DHSC annual statement of compliance with the Concordat to Support Research Integrity: 2025 to 2026
Published 21 July 2026
Applies to England
Introductory statement and summary of actions
The Department of Health and Social Care (DHSC) is committed to maintaining the highest standards of research integrity across all aspects of the research it commissions, funds, supports and enables.
It leads and funds the National Institute for Health and Care Research (NIHR), which has a dual mandate to improve the health and wealth of the nation by funding and supporting the generation of high-quality research that benefits patients, the public, and health and social care services.
DHSC achieves this by:
- investing in research programmes, infrastructure and a world-class workforce
- creating partnerships that strengthen the UK’s position as a global leader in health and care research with:
- the NHS
- universities
- industry
- research communities
DHSC, through NIHR, is a signatory to the Concordat to Support Research Integrity and continues to align its policies, funding conditions and assurance processes with the principles of the concordat.
During 2025 to 2026, DHSC - through NIHR - continued to strengthen its approach to research integrity by undertaking a range of activities, including:
- sponsorship of the Health Research Authority (HRA), which provides ethical approval of heath and care research proposals to safeguard participant wellbeing, ensure legal compliance and maintain high ethical standards
- strengthening processes for managing concerns and complaints relating to NIHR-funded research
- continuing delivery of Good Clinical Practice (GCP) training to support high standards in clinical research delivery
- implementing research inclusion requirements as a condition of funding for domestic programmes
- introducing a sex and gender policy requiring applicants to address sex and gender considerations in research design and analysis
- continuing to promote transparency and open science through the NIHR Open Access publication policy, trial registration requirements, and public reporting of NIHR-funded awards and outputs
- engaging with external partners and cross-sector groups to share best practice and strengthen approaches to research integrity across the wider research system
In addition to the above activity, DHSC’s Chief Scientific Adviser (CSA) (who is also NIHR’s Chief Executive) commissioned an independent review to consider the Infected Blood Inquiry’s findings in relation to ethical and inclusive research governance.
This focused on whether changes in research governance approaches adequately address the concerns identified by the inquiry, and considered issues that require further discussion and action. It led to the publication of the From subject to participant and partner report, which set out the conclusions of this work and follow-up actions on public engagement and inclusivity in health research.
Governance
Research integrity at DHSC is supported by robust governance structures. Oversight is led by the following 2 people who are responsible for safeguarding integrity across all research activities:
- DHSC’s CSA (who is also Chief Executive of NIHR)
- DHSC’s Director for Science, Research and Evidence (who is also Deputy Chief Executive of NIHR)
They are supported by advice from the NIHR board on setting policy for research funding. The board is composed of:
- senior management from across the NIHR board
- deputy directors from across DHSC’s Science, Research and Evidence directorate
- 4 senior NIHR scientific directors who also play a role in providing the CSA with strategic guidance and scientific challenge to strengthen the quality and relevance of DHSC’s research portfolio
The deputy director of NIHR research systems is the named overall policy lead for research integrity on the NIHR board, working closely with the operational lead, NIHR’s head of assurance, who acts as NIHR’s named first point of contact for matters relating to research integrity. The deputy director of research systems chairs NIHR’s sub-committee on Finance, Risk and Assurance (FRAC). They play an important leadership role in ensuring research aligns with DHSC policies and adheres to best practice standards.
A critical mechanism for DHSC’s oversight on research integrity is through the Science, Research and Evidence directorate’s sponsorship of HRA, a non-departmental public body with responsibility for providing a research ethics service for health and social care research in England.
HRA ensures all research proposals are reviewed and approved by a research ethics committee (REC). This safeguards participant wellbeing, legal compliance and ethical standards, ranging from complex drug trials and qualitative interviews to basic biological science and data-only studies.
HRA protects and promotes the interests of patients and the public in health and social care research by ensuring that RECs protect the rights, safety, dignity and wellbeing of research participants.
The Medicines and Healthcare products Regulatory Agency (MHRA) also plays an important oversight role in health research with a focus on patient safety, acting as the competent authority for approving clinical trials and ensuring compliance with GCP.
Processes to support culture of research integrity
DHSC, through NIHR, is a signatory to the Concordat to Support Research Integrity. This underpins NIHR’s approach to promoting high standards of integrity across the research it funds. A range of internal policies, assurance processes and oversight mechanisms are in place, which are designed to support a culture of high-quality, ethical and transparent research, including:
- a conflict-of-interest policy for funding and awards, which supports the identification, declaration and management of both personal and institutional conflicts throughout the funding life cycle
- a publicly available concerns and complaints policy, providing accessible mechanisms for raising concerns relating to NIHR-funded research
- central systems for recording, monitoring and analysing concerns and complaints to identify trends, risks and opportunities for improvement
- a counter fraud, bribery and corruption policy, clear standards on fraud, safeguarding and reporting in all research contracts, and mandatory annual fraud awareness training
DHSC, through NIHR, adopts a proportionate, risk-based approach to assurance and oversight, informed by the nature, scale and complexity of funded activity. Each year, an overall assurance plan is established to strategically guide this work. Risks relating to research integrity are identified and monitored through assurance activity, audits, annual funding reviews, concerns and complaints, and ongoing engagement with funded organisations. Identified risks are reviewed and discussed at the FRAC sub-committee of the NIHR board.
NIHR undertakes annual funding reviews (AFRs) of organisations in receipt of NIHR funding as part of its wider assurance arrangements. These reviews assess whether organisations have the appropriate policies, systems and processes in place to manage NIHR funding appropriately and in line with the terms and conditions of funding, including those relating to research integrity, safeguarding and research governance. In 2024 to 2025, approximately 14% of the NIHR budget was covered by AFRs.
Where issues or areas for improvement are identified through these reviews, findings and recommendations are issued to the organisation concerned. Organisations are expected to implement appropriate remedial actions, and NIHR maintains follow-up arrangements to monitor implementation and ensure identified issues are addressed appropriately.
More widely, DHSC is subject to assurance from external bodies that support the culture of research integrity. For Official Development Assistance (ODA)-related global health research, DHSC has been reviewed by the Independent Commission for Aid Impact and regularly engages with the Government Internal Audit Agency.
Guidance for researchers, employers and commissioners of research
DHSC’s research investment through NIHR is compliant with:
- the definition of research in the Organisation for Economic Co-operation and Development (OECD) Frascati Manual 2015
- the research exemption as set out in Procurement Act 2023 guidance documents - plan phase (replacing the Public Contract Regulations 2015)
- HM Treasury’s Managing public money
NIHR’s peer review system stems from the Haldane Report of 1918. The Haldane Principle established that decisions concerning how research funds are spent should be made by independent researchers and experts through peer review, rather than by politicians or government officials. Therefore, all DHSC research investments through NIHR are subject to peer review - drawing from the health and care research community, academics and those who work in, manage and use health and care services.
Patients and the public contribute to and take part at every level of NIHR’s work. NIHR does this to ensure that they:
- shape all research
- are represented on research funding approval committees
- are given opportunities to participate in the research itself
NIHR provides a range of guidance, policies and contractual requirements for internal staff and the wider health and care research community. These ensure that the research it funds is conducted in accordance with high standards of integrity, transparency and ethical practice.
Core expectations and requirements are communicated through:
- NIHR funding calls
- award documentation
- research contracts
- programme guidance
- policies published on the NIHR website
NIHR standard contracts require funded organisations to comply with:
- the UK Policy Framework for Health and Social Care Research
- the Concordat to Support Research Integrity
- other relevant regulatory and ethical requirements, including HRA’s UK REC policy documents
For ODA-funded research, DHSC - through NIHR - requires organisations to comply with ODA eligibility and transparency requirements, and this is reflected in research contract arrangements.
NIHR guidance and requirements are also provided to funded research organisations relating to:
- clinical trial registration and disclosure of results
- Open Access publication and transparency of research outputs
- safeguarding responsibilities and protections for participants and communities
- equality, diversity and inclusion - including involving people and communities - in the end-to-end research cycle
- counter fraud, bribery and corruption
- management and sharing of research data
- international and ODA-funded research
During the reporting period, DHSC - through the NIHR - introduced research inclusion as a condition of funding for domestic programmes. This is now a core part of how research proposals are judged. In 2025, NIHR also implemented a sex and gender in research policy requiring applicants to address sex and gender considerations within research design and analysis. Inclusive design requirements will extend to infrastructure and global health research awards later in 2026.
NIHR contracts also include fraud, bribery, corruption and safeguarding clauses applicable across all awards, with additional provisions included, where required, to reflect the specific risks associated with international and ODA-funded research contexts.
NIHR will continue to review and update its guidance framework to ensure alignment with evolving best practice and regulatory expectations, including the planned introduction of a formal research misconduct policy during 2026 to 2027.
Training and awareness raising
DHSC provides funding for training and support to health, care and public health researchers at all stages of their careers through the NIHR Academy. The academy aims to build a skilled and innovative research workforce that is dedicated to improving healthcare outcomes with research integrity at its core. Through the NIHR Academy and broader training and awareness-raising activities, NIHR promotes high standards of research conduct and integrity across the health and care research system.
DHSC - through NIHR Learn - offers free GCP training courses for individuals supporting clinical research delivery in the UK. Courses include GCP introduction and refresher training, informed consent training, and a range of proportionate training modules tailored to different research delivery roles and settings. GCP is the internationally recognised standard for conducting clinical research and is a requirement for researchers involved in clinical trials of investigational medicinal products.
The training supports the protection of participant rights, safety and wellbeing, and the collection of credible and reliable research data. During the reporting period, NIHR worked closely with MHRA and HRA to update its training packages in preparation for new UK clinical trials regulations, The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025, which came into force in April 2026.
NIHR is currently developing a formal research integrity policy that is expected to be published during 2026 to 2027. This policy will further bring together and clarify NIHR’s expectations regarding standards of research conduct and the management of research misconduct concerns.
External engagement
DHSC’s governance of NIHR helps connect organisations across the health and care research ecosystem, enabling effective information sharing to improve practice.
At an organisation-wide level, NIHR’s Strategy and Engagement Board advises on strategic matters and provides a large forum for discussing how to deliver against priorities across NIHR’s distributed structure. Members of the Strategy and Engagement Board include:
- members of the NIHR board
- directors of the NIHR research programme
- editor-in-chief of the NIHR Journals Library
- representatives of NIHR infrastructure and research schools
- representatives of NIHR research professors and early career researchers
- representatives of NIHR public contributors
It informs the work of the NIHR board. Members of the NIHR Strategy and Engagement Board are expected to play an ambassadorial role, engaging partners and stakeholders in NIHR’s work, including in promoting high standards of research conduct and integrity.
DHSC - through NIHR - actively engages with a range of organisations and cross-sector groups to share information, promote best practice and strengthen approaches to research integrity across the wider research system. At a high level, this includes NIHR membership and participation in:
- the Research Integrity Concordat Signatories Group, which brings together representatives from across the research sector, including funders and research-performing organisations. The group supports implementation of the Concordat to Support Research Integrity, and provides a forum for sharing good practice, discussing emerging issues and promoting continuous improvement
- the Funders Policy Alignment Group, which works collaboratively to improve consistency and alignment across research funder policies and assurance requirements
- the Funding Policy Assurance Portal - this shared digital platform supports cross-funder assurance activity and enables participating organisations to review institutional compliance with funding policies and grant conditions, including policies relating to research integrity
DHSC also works closely across government with primary health research partners on policy related to health integrity, specifically:
- the devolved governments
- the Department for Business, Innovation, Science and Trade
- UK Research and Innovation
- the Medical Research Council
- the Office of Life Sciences
Beyond the UK government, DHSC has strategic relations with the Academy of Medical Sciences, Association of Medical Research Charities and other major philanthropic funders such as the Wellcome Trust.
Open science and research protocols
DHSC - through NIHR - remains committed to the principles of open science in order to maximise the transparency, accessibility and impact of the research it funds.
Core activities during the reporting period include the following.
Open Access publication policy
DHSC - through NIHR - requires peer-reviewed research articles arising from NIHR-funded awards to be freely, immediately and permanently accessible.
Publications are generally required to be published under a Creative Commons attribution (CC BY) licence to maximise reuse and dissemination.
Ensuring Value in Research (EViR)
As a member of the EViR Funders Forum, NIHR supports initiatives designed to minimise research waste and improve transparency throughout the research life cycle, including meaningful stakeholder engagement and improved dissemination practices.
Research inclusion
From November 2024, research inclusion became a mandatory condition of funding for domestic NIHR programmes. From March 2026, all NIHR applicants across all award types are required to design their research inclusively in order to receive NIHR funding.
Data sharing
NIHR requires appropriate data access and management plans to support responsible management, preservation and sharing of research data, helping to improve transparency and reproducibility.
Under the NIHR policy on clinical trial registration and disclosure of results, all DHSC-funded primary research studies delivered through NIHR are required to register in an appropriate public registry. Registration must occur prior to the commencement of interventions, participant recruitment or data collection.
DHSC - through NIHR - requires contract holders to submit research protocols and statistical analysis plans during study setup. Final study protocols are expected to be made publicly available in accordance with NIHR’s transparency and disclosure requirements.
Publication of research
DHSC is committed to the timely and transparent publication and dissemination of NIHR research findings.
Policy and practice on publication and recording of research
DHSC - through NIHR - requires the results of clinical studies to be published within 2 years of study completion. Following the planned closure of the NIHR Journals Library, NIHR is currently transitioning to a new publication model, which is intended to streamline reporting arrangements while maintaining commitments to transparency, accessibility and Open Access publication.
All DHSC-funded research awards through NIHR are recorded centrally and made publicly available through the NIHR Funding and Awards website and associated open data platforms, which are updated regularly to support transparency and public accountability.
DHSC ODA-funded research through NIHR is also reported in line with the International Aid Transparency Initiative Standard, thus increasing the transparency of resources flowing into developing countries.
DHSC-funded studies are also required to complete a final output, including a plain language summary, for publication and dissemination.
Rapid and transparent publishing
NIHR Open Research (NOR) provides DHSC-funded researchers with an open research publishing platform through which they can publish a broad range of research outputs. Articles published through NOR benefit from:
- rapid Open Access publication
- transparent peer review processes
- guidance promoting the open sharing of underlying research data, where appropriate
Publication through NOR requires authors to confirm that all relevant publishing, ethical and research integrity standards have been met. Articles and other outputs that do not comply with these requirements may not be accepted for publication.
In addition to traditional research articles, NOR supports publication of a range of outputs across the research life cycle, including end-of-grant reports and other research-related documents.
Where outputs contain identifiable participant information, images or data sets, authors are required to confirm that appropriate informed consent has been obtained or that data has been sufficiently anonymised in accordance with ethical and publishing standards.
NOR will not accept advertorial content and operates in accordance with recognised principles of good scientific and publishing practice.
From January 2026, NIHR-funded researchers based at eligible Jisc institutions are able to publish in NOR without direct cost to authors under a ‘read and publish’ agreement.
Non-publication of research
Currently, approximately 90% of DHSC studies through NIHR have their primary results available within the public domain.
DHSC - through NIHR - monitors publication compliance through regular reporting arrangements, including annual data collection through Researchfish and assurance activity. Where delays or non-publication are identified, NIHR works directly with award-holding organisations to support timely resolution.
Instances of delayed publication are uncommon and may arise for legitimate reasons, including:
- protection of sensitive participant information
- intellectual property or commercial considerations
- the need for additional verification and validation to ensure research findings are accurate, robust and reliable prior to publication