Study eligibility for Research Delivery Network support - FAQs

Introduction

The purpose of this document is to provide the NIHR Research Delivery Network with a set of Frequently Asked Questions (FAQs) to support the implementation of the Department of Health and Social Care Eligibility Criteria for NIHR Research Delivery Network support policy.

Frequently asked questions

E1. My study supports the establishment / running of a tissue bank, a disease registry, data bank, cohort or other resource which underpins a number of research studies. Is it eligible for NIHR Research Delivery Network support?

A “research project” is defined as a structured activity which is intended to provide new knowledge which is generalisable or transferable. The establishment and running of tissue banks or disease registries does not, in itself, constitute a research project (as there is no “research question”) and these activities are therefore not eligible for Research Delivery Network (RDN) support.

However, activities such as the collection and banking of biological samples, inclusion of patient details on a registry, or development of a patient cohort, which form an integral part of a structured research project, or research projects which utilise such resources, are eligible for RDN support (subject to meeting the other eligibility criteria).

The assessment of whether or not a study meets the DHSC Eligibility Criteria for NIHR RDN Support definition of research is made independently of how the study sponsor has classified the study (as per the UK Policy Framework), for the purposes of gaining ethical approval. The aims and objectives of the work and its potential to generate generalisable and transferable new knowledge should be carefully considered. Studies that have undergone ethical review as tissue banks or databases, but which meet the above definition of research and all other aspects of the Eligibility Criteria, can be supported by the RDN, if the following are satisfied: (1) The research questions and anticipated outcomes are clearly stated; and (2) The research methodology to be used (in addition to methods of sample collection / processing / storage) are clearly described; and (3) The outcome(s) can reliably be extrapolated from the subjects who participated to a broader patient population and a broader range of clinical settings; and (4) Evidence is provided to confirm that funding secured covers all research costs as well as sample collection / processing / storage.

Please note that whilst studies using previously collected samples or data only, may be included on the Portfolio, if they meet the definition of research and all other requirements of the Eligibility Criteria, they cannot upload recruitment. Recruitment can only be captured when new informed consent is given for the collection of new samples or data (i.e. samples/data that have not previously been stored).

E2. My study supports the undertaking of a local service evaluation/improvement. Is it eligible for NIHR Research Delivery Network support?

No, a 'research project' is defined as  the attempt to derive generalisable or transferable new knowledge to answer or refine relevant questions with scientifically sound methods. The undertaking of a local service evaluation or improvement does not, in itself, constitute a research project (as there is no “research question”) and these activities are therefore not eligible for Research Delivery Network (RDN) support. However, if the evaluation/improvement (i) involves services delivered in more than one NHS / care organisation (eg. NHS Trust or care home); (ii) can be scaled across other organisations or services; and (iii) the outcome can reliably be extrapolated from the subjects who participated to a broader patient population and a broader range of clinical settings, then this evaluation/improvement would be considered eligible (subject to meeting the other eligibility criteria) since the activity is generating generalisable or transferable new knowledge.

E3. My study is funded by the NIHR or other areas of central government. Is it eligible for NIHR Research Delivery Network support?

All funding streams administered by, and research commissioned from, central government sources (e.g. NHS England, NICE, Research Councils) or any branch of the NIHR, that are provided for the primary purpose of undertaking research and not intended to support infrastructure (including NHS Service Support Costs), are considered automatically eligible for NIHR RDN support.

Studies funded by regional government awards that are intended to support local, not national, activities, including Academic Health Science Networks are not considered eligible, even where the activity being funded is classified as ‘research’.

E4. My study is funded by a non-commercial (non profit making) organisation (e.g. a research charity). Is it eligible for NIHR Research Delivery Network support?

Non-commercial studies are eligible to receive NIHR Research Delivery Network (RDN) support if (1) the non-commercial organisation / funder is an NIHR RDN Non-commercial Partner and has self-declared that the funding stream supporting the study meets the Eligibility Criteria and (2) the study satisfies all other aspects of the Eligibility Criteria including the definition of research (see section 2.1).

NIHR RDN Non-commercial Partners are non-commercial organisations that:

• Award research funds as a result of open national competition across England with high-quality peer review; and
• Fund research that is of clear value to the NHS, social care or public health; and
• Take appropriate account of the priorities, needs and realities of the NHS, social care or public health in making decision about the research they fund.

A list of the NIHR RDN Non-commercial Partners can be found on the NIHR website.

E5. My study is funded by a university, college or local healthcare organisation. Is it eligible for consideration for NIHR Research Delivery Network support?

No, UK universities, colleges and local healthcare organisations (including NHS Trusts) do not fulfil the criteria for NIHR RDN Non-commercial Partner status, since funding does not meet the 'open competition' requirement. Studies funded by these organisations are therefore not eligible for NIHR Research Delivery Network support.

E6. My not-for-profit organisation / charity funds research in England. Can I be considered for NIHR RDN Non-commercial Partner status?

Yes, non-commercial organisations which fund research across England can apply to become an NIHR RDN Non-commercial Partner via a self-declaration process. Interested organisations should contact the Study Support Service Helpdesk at supportmystudy@nihr.ac.uk. By signing the self-declaration, funding organisations are confirming that the funding streams they administer meet the NIHR RDN Non-commercial Partner criteria as set out in the Department of Health and Social Care policy document “Eligibility Criteria for NIHR Research Delivery Network Support”, see FAQ E4 for further information.

If your organisation has recently applied for membership of the Association of Medical Research Charities (AMRC), you had the option of agreeing for relevant information from your AMRC membership form to be shared with the NIHR RDN. If you have selected this option, we will already have received this information and will have started to assess whether your organisation meets the NIHR RDN Non-commercial Partner criteria. Organisations meeting the AMRC’s membership criteria e.g. automatically satisfy the NIHR RDN peer review criteria detailed in Appendix 1 of the Eligibility Criteria policy linked above making the assessment process more efficient. The NIHR RDN will contact you by email as part of the assessment. 

E7. My study is funded as part of a programme or centre grant. Is it eligible for NIHR Research Delivery Network support?

Individual studies funded as part of programme or centre grants are required to have undergone protocol peer review before they can be considered for NIHR Research Delivery Network support. Appendix 1 of the Eligibility Criteria policy document outlines the standard of peer review required. It is a study Sponsor's responsibility to provide confirmation of appropriate peer review.

E8. My study is funded as part of a Research Training Award. Can the work I do be supported by the NIHR Research Delivery Network?

Individual studies funded as part of Research Training Awards are required to have undergone protocol peer review before they can be considered for Research Delivery Network support. Eligibility for NIHR Research Delivery Network support is determined on a study-by-study basis, with emphasis on the study rather than the activity of an individual. If you hold a Research Training Award and the specific project which you are working on underwent protocol peer review then no further peer review is required. However, if your project was not peer-reviewed as part of the grant award process, confirmation that the study has been peer-reviewed in line with the Eligibility Criteria will be required from the study sponsor before the study can be considered for Research Delivery Network support.

If your personal award is funded as an Investigator Initiated Trial, or by an overseas Government or overseas charity, the study will require formal consideration through the non-commercial extended review process. Confirmation that the specific project has been subject to high quality peer review according to the standards outlined in Appendix 1 of the Eligibility Criteria policy document will be required.

E9. My study is supported by several non-commercial funding organisations. How is eligibility determined?

A non-commercial study supported by multiple funders is automatically eligible for consideration for NIHR Research Delivery Network support if (1) one of the funding streams is administered by the NIHR, other area of central Government or an NIHR RDN Non-commercial Partner that has self-declared the individual stream to be ‘eligible’ and (2) the study satisfies all other aspects of the Eligibility Criteria including the definition of research (see section 2.1).

If none of the funders include the NIHR, other area of Central Government or an NIHR RDN Non-commercial Partner then the study may still be considered for Research Delivery Network support via the non-commercial extended review process.

E10. My non-commercial study is supported by a funding stream which has multiple funding partners. How is eligibility determined?

The eligibility of studies that are supported by a funding stream which has multiple funding partners will be determined by the organisation that has managed the funding competition, specifically the peer review process. For example, the Stroke Association and the British Heart Foundation operated a joint programme grant funding stream. The Stroke Association managed the funding competition, including the peer review process, so it is the Stroke Association who was required to self-declare with respect to this funding stream.

E11. My study is funded by an overseas Government. Is it eligible for NIHR Research Delivery Network support?

Studies that are funded by overseas Governments are considered for eligibility for RDN support via the non-commercial extended review process. Studies need to demonstrate that they meet the eligibility criteria set out in the Department of Health and Social Care policy document “Eligibility Criteria for NIHR Research Delivery Network Support.” In order to meet the criteria of open competition and highquality peer review, the funding call from the overseas government must have been open to all qualified individuals in England to apply (as lead or co-applicant), or, where the study is an international collaboration led from overseas, for all qualified individuals within the lead country to apply and for participation to have been open to all qualified sites in England. 

E12. My study is funded by a non-commercial (non-profit making / charitable) organisation operating solely outside England. Is it eligible for NIHR Research Delivery Network support?

Studies that are funded by a charity operating solely outside of England are considered for eligibility for RDN support via the Non-commercial extended review process. Studies need to demonstrate that they meet the eligibility criteria set out in the Department of Health and Social Care policy document “Eligibility Criteria for NIHR Research Delivery Network Support”. In order to meet the criteria of open competition and high-quality peer review, the funding call from the non-commercial organisation must have been open to all qualified individuals in England to apply (as lead or co-applicant), or, where the study is an international collaboration led from overseas, for all qualified individuals within the lead country to apply and for participation to have been open to all qualified sites in England.

E13. My study is funded by an award (fellowship / studentship) from an overseas government/charity. Is this eligible for NIHR Research Delivery Network support?

Research funded following open international competition and high-quality peer review by overseas governments or charities is considered for NIHR Research Delivery Network (RDN) support via the non-commercial extended review process. In order to meet the criteria of open competition as defined in Appendix 1 of the Eligibility Criteria for NIHR Research Delivery Network Support, the funding call must have been open to all qualified individuals in England to apply (as lead or co-applicant), or, where the study is an international collaboration led from overseas, for all qualified individuals within the lead country to apply and for participation to have been open to all qualified sites in England.

Therefore, where an overseas government has funded one of its nationals (i.e. award made to one individual) to conduct research or training overseas without any element of international competition or collaboration, the study funded by this award will not be eligible for RDN support.

E14. Why is my study being assessed via the extended review process? 

The requirement for a study to be assessed through the extended review process is determined by the source of research funding together with the sponsorship arrangements which are in place.

Non-commercial studies (usually sponsored by a University or NHS Trust) which are funded by potentially eligible funding streams undergo additional eligibility checks to ensure the study meets the Department of Health and Social Care policy document “Eligibility Criteria for NIHR Research Delivery Network Support”. This is referred to as the non-commercial extended review process.

The following types of non-commercial studies are considered potentially eligible:

• Investigator-initiated, commercial-collaborative studies (Industry-funded, non-industry sponsored studies)
• Non-commercial studies funded by overseas governments
• Non-commercial studies funded by overseas charities
• Certain other high-quality studies

As well as ensuring that the study meets the definition of research and full funding for research costs are in place, studies going through the non-commercial extended review process are reviewed against specific criteria focused on:

• Quality (as evidenced by peer review).
• Funding being open to all qualified researchers in England.

Provided that the study meets all of the above requirements then it will be deemed eligible for NIHR RDN support.

E15. My study is funded and supported by an NIHR Biomedical Research Centre (BRC), NIHR Applied Research Collaboration (ARC) or NIHR Patient Safety Research Collaboration (PSRC). Is it eligible for NIHR Research Delivery Network support?

Funding for NIHR Biomedical Research Centres (BRCs), NIHR Applied Research Collaborations (ARCs) and NIHR Patient Safety Research Collaborations (PSRCs) is “self-contained” i.e. funding for both research costs and NHS infrastructure for research (including NHS Support costs) are included in the award. The funding goes directly to the contracted NHS/University partnership and formal partners in each of these NHS/University collaborations. Studies which are fully funded as part of a BRC/ARC/PSRC programme, and take place within the contracted NHS/University partnership and formal partners, will therefore not require additional research infrastructure support from the NIHR RDN.

Multi-centre, non-commercial, BRC/ARC/PSRC studies may require NIHR Research Delivery Network support if an additional collaborating site/s (i.e. not the contracted NHS/ University partnership and formal partners) is involved and requires support.

In addition, where studies conducted in/led by NIHR BRCs/ARCs/PSRCs are in receipt of funding from other NIHR research programmes, NIHR RDN Non-commercial Partners or other areas of central government (including research councils), support, including NHS Support Costs, may be sought from the NIHR RDN. Please note that this does not extend to single-centre investigator-initiated or industry-collaborative research, and research funded by overseas organisations or ineligible funding streams. The NHS Support Costs for these should be met through the NIHR BRC/ARC/PSRC award (as outlined in the BRC/ARC/PSRC award documentation produced by NIHR Central Commissioning Facility). Furthermore, where early translational (experimental medicine) research funded through the BRC funding scheme is conducted within a Clinical Research Facility (CRF) funded by NIHR, the NHS Support Costs associated with the research should be funded from the NIHR BRC funding award.

NIHR BRC/ARC/PSRC led studies deemed eligible for ‘additional’ NIHR support from the RDN will be added to the NIHR RDN Portfolio. Recruitment data should be provided for all UK sites (i.e. both the RDN and the contracted NHS/ University partnership and formal partners - BRC/ARC/PSRC sites) and mapped in line with guidance.

It is recognised that the requirement for NIHR RDN support may change during the lifecycle of the study, for example a fully funded BRC/ARC/PSRC study (within the contracted NHS/ University partnership and formal partners) may need to open in new RDN supported sites to achieve the study’s recruitment target. Should this situation arise an application for NIHR RDN support should be made following discussion with the Regional Research Delivery Network (RRDN).

E16. My study is funded and supported by the NIHR BioResource, the NIHR Health Informatics Collaborative (HIC) or a Translational Research Collaborations (TRCs). Is it eligible for NIHR Research Delivery Network support?

Additional NIHR Infrastructure support is provided through the NIHR BioResource, NIHR Health Informatics Collaborative (HIC) and eight Translational Research Collaborations (TRCs). These awards are made, via BRC contract variations, to organisations/groups of organisations already in receipt of BRC awards. Therefore the same principles apply to BioResource, HIC and TRC supported studies as to those supported by BRC awards (see E15).

E17. My study is supported by another NIHR Infrastructure award but requires additional RDN support, how can I apply for this?

Where possible an application should be made, prior to the study opening

• via the Integrated Research Application System (IRAS). Select "No" to question 5a on the IRAS Project Filter form, this generates question 5b. Select "Yes" to Question 5b “Do you wish to make an application for the study to be considered for NIHR Research Delivery Network (RDN) support and inclusion in the NIHR Research Delivery Network Portfolio?".
• or via the Non-commercial Portfolio Application service in CPMS. 

Visit our RDN Portfolio page for more information.

NIHR Infrastructure led studies deemed eligible for ‘additional’ NIHR support from the RDN will be added to the NIHR RDN Portfolio. Recruitment data should be provided for all UK sites (i.e. both the RDN and the contracted NHS/ University partnership and formal partners- Infrastructure sites) and mapped in line with guidance.

It is recognised that the requirement for NIHR RDN support may change during the lifecycle of the study, for example a fully funded NIHR Infrastructure study (within the contracted NHS/ University partnership and formal partners) may need to open in new RDN supported sites to achieve the study’s recruitment target. Should this situation arise an application for NIHR RDN support should be made following discussion with the Regional Research Delivery Network.

E18.My study is being conducted within a Clinical Research Facility. Is it eligible for NIHR Research Delivery Network support?

NIHR funding for Clinical Research Facilities (CRFs) does not include funding for research costs. All NIHR CRF supported studies therefore require external funding for research costs which will determine eligibility for NIHR Research Delivery Network support and inclusion in the NIHR RDN Portfolio.

The purpose of NIHR funding for CRFs is to meet the necessary recurrent NHS infrastructure costs of CRFs. This includes funding to meet NHS Support Costs. Therefore the need for any “additional” NHS support from the Research Delivery Network should be considered on a case-by-case basis at a local level.

To note: where early translational (experimental medicine) research funded through the BRC funding scheme is conducted within a CRF funded by NIHR, the NHS Support Costs associated with the research should be funded from the NIHR BRC funding award.

NIHR CRF supported studies deemed eligible for ‘additional’ NIHR support from the RDN will be added to the NIHR RDN Portfolio. Recruitment data should be provided for all UK sites (i.e. both the RDN and the contracted NHS/ University partnership NIHR CRF sites) and mapped in line with guidance.

It is recognised that the requirement for NIHR RDN support may change during the lifecycle of the study, for example an NIHR CRF supported study may need to open in new RDN supported sites to achieve the study’s recruitment target. Should this situation arise an application for NIHR RDN support should be made following discussion with the Regional Research Delivery Network.

E19. My study is being conducted within an Experimental Cancer Medicine Centre. Is it eligible for NIHR RDN support?

Experimental Cancer Medicine Centres (ECMCs) are funded jointly by Cancer Research UK (CRUK), the Little Princess Trust, the NIHR in England, and the Health Departments for Scotland, Wales and Northern Ireland.

In England the CRUK/NIHR ECMCs are joint University/NHS partnerships. The purpose of funding is to meet the costs of research infrastructure (via the CRUK element of funding to the University partner) and the costs of NHS infrastructure for research including NHS Support Costs (via the NIHR element of funding to the NHS partner). Funding is not intended to meet the direct research costs of individual studies.

As CRUK is an NIHR RDN Non-commercial Partner, all studies supported by an ECMC award are technically eligible for consideration for NIHR Research Delivery Network support and hence inclusion in the NIHR RDN Portfolio. However, as NIHR funding for ECMCs includes some funding for NHS Support, “additional” NHS support from the Research Delivery Network will be considered on a case-by-case basis at a local level and studies which are fully funded as part of an ECMC programme, and taking place solely within the contracted NHS/University partnership, will not usually be accepted.

Multi-centre, non-commercial, ECMC studies may require NIHR Research Delivery Network support if an additional collaborating site/s is involved and requires support.

In addition, where studies conducted in/led by ECMCs are in receipt of funding from other NIHR research programmes, NIHR RDN Non-commercial Partners or other areas of central government (including research councils), support, including NHS Support Costs, may be sought from the NIHR RDN. Please note that this does not extend to single-centre investigator-initiated or industry-collaborative research, and research funded by overseas organisations or ineligible funding streams. The NHS Support Costs for these should be met through the ECMC award.

NIHR ECMC led studies deemed eligible for ‘additional’ NIHR support from the RDN will be added to the NIHR RDN Portfolio. Recruitment data should be provided for all UK sites (i.e. both the RDN and the contracted NHS/ University partnership and formal partners- ECMC sites) and mapped in line with guidance.

It is recognised that the requirement for NIHR RDN support may change during the lifecycle of the study, for example a fully funded ECMC study (within the contracted NHS/ University partnership and formal partners) may need to open in new RDN supported sites to achieve the study’s recruitment target. Should this situation arise an application for NIHR RDN support should be made following discussion with the Regional Research Delivery Network.

E20. My study is public health research, can it be considered for NIHR Research Delivery Network support?

Yes, the purpose of the NIHR Research Delivery Network (RDN) is to provide infrastructure support for the initiation and delivery of high-quality research which benefits the NHS, including relevant research into public health. Public health research studies, regardless of study setting (i.e. conducted within or outside NHS settings), which meet the RDN Eligibility Criteria, are able to receive support through the Research Delivery Network’s Study Support Service. NHS Support (or the equivalent of NHS Support in non-NHS settings) can be provided for attributed activities, as defined by ‘AcoRD’ - the Department of Health and Social Care guidance for attributing the costs of health and social care research. For studies funded by NIHR RDN Non-commercial Partner charities who are also members of the Association of Medical Research Charities, support will extend to the provision of ‘Part B Research costs’, as outlined in the AcoRD Frequently Asked Questions.

To be considered eligible, a public health research study must meet the definition of research; have appropriate ethical approval (e.g. NHS Research Ethics Committee (REC), Social Care REC, Ministry of Defence REC, or REC approval from a University); and Health Research Authority (HRA) Approval where required, and have full research funding (i.e. funding to meet all Research Costs in compliance with the AcoRD).

E21. My study is a social care research study taking place in a setting outside of the NHS, is it eligible for NIHR Research Delivery Network support?

Yes, the purpose of the NIHR Research Delivery Network (RDN) is to provide infrastructure support for the initiation and delivery of high-quality research which benefits the NHS, including relevant research into social care. 

Social care research studies, regardless of study setting (i.e. conducted within or outside NHS settings) are able to receive support through the Research Delivery Network's Study Support Service if they meet RDN Eligibility Criteria.

NHS Support (or the equivalent of NHS Support in non-NHS settings) can be provided for attributed activities, as defined by ‘AcoRD’ - the Department of Health and Social Care guidance for attributing the costs of health and social care research. If your study is funded by a NIHR RDN Non-commercial Partner charity that is also a member of the Association of Medical Research Charities, support will extend to the provision of ‘Part B Research costs’, as outlined in the AcoRD Frequently Asked Questions.

To be considered eligible, your social care research study must meet the definition of research; have appropriate ethical approval (e.g. NHS Research Ethics Committee (REC), Social Care REC, Ministry of Defence REC, or REC approval from a University); and Health Research Authority (HRA) Approval where required, and have full research funding (i.e. funding to meet all Research Costs in compliance with the AcoRD)

E22. How do I apply for NIHR Research Delivery Network support if my study is taking place outside of the NHS and does not require HRA Approval?

You can submit an application through the Non-commercial Portfolio Application service in CPMS. This service allows investigators to apply earlier and receive an eligibility decision sooner to benefit from the full range of support that our Study Support Service offers.

In order to use the Non-commercial Portfolio Application service, you must first create an account in CPMS. Find out how to create an account and log in to CPMS.

Before starting your application, it is expected that you will have:

• Discussed your study with your Regional Research Delivery Network, through our Study Support Service
• Confirmed the sponsorship arrangements for your study
• Obtained an IRAS ID for your study by following the guidance on the IRAS website
• Secured full research funding for your study, in line with the Department of Health and Social Care’s AcoRD policy.

You should submit your application as soon as you have secured full research funding for your study, in line with the Department of Health and Social Care’s (DHSC) Attributing the costs of health and social care research (AcoRD) policy. There is no need to wait until you are ready to apply for ethical approvals.

To complete your application you will need to provide a copy of your study protocol and evidence of the research funding you have secured so have these ready before starting your application.

Once we receive your application it will be reviewed against the Department of Health and Social Care’s Eligibility Criteria, and you will be notified of the outcome via email.

E23. My study is already open to recruitment, is it eligible for NIHR Research Delivery Network support?

Although we strongly encourage you to submit your application as soon as you have secured funding, we will accept applications for studies that are at a later stage, e.g. when regulatory approval has been received, or the study has opened to recruitment. Studies in their last six months of recruitment (or, for shorter studies, have less than half the recruitment time left) will not be considered. This is to ensure there is enough time left for the RDN to provide benefit to the delivery of the story. 

If your study is open to recruitment, you can submit an application for NIHR Research Delivery Network support via the Non-commercial Portfolio Application service in CPMS. 

In order to use the Non-commercial Portfolio Application service, you must first create an account in CPMS. Find out how to create an account and log in to CPMS on our website. 

To complete your application you will need to provide a copy of your study protocol and evidence of the research funding you have secured. Have these ready before starting your application. 

Once we receive your application it will be reviewed against the Department of Health and Social Care's Eligibility Criteria and you will be notified of the outcome via email. Download the criteria below.

E24. My study does not consent participants or the activity does not meet the NIHR RDN definition of recruitment, is it eligible for NIHR RDN support?

Yes. All studies which meet the Eligibility Criteria for Research Delivery Network (RDN) Support are included on the NIHR RDN Portfolio regardless of whether or not the study consents participants or whether the activity meets the NIHR RDN definition of recruitment.

Definition of recruitment

“Recruitment is the enrolment of an individual person meeting specific inclusion criteria into a research study. Each study participant who has both provided informed consent to join a study and is taking part in the study (i.e. participants who count towards the sample size of the study as set out in the study protocol), should be recorded as a participant in our NIHR Central Portfolio Management System (CPMS).”