CASRAI Dictionary

Tag: NHS research governance

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 The original Department of Health document of that name (2001, second edition 2005) was withdrawn on 7 November 2017 and replaced by the UK Policy Framework for Health and Social Care Research, published by the Health Research Authority (HRA).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    Why was the original framework withdrawn — and what replaced it?

    GOV.UK’s official record confirms the Research Governance Framework for Health and Social Care “was withdrawn on 7 November 2017”. It was superseded by the UK Policy Framework for Health and Social Care Research, published in October 2017 by the HRA together with the health departments of Northern Ireland,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

    Research misconduct NHS allegations are not resolved as a purely internal university disciplinary matter. Because a designated research sponsor and the Health Research Authority (HRA) hold formal accountability under the UK Policy Framework for Health and Social Care Research, misconduct in NHS-hosted clinical studies routes through trust-level research governance and, for doctors, potential General Medical Council scrutiny — running alongside, not instead of, any university process.

    Research misconduct is behaviour that deliberately or recklessly falls short of the standards expected in the conduct of research, spanning fabrication, falsification, plagiarism, and breaches of the ethical or regulatory approvals a study depends on.

    What Counts as Research Misconduct in NHS-Hosted Research?

    In an NHS setting, research misconduct covers the same core categories recognised across UK research generally, but with an added patient-safety dimension. Proceeding without the ethics approval, HRA Approval, or informed consent a study requires is treated as seriously as fabricating data.

    • Fabrication or falsification of results, including patient consent records
    • Plagiarism of ideas, protocols, or published text
    • Undeclared conflicts of interest affecting clinical decision-making
    • Conducting research without the required ethical or regulatory permissions in place
    • Deviating from an approved protocol without reporting the change

    The UK Research Integrity Office (UKRIO) frames this as behaviour that “deliberately or recklessly” falls short of expected standards — a threshold that separates genuine misconduct from honest error, which most NHS trust policies classify instead as a “questionable research practice” requiring correction rather than disciplinary action.

    Who Investigates? The Sponsor, the HRA and Trust Governance

    The pivotal difference from a university-only inquiry is the statutory concept of the research sponsor. Under the UK Policy Framework for Health and Social Care Research (Health Research Authority and the four UK health departments, first published 2017), the sponsor — usually the NHS trust, a university, or a commercial entity — takes on legal responsibility for confirming a study’s initial and ongoing suitability.

    This changes who is notified and when:

    • The NHS trust’s Research and Development (R&D) office, or the trust’s Director of Research, typically leads the initial assessment of an allegation raised on trust premises
    • Serious breaches of Good Clinical Practice or the approved protocol in a clinical trial must be reported by the sponsor to the HRA (and, for medicines trials, the MHRA) within statutory timeframes — a duty that has no direct equivalent in a purely observational university study
    • The relevant NHS Research Ethics Committee must be informed where the breach affects participant safety or the ethical basis of the study
    • Where fraud is suspected, the NHS Counter Fraud Authority can be engaged in parallel to any research-integrity investigation
    • For registered doctors, nurses, or other regulated professionals, a finding of misconduct can trigger a separate referral to the General Medical Council or equivalent professional regulator, independent of the employer’s own outcome

    UKRIO’s model procedure — the template most university codes of practice are built on — is advisory rather than statutory. NHS research governance, by contrast, sits inside a framework with mandatory reporting duties attached to the sponsor role, which is why an allegation in an NHS-hosted trial can trigger regulatory notifications a university-only investigation would never generate.

    NHS Research Misconduct vs University Procedures: Where They Diverge

    Both systems share the same underlying commitments — the Concordat to Support Research Integrity (Universities UK, 2019) and UKRIO’s guidance inform both — but the accountable parties and mandatory notifications differ sharply.

    Dimension University-led research NHS-hosted clinical research
    Primary framework Concordat to Support Research Integrity (Universities UK, 2019) UK Policy Framework for Health and Social Care Research (HRA, 2017)
    Accountable party The employing institution’s “Named Person” / Responsible Officer The research sponsor, working with the host trust’s R&D office
    Investigating body Institutional panel, often with external academic peers Trust governance process, informed by sponsor obligations to the HRA
    Mandatory external notification Rare — typically only funders or journals if the record needs correcting HRA/MHRA for serious breaches; REC for participant-safety issues; Counter Fraud Authority where fraud is suspected
    Professional regulator exposure Uncommon unless a professional body membership is engaged Possible GMC, NMC or equivalent fitness-to-practise referral for regulated clinicians
    Guiding non-statutory body UKRIO model procedure UKRIO guidance, applied within HRA sponsor obligations

    The practical effect: an NHS-hosted allegation can generate two or more concurrent processes — sponsor/trust governance and, if a professional regulator becomes involved, a fitness-to-practise track — whereas a university-only case usually resolves within a single institutional procedure.

    What Dual-Employment Researchers Need to Know

    Most clinical academics hold a substantive university post alongside an honorary research contract or “letter of access” with an NHS trust, arranged through the NHS Research Passport system. This dual status means an allegation can, in principle, be picked up by either employer’s procedure — or both.

    • Establish early which organisation is the study’s sponsor: sponsor obligations under the UK Policy Framework sit with that entity, not automatically with the employer
    • Expect the university and the NHS trust to agree a lead institution for the investigation, informed by UKRIO’s guidance on cross-institutional cooperation, with the second body kept informed rather than running a parallel duplicate inquiry
    • Understand that an honorary contract does not exempt a researcher from either institution’s disciplinary powers — sanctions (suspension of research privileges, restriction of clinical duties, dismissal) can be applied independently by each party
    • Keep records of ethical approvals, protocol versions, and consent documentation accessible to both employers, since a trust R&D office and a university research office may request the same evidence separately

    Research administrators supporting joint appointments should confirm, before a study opens, which institution’s misconduct procedure will apply if a concern is raised — this sits alongside the wider governance responsibilities covered under research administration frameworks.

    Frequently Asked Questions

    What is an example of misconduct in the NHS?

    In an NHS research context, a documented example is proceeding with a clinical trial without valid ethics approval or falsifying patient consent records. Both breach the UK Policy Framework for Health and Social Care Research and trigger sponsor reporting duties to the Health Research Authority, independent of any wider workplace conduct issue.

    What are the three types of research misconduct?

    The three most widely recognised categories are fabrication (inventing data or results), falsification (manipulating data, materials, or processes to misrepresent findings), and plagiarism (using others’ work or ideas without acknowledgement). UK bodies including UKRIO also recognise a broader “questionable research practices” category for less severe lapses.

    What is considered the most serious form of research misconduct?

    Fabrication of results or consent data is generally treated as the most serious category, because it directly corrupts the evidence base and, in clinical research, can endanger patient safety. In NHS-hosted studies, fabrication findings typically prompt both sponsor notification to the HRA and professional regulator referral for the individual involved.

    What is a sackable offence in NHS?

    A confirmed finding of fabrication or falsification in NHS-hosted research is normally treated as gross misconduct and can constitute a sackable offence under trust disciplinary policy. For registered clinicians, the same finding can additionally trigger a General Medical Council fitness-to-practise referral, separate from the employer’s own decision.

    The structural distinction matters beyond individual cases. As more clinical trials run through joint university–NHS sponsorship arrangements, institutions that treat research governance as a single, unified track — rather than mapping sponsor, trust, and employer obligations separately — risk missing mandatory notifications the UK Policy Framework requires. Clear, pre-agreed lead-institution protocols for dual-employment researchers remain the most effective safeguard.