catch drift once they are under way — not to adjudicate whether a named researcher acted dishonestly.

    Research Governance Officer vs Research Integrity Officer

    The two roles are frequently confused because both sit under an institution’s wider compliance function, but they answer different questions. Governance asks “was this study set up and run according to the rules?” Integrity asks “did this researcher tell the truth?”

    Aspect Research Governance Officer Research Integrity Officer
    Primary focus Legal, contractual and regulatory compliance of a study Ethical conduct and honesty of individual researchers
    Typical trigger Study setup, amendment, or routine monitoring An allegation of misconduct (fabrication, falsification, plagiarism)
    Timing Before and during the research Usually after a concern is raised
    Governing reference UK Policy Framework for Health and Social Care Research; ICH Good Clinical Practice US Public Health Service Policies on Research Misconduct, 42 CFR Part 93 (US); institutional codes of practice (UK/EU)
    External liaison Health Research Authority, funders, sponsors, ethics committees Office of Research Integrity (US), UK Research Integrity Office, COPE

    Because the remits differ, the two functions are usually kept organisationally separate. A research governance officer who also adjudicated misconduct cases would face an obvious conflict of interest with the sponsors and investigators they routinely work alongside.

    Typical Reporting Lines and Where the Role Sits

    A research governance officer usually reports to a Head of Research Governance, R&D Manager, or Director of Research Operations, who in turn reports to a Pro-Vice-Chancellor for Research at a university, or a Director of Research and Development at an NHS trust or health board. In UK NHS organisations, the post commonly sits within a Research and Development (R&D) office and works closely with the local Research Ethics Committee (REC) and the sponsor’s clinical trials unit.

    By contrast, a research integrity officer is deliberately positioned for independence — often reporting directly to a Vice-Chancellor, Provost, or an institutional Research Integrity Committee, rather than through the same line as the operational governance team. This separation protects whistleblowers and preserves the impartiality of any misconduct investigation.

    Professional bodies such as ARMA (the Association of Research Managers and Administrators, UK), EARMA (Europe), NCURA (US) and the international umbrella body INORMS have progressively professionalised research management and governance as a distinct career track, with defined competency frameworks separate from research integrity casework.

    Research Governance Frameworks: UK, Australia and Beyond

    The specific rules a research governance officer applies vary by jurisdiction, though the underlying purpose — assuring quality, safety and accountability — is consistent internationally.

    In the UK, the Health Research Authority (HRA) maintains the UK Policy Framework for Health and Social Care Research (first published 2017, updated 2018), which superseded the 2005 Research Governance Framework for Health and Social Care. Clinical research governance officers also apply the ICH Good Clinical Practice (GCP) guideline, which sets international standards for the design, conduct and reporting of clinical trials.

    In Australia, the equivalent function is often titled Research Governance Officer explicitly, and is built around the NHMRC’s National Statement on Ethical Conduct in Human Research (2023). These officers conduct Site-Specific Assessment (SSA) reviews under state-based mutual acceptance schemes, checking local site capacity and resourcing after a Human Research Ethics Committee (HREC) has already approved the ethical dimensions of a study — a two-stage model (ethics, then governance) that is more formally separated than the equivalent UK process.

    This ethics/governance split is a genuine structural distinction most UK-focused explainers of the role omit: in the Australian National Mutual Acceptance model, ethical review and site governance review are statutorily distinct steps performed by different bodies, whereas UK practice more often blends elements of both within a single R&D sign-off.

    Common Questions About the Research Governance Officer Role

    What is a research governance officer?

    A research governance officer provides support and advice to investigators, sponsors, ethics committees and site leadership on regulatory compliance, contracts and risk before and during a study. The role ensures research is conducted in line with national frameworks, institutional policy and applicable legislation, rather than assessing individual researcher conduct.

    What is the role of a governance officer?

    A governance officer checks that an organisation’s activities comply with the rules that apply to them. In a research setting, this means verifying approvals, contracts, insurance and data-handling arrangements are in place before work starts, and monitoring compliance as the project progresses — a risk-management function, not a disciplinary one.

    Is governance a good career?

    Research governance offers a structured career path through R&D offices, university research services, and NHS trusts, with progression from officer to manager to director-level roles. Bodies such as ARMA, EARMA and INORMS provide competency frameworks and professional development routes, giving the field defined progression that is less common in adjacent compliance roles.

    Why the Distinction Matters for Institutions

    Institutions that conflate governance and integrity functions risk two failures: slower study setup, because a single overstretched post is asked to do both routine compliance checks and rare, high-stakes misconduct investigations; and weaker independence, because the same person cannot simultaneously advise a sponsor on contract terms and later investigate that sponsor’s investigator for alleged fabrication. Keeping the roles organisationally distinct — with separate reporting lines as described above — protects both throughput and impartiality.

    As research increasingly spans borders, jurisdictional literacy also matters: a governance officer working across UK and Australian sites needs to recognise that “research governance officer” describes a materially different process step in each system, not merely a different job title for the same task. Institutions building shared services or international collaborations should map these differences explicitly rather than assuming equivalence. For readers mapping this role against the wider research administration landscape, CASRAI’s research administration resources set out how governance, integrity and related functions fit together, and the CASRAI Dictionary collects definitions for adjacent terms.

  • 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.