Centres of Excellence for Regulatory Science and Innovation (Grant)

This opportunity is open to organisations based in the UK with standard eligibility. Check if your organisation is eligible

This funding opportunity is open to all eligible applicants and is not restricted to organisations or individuals that have previously received funding for a CERSI.

Who is eligible to apply

The nominated centre director (project lead) should lead the application, alongside a leadership team, and with the full support of their host research organisations.

To be eligible to apply for this funding opportunity you must:

• be from a single eligible research organisation or a partnership of eligible organisations

• have the relevant expertise and experience to lead or contribute to a CERSI and its research culture

• show how you will strategically direct the CERSI and be actively engaged in the work

• focus your application on one of the four CERSI strategic themes

For applicants who do not have a contract of employment for the duration of the proposed project, by submitting an application, the research organisation is confirming if it is successful:

• contracts will be extended beyond the end date of the project

• all necessary support for the project and the applicants will be provided, including mentorship and career development for early career researchers

Who is not eligible to apply

You are not eligible to apply for this funding opportunity as a project lead if you are based at an international research organisation.

This also includes project leads from MRC Unit The Gambia at the London School of Hygiene and Tropical Medicine (LSHTM) or MRC/UVRI (Uganda Virus Research Institute) and LSHTM Uganda Research Unit.

If you are employed by any of the following organisations you cannot apply as project lead or project co-lead, but can participate as project partners on an application led by an eligible UK organisation:

• businesses

• charity and third sector organisations

However, charities and third sector organisations that are approved UK Research and Innovation (UKRI) independent research organisations are eligible to apply as project lead or project co-lead.

International researchers

As MRC is a lead funder for this funding opportunity, international researchers can apply as ‘project co-lead (international)’.

Project co-leads (international) make a major intellectual contribution to the design or conduct of the project. Their contribution and added value to the research should be clearly explained and justified in the application, see ‘Applicant and team capability to deliver’.

Read the UKRI project co-lead (international) eligibility for more details. Please contact us if you are uncertain about eligibility. Find contacts in the ‘Contact details’ section

You should include all other international collaborators (or UK partners not based at approved organisations) as project partners.

Equality, diversity and inclusion

We are committed to achieving equality of opportunity for all funding applicants. We encourage applications from a diverse range of researchers.

We support people to work in a way that suits their personal circumstances. This includes:

• career breaks

• support for people with caring responsibilities

• flexible working

• alternative working patterns

UKRI can offer disability and accessibility support for UKRI applicants and grant holders during the application and assessment process.

Demand management

Demand management is not being applied to this funding opportunity.

Aim

Through this funding opportunity, the MRC, Medicines and Healthcare products Regulatory Agency (MHRA) and the Office for Life Sciences (OLS), aim to establish four Centres of Excellence for Regulatory Science and Innovation (CERSIs) across the UK. Each CERSI will seek to address regulatory science areas of strategic importance to the UK, by bringing together expertise from:

• academia

• regulators

• industry

• healthcare providers

• patients and public partners

• devolved administrations and local regions

CERSIs will play a vital role in the UK regulatory innovation ecosystem by advancing regulatory science. This will help address regulatory challenges and uncertainties, enabling innovative healthcare products and solutions to reach patients safely and more efficiently.

CERSI aims

CERSIs will support the development of the evidence, methods and tools needed for future regulatory decision-making, while supporting their translation into regulatory practice. CERSIs will strengthen the UK’s position as a global leader in regulatory science and support safe, effective and timely patient access to healthcare innovation.

The research programmes delivered through CERSIs should address clear regulatory challenges, evidence gaps or emerging issues, with a credible pathway to informing regulatory:

• policy

• practice

• tools

• decision making

Creating national capability

The intention is to fund four centres that deliver research excellence while creating national capability in priority areas of regulatory science. Proposed centres should complement existing investments and infrastructure, connecting relevant expertise and capabilities from devolved administrations and local regions, creating added value that could not be achieved through a collection of separate research projects.

The CERSI initiative aims to generate broadly applicable regulatory science:

• knowledge

• methods

• tools

• standards

Research solely focused on an individual healthcare product without broad applicability is not in scope.

Adaptive portfolio to respond to emerging priorities

Regulatory science priorities are expected to evolve over the lifetime of the award. CERSI research programmes will therefore operate as an adaptive portfolio, informed by:

• horizon scanning

• engagement with regulators

• researchers

• patients

• industry and other stakeholders

• devolved administrations and local regions

• oversight of the wider CERSI programme

Centres will be expected to respond to emerging regulatory science priorities in areas related to their CERSI theme, identified through CERSI governance arrangements. Where required, centres will adapt elements of their work programmes to address these priorities, while continuing to deliver their core objectives and maintaining scientific excellence.

UK CERSI model

UK CERSIs were initially established in 2025 by MHRA, OLS, Innovate UK and MRC following a recommendation in Professor McLean’s 2023 Pro-innovation Regulation of Technologies Review. CERSIs support the Life Sciences Sector Plan ambition for the UK to be a global leader in regulation by 2035. Seven pilot centres received one year of seed funding to test and develop new approaches to regulatory science research and collaboration across different themes.

Lessons learned have informed the design of an enhanced UK CERSI initiative. A key change is the provision of programme funding for up to five years, recognising that addressing complex regulatory science challenges requires sustained investment in:

• knowledge

• expertise

• capability

• partnerships

This longer-term funding model will support CERSIs to build enduring partnerships between the research community, regulators and wider stakeholders. This will provide a mechanism to identify, investigate and translate solutions to regulatory science challenges, that cannot be addressed through individual projects alone.

CERSIs are part of a wider MHRA framework for de-risking innovation. Emerging technologies are identified through horizon scanning and regulatory intelligence activities. CERSIs then carry out research to address the regulatory challenges these technologies may present. This research may generate:

• evidence

• methods

• tools

• standards

These outputs may then be used to inform or support activities such as regulatory sandboxes, guidance development, standards and regulatory pathways helping innovations reach patients and the public safely and more quickly.

CERSIs will provide a clear route for translating research into regulatory practice. You should explain how your proposed research could contribute to this pathway and support future regulatory decision-making.

Successful CERSIs will be expected to:

• deliver high-quality research addressing priority regulatory science challenges

• develop and evaluate new methods, tools, standards and evidence approaches

• provide access to multidisciplinary expertise, data, facilities and research capability

• foster collaboration and knowledge exchange across academia, regulators, patients, industry and the wider health system

• anticipate and respond to emerging scientific and technological developments

• translate research findings into recommendations for regulatory policy, practice and impact

• contribute to a sustainable and connected UK regulatory science ecosystem

CERSIs are not intended to provide regulatory advice to individual product developers or to replace the MHRA’s established scientific advice and regulatory advice services.

Collectively, CERSIs will form a UK regulatory science network.

CERSIs will work closely with the MHRA, ensuring that research findings can be translated into practical regulatory application and public benefit. This may include the co-development and refinement of research questions, such as:

• collaboration on individual projects or work packages

• ongoing exchange of knowledge and expertise

Scope

For the purposes of this funding opportunity, regulatory science is defined as the development and application of scientific methods, tools, standards and approaches that support the evaluation and regulation of medicines, medical devices and other healthcare products.

Regulatory science research addresses questions that are directly relevant to regulatory decision making, seeking to improve the evidence, methodologies and frameworks that underpin regulatory policy and practice.

Regulatory science research spans the full product lifecycle, from discovery to monitoring and post-market surveillance.

Applications must align with one of the four strategic themes of the CERSI initiative, which are:

• data-driven approaches and artificial intelligence

• prevention, early detection and novel evidence approaches

• personalised healthcare and pharmacogenomics

• novel platform technologies

Unless otherwise stated, themes will encompass:

• medicines

• medical devices including software

• in vitro diagnostic medical devices

• combination products

• other healthcare products where relevant

Patient benefit, patient experience and public confidence are central considerations across all CERSI themes. You should consider how the public will contribute to the proposed research and how the research contributes to:

• patient centred regulation

• equitable patient access

• public trust in regulatory process and decision making

Meaningful public partnerships should be embedded throughout the research lifecycle where possible, including in the identification, design, conduct, dissemination and translation of research.

All proposals for individual themes are encouraged to include methodologies to address theme specific questions applicable to:

• patient safety and benefit-risk

• patient-centred regulation and public trust

• health inequalities and representativeness

• adaptive regulation and lifecycle oversight

• regulatory convergence and international alignment, where appropriate

Applications should clearly articulate the primary regulatory science challenge being addressed and explain how the proposed programme complements, rather than duplicates, activity that may be undertaken within other thematic areas. Potential duplication of research activity will be avoided through the proposed governance structures for CERSI oversight.

Expectations for CERSIs

Research conducted by CERSIs should address challenges of broad relevance to the UK regulatory science and innovation ecosystem. Recognising that regulatory science is inherently multidisciplinary, projects are expected to bring together expertise from:

• academia

• regulators

• healthcare

• industry

• other relevant partners

The programme will support research that develops regulatory science capability and enables translation into regulatory practice. You should clearly describe the regulatory science challenge being addressed, the expected outputs, and how these could contribute to future regulatory decision-making, standards, guidance, methodologies or tools.

Applications should demonstrate how they will build sustainable capability, foster collaboration and maximise opportunities for knowledge exchange, implementation and wider impact.

CERSIs will also be expected to build strong partnerships with SMEs, industry and innovators to support the development, testing and adoption of new regulatory science approaches. CERSIs will also maximise the impact of programme outputs across the healthcare innovation ecosystem.

Applications must:

• align with one of the four CERSI strategic themes

• address clearly defined theme-specific regulatory science challenges of national or international relevance

• generate theme-specific evidence, methods, tools, standards or approaches with broad applicability across healthcare products or regulatory systems

• demonstrate scientific excellence, innovation and clear potential for regulatory impact

• describe how the proposed research could inform future regulatory policy, guidance, methodologies or decision-making

• bring together the expertise needed to address the proposed challenge through effective multidisciplinary collaboration

• demonstrate meaningful engagement with relevant stakeholders, including regulators and, where appropriate, healthcare professionals, patients, industry and other end users

• contribute to developing sustainable UK capability in regulatory science through collaboration, knowledge exchange and skills development

Applications should explain how outputs will be disseminated and translated into regulatory practice to maximise benefit for patients, regulators, developers and the wider healthcare ecosystem.

Applications should ensure that intellectual property arrangements, particularly where partners are involved, do not restrict MHRA’s ability to access and use relevant outputs for regulatory purposes.

Coherent programmes

Successful CERSIs will be expected to deliver a coherent programme of research aligned to one of the thematic areas described in this funding opportunity.

Successful CERSIs will also be expected to retain sufficient flexibility, responding to:

• emerging technologies

• evidence needs

• regulatory priorities over the funding period

The four CERSIs will be expected to organise and participate in joint activities such as annual symposia and other mechanisms for cross-centre learning and dissemination.

We will take a portfolio approach to funding the CERSIs and this means we expect to fund only one CERSI for each of the four CERSI strategic themes.

CERSI strategic themes, scopes and specific questions

CERSI theme one:  Data-driven approaches and artificial intelligence

How can data-driven methodologies and artificial intelligence be used to generate trustworthy, regulatory-grade evidence across the lifecycle of healthcare products?

This theme one focuses on the generation, integration, analysis and regulatory use of data, including:

• AI-enabled methodologies

• real-world evidence

• modelling and simulation

• digital technologies

• advanced analytics

In this theme, the emphasis is on evidence generation and decision-making rather than regulation of AI technology alone. This includes the validation of:

• algorithms

• modelling and simulation

• analytical methods

• bioinformatics

• the continuous learning approaches

• the development of standards and referencing approaches for regulatory-grade evidence generation

Examples of in-scope topics for evaluation under CERSI theme one, include:

• data provenance, quality and integrity

• validation and explainability methodologies for AI and advanced analytics

• calibration, adaptation and model drift of AI models

• real-world data and evidence

• synthetic data

• modelling and simulation

• digital twins

• decentralised and hybrid trials

• continuous learning systems

• human-AI interaction

• AI-assisted software development

• advanced signal detection

• lifecycle performance monitoring

Examples of theme one specific regulatory questions

Your programme should ensure it addresses regulatory questions specific to data-driven approaches and AI, such as:

• how should data provenance, quality and integrity be assessed for regulatory use?

• what validation frameworks are required for AI algorithms, analytical models and digital tools?

• how should regulators assess continuously learning and adaptive AI systems?

• how can AI-generated outputs and AI-assisted software development be validated and assured?

• how should human-AI systems be evaluated, including automation bias and clinical decision-making?

• what evidence standards are required for digital twins, modelling and simulation?

• how can real-world data , real-world evidence and synthetic data be used reliably for regulatory decisions?

• what regulatory approaches are needed for decentralised trials, remote monitoring and wearable-generated evidence?

• how can lifecycle performance monitoring and post-market surveillance be modernised using advanced analytics?

• how can data-driven approaches improve earlier detection of safety signals?

• how can bias, missingness and uncertainty be identified, quantified and mitigated?

• how should AI-generated and machine-derived data be governed within regulatory evidence frameworks?

• how should cybersecurity, system resilience and digital trustworthiness be evaluated within regulatory frameworks for AI-enabled and connected technologies?

• what evidence standards are required to demonstrate safety, performance, effectiveness and benefit-risk?

• what constitutes sufficient evidence at different stages of the product lifecycle?

• how can reproducibility, generalisability and robustness of evidence be demonstrated across populations and settings?

This is not an exhaustive list of specific regulatory questions and you are not expected to address all these questions.

Out of scope

The following is not in scope for this funding opportunity:

• development of individual AI products, software applications or data platforms where the primary objective is product development rather than advancement of regulatory science

• development of AI algorithms purposed to solely improve clinical performance, without addressing a regulatory science question

CERSI theme two: Prevention, early detection and novel evidence approaches

How can regulatory systems support healthcare products intended to predict, prevent, detect or intervene earlier in disease, while advancing the development of novel evidence approaches for regulatory decision-making?

Theme two focuses on two complementary areas of regulatory science. The first area includes:

• prevention

• risk prediction

• screening and early detection

• use of medical devices and diagnostic tests

• preventative therapies, including vaccines

• longitudinal health monitoring

The second complementary area of regulatory science for theme two, includes the development, validation and qualification of:

• surrogate clinical, diagnostic and digital endpoints

• biomarkers

• study designs

• evidence approaches

These will support regulatory decision-making across healthcare products and a broad range of disease areas.

The primary focus of theme two is primary prevention. While secondary prevention is not a primary focus, proposals in this area may be considered where a strong and compelling case is made that the work addresses important and broadly applicable regulatory science questions relevant to prevention and regulatory decision-making.

Note: theme two focuses on predicting, detecting or preventing disease. However, individualised treatment selection after diagnosis sits within CERSI theme three.

Examples of in-scope topics for evaluation under CERSI theme two

In-scope topics for evaluation by CERSI theme two, include:

• regulatory approaches to endpoints in primary prevention

• precision approaches to prevention

• prevention for rare diseases and genetically defined populations

• early detection technologies

• screening

• diagnostics (including companion diagnostics)

• risk prediction tools, patient identification and stratification

• remote and continuous monitoring technologies

• prevention-focused trial methodologies

• novel endpoints (including intermediate endpoints) and evidence approaches

• digital biomarkers

• imaging biomarkers

• surrogate endpoints

• endpoint validation and qualification

• longitudinal evidence generation

• adaptive evidence pathways

• adoption and implementation of prevention interventions

• repurposing authorised medicines for preventative indications

Examples of theme two specific regulatory questions

Your programme should ensure it addresses regulatory questions specific to prevention and early detection. This is particularly important where long-term exposure and or long follow-up periods may be required to definitively establish benefit and safety. Here are examples of regulatory specific questions for theme two:

• what evidence standards are required for licensing of healthcare products for prophylaxis/primary or secondary prevention?

• what constitutes regulatory-grade evidence for risk prediction tools, screening and early detection approaches?

• what trial designs and evidence-generation approaches are appropriate when clinical outcomes may only occur many years later and products may be used for extended periods?

• what evidence, methods, tools and approaches are needed to design and evaluate prevention programmes that maximise benefit-risk, public trust, equity of access and informed decision-making, while minimising overdiagnosis, overtreatment and unintended harms, particularly in healthy or largely asymptomatic populations?

• when should healthcare products be commenced and continued for the long term and how can the benefit-risk be optimised to ensure people avoid unnecessary treatment?

• what evidence standards are appropriate for preventive interventions targeting rare or genetically defined high-risk populations where recruitment of large trial populations may not be feasible?

• what evidence standards are required to support the development, approval and lifecycle management of vaccines and other prophylactic interventions intended to prevent disease?

• what regulatory frameworks are needed for adaptive licensing and rolling evidence generation?

• what evidence is required to support effective risk communication and informed decision-making for risk-stratified prevention approaches?

• what factors impact the public’s acceptance and trust for risk stratified prevention approaches and subsequently impact uptake and adherence to these interventions?

• what factors impact clinician decision making for novel preventative approaches?

• what evidence is required to validate and support AI-enabled risk prediction and early detection systems?

• how should clinical decision-support technologies be evaluated in preventive healthcare settings?

• what regulatory and evidentiary approaches could facilitate the extension of marketing authorisations for established products used for preventive indications where commercial incentives are limited?

• how should post-authorisation evidence generation and uncertainty management be used to confirm long-term preventive benefit and safety?

Your programme should ensure it addresses regulatory questions specific to novel endpoints and evidence approaches, such as:

• what methods should be used for novel endpoints, biomarkers, intermediate and surrogate endpoints to enable them to be identified, validated and qualified to support regulatory and health technology assessment decision-making, particularly when clinical outcomes take many years to emerge?

• how should digital biomarkers, imaging biomarkers and diagnostic markers be validated and qualified and be linked reliably to clinically meaningful outcomes to enable regulatory confidence?

• how can longitudinal real-world data and cohort data support regulatory decision-making?

• what evidence frameworks are needed to support the use of novel endpoints, biomarkers and diagnostic measures where traditional clinical outcomes are delayed, impractical or difficult to measure?

This is not an exhaustive list of specific regulatory questions and you are not expected to address all these questions.

Out of scope

The following is not in scope for this funding opportunity:

• research primarily concerned with selecting, stratifying or optimising treatment of an individual following diagnosis, rather than preventing disease occurrence or enabling earlier detection

• research on endpoints, biomarkers or evidence methodologies where the primary objective is development of a specific product, biomarker, diagnostic or clinical application rather than advancement of broadly applicable regulatory science approaches, standards, qualification methods or evidence frameworks

• research focused primarily on generic data or AI validation methodologies that are not applicable to the regulatory challenges of prediction, prevention and early detection

Please note, research focused primarily on generic data or AI validation methodologies that are more appropriate to be addressed through theme one.

CERSI theme three: Personalised healthcare and pharmacogenomics

How can regulation enable personalised healthcare approaches that use individual-specific information to identify the most appropriate intervention, monitoring strategy or therapeutic pathway while ensuring equitable, safe and effective outcomes?

This theme three includes pharmacogenomics, genomics-enabled healthcare, biomarker-guided approaches, phenotypic and digital information that support patient stratification and treatment optimisation. It encompasses the regulatory science needed to assure the analytical validity, clinical validity and clinical utility of genomic and biomarker-based assays used to guide regulatory and clinical decision-making, as well as to develop future reference materials and standards.

Prevention approaches are explicitly out of scope as this is under the remit of CERSI theme two.

Examples of in-scope topics for evaluation by CERSI theme three

In-scope topics for evaluation by CERSI theme three, include:

• pharmacogenomics

• companion diagnostics

• biomarker-guided treatment

• patient stratification

• multi-omic approaches

• precision dosing

• genomics-enabled safety monitoring

• rare diseases

• AI-supported treatment selection

• integrated diagnostic-treatment pathways

Examples of theme three specific questions

Your programme should ensure it addresses regulatory questions specific to personalised healthcare and pharmacogenomics, such as:

• what evidence standards are required for pharmacogenomic-guided treatment decisions?

• how should companion diagnostics and medicines be evaluated as integrated systems?

• how can multi-omic biomarkers and polygenic risk scores be validated and regulated?

• what evidence is required to support AI-enabled patient stratification?

• how should increasingly small and molecularly defined patient populations be evaluated to ensure robust benefit-risk decisions can be made?

• what regulatory approaches are required for precision dosing strategies?

• how can genomics be incorporated into benefit-risk assessment and safety monitoring?

• how should rare disease applications be evaluated where evidence generation is inherently challenging?

• how can regulators assess genomic predictors of adverse events and treatment response?

• how can personalised approaches avoid worsening health inequalities due to data or population biases?

This is not an exhaustive list of specific regulatory questions and you are not expected to address all these questions.

Out of scope

The following is not in scope for this funding opportunity:

• development of genomic tests, biomarkers, companion diagnostics or personalised therapies without addressing a broader regulatory science question

• research primarily concerned with population or individual risk prediction, screening, early detection, or prevention rather than treatment selection following diagnosis

• generic AI or data methodology research unless the primary regulatory science question concerns its use for individualised treatment selection or optimisation

CERSI theme four: Novel platform technologies

How can regulatory systems enable platform-based innovation for development and lifecycle management of healthcare products through reuse of evidence, knowledge, components and regulatory approaches?

This theme addresses emerging and disruptive platform technologies as a regulatory science challenge rather than a specific technology category. It focuses on shared architectures, reusable evidence and convergence across medicines, devices, diagnostics and software.

Examples of in-scope topics for evaluation by CERSI theme four, include:

• platform technology definitions

• reusable evidence packages

• comparability science

• lifecycle change management

• platform manufacturing

• shared software architectures

• device ecosystems

• integrated diagnostic-therapeutic platforms

• third-party platform providers

• data-sharing frameworks

• common data standards and core datasets

• cross-product regulatory pathways

• regulatory convergence

Examples of theme four specific questions

Your programme should ensure it addresses regulatory questions specific to platform technologies, such as:

• what evidence-generation and evaluation methodologies are needed where conventional approaches are impractical, and what criteria should determine when alternative approaches are sufficiently robust for regulatory decision-making?

• how can prior knowledge and existing evidence be reused across products and clinical indications, and what scientific criteria and methodologies are needed to determine when such evidence can appropriately be borrowed?

• what constitutes meaningful change to a platform and what comparability and assessment frameworks are needed when platform components are modified?

• what evidence is required to support platform-based manufacturing approaches?

• how should regulatory pathways adapt to accelerate development of products built on established platforms?

• what governance frameworks are required for third-party platform providers and ecosystem partners?

• how should data-sharing and intellectual property challenges be managed by regulators within platform ecosystems?

• how can integrated diagnostic, therapeutic, software and device platforms be regulated coherently?

• how can regulatory convergence be achieved across medicines, diagnostics, devices and AI-enabled products that share common platforms?

This is not an exhaustive list of specific regulatory questions and you are not expected to address all these questions.

Out of scope

The following is not in scope for this funding opportunity:

• development or evaluation of an individual novel technology or product solely because it uses an innovative technology

• applications should not be considered platform research unless they address a regulatory science challenge arising from the shared, reusable or extensible nature of the platform, such as evidence reuse, comparability, shared components, manufacturing approaches, lifecycle change or cross-product regulatory pathways

• platform trial methodologies

Cross-cutting regulatory science topics

Examples of questions related to the cross-cutting regulatory science topics are provided that each CERSI may address within each theme.

Patient safety and benefit-risk:

• how can emerging technologies improve prediction, detection and prevention of harm?

• what new approaches are needed for signal detection, safety monitoring and risk mitigation?

• how should benefit-risk assessments evolve throughout the product lifecycle?

Patient-centred regulation and public trust:

• how should patient perspectives and patient-centred outcomes be incorporated into evidence generation?

• how can ethical considerations, trust, transparency, explainability and accountability be demonstrated for novel technologies?

• how do human factors, behavioural science and user interactions influence safety and effectiveness?

• how can public confidence be maintained as technologies become increasingly complex and autonomous?

Health inequalities and representativeness:

• how can emerging technologies help reduce, rather than widen, existing health inequalities?

• how can evidence generation better represent under-served, under-represented and high-risk populations across the product lifecycle?

• how can regulatory frameworks support equitable access, safety and effectiveness across diverse populations?

• what evidence, methods and standards are needed to assess and address inconsistent product performance across population groups?

Adaptive regulation and lifecycle oversight:

• how should regulatory frameworks evolve to support safe, effective and high quality healthcare products while achieving accelerated development and access?

• what evidence is required to support iterative updates while maintaining safety, effectiveness and quality?

• how can pre-market and post-market evidence generation be integrated into a continuous lifecycle model?

• what approaches enable adaptive authorisation while maintaining public confidence?

Regulatory convergence and international alignment

Where appropriate, CERSI outputs should support international collaboration, regulatory alignment and convergence. Outputs should seek to enable UK leadership while ensuring evidence, methods and frameworks remain relevant and usable across jurisdictions.

Duration

The duration of this award is up to five years. Awards will initially be confirmed for funding the first three years, with a further two years funding dependent on the outcome of the government spending review and budget availability. You are expected to apply for five years funding. A mid-point review will take place at two and a half years to inform the decision process for funding for years four and five.

Projects must start on 1 April 2027.

Funding available

We will fund 80% of the full economic cost (FEC). Any identified exceptions will be funded at 100%. The maximum funder contribution for each CERSI over five years, including any identified exceptions funded at 100%, is £5 million. The maximum funder contribution for the first three years is £3 million.

UK Research and Innovation (UKRI) indexation will be applied at the time of award. We will not supplement awards for inflation after they have started.

We will provide all the awarded funding to the lead organisation, to manage and distribute accordingly. Awards spanning multiple organisations will require a clear plan addressing award governance and management to ensure funds can be used flexibly to support changes in research delivery and opportunity across the course of the award.

We will support a limited number of interlinked research activities or themes, with funding focused on key strategic objectives, achievable during the lifespan of the award.

We expect to fund up to four CERSIs within the published budget.

What we will fund

You can request funding for costs such as:

• a contribution to the salary of the project lead and co-leads

• support for other posts such as research and technical staff

• research consumables

• equipment

• travel costs

• data preservation, data sharing and dissemination costs

• estates and indirect costs

• NHS research costs, when they are associated with NHS studies

• public partnerships and related activities, including payments to public contributors

• costs associated with cross-CERSI activities, such as, knowledge exchange, networking and dissemination

You can also request costs for work to be undertaken at international organisations by international project co-leads. We will fund 100% of the eligible costs.

The total of such costs requested for international applicants from high-income countries (those not on the OECD DAC list of ODA recipients), India and China must not exceed 30% of the total resources requested.

There is no cap on costs requested for international applicants from DAC (Development Assistance Committee) list countries.

What we will not fund

We will not fund:

• applications that do not align with at least one of the four CERSI strategic themes

• clinical trials

• costs for PhD studentships

• infrastructure only

• publication costs

• funding to use as a ‘bridge’ between grants

Project partner

You may include project partners that will support your research project through cash or in-kind contributions, such as:

• staff time

• access to equipment

• sites or facilities

• the provision of data

• software or materials

• recruitment of people as research participants

• providing samples, such as human tissue, for the project

Each project partner must provide a statement of support. If your application involves industry partners, they must provide additional information if the team project partner falls within the industry collaboration framework.

Find out more about subcontractors and dual roles.

Who cannot be included as a project partner

Any individual included in your application with a core team role cannot also be a project partner.

Any organisation that employs a member of the application core team cannot be a project partner organisation. This includes other departments within the same organisation.

If you are collaborating with someone in your organisation, consider including them as project co-lead, or specialist. They cannot be a project partner.

Human participation in research

If you are applying to do research in the NHS, public health or social care you usually need to complete a Schedule of Events Cost Attribution Tool (SoECAT). We are looking for evidence you have taken the appropriate steps and for the full costs of your research to be appropriately attributed.

It is important to complete a SoECAT to be eligible for support from the National Institute for Health Research (NIHR) Research Delivery Network (RDN). You must complete a SoECAT even if you don’t think your research will involve excess treatment costs (ETCs).

See MRC guidance on who needs to complete a SoECAT.

SoECAT guidance can be found on the NIHR website.

These are the steps you need to take:

1. Contact an attributing the costs of health and social care Research & Development (AcoRD) specialist as early as possible in the application process.

2. Complete an online SoECAT. If you do not have an account for NIHR’s Central Portfolio Management System (CPMS) you will need to create and activate one.

3. Request authorisation of your SoECAT.

4. When you have authorisation, include the ‘funder export’ Excel document from your SoECAT as part of your application in the Human participation in health-related research section.

Contact us about any issues including a SoECAT or AcoRD specialist feedback in your application, such as:

• your proposed research involves human participation and the NHS, but you don’t think you need a SoECAT, explain why not when you contact us

• your proposed research involves human participation in Health and Social Care (not NHS), and you think you need a SoECAT

Supporting skills and talent

We encourage you to follow the principles of the Concordat to Support the Career Development of Researchers and the Technician Commitment.

Trusted Research and Innovation (TR&I)

UKRI is committed in ensuring that effective international collaboration in research and innovation takes place with integrity and within strong ethical frameworks. Trusted Research and Innovation (TR&I) is a UKRI work programme designed to help protect all those working in our thriving and collaborative international sector by enabling partnerships to be as open as possible, and as secure as necessary. Our TR&I Principles set out UKRI’s expectations of organisations funded by UKRI in relation to due diligence for international collaboration.

As such, applicants for UKRI funding may be asked to demonstrate how their proposed projects will comply with our approach and expectation towards TR&I, identifying potential risks and the relevant controls you will put in place to help proportionately reduce these risks.

See further guidance and information about TR&I, including where applicants can find additional support.

Assessment process

We will assess your application using the following process.

Examination of applications

All applications will be examined to ensure they meet the eligibility criteria and scope of the funding opportunity. If your application is outside the scope, you will be advised by email, and we will not assess your application.

Panel

There will be no externally written expert review for this funding opportunity. All applications will be assessed by an independent expert panel, who will make a funding recommendation.

For more information on how we prioritise applications for funding please visit How we make decisions.

We will take a portfolio approach to funding the CERSIs and this means we expect to fund only one CERSI for each of the four CERSI strategic themes.

The funders will make the final funding decision.

Principles of assessment

We support the San Francisco declaration on research assessment and recognise the relationship between research assessment and research integrity.

Find out about the UKRI principles of assessment and decision making.

Using generative artificial intelligence (AI) in expert review

Generative AI may be used only for the purpose of language refinement during application assessment. When using generative AI to refine the language of a review, expert reviewers and panellists must ensure that:

• no part of the application being assessed is entered into a generative AI tool

• no personal information from the application is disclosed

• generative AI is not tasked with understanding, summarising or evaluating the application’s content

Expert reviewers and panellists must also:

• comply with relevant intellectual property and data protection legislation

• not take into account or speculate within their assessment whether generative AI has been used to develop the application

For more detail see our policy on the use of generative AI.

Sharing data with co-funders

We will need to share the application (including any personal information that it contains) with the Office for Life Sciences (OLS) so that they can participate in the assessment process.

Find out more information on how OLS uses personal information.

Sharing data with partners

We will need to share the application (including any personal information that it contains) with the Medicines and Healthcare products Regulatory Agency (MHRA) so they can participate in the assessment process and prepare to work with awardees.

Find out more information on how MHRA uses personal information.

We reserve the right to modify the assessment process as needed.

Assessment areas

The assessment areas we will use are:

• vision

• approach (including reproducibility, robustness and methodological design, where applicable, and data management)

• leadership, governance and agility

• capability of the applicant or applicants and the project team to deliver the project, including project partners

• ethical and responsible research and innovation considerations of the project

• resource justification and cost

Find details of assessment questions and criteria under the ‘Application questions’ heading in the ‘How to apply’ section.

Webinar for potential applicants

We will hold a webinar on 13 October 2026 at 10:00am UK time. This will provide more information about the funding opportunity and a chance to ask questions.

Register for the webinar

Click here to start an application on the UKRI Funding Service:  

https://funding-service.ukri.org/OPP1354/apply/1379

We are running this funding opportunity on the new UK Research and Innovation (UKRI) Funding Service so please ensure that your organisation is registered. You cannot apply on the Joint Electronic Submissions (Je-S) system.

The project lead is responsible for completing the application process on the Funding Service, but we expect all team members and project partners to contribute to the application.

Only the lead research organisation can submit an application to UKRI.

To apply

Select ‘Start application’ near the beginning of this Funding finder page.

1. Confirm you are the project lead.

2. Sign in or create a Funding Service account. To create an account, select your organisation, verify your email address, and set a password.

3. Answer questions directly in the text boxes. You can save your answers and come back to complete them or work offline and return to copy and paste your answers. If we need you to upload a document, follow the upload instructions in the Funding Service. All questions and assessment criteria are listed in the How to apply section on this Funding finder page.

4. Allow enough time to check your application in ‘read-only’ view before sending to your research office.

5. Send the completed application to your research office for checking. They will return it to you if it needs editing.

6. Your research office will submit the completed and checked application to UKRI.

Please be aware that research office and finance teams undertake checks on hosting arrangements and financial eligibility. The ultimate responsibility for ensuring compliance with all opportunity requirements lies with the applicant.

Where indicated, you can also demonstrate elements of your responses in visual form if relevant.

When including images, you must:

• provide a descriptive caption or legend for each image immediately underneath it in the text box (this must be outside the image and counts towards your word limit)

• insert each new image on a new line

• use files smaller than 5MB and in JPEG, JPG, JPE, JFI, JIF, JFIF, PNG, GIF, BMP or WEBP format

Images should only be used to convey important visual information that cannot easily be put into words. The following are not permitted, and your application will be rejected if you include:

• sentences or paragraphs of text

• tables

• excessive quantities of images

A few words are permitted where the image would lack clarity without the contextual words, such as a diagram, where text labels are required for an axis or graph column.

For more guidance on the Funding Service, see:

• how applicants use the Funding Service

• how research offices use the Funding Service

• how reviewers use the Funding Service

References

References should be included within the word count of the appropriate question section. You should use your discretion when including references and prioritise those most pertinent to the application.

Hyperlinks can be used in reference information. When including references, you should consider how your references will be viewed and used by the assessors, ensuring that:

• references are easily identifiable by the assessors

• references are formatted as appropriate to your research

• persistent identifiers are used where possible

General use of hyperlinks

Applications should be self-contained. You should only use hyperlinks to link directly to reference information. You must not include links to web resources to extend your application. Assessors are not required to access links to conduct assessment or recommend a funding decision.

Generative artificial intelligence (AI)

Use of generative AI tools to prepare funding applications is permitted, however, caution should be applied.

For more information see our policy on the use of generative AI in application and assessment.

Deadline

MRC must receive your application by 12 January 2027 at 4:00pm UK time.

You will not be able to apply after this time.

Make sure you are aware of and follow any internal institutional deadlines.

Following the submission of your application to this funding opportunity, your application cannot be changed, and submitted applications will not be amended. If your application does not follow the guidance, it may be rejected.

Personal data

Processing personal data

MRC, as part of UKRI, will need to collect some personal information to manage your Funding Service account and the registration of your funding applications.

We will handle personal data in line with UK data protection legislation and manage it securely. For more information, including how to exercise your rights, read our privacy notice.

MRC, as part of UKRI, will need to share the application and any personal information that it contains with Office for Life Sciences (OLS) and the Medicines and Healthcare products Regulatory Agency (MHRA) so that they can participate in the assessment process. Find out more information on how OLS uses personal information. Find out more information on how MHRA uses personal information.

We reserve the right to modify the assessment process as needed.

Sensitive information

If you or a core team member need to tell us something you wish to remain confidential, email cersi@mrc.ukri.org

Include in the subject line: [the funding opportunity title; sensitive information; your Funding Service application number].

Typical examples of confidential information include:

• individual is unavailable until a certain date (for example due to parental leave)

• declaration of interest

• additional information about eligibility to apply that would not be appropriately shared in the ‘Applicant and team capability’ section

• conflict of interest for UKRI to consider in reviewer or panel participant selection

• the application is an invited resubmission

For information about how UKRI handles personal data, read UKRI’s privacy notice.

Institutional matched funding

There is no requirement for matched funding from the institutions hosting the project lead, project co-leads or other staff employed on the application, beyond the standard 20% FEC. Expert reviewers and panels assessing UKRI funding applications must not consider levels of institutional matched funding as a factor on which to base recommendations. Direct and in-kind contributions from third party project partners are encouraged.

This policy does not remove the need for support from host organisations who must provide the necessary research environment and infrastructure for award-specific activities funded by UKRI. For example, research facilities, training and development of staff.

Publication of outcomes

MRC as part of UKRI, will publish the outcomes of this funding opportunity at board and panel outcomes.

If your application is successful, we will publish some personal information on the UKRI Gateway to Research.

Summary

Word limit: 550

In plain English, provide a summary we can use to identify the most suitable experts to assess your application.

We usually make this summary publicly available on external-facing websites, therefore do not include any confidential or sensitive information. Make it suitable for a variety of readers, for example:

• opinion-formers

• policymakers

• the public

• the wider research community

Guidance for writing a summary

Clearly describe your proposed work in terms of:

• context

• the challenge the project addresses

• aims and objectives

• potential applications and benefits

Core team

List the key members of your team and assign them roles from the following:

• project lead (PL)

• project co-lead (UK) (PcL)

• project co-lead (international) (PcL (I))

• specialist

• grant manager

• professional enabling staff

• research and innovation associate

• technician

• visiting researcher

• researcher co-lead (RcL)

Only list one individual as project lead. If you include more than one project lead your application will fail at the checking stage.

UKRI has introduced a new addition to the ‘Specialist’ role type. Public contributors such as people with lived experience can now be added to an application.

Find out more about UKRI’s core team roles in funding applications.

Application questions

Vision

Word limit: 1,000

What are you hoping to achieve with your proposed work?

What the assessors are looking for in your response

Explain how your proposed work:

• is of excellent quality and importance within or beyond the field(s) or area(s)

• has the potential to advance current understanding, or generate new knowledge, thinking or discovery within or beyond the field or area

• is timely given current trends, context, and needs

Within the Vision section we also expect you to:

• advance current understanding, or generate new knowledge, methods, tools, standards, approaches or thinking, within a chosen field or area of regulatory science

• articulate the regulatory science challenge(s) the proposed CERSI will address and explain their significance

• explain how the proposed CERSI aligns with one of the strategic themes set out in this funding opportunity

• explain the potential for the work to inform regulatory policy, practice, guidance, methodologies or decision-making

We also expect you to demonstrate the ambition, coherence and added value of the proposed CERSI as a Centre of Excellence, describing how it will:

• bring together the critical mass of expertise needed to address the identified regulatory science challenge(s)

• build effective partnerships with industry and other relevant stakeholders

Ensure you explain how the proposed work will generate regulatory science:

• knowledge

• evidence

• methods

• tools

• standards or approaches

These must have potential for broad applicability, enabling innovation in the development and regulation of healthcare products.

You are also required to identify the potential direct and indirect benefits of the proposed CERSI and who the beneficiaries might be, including:

• potential benefits to patients and the public

• the health system

• the life sciences sector and the wider regulatory science ecosystem

References may be included within this section.

You may demonstrate elements of your responses in visual form if relevant. Further details are provided in the Funding Service.

Approach

Word limit: 3,500

How are you going to deliver your proposed work?

What the assessors are looking for in your response

Explain how you have designed your approach so that it:

• is effective and appropriate to achieve your objectives

• uses a clearly written and transparent methodology (if applicable)

• summarises the previous work and describes how this will be built upon and progressed (if applicable)

• will maximise translation of outputs into outcomes and impacts

• describes how your, and if applicable your team’s, research environment (in terms of the place and relevance to the project) will contribute to the success of the work

Within the Approach section we also expect you to:

• describe your approach to the proposed programme of research. You should describe how its component work packages or activities form a coherent programme, addresses the CERSI’s overall vision, aim and objectives

• provide your CERSI programme plan including key milestones, dependencies and timelines, in the form of an embedded Gantt chart or similar

• demonstrate access to the appropriate services, facilities, infrastructure, or equipment to deliver the CERSI programme

• where relevant, explain how cross-cutting regulatory science considerations identified in the funding opportunity inform the proposed programme of work

• if applicable, explain and justify how you will approach diversity and inclusion in the study population and follow the MRC embedding diversity in research design policy

• demonstrate that the proposed CERSI programme of work is appropriately focused and achievable within the timeframe, scope and resources of the award

• show how you will use male and female animals or tissues and cells from female and male donors, if applicable, in your research. If you are not proposing to do this justify why, if applicable

• describe your approach to ethical and regulatory approvals and their status. Consider the MRC guidance on ethics and approvals

• explain and justify any involvement of human participants, including participant numbers, characteristics, recruitment methods, the procedures to be undertaken, and their severity

• explain and justify any use of human tissues or biological samples, including the type of material to be used, quantity required, and its source

You should also ensure you justify and describe how you will engage with relevant stakeholders and the added value their involvement will bring, including:

• regulators

• patients and public partnerships

• healthcare professionals

• industry and other end users (as appropriate)

• devolved administrations and local regions

• throughout the development, delivery and translation of the CERSI

This must include how you plan to develop partnerships with industry and other relevant stakeholders to maximise outputs and impact.

You must explain how the CERSI will contribute to developing sustainable UK regulatory science capacity and capability, including through:

• skills development

• training

• knowledge exchange

• any other relevant and appropriate activities

References may be included within this section.

You may demonstrate elements of your responses in visual form if relevant. Further details are provided in the Funding Service.

Leadership, governance and agility

Word limit: 1,000

How will leadership and governance be organised in the CERSI to enable effective programme delivery and be sufficiently adaptable to respond to evolving regulatory science needs?

What the assessors are looking for in your response

Explain how the proposed CERSI will:

• be effectively and inclusively led and managed, with clear systems, structures, roles, responsibilities, oversight and accountability for programme delivery

• establish and implement effective governance and decision-making arrangements across collaborating disciplines and organisations

• work collaboratively with MHRA and the CERSI programme’s oversight structure to maintain alignment with current regulatory science needs

• maintain awareness of emerging scientific and technological developments relevant to the CERSI and identify their implications for regulatory science

• identify and prioritise activities, including the processes and criteria for initiating, adapting or discontinuing work where appropriate

• monitor progress against agreed milestones, deliverables and intended outcomes, and manage risks or underperformance

• maintain sufficient flexibility in programme management and decision-making arrangements to respond to new priorities while retaining coherence with the overall CERSI vision, aims and objectives

Reproducibility and statistical design

Word limit: 500

How will you ensure your proposed work is reliable, robust and reproducible?

What assessors are looking for in your response

Provide information about reproducibility and how you will ensure reliability and robustness of the research, methods, tools, models, frameworks or evidence approaches developed or evaluated through your CERSI programme, such as:

• further details of statistical analyses

• methodology

• validation

• experimental design

These should be appropriate to the proposed regulatory science, not provided in your approach.

We expect you to seek professional statistical or other relevant methodological advice, where appropriate. Depending on the nature of the proposed work your response should include, as appropriate:

• methods for assessing the validity, reliability, robustness and reproducibility of proposed approaches

• validation and evaluation approaches, including appropriate comparators, benchmarks or performance criteria where relevant

• sample and effect sizes, where applicable

• planned statistical analyses, where applicable

• models chosen (for example animal model, cell lines, computational or analytical models)

• potential sources of bias and how these will be mitigated during analysis

• generalisability and applicability across relevant populations, settings, data sources or regulatory contexts, where appropriate

• how your approach to addressing diversity is reflected in the design, evaluation and analyses of the proposed work, where relevant

Refer to the MRC guidance for applicants, for further information, examples and online tools.

If your proposed work involves animals, and you provide information on animal sample sizes and statistical analyses here, you should not duplicate it in the ‘Animal involvement and ‘3Rs’’ section. Use the ‘Animal involvement and ‘3Rs’’ section to provide information on the rationale for using animals, choice of species, welfare and procedure severity.

You may demonstrate elements of your responses in visual form if relevant. Further details are provided in the Funding Service.

The length of your response will vary depending on the type of project, you may not need to use 500 words.

Data management and sharing

Word limit: 1,500

How will you manage and share data collected or acquired through the proposed research?

What the assessors are looking for in your response

Provide a data management plan which should clearly detail how you will comply with MRC’s published data management and sharing policies, which includes detailed guidance notes.

Provide your response in the text box following the headings in the MRC data management plan template. You are not required to upload the document to your application.

The length of your plan will vary depending on the type of study being undertaken, as follows:

• population cohorts, longitudinal studies, genetic, omics and imaging data, biobanks, and other collections that are potentially a rich resource for the wider research community: maximum of 1,500 words

• all other research, less complex, the plan may be as short as 500 words

Applicant and team capability to deliver

Word limit: 3,000

Why are you the right individual or team to successfully deliver the proposed work?

What the assessors are looking for in your response

Evidence of how you, and if relevant your team, have:

• the relevant experience (appropriate to career stage) to deliver the proposed work

• the right balance of skills and expertise to cover the proposed work

• the appropriate leadership and management skills to deliver the CERSI programme and your approach to develop others

• contributed to developing a positive research environment and wider research and regulatory science community

You may demonstrate elements of your responses in visual form if relevant. Further details are provided in the Funding Service.

The word limit for this section is 3,000 words: 2,500 words to be used for Résumé for Research and Innovation (R4RI) modules (including references) and, if necessary, a further 500 words for Additions.

Use the R4RI format to showcase the range of relevant skills you and, if relevant, your team (project and project co-leads, researchers, technicians, specialists, partners and so on) have and how this will help deliver the proposed work. You can include individuals’ specific achievements but only choose past contributions that best evidence their ability to deliver this work.

You are encouraged to include ORCID iDs for individuals where relevant, as this can help to demonstrate and verify their achievements.

Complete this section using the R4RI module headings listed. Use each heading once and include a response for the whole team, see the UKRI guidance on R4RI. You should consider how to balance your answer, and emphasize where appropriate the key skills each team member brings:

• contributions to the generation of new ideas, tools, methodologies, or knowledge, this may include your previous funding and key outputs such as publications

• the development of others and maintenance of effective working relationships

• contributions to the wider research and innovation community

• contributions to broader research or innovation users and audiences and towards wider societal benefit, including public partnerships

• the appropriate breadth and balance of multidisciplinary expertise across regulatory science and the scientific, methodological and translational disciplines relevant to the proposed CERSI

• experience of working collaboratively across relevant sectors and disciplines, including with regulators and other research users, as appropriate

Additions

Provide any further details relevant to your application. This section is optional and can be up to 500 words. You should not use it to describe additional skills, experiences, or outputs, but you can use it to describe any factors that provide context for the rest of your R4RI (for example, details of career breaks if you wish to disclose them).

Complete this as a narrative. Do not format it like a CV.

References may be included within this section.

The roles in funding applications policy has descriptions of the different project roles.

Project partners

Add details about any project partners contributions. If there are no project partners, you can indicate this on the Funding Service.

A project partner is a collaborating person or organisation who will have an integral role in your proposed research. This may include direct contributions for example cash, donated equipment and resources, or staff seconded to the project, or indirect and in-kind contributions for example use of project partner’s equipment, datasets, or facilities. Project partners may be in industry, academia, third sector or government organisations in the UK or overseas, including partners based in the EU.

A project partner is not anyone in your core team or anyone from your organisation or any of the other organisations represented by core team members.

Add the following project partner details:

• the organisation name (searchable via a drop-down list or enter the organisation’s details manually, as applicable)

• the project partner contact name and email address

• the type of contribution (direct or in-direct) and its monetary value

If a detail is entered incorrectly and you have saved the entry, remove the specific project partner record and re-add it with the correct information.

If there are specific circumstances where project partners do require funding for minor costs such as travel and subsistence, these project partner costs should be claimed and justified within the resources and costs section of your application.

Important information

If you are adding a project partner to this section, you must ensure they provide you with a letter or email of support and you upload it to ‘Project partners: letters or emails of support’.

If your project partners are from industry or a company, you must also complete the ‘Industry Collaboration Framework (ICF)’ section.

Project partners responsible for carrying out animal work

If the project partner is responsible for conducting animal work or providing animals or animal tissue samples, you must ensure that you complete and upload the appropriate forms under ‘Animal Involvement and ‘3Rs’’ section (if applicable).

For audit purposes, UKRI requires formal collaboration agreements to be put in place if an award is made.

Project partners: letters (or emails) of support

Word limit: 10

Upload a single PDF containing the letters or emails of support from each partner you named in the ‘Project partners’ section. These should be uploaded in English or Welsh only.

What the assessors are looking for in your response

If you do not have any project partners, you will be able to indicate this in the Funding Service.

What supporting statements we are looking for

We are looking for you to provide letters or emails of support from all your identified project partners.

What we are not looking for

We don’t want any other letters (or emails) of support, from people who are not your identified project partners, such as those simply expressing general support for your project. If these are included by you, they will be ignored by us and will not be used in the assessment process.

Important information

You should only provide letters or emails of support from people you have identified in the project partner section of your application, who will have an integral role in your proposed research.

What each project partner letter or email of support must include

Each project partner letter or email you provide should:

• include the name of the project partner organisation and contact information

• explain the project partners’ commitment to the project

• explain the value, relevance, and possible benefits of the proposed work, to them

• describe any additional value they will bring to the project

• not exceed two sides of A4 per project partner

Project partner letters and emails of support are not required to be on headed paper or include handwritten signatures (electronic signatures are acceptable).

The Funding Service will provide document upload details when you apply.

Project partners from industry or a company

Industry or company project partners are required to download and complete the industry or company letter of support template. You must also complete the ‘Industry Collaboration Framework (ICF)’ section. Find out more about ICF.

Project partners responsible for recruiting research participants or providing human tissue or samples

If the project partner is responsible for the recruitment of people as research participants or providing human tissue their letter or email of support should include:

• agreement that the project partner will recruit the participants or provide tissue

• confirmation that what is being supplied is suitable for the proposed work

• confirmation that the quantity of tissue being supplied is suitable, but not excessive for achieving meaningful results (if applicable)

Agreement with your project partners

Ensure you have prior agreement from project partners so that, if you are offered funding, they will support your project as indicated in the ‘Project partners’ section.

For audit purposes, UKRI requires formal collaboration agreements to be put in place if an award is made.

Industry Collaboration Framework (ICF)

Word limit: 1,500

Does your application include collaboration with industry or company project partners?

What the assessors are looking for in your response

The assessors are looking for you to confirm if your proposed work involves collaboration with an industry or company project partner. If it does, you will need to follow the MRC Industry Collaboration Framework.

By ‘industry or company’ we mean an enterprise that puts or has intention to put goods or services on a market.

For guidance to assist your decision if your proposed work requires you to follow ICF, you should explore the ICF decision tree and find out more about ICF which includes:

• collaboration agreements

• definitions of basic or applied research

• internationally based companies

• subsidy control

• intellectual property (IP) arrangements

• fully flexible and gated contributions

• the ICF assessment criteria

Enter ‘Yes’ in the text box if you have industry or company project partners and you are likely to follow ICF. You should also confirm your answers to the ICF questions one to nine in the text box for each ICF project partner.

Contact us if you are unsure if your application should follow ICF. Find contacts in the ‘Contact details’ section

In addition to the project partner information completed in the previous section, the assessors are looking for information relating to the nature, goals and conditions of the collaboration and any restrictions or rights to the project results that could be claimed by the industry or company project partner.

Confirm your answers to the ICF questions in the text box, repeat this process for each ICF project partner.

1. Name the industry or company project partner considered under ICF.

2. Indicate whether your application is basic research or applied research.

3. Explain why, in the absence of the requested UKRI funding, the collaboration and the planned research could not be undertaken.

4. State whether your application is under the category of fully flexible contribution or gated contribution (based on the IP sharing arrangements with the industry or company partner).

5. Outline the pre-existing IP (‘background IP’) that each partner, including the academic partner, will bring to the collaborative research project and the terms under which partners may access these assets.

6. Outline the IP that is expected to be developed during the collaborative research project (‘foreground IP’) and briefly outline how it will be managed, including:

   • who will own this IP

   • what rights industry or company partners will have to use academically-generated foreground IP during and after the research project, for internal research and development or for commercial purposes

   • any rights of the academic partner to commercialise the foreground IP, including foreground IP generated by industry or company partners

   • how IP arrangements will ensure MHRA’s ability to access and use relevant outputs for regulatory purposes is not restricted

7. Outline any restrictions to dissemination of the project results, including the rights of the industry or company partner to:

   • review, approve or delay publications (including the time period associated with such rights)request or require the removal of any information

8. Declare any conflicts of interest held by the applicants in relation to the industry or company project partners and describe how they will be managed.

9. Justify collaborating with an overseas industry or company under ICF (if applicable).

Failure to provide the information requested for industry or company partners under ICF could result in your application being rejected.

You are recommended to discuss the goals and conditions of any collaboration with an industry or company with your technology transfer or contracts office before applying.

For audit purposes, UKRI requires formal collaboration agreements to be put in place if an award is made. You must provide us with a copy of the collaboration agreement, signed by all partners, before an ICF award starts.

If this does not apply to your proposed work, you will be able to indicate this in the Funding Service.

Facilities

Word limit: 250

Does your proposed research require the support and use of a facility?

What the assessors are looking for in your response

If you will need to use a facility, follow your proposed facility’s normal access request procedures. Ensure you have prior agreement so that if you are offered funding, they will support the use of their facility on your project.

For each requested facility you will need to provide the:

• name of facility, copied and pasted from the facility information list (DOCX, 43KB)

• proposed usage or costs, or costs per unit where indicated on the facility information list

• confirmation you have their agreement where required

Facilities should only be named if they are on the facility information list above. If you will not need to use a facility, you will be able to indicate this in the Funding Service.

Ethics and responsible research and innovation (RRI)

What are the ethical and RRI considerations, implications and issues relating to the proposed work? If you do not think that the proposed work raises any ethical or RRI issues, explain why.

What the assessors are looking for in your response

Demonstrate that you have identified and evaluated:

• the relevant ethical and RRI considerations, including both the research or topic area itself and the design and delivery of the project

• the wider implications of the proposed work, and how you will maximise the positive societal, environmental, and economic benefits arising from the project, whilst minimising unintended negative impacts, such as research misuse or accidental harm

• how you will manage these considerations throughout the lifecycle of the project

You may demonstrate elements of your responses in visual form if relevant. Further details are provided in the Funding Service.

Please refer to the UKRI position statement on funding ethical research and Responsible innovation for more information around our expectations on ethical and responsible research and innovation.

Animal involvement and ’3Rs’

You must complete this section about how your proposed project will involve or impact animals.

If your project does not involve or impact animals, you must confirm this on the next page.

You may be asked about:

• what animals you are involving

• the severity of the procedures you are using

• where the procedures will take place

• welfare standards you aim to meet

• the relevance of your project to the development, validation or dissemination of the 3Rs

You may also need to download, complete, and upload at least one set of additional questions. You will be told how to do this towards the end of this section.

To complete this section and check whether your project is in the scope of the questions, refer to the UKRI policy for research and innovation involving animals.

What counts as an animal

UKRI policy relates to all animals in the Kingdom Animalia, including vertebrates and invertebrates.

Genetically modified organisms and biological risk

You must complete this section if your project will include genetically modified organisms or genetic technologies.

If your project does not involve genetically modified organisms or genetic technologies, you must confirm this on the next page.

You may be asked about:

• the type of organism your project will involve and the procedures your project will include

• the intended use of the organism or genetic technology

• the genetic, biological and environmental risks of your project

For more information, see UKRI’s guidance on genetic technologies.

Human participation in health-related research

You must complete this section about whether your project will include human participation.

If your project does not involve human participation, you must confirm this on the next page.

You may be asked about:

• what type of human participation your project includes

• the project design for human participation

• the phase of the clinical trial

• whether the project will be in an NHS setting, if so how the project will be registered

• whether diversity and inclusion will be considered

For more information, see UKRI’s guidance for human participants in research.

Resources and cost justification

Word limit: 1,500

What will you need to deliver your proposed work and how much will it cost?

What the assessors are looking for in your response

Justify the application’s more costly resources, in particular:

• project staff

• significant travel for field work or collaboration (but not regular travel between collaborating organisations or to conferences)

• any equipment that will cost more than £25,000

• any consumables beyond typical requirements, or that are required in exceptional quantities

• all facilities and infrastructure costs

• all resources that have been costed as ‘Exceptions’

• support for public and patient involvement and engagement. See Payments to public partners

• support for preserving, long-term storage, or sharing of data

• support for international co-leads, demonstrating this is within the 30% costs cap for co-leads from high-income countries, India and China. There is no cap on costs requested for international applicants from DAC list countries

• NHS research costs, when they are associated with NHS studies

• animal costs, such as numbers that need to be bred or maintained and to maintain high welfare standards

You can request costs associated with reasonable adjustments where they increase as a direct result of working on the project. For further information see Disability and accessibility support for UKRI applicants and grant holders. Where a funding limit is imposed on the opportunity, requested costs for reasonable adjustments may exceed the maximum funding amount.

Assessors are not looking for detailed costs or a line-by-line breakdown of all project resources. Overall, they want you to demonstrate how the resources you anticipate needing for your proposed work:

• are comprehensive, appropriate, and justified

• represent the optimal use of resources to achieve the intended outcomes

• maximise potential outcomes and impacts

Public partnerships

Word limit: 750

How does your application involve collaboration with public partners?

What the assessors are looking for in your response

Please provide the following details:

• how public partners have contributed to or co-designed the application

• how public partners will be involved in conducting or supporting the CERSI programme

• how public partners will be selected

• provide the names of applicants who are public partners and their ‘Role type’, where applicable

When outlining your approach, describe the expertise and experience of the team in delivering effective public involvement and engagement. Do not duplicate information provided in other sections such as the ‘Approach’ and ‘Applicant and team capability to deliver’ sections, you may cross refer to those sections, if necessary.

Read more about what we mean by public partnerships.

Trusted Research and Innovation (TR&I)

Trusted Research and Innovation is the protection of the UK’s intellectual property, sensitive research, people, and infrastructure from potential theft, misuse, and exploitation.

Organisations receiving UKRI funding are obliged to act in line with UK government legislation. They are also expected to undertake appropriate due diligence assessments of organisations involved in research partnerships, collaboration agreements, and commercial contracts.

You will be asked about:

• which areas of the National Security and Investment (NSI) Act your project relates to

• who you intend to collaborate with and how

• if your project requires an export control licence

Your answers may affect the T&Cs of your funding agreement if you are successful. We may use your answers to determine that our current T&Cs are sufficient or if additional T&Cs are required.

Research and innovation impact

Impact can be defined as the long-term intended or unintended effect research and innovation has on society, economy and the environment; to individuals, organisations, and the wider global population.

Research disruption due to COVID-19

We recognise that the COVID-19 pandemic has caused major interruptions and disruptions across our communities. We are committed to ensuring that individual applicants and their wider team, including partners and networks, are not penalised for any disruption to their career, such as:

• breaks and delays

• disruptive working patterns and conditions

• the loss of ongoing work

• role changes that may have been caused by the pandemic

Reviewers and panel members will be advised to consider the unequal impacts that COVID-19 related disruption might have had on the capability to deliver and career development of those individuals included in the application. They will be asked to consider the capability of the applicant and their wider team to deliver the research they are proposing.

Where disruptions have occurred, you can highlight this within your application if you wish, but there is no requirement to detail the specific circumstances that caused the disruption.

Related content

• UKRI policies and standards

• MRC policies and standards

• MRC guidance for applicants

Get help with your application

If you have a question and the answers aren’t provided on this page

The helpdesk is committed to helping users of the UK Research and Innovation (UKRI) Funding Service as effectively and as quickly as possible. In order to manage cases at peak volume times, the helpdesk will triage and prioritise those queries with an imminent opportunity deadline or a technical issue. Enquiries raised where information is available on the Funding finder opportunity page and should be understood early in the application process (for example, regarding eligibility, content or remit of a funding opportunity) will not constitute a priority case and will be addressed as soon as possible.

Contact details

For help and advice on costings and writing your application please contact your research office in the first instance, allowing sufficient time for your organisation’s submission process.

For questions related to this specific funding opportunity please contact cersi@mrc.ukri.org

Any queries regarding the system or the submission of applications through the Funding Service should be directed to the helpdesk.

Email: support@funding-service.ukri.orgPhone: 01793 547490

Our phone lines are open:

• Monday to Thursday 8:30am to 5:00pm

• Friday 8:30am to 4:30pm

To help us process queries more efficiently, we request that users highlight the council and opportunity name in the subject title of their email query, include the application reference number, and refrain from contacting more than one mailbox at a time.

For further information on submitting an application read How applicants use the Funding Service.