PSP040: Eligibility Criteria for NIHR Research Delivery Network (RDN) Support: Policy (October 2024)
Implementation Guidance Document, including Annex A and B

1.1. The purpose of this document is to provide the NIHR Research Delivery Network (RDN) with supplementary guidance to support the implementation of the Department of Health and Social Care policy document “Eligibility Criteria for NIHR Research Delivery Network Support (October 2024)"

1.2. The Department of Health and Social Care policy document “Eligibility Criteria for NIHR Research Delivery Network Support (October 2024)” applies to all studies irrespective of study type (both commercial and non-commercial) and study setting; no exceptions can be made. 

1.3. The cost of delivering non-commercial research is borne by the public purse, whereas commercial contract research, deemed eligible for NIHR RDN support, is delivered on a full cost recovery basis whereby NHS costs are recouped from the company. As such, non-commercial studies undergo a more rigorous Eligibility review process; the Eligibility of commercial studies, specifically whether the study meets the definition of ‘research’ is determined by the Study Planning and Placement Team [note: for a commercial study to continue to receive support from the NIHR RDN one or more delivery organisation/s within the health and care system in England must confirm it has the required capacity and capability to participate]. This document focuses on the implementation of the Eligibility policy for non-commercial studies, however commercial contract research is also referenced where applicable.

1.4. The following sections of this document directly reflect those in the policy document “Eligibility Criteria for NIHR Research Delivery Network Support” and provide additional guidance and links to reference material on the key items of policy. 

1.5. Applications for NIHR RDN support are made via the Non-commercial Portfolio Application (NPA) service  in CPMS, for all non-commercial English-led studies, including studies that do not need, and, therefore, are not applying for Health Research Authority (HRA) Approval, with the following exceptions:

• Studies that are applying for HRA Approval through standard IRAS. These studies  apply for NIHR RDN support by selecting ‘yes’ to question 5b of the IRAS Project Filter.

• Studies that are fully supported by other NIHR Research Infrastructure. These studies will not require additional support from the NIHR RDN and need not apply.

Studies that are led by a Devolved Administration which have English sites are not automatically received into CPMS via standard IRAS and cannot currently be received by the Non-commercial Portfolio Application service. These studies should apply for NIHR RDN support for their English site(s) by submitting a manual application to the Portfolio Eligibility Team via email (Annex B - DA-Led studies). Companies requesting support for commercial contract research must submit an application through the NIHR RDN’s Central Portfolio Management System  as described in the respective guidance document.

1.6.  Assessment of whether or not a non-commercial study is eligible for consideration for NIHR RDN support is made by the NIHR RDN Portfolio Eligibility Team of the Research Delivery Directorate in the RDN Coordinating Centre. Applications for non-commercial studies funded by the NIHR, NIHR non-commercial Partners, or other areas of central government undergo a standard review, whilst non-commercial studies funded by commercial companies (collaborative research, including investigator initiated trials/IITs), overseas governments, overseas charities or other high-quality studies outlined in section 3.16 of the Eligibility Criteria, undergo an extended review process. 

1.7.  This guidance document is supported by two annexes, listed below: 

• Annex A - Frequently Asked Questions (this can also be found at the end of the site)

• Annex B- Overview of the self-declaration process for NIHR RDN non-commercial Partners (this can also be found at the end of the site)

2.1.1.  Section 1.2 of the Eligibility Criteria for NIHR Research Delivery Network Support defines the NIHR RDN Portfolio as consisting of research studies that are eligible for support from the NIHR RDN in England. These studies are required to meet the eEligibility cCriteria to be accepted onto the Portfolio and throughout the duration of their delivery.

2.1.2.  Once eligible, all studies must adhere to the Terms and Conditions for NIHR Clinical Research Network Support to maintain access to NIHR Research Delivery Network support in England, and for continued inclusion on the NIHR RDN Portfolio.

2.2.1.  Section 2.1 of the Eligibility Criteria for NIHR Research Delivery Network Support defines ‘research’ as: the attempt to derive generalisable or transferable new knowledge to answer or refine relevant questions with scientifically sound methods. This definition is taken from the UK Framework for Health and Social Care Research. 

2.2.2.  Activity defined as any of the following is not considered research and therefore is not eligible for RDN support:

2.2.2.1.  Audit

2.2.2.2.  Needs assessments

2.2.2.3.  Quality improvement and other local service evaluations

2.2.2.4.  Routine banking of biological samples or data; except where this activity is integral to a self-contained research project designed to test a clear hypothesis.

2.2.3.  When considering studies that involve any of the above activities the potential to generate generalisable and transferable new knowledge must be carefully considered in line with the following additional guidance:

2.2.4.  Service evaluations: To qualify as an eligible service evaluation that generates generalisable new knowledge, the following general principles should be met: 

• The evaluation involves services delivered in more than one NHS / care organisations (e.g. NHS Trusts or care homes); and

• The evaluation can be scaled across other organisations or services; and

• The outcome(s) can reliably be extrapolated from the subjects who participated to a broader patient population and a broader range of settings¹ 

2.2.5.  Research tissue banks and databanks: The RDN does not support the establishment of research tissue/data banks, since these do not offer immediate benefit to the NHS, public health or social care. However, where a tissue/data bank is being established to support specific research activity, RDN support may be granted if the following are satisfied:

2.2.5.1.  The research questions and anticipated outcomes are clearly stated; and 

2.2.5.2.  The research methodology to be used to address the research questions (in addition to methods of sample collection / processing / storage) are clearly described, including details of the sample size; and 

2.2.5.3.  The outcome(s) can reliably be extrapolated from the subjects who participated to a broader patient population and a broader range of settings¹; and 

2.2.5.4.  appropriate ethical approval is in place as determined by the sponsor (see section 2.3.9 below); and 

2.2.5.5.  Evidence is provided to confirm that the funding secured covers all research costs as well as sample collection / processing / storage.

2.2.5.6.  All other aspects of the Eligibility Criteria are satisfied, i.e. funding has been secured following an open national competition, the study has been subject to high-quality peer review, and it is of value to, and meets the needs, priorities and realities of the NHS, public health and social care.

2.2.6.  Surveillance: Surveillance uses only routinely collected and anonymised data/samples to observe changing trends. It is not expected to meet the DHSCs Eligibility Criteria definition of research and is thus not eligible for support. Surveillance activity within the NHS falls outside the remit of HRA Approval. Where surveillance activity is linked with research activity e.g. where additional data or samples are collected with consent, then RDN support can be considered, subject to the necessary approvals for a research study being in place.  [Note: It has been agreed by RDN Executive Director and DHSC that surveillance is an activity that is not considered research.] Post-market surveillance studies can be considered for RDN support if the study does not meet all of the points listed in the HRA decision tool glossary. The study must also meet the Eligibility Criteria for NIHR Research Delivery Network Support definition of research.

2.2.7.  Networks: The RDN does not support the establishment of networks since these do not offer immediate benefit to the NHS, public health or social care. However, where a network is being established to support specific research activity, RDN support may be granted if the critiera listed in 2.2.5.1 - 2.2.5.6 are satisfied. 

2.2.8.  Where the eligibility reviewer requires additional expert input to make a decision, the chair of the relevant Specialty and Setting group will be consulted.

2.2.9.  Section 2.2 of the Eligibility Criteria for NIHR Research Delivery Network Support states that the definition of research set out in section 2.1 of the policy document should be applied to all studies regardless of study type and research funder. This definition of research therefore applies to both commercial and non-commercial studies

See also Annex A FAQs: E1 and E2 

¹Based on the definition of ‘generalisable new knowledge’ used in the HRA research decision tool: “the extent to which the findings of a clinical study can be reliably extrapolated from the subjects who participated in the study to a broader patient population and a broader range of clinical settings”

2.3.1. Section 2.1 outlines the conditions that must be met in order for a study to be deemed eligible for NIHR RDN support, including meeting the above definition of research, having appropriate ethical approval in place and securing funding to cover the full research costs of the study.

2.3.2.   Section 3.1 (ii) specifies that appropriate ethical approval (e.g. NHS REC, Social Care REC, or Ministry of Defence REC); and Health Research Authority (HRA) Approval, where required, is a prerequisite for research to be supported via the NIHR RDN. 

2.3.3.  The rationale for this policy statement being that the purpose of the RDN is to provide infrastructure support for the initiation and delivery of high-quality research which benefits patients and the NHS, including relevant research in public health and social care. Where research requires HRA Approval in accordance with the UK policy framework for health and social care research, the study must have this in place in order to receive NIHR RDN support. However where research falls outside the scope of HRA Approval, e.g. research taking place in non-NHS settings, NIHR RDN support can still be provided subject to appropriate ethical approval being in place.

2.3.4  Review by an independent Research Ethics Committee (REC) is incorporated into HRA Approval and, the following principles apply: The requirements for ethical review by a Research Ethics Committee (REC) within the UK Health Departments Research Ethics Service are set out in ‘Governance Arrangements for Research Ethics Committees (GAfREC)’. In most cases, for research undertaken via the NIHR RDN the relevant REC within the UK Health Departments Research Ethics Service will be an NHS REC. The National Social Care Research Ethics Committee is a committee within the UK Health Departments Research Ethics Service that can review studies taking place in NHS settings with NHS staff and patients where the approach to data collection uses social science or qualitative methods, provided that the research does not involve any change in treatment or clinical practice. Any study requiring review by a REC within the UK Health Departments Research Ethics Service, must have received a favourable opinion from either an NHS REC or the National Social Care REC in order to receive RDN support. 

2.3.5.  Certain research studies within the NHS are permitted to be undertaken without review by a REC within the UK Health Departments Research Ethics Service, these are listed in section 2.3.9 - 2.3.17 of the Governance arrangements for research ethics committees (2020 edition). Such a study will still be able to receive RDN support if they meet all other eligibility criteria. If ethical approval is not required because the study is not classified as research (i.e. it is classified as audit, evaluation or surveillance), then it will not be eligible for RDN support.

2.3.6.  Where research is taking place outside of the NHS, and review by an NHS REC or the National Social Care REC is therefore not appropriate, it is expected that the study will instead have received a favourable opinion from a REC convened by the sponsoring organisation (e.g. Higher Education Institute (HEI) REC).

2.3.7.  HRA Approval is not required for the establishment of research tissue banks or research databases. However, host organisations should still apply for a generic ethical review of their arrangements for collection, storage, use and distribution of tissue/data. For databases the requirement for ethical review is voluntary. A favourable generic ethical opinion can facilitate programmes of research without a need for individual project-based ethical approval. 

2.3.8.  Research activity taking place under generic Research Tissue/Data Bank (RTB/RDB) REC can be supported by the RDN, provided the conditions in section 3.2.5 above are met. Evidence that the Tissue bank has given their approval  for a study to  use their generic REC should be sought.

2.3.9.  The UK Policy Framework states that it is the sponsor’s responsibility to ensure appropriate ethical and regulatory approvals are in place before research activity commences. Where research is taking place outside the NHS and formal sponsorship agreements are not required, responsibility rests with the (lead) host institution. It is therefore not the RDN’s responsibility to determine what approvals are required for a study.  However, should the RDN have any concerns relating to approvals they will be raised with the HRA, study sponsor or the contact within the lead host institution i.e. with the person who holds the legal responsibility for the study as appropriate".  

2.3.10.  Section 3.1 (iv) of theEligibility Criteria for NIHR Research Delivery Network Support states that all studies must have secured full research funding (i.e. funding to cover the full research costs as defined by AcoRD) and in line with the UK policy framework for health and social care research before they can be considered for RDN support. 

2.3.11.  The UK policy framework for health and social care research states that the research funder² is responsible for “reviewing information about the attribution of costs to confirm that costs to all parties (including excess treatment costs) have been identified and described in accordance with national guidance - Government Publications Guidance where applicable, and that the costs are not disproportionate compared to the value of the output”. It further states that the sponsor³ is responsible for “putting and keeping in place arrangements for adequate finance and management of the research project [...]”.

2.3.12.  Therefore it is a Study Sponsor's responsibility to ensure that there are proper arrangements in place to finance a study in line with AcoRD guidance with completion of Capability and Capacity assessment (or equivalent for non-NHS settings) serving as confirmation that the study has been appropriately costed and financed.

2.3.13.  All funding secured for studies applying for NIHR RDN support should be listed in question A65 in the IRAS Form, as part of the IRAS submission, and evidence should be uploaded with the IRAS checklist. For studies applying outside of IRAS (see 1.5 above), this information should also be included in the application. 

2.3.14.  Where a study is in receipt of funding from multiple sources, all sources of funding should be listed and should be considered as contributing towards the full research costs of the study and will be recorded in the study record. However, eligibility will be determined by just one funding source with ‘automatically eligible’ funding streams considered ahead of ‘potentially eligible’ funding streams.

2.3.15.  The RDN Portfolio Eligibility Team function will check that evidence of the research funding, in the form of a final grant award letter or signed contract, has been supplied and that this is valid, current and matches the funding listed on the study submission. No further checks will be undertaken; sign-off by the sponsor of the IRAS submission (or for studies applying outside IRAS via the Non-commercial Portfolio Application service) will be accepted as a declaration that the full research costs for a study are in place. Site research costs will also be confirmed as part of their local assessment of Capacity and Capability (or equivalent for non-NHS sites). By adopting this approach the RDN can be assured that the full research costs of a study have been secured in line with the Eligibility Criteria. 

2.3.16. The eligibility decision for a study is valid until the end of the original study. The recruitment end date and/or sample size may be extended/amended as notified by the study sponsor as per the Data Entry and Integrity Guidance. However, if there are changes to e.g. the research question and/or study objectives that meet the criteria for a ‘new study’ described in the Identifying when to manage a sub-study within an existing study record guidance document, the study team will have to submit a new application for RDN support to be reviewed by the Portfolio Eligibility team.

2.3.17.  Section 3.2 of the Eligibility Criteria for NIHR Research Delivery Network Support states that NIHR RDN support for non-commercial research studies includes meeting the NHS Support Costs (or equivalent in non-NHS settings) of these studies. As these are funded via the public purse, non-commercial studies seeking NIHR RDN support must also meet the requirements detailed in section 3.5 and Appendix 1 of the policy, i.e. research funding must have been awarded following an open national competition, including assessment through high-quality peer review, and the study must be of clear value to the NHS, social care or public health and meet the needs priorities and realities of the NHS, social care or public health. Eligibility Criteria for NIHR Research Delivery Network Support

2.3.18. As stated in section 3.3 of the Eligibility Criteria for NIHR Research Delivery Network Support the principal determinant of eligibility for RDN support is a study’s source of research funding. This is because the manner by which research funding is awarded is used as a measure of quality. Only the highest quality research will secure funding following an open national competition (i.e. one with a large pool of applicants) that uses high-quality peer review to inform the selection process. Peer review must be part of the funding award process, it cannot be undertaken post award. (Exceptions are only made with respect to programme / centre / research training awards i.e. ‘personal awards’, and Investigator Initiated Trials (IITs) as detailed in sections 3.7 and 3.14 respectively.)

2.3.19. Research funding broadly falls into two categories; it is either automatically eligible or potentially eligible for consideration for RDN support. 

2.3.20.  As stated in section 3.4 of the policy document, research studies funded by ‘automatically eligible’ funding streams will be deemed eligible for consideration for RDN support, provided all other aspects of the Eligibility Criteria are satisfied. 

Funding from NIHR or other areas of central government:

2.3.21.  The NIHR and central government funded streams (including non-departmental public bodies (NDPBs), which include the research councils and devolved administration governments) are automatically eligible for consideration for NIHR RDN support.

2.3.22.  New funding streams of the Research Councils and NDPBs are validated by referring to publically available online information and via email where necessary. Validation checks seek to establish the purpose of the funding (e.g. to undertake research, delivery of a service …) and the nature of the funding (e.g. Project grant, Training award, Centre grant …) to determine the eligibility of the funding (further described in the sections below and 3.3.32 - 3.3.34).

2.3.23.  All funding streams administered by, and research commissioned from, the NIHR or central government sources (eg. NHS England, NICE) that are provided for the primary purpose of undertaking research or are linked to a national strategy that includes research activities, and which are not intended to support infrastructure (including NHS Service Support Costs), are considered automatically eligible. No validation against the NIHR RDN non-commercial Partner Criteria is required.

2.3.23.1. Note: Specialised services would not normally be eligible but may be considered if they are providing funding for an activity where specific research outcomes are part of the award/strategy. 

2.3.23.2 Note: as per section 3.7 of the Eligibility Criteria Policy, training awards i.e. ‘personal awards’ from these and other Funders are required to undergo additional checks (see 3.3.34)

2.3.24.  Where central government funding is awarded for the purpose of delivering a service, the outcome of which is being assessed in a research study, and peer review of the study protocol was not part of the initial funding award (eg. the implementation of a national NHS England funded initiative), confirmation of protocol peer review in line with Eligibility Criteria for NIHR Research Delivery Network Support, will be sought from the study sponsor prior to confirmation of eligibility. 

2.3.25.  Studies funded by regional government awards that are intended to support local, not national, activities, such as Academic Health Science Networks and local NHS England funding ‘pots’, including Integrated Care Systems (ICS) (including Integrated care partnership (ICP), Integrated care board (ICB), Local authorities, Place-based partnerships , Provider collaboratives) and Operational Delivery Networks are not considered eligible, even where the activity being funded is classified as ‘research’.

See also Annex A FAQ E3

NIHR RDN Non-commercial Partners 

2.3.26.  Section 2.5 defines the Criteria for NIHR RDN Non-commercial Partner status; further clarification regarding this definition is included in Appendix 1 of the policy document.

2.3.27. NIHR RDN Non-commercial Partners are those organisations that:

• Award research funds as a result of open 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 decisions about the research that they fund.

2.3.28. Section 2.7 of the ligibility Criteria for NIHR Research Delivery Network Support states that, NIHR Non-commercial Partner status is confirmed via a self-declaration process. This self-declaration process, which is managed by the NIHR RDN Portfolio Eligibility Team in the Research Delivery Directorate in the RDN Coordinating Centre, is outlined in Annex B. 

2.3.29.  Section 3.6 of the ligibility Criteria for NIHR Research Delivery Network Support states that non-commercial funding organisations that self-declare as NIHR Non-commercial Partners may be audited to ensure that the funding they administer meets the Eligibility criteria. If the NIHR RDN Portfolio Eligibility Team is concerned that a funding organisation that has self-declared does not meet the Partner Criteria, their concerns will be referred to the Department of Health and Social Care. This process is outlined in Annex B. 

2.3.30.  A public list of non-commercial organisations that have been deemed NIHR RDN Non-commercial Partners is maintained by the RDN Portfolio Eligibility Team and updated fortnightly on the NIHR website by the RDN Comms Team.  

2.3.31.  Some NIHR RDN Non-commercial Partner organisations administer funding streams that do not meet the Eligibility Criteria or award funds for purposes other than research. The eligibility of individual funding streams is communicated during the NIHR RDN Non-commercial Partner self-declaration process. The Portfolio Eligibility Team maintain a list of all NIHR RDN Non-commercial Partners and their self-declared Funding Streams, within the ‘Funders and funding streams’ tab of CPMS. Access to this data is restricted to staff within the NIHR RDN Coordinating Centre⁴.

Projects funded through Programme/Centre grants and Research Training Awards

2.3.32. Programme and Centre awards are large grants awarded to individuals, groups or research institutions [Please note that programme and centre grants that do not provide funding for research costs of individual studies are ‘not eligible’ funding sources (e.g. Cancer Research UK Centre Awards, Institute Core Awards and Radiation Research Centres of Excellence do not provide funding for research projects). Applications for RDN  support listing these centres as the funding source will need to evidence an additional award to cover research costs]. When studies are funded in the context of a programme grant, the level of detail provided in the proposal in relation to the individual projects, and consequently the amount of detail included in the peer review, is by its nature less detailed than that provided in project grant applications that are designed to address a single hypothesis. Studies conducted in the later stages of the programme will be influenced by outcomes of the earlier pilot / developmental work. These later studies may therefore differ from those described in the submitted programme application. 

2.3.33.  A Research Training Award is a Fellowship or Studentship funded by the Department of Health and Social Care/ NIHR, by a Research Council, or by an NIHR RDN Non-commercial Partner and is a recognised part of a research career pathway. The Portfolio Eligibility Team refers to these collectively as ‘personal awards’. Undergraduate projects do not meet the definition of a Research Training Award and therefore are not eligible for RDN support. Furthermore, research training awards are only eligible where funding to cover research costs is included in the award. Applications for Research Training Awards may focus on the quality of the applicant and provide only a broad overview of the proposed research project.

2.3.34.  Section 3.7 of the Eligibility Criteria for NIHR Research Delivery Network Support states that “individual studies funded as part of a programme or centre grant or as part of a research training award will be required to have undergone protocol peer review before they can be considered for NIHR RDN support”. This requirement is specified in the NIHR RDN Non-commercial Partner self-declaration. NIHR RDN Non-commercial Partners supporting Programme or Centre grants or Research Training Awards will be required to self-declare if the funding assessment process includes protocol peer review of all individual studies in addition to review of the overall programme of work / the research trainee. If protocol peer review isn’t undertaken as part of the grant award process, this will be noted by the RDN Portfolio Eligibility Team.  The requirement to assess the level of peer review undertaken applies to programme/centre grants and personal awards awarded by the NIHR and other areas of central Government. Confirmation of protocol peer review will be required from the sponsor before these studies can be considered for RDN support. Funding streams that require this additional check are called ‘conditionally eligible’.

2.3.35.  One-off funding awards: Where funding is awarded on a one-off basis, by an NIHR RDN Non-commercial Partner, the funding and the study it was awarded for should be included on the self-declaration form. Self-declaration by the Partner organisation is sufficient and extended review as an ‘other high-quality’ study is not required.

2.3.36.  Multiple funders: Section 3.8 states that a non-commercial study in receipt of funding from more than one source is automatically eligible for consideration for RDN support if one of the funding streams is administered by the NIHR, other areas of central government or an NIHR RDN Non-commercial Partner; and the funding stream itself has been self-declared as eligible; and the study meets all other aspects of the eligibility criteria (i.e. is fully funded and meets the definition of research in section 2.1). The rationale being that if the NIHR, other areas of central government or an NIHR RDN Non-commercial Partner is providing any support for the study, it will have been through their grant award processes. Specifically,  for studies funded by a NIHR RDN Non-commercial Partner, the study will have been subject to high-quality peer review and the funding awarded in open competition across England and hence will be high-quality research. 

2.3.37.  Joint funding streams: As stated in section 3.9, the eligibility of studies that are supported by a funding stream that has multiple funding partners will be determined by the organisation who 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 and so it was the Stroke Association who was required to self-declare with respect to this funding stream. 

2.3.38. Grants awarded by centres: If a centre manages a funding competition which entirely uses funds that were awarded as part of the original centre grant received from the NIHR RDN Non-commercial Partner, NIHR or government, then the centre itself is not regarded as the funder of the stream. Instead, the original centre grant should be used to determine eligibility.

See also Annex A FAQs: E4, E6, E7, E8, E9 and E10

2.3.39.  Section 3.10 of the  Eligibility Criteria for NIHR Research Delivery Network Support states that non-commercial research studies funded by ‘potentially eligible’ funding streams are required to undergo ‘additional’ checks to ensure they meet the same high-quality standards as studies funded by ‘automatically eligible’ funding streams. These studies must meet the definition of research described in section 1.1 and are assessed, on a case-by-case basis (rather than via self-declaration), via the non-commercial extended review process to ensure that the criteria described in section 2.5 are also satisfied.

2.3.40.  The non-commercial extended review process is managed by the Portfolio Eligibility Team within the RDN Coordinating Centre, on behalf of the Department of Health and Social Care.

2.3.41.  The types of non-commercial studies that are considered ‘potentially eligible’ and reviewed through the non-commercial extended review process are listed in section 2.11 of the policy and below

• Investigator-initiated, commercial-collaborative studies (Industry-funded, non-industry sponsored studies) (see 2.12-14)

• Non-commercial studies funded by overseas governments (see 2.15)

• Non-commercial studies funded by overseas charities (see 2.16)

• Certain other high-quality studies (see 2.16). 

Investigator-initiated, commercial collaborative research:

2.3.42.  Investigator-initiated, commercial collaborative studies (IITs) are those that are initiated by non-commercial investigators (e.g. University or NHS staff) with the research funding being provided by a commercial organisation (e.g. a pharmaceutical, biotechnology or devices company) specifically to support that study as described in 3.12 of the Eligibility Criteria for NIHR Research Delivery Network Support. If network staff are unsure if a study should be considered an IIT they should review the contract for the study, which to qualify as an IIT, should include provision for the investigator to take responsibility for analysis, interpretation and publication of findings. 

2.3.43. IITs are considered for eligibility for RDN support via the non-commercial extended review process meaning. PET assesses on study-by-study basis specific criteria focused on the funding award process to check that: (1) Funding was awarded as a result of high-quality (independent, expert, proportionate) peer review, and (2) Funding was awarded as a result of open competition to all qualified researchers in England. As per the UK Policy Framework for Health and Social Care Research, the funder is responsible for assessing (or arranging for assessment of) the scientific quality, the relevance of the research to the target population, and, if appropriate, the value for money of the research as proposed. Additionally, ethical implications will be addressed as part of gaining a favourable opinion from a Research Ethics Committee. This provides assurance that the criteria in Appendix 1 section 1.ii and 1.iii, respectively, of the Eligibility Criteria for RDN Support are met.   

2.3.44.  As stated in section 2.13 it is recognised that commercial organisations do not usually award funding by means of a structured competition, however to be eligible for NIHR RDN support, the potential field of researchers who could be awarded the funding must not have been restricted to specific Universities or NHS Trusts within England. As such written confirmation that the funding opportunity was open to all qualified researchers in England is required from the funder (i.e. company). The following question will be asked “To be eligible for NIHR RDN support the potential field of researchers who could be awarded the funding must not have been restricted to specific Universities or NHS Trusts within England. Was this funding opportunity open to all suitably qualified researchers in England?". 

2.3.45. In addition, section 2.14 states that all IITs must have been subject to high-quality peer review before they can be considered for RDN support. Since it is accepted that commercial companies do not always review proposals from a purely scientific perspective, post award peer review is acceptable for IITs. The Study Sponsor is required to provide confirmation of appropriate peer review as part of the non-commercial extended review process, if the information provided in the application is insufficient. 

Non-commercial studies funded by overseas Governments or Charities:

2.3.46. Non-commercial studies funded by overseas governments or other non-English non-commercial organisations or charities (section 3.15) are considered for eligibility for RDN support via the non-commercial extended review process. Studies funded by overseas governments (e.g. EU or US National Institute of Health) or Charities (and/or other non-English, non-commercial / not for profit organisations) must have been funded in open competition with high-quality peer review. Confirmation of this will be sought from the research funder. See 3.3.43 regarding the criteria in Appendix 1 section 1.ii and 1.iii, respectively, of the Eligibility Criteria for RDN Support. 

2.3.47. Where the research study is taking place solely within England, research funding from the overseas organisation must have been open for all qualified individuals in England to apply as lead or co-applicant. However where the research study is an international effort/collaboration led from outside England, open competition with high-quality peer review within the lead/host country, will be considered an equivalent marker of quality provided that the funder has placed no restriction on which English sites 2.17 can participate in the study (i.e. participation is open to all qualified English sites).

2.3.48. Where the research study is commissioned and funded by a collaborative network, the open competition critiera are considered satisfied, if the knowledge of the commission is available to all appropriately qualified individuals and any qualified researcher in England can apply to undertake the study. If it is a requiement to be part of the network to apply for the comissioned study, membership of the network must be open to all appropriately qualified individuals and knowledge of this must be available of all appropriate qualified individuals. Confirmation of peer review is initially sought from the funder but retrospective peer review arranged and confirmed by the sponsor is acceptable.

Potentially eligible commercial collaborative research (“Reverse IITs”):

2.3.49.  Studies sponsored by a commercial organisation (e.g. a pharmaceutical, biotechnology or devices company) but which are funded by a non-commercial funding organisation. The eligibility of these studies is determined, as for all studies, by the source of funding. If funding is provided by the NIHR, other area of central government or an NIHR RDN Non-commercial Partner that has self-declared the funding stream to be ‘eligible’, the study will be considered automatically eligible provided it meets all other aspects of the Eligibility Criteria; if funding is provided by an overseas government or charity, the study will be considered potentially eligible and reviewed through the non-commercial extended review process. 

Certain other high-quality studies (3.16):

2.3.50.  In exceptional cases studies funded by any other source of funding not detailed in the Eligibility Criteria for NIHR Research Delivery Network Support policy document, but which appear to meet the criteria set out in sections 1.1 and 2.5 of the policy document (i.e. research studies, awarded funding via an open national competition across England with high-quality peer review, and which are of value to the NHS, social care or public health and take account of the priorities, needs and realities of the NHS, social care or public health) may be considered for eligibility via the non-commercial extended review process. Use of this category is at the discretion of the Portfolio Eligibility Team within the RDN Coordinating Centre.

2.3.51. It is anticipated that this policy item relates to studies funded by one-off pieces of funding or by organisations whose primary purpose is not research.

2.3.52.  New funding models: Due to increased pressure on limited ‘traditional’ sources of funding, the NIHR RDN are increasingly receiving applications from studies funded through new funding models, such as crowdfunding and continuation funding. How these are considered is described below.

2.3.53.  Studies funded by continuation funding: Continuation funding is awarded by an organisation to recipients who are already receiving funds through a traditional funding stream and who are seeking to complete or build upon the currently funded work. Continuation funding can only be considered an eligible source of funding if it has been awarded as a result of open competition e.g. where applications for continuation funding (from previously funded researchers/groups) are considered alongside other applications for funding from previously unfunded researchers/groups. 

2.3.54. Continuation funding is considered different from an extension to funding. Extensions are usually awarded where a study has run into difficulties and requires additional funding or additional time (no-cost extension) to complete the work outlined in the original grant application. Extensions are usually considered by the funder on a case by case basis, rather than via a structured competition. The eligibility of studies funded by an extension is determined by the eligibility of the original grant. 

2.3.55. Other new models of research funding: New models of funding will be considered on a case-by-case basis, giving acknowledgement to the precedents set in the above examples.

See also Annex A FAQs: E11, E12, E13 and E14

2.3.56. Section 3.18 of theEligibility Criteria for NIHR Research Delivery Network Support states that in order for a commercial contract study to be eligible for RDN support, the study must meet the definition of ‘research’ as defined in section 2.1 of the Eligibility Criteria for NIHR Research Delivery Network Support and the study must have appropriate ethical approval (e.g. NHS, Social Care REC, or Ministry of Defence REC); and Health Research Authority (HRA) Approval where required; and full funding for all costs for commercial contract studies in compliance with AcoRD guidance; prior to initiation at individual delivery organisations. 

2.3.57. Commercial contract research studies apply for RDN support by applying for one of the commercial site services (Site Identification or Site Intelligence)  via the Central Portfolio Management System (CPMS).,  o On receipt,  the Study Planning and Placement Team check that the studies meet the definition of research. HRA and ethical approval are confirmed after the Study Planning and Placement services have been completed but before individual sites are initiated. Further information on the commercial site services  is available on the NIHR website.

2.3.58. As stated in section 2.20 pharmacovigilance studies and other post authorisation safety studies, required by regulatory authorities, are in scope and can access NIHR RDN support, however studies whose primary objective is to support product marketing are not eligible for NIHR RDN support. This is in keeping with NIHR’s mission to improve the health and wealth of the nation (growth) through research.

2.3.59. Costings for commercial contract research are summarised in section 2.21: Industry-sponsored studies that are deemed eligible for NIHR RDN support are able to access the NIHR RDN Support and Services free of charge. However, funding of study related activities, including NHS Service Support Costs (or equivalent in non-NHS settings), as outlined in AcoRD, require full cost recovery from industry (section 3.22).

2.3.60. Studies are classified as commercial or non-commercial based on the source of research funding and the sponsorship arrangements. In general commercial studies are sponsored and fully funded by the commercial company (i.e. commercial contract research), whereas non-commercial studies are sponsored by a non-commercial entity (e.g. NHS Trust, University) and funded by either an automatically or potentially eligible funding stream. However, where a study is undertaken as a collaboration between multiple commercial and non-commercial entities or multiple companies, the classification may not be clear. Details on the classification of studies can be found in the Guide to RDN classification of studies and study management routes. 

2.3.61. Where the NIHR Coordinating centre is unsure, advice and input will be requested from local Clinical Research Networks as required. NOTE: In borderline cases, where the non-commercial Eligibility Criteria are not satisfied (i.e. open competition and peer review), if the Sponsor and/or Commercial Company are willing and able to cover the NHS Support Costs (i.e. full cost recovery for the RDN) the study may be considered for inclusion through the commercial route.

2.3.62. As outlined in section 2.23, the NIHR has other funding schemes which provide research infrastructure in the NHS and the associated NHS Support costs for their early translational, clinical research and applied health research programmes. These are large and prestigious awards granted to individual research institutes or as collaborations (collectively called NIHR Infrastructure awards from herein) and include: 

• Biomedical Research Centres (BRCs)

• Applied Research Collaborations (ARCs)

• Patient Safety Research Collaborations (PSRCs)

• Clinical Research Facilities (CRFs)

• Experimental Cancer Medicine Centres (ECMCs; jointly funded with Cancer Research UK)

• Health Tech Research Centres

2.3.63.  Additional NIHR Infrastructure support is provided through the NIHR BioResource, NIHR Health Informatics Collaborative (HIC) and three Translational Research Collaborations (TRCs). These awards are made, via Biomedical Research Centre (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.

2.3.64.  The MRC/NIHR National Phenome Centre does not fund research, therefore we would not expect to receive studies with this NIHR Infrastructures listed as funding organisation. 

2.3.65. Section 3.24 of the Eligibility Criteria for NIHR Research Delivery Network Support states that studies which are fully funded by NIHR Infrastructure awards and which are taking place solely within the NHS/University partnership that holds the contract and/or formal partner organisations will not require additional support from the NIHR RDN. This is because funding for NIHR Infrastructure is “self-contained” i.e. funding for both research costs and NHS infrastructure for research (including NHS Support costs) are included in the award. Since this funding goes directly to the NHS partner/s in each of these NHS/University collaborations, studies that have been funded as part of an NIHR Infrastructure award should be appropriately costed so as not to require ‘additional’ NIHR Infrastructure support via the NIHR RDN. ‘Additional’ NIHR Infrastructure support will only be granted in two situations as outlined below and in sections 3.25 and 3.26 of the Eligibility Criteria for NIHR Research Delivery Network Support.

2.3.66. Multi-centre non-commercial research, funded and supported by NIHR Research Infrastructure may require ‘additional’ NIHR Infrastructure support via the NIHR RDN if additional collaborating site/s (i.e. not the contracted NHS/ University partnership and/or formal partners) are involved in study activities (eg recruitment) that cannot reasonably be covered by the NIHR Infrastructure. This also applies when the study under review has additional funding from industry or overseas sources or ineligible funding. For instance, it is accepted that if a study funded by the Cambridge BRC needs to recruit from additional sites in London and Manchester, in order to meet recruitment targets, Cambridge BRC staff cannot be expected to travel to these additional sites, therefore NIHR RDN support can be granted to support recruitment in London and Manchester. 

2.3.67. In addition, where single centre studies conducted in/led by NIHR BRCs are in receipt of funding from other NIHR research programmes, NIHR RDN Non-commercial Partners or other areas of central government (including research councils and devolved administration governments), NHS Support Costs may be sought from the NIHR RDN. However, NHS Support Costs for single centre investigator-initiated or industry-collaborative research, and research funded by overseas organisations or ineligible funding streams, should be met through the NIHR Infrastructure award (as outlined in the guidance issued by Central Commissioning Facility).

2.3.68. During the eligibility review, the Eligibility Team of Research Delivery in the CC will consider whether NIHR Infrastructure supported studies require additional NIHR RDN support and if it is unclear, will query with the regional RDN. It is the RRDN's responsibility to respond accurately and in a timely manner to such requests. Where support is considered necessary, the NIHR Infrastructure funding will be considered conditionally eligible i.e. automatically eligible subject to confirmation of peer review in line with Eligibility Criteria. However, if automatically eligible funding is also in place this may be used for the eligibility assessment.

2.3.69. 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 NIHR Infrastructure supported sites) and mapped in line with guidance. 

2.3.70. Where possible NIHR Infrastructure studies that require additional RDN support should submit an application before opening via the standard IRAS linked application process or via the Non-commercial Portfolio Application service as applicable. However it is recognised that the requirement for RDN support may change during the lifecycle of the study, for example an NIHR Infrastructure study may need to open in new RDN supported sites to achieve the study’s recruitment target or may secure additional funding. In such cases an application may be submitted to the Portfolio Eligibility Team  via the Non-commercial Portfolio Application service. 

See also Annex A FAQs: E15- E19

² The UK policy framework for health and social care research defines the funder as “the organisation or group of organisations providing funding for the research project. The funder is normally the sponsor in the case of commercial research”.

³ The UK policy framework for health and social care research defines the sponsor as “the individual, organisation or partnership that takes on overall responsibility for proportionate, effective arrangements being in place to set up, run and report a research project. All health and social care research has a sponsor. The sponsor is normally expected to be the employer of the chief investigator in the case of non-commercial research or the funder in the case of commercial research”.

⁴ This is a Department of Health and Social Care requirement

2.4.1. The purpose of this policy and the Eligibility review process is to identify those high-quality research studies that can be considered for NIHR RDN support, not to assess the deliverability of these studies.

2.4.2. Following the launch of the NIHR RDN Study Support Service it is recognised that RDN support encompass more than the provision of NHS Support Costs (or equivalent in non-NHS settings) and, for studies funded by the Association of Medical Research Charities (AMRC) members, AcoRD Part B Research Costs. Therefore, the NIHR RDN should support all high-quality research studies that meet the Eligibility Criteria regardless of the delivery setting or the level of active support required. This includes social care studies and public health studies, and other studies taking place outside the NHS; non-consenting studies⁵ and studies where no attributable costs have been identified in AcoRD (i.e. where support is limited to engagement with sites and provision of Study Support Services).

2.4.3. Section 4.1 of the Eligibility Criteria states it is the responsibility of the relevant Regional Research Delivery Network to consider a study’s requirement for NIHR RDN support at each site. This should be initiated by deliverability assessments at the earliest opportunity in line with NIHR RDN Study Support Service. It is expected that a study will be optimised for delivery in the NHS, Social Care or Public health settings, i.e. that it should be both eligible and deliverable, before support commences.

2.4.4. It is accepted that for multi-centre studies the NIHR RDN support required and provided may vary across Regional Research Delivery Networks and research sites, based upon need. Furthermore the need for NIHR RDN  support may change during the lifecycle of the study.  The RDN provides support with study delivery and performance to sponsors and their delegates upon request in line with NIHR RDN Study Support Service.

2.4.5. The Portfolio Eligibility Team will no longer query whether RDN support is required, except where other NIHR Infrastructure is involved and the need for ‘additional’ NIHR support via the RDN is unclear. (Where other NIHR Infrastructure is involved the principles laid out in section 3.23 should be followed.)

⁵ Non-consenting studies (i.e. those that do not consent individual participants or where the activity does not meet the NIHR RDN definition of recruitment) that meet the Eligibility Criteria and require regional Network support should be included on the NIHR RDN Portfolio and should not be deprioritised at the local level. Non-consenting studies must be recorded on CPMS appropriately as having no recruitment to upload.

2.5.1. The resources needed to support research, both NHS Support (and equivalent in non-NHS settings) and availability of suitable/appropriate participants, are finite. Section 5.1 of the Eligibility Criteria provides guidance on how study delivery should be prioritised if resources become stretched. If an RRDN is unable to provide the necessary NHS research infrastructure support (or equivalent in non-NHS settings) to all eligible studies open in their ‘patch’, then effort and resource should be focused on studies with the highest priority as outlined in section 5.2. Studies with a lower priority can still receive RDN support but participant recruitment may take a little longer.

2.5.2. Prioritisation of NIHR RDN support for eligible studies is based solely on the source of research funding, as indicated in the table below. There should be no need for there to be any prioritisation of NIHR RDN Non-commercial Partner studies on the basis of the costs of support. Nor should non-consenting studies (those where recruitment activity is not captured) ever be deprioritised.

• Non-commercial research funded by: NIHR, other areas of central government or an NIHR RDN Non-commercial Partner

• Commercial contract research

• Non-commercial research funded by overseas governments

• Commercial collaborative research, including Investigator-initiated Trials

• Non-commercial research funded by overseas charities

• Non-commercial research funded by any source of funding not mentioned above, but which meet the criteria set out in 2.5

2.6.1.  Appendix 1 of the Eligibility Criteria further defines the requirements for non-commercial studies seeking NIHR RDN support, including defining the key terms ‘Open Competition’ and ‘High quality peer review’.

2.6.2. Open competition ensures that the best range of researchers are able to apply for the funding. In the Eligibility Criteria open competition is defined by:

1. The competition being open to all appropriately qualified individuals; and 

2. Knowledge of the competition being available to all appropriately qualified individuals; and

3. The research funder (organisation/ institution that awards the funds) being completely independent of the recipient (organisation/ institution that will receive the funds); and

4. The competition being open to all appropriate host organisations i.e. there is no geographical restriction on where, in England, the research can be undertaken, unless, the award is linked to a training post that is only available at a limited number of sites.

2.6.3. A requirement to be a member of a professional society is acceptable, provided membership is open to all qualified individuals in England and any membership fees are not prohibitive. 

2.6.4. Use of the NIHR Expertise Partnering Service by a commercial company to secure a research collaboration satisfies this criterion.

2.6.5. In exceptional cases it may be considered acceptable for a research funder to invite a small subset of researchers to apply for funding if they are the only ones with the necessary expertise to undertake research in a particular field, i.e. rare diseases. In these cases, the Portfolio Eligibility Team will seek guidance from experts in the field (RDN National Specialty and Settings Groups) with respect to whether such an approach is appropriate for a specific field.

2.6.6. Where a research study is part of an international effort, collaboration or consortium, funded by potentially eligible funding and involving more than one country, open competition and high-quality peer review within the host country, even if not open to English applicants directly, will be accepted as an equal measure of high-quality, provided that the funder has placed no restriction on which English sites can participate in the study. (i.e. participation is open to all qualified English sites.) 

2.6.7. The above principle will also be applied to studies led from the Devolved Administrations i.e. provided participation in the study is open to all qualified sites in England, it is acceptable to consider open competition within the host administration only, as the marker of quality i.e. funding open to all researchers with Scotland, Wales or Northern Ireland will be accepted.

2.6.8. Studies in receipt of such funding (described in 3.6.6 and 3.6.7 above) will therefore be deemed eligible provided they meet all other aspects of the Eligibility Criteria and this will be determined via the non-commercial extended review process. This approach will ensure RDN support is available to all high-quality international and cross-border research studies. 

2.6.9. As the above approach only applies to research involving more than one country, it is not anticipated that studentships/fellowships awarded by a single country to be undertaken in England will be considered eligible.

2.6.10.  It is expected that the availability of funding would be advertised nationally via an organisation’s own website or that of a relevant professional society.

2.6.11. The Funder is the institution or organisation that awards the funds; the Recipient is the employing institution or organisation that receives the funds. The funding and recipient organisations cannot be the same e.g. research studentships or other funding awarded by an academic or healthcare organisation to students undertaking research at or supervised by that organisation are not eligible.

2.6.12. The funding competition must be open to all appropriate host organisations i.e. there can be no geographical restriction on where, in England, the research can be undertaken, unless, the award is linked to a training post that is only available at a limited number of sites.

2.6.13. The research funder must allow all research to be undertaken anywhere i.e. for all awarded funds to be transferred to any English organisation. This refers to where the primary grant funding is transferred and does not include the subsequent transfer of funds to sites elsewhere in England i.e. a requirement for the lead- or co-applicant to be based within a specific region is not acceptable, even if sites from outside the region can participate and thus receive funds via subsequent transfers.

2.6.14. A funding requirement to deliver research in a particular centre can be accepted only where this is linked to a training post that is only available at a limited number of sites.

2.6.15.  To be eligible for NIHR RDN support studies must have undergone high-quality peer review. To classify as high-quality, the peer review of the study must be independent, expert, and proportionate:

1. Independent: At least two individual experts should have reviewed the study. The definition of independent used here is that the reviewers must be external to the investigators’ host institution, have no conflicts of interest,  and not involved in the study in any way. Reviewers do not need to be anonymous. 

2. Expert: Reviewers should have knowledge of the relevant discipline to consider the clinical and/or service based aspects of the protocol, and/or have the expertise to assess the methodological and statistical aspects of the study.

3. Proportionate: Peer review should be commensurate with the size and complexity of the study. Large multicentre studies should have higher level (more reviewers with broader expertise and often independent review committee or board), and potentially international peer review⁶  

2.6.16. Peer review must form part of the grant awarding process i.e. completed and used to make the decision on whether a study is awarded funding. Peer review does not necessarily have to be undertaken by the awarding research funder themselves, it may be completed by another organisation (in the form of peer review/ endorsement) on behalf of the funder, as long as the awarding organisation actively takes account of the external peer review (or endorsement) when deciding which applications to fund. 

2.6.17. The only exceptions to this are with respect to programme / centre / research training awards, and Investigator Initiated Trials (IITs) as detailed in sections 2.7 and 2.14 respectively. In these examples, the Portfolio Eligibility Team in the National RDN Coordinating Centre will review Question A54 in the IRAS Form or the ‘Peer Review’ section in the Non-commercial Portfolio Application in CPMS for confirmation of whether the study has had appropriate peer review (i.e. independent, expert and proportionate). If it is unclear from the information provided in the application that the study has had protocol peer review (i.e. independent, expert and proportionate), the RDN Portfolio Eligibility Team will ask the Study Sponsor (as listed in A64 of the IRAS submission/’Sponsor’ section of the Non-commercial Portfolio Application in CPMS), copying in the Lead RRDN, for confirmation that "the study protocol has been peer reviewed in accordance with the standards of peer review outlined in Appendix 1 of the "Eligibility Criteria for Research Delivery Network Support policy document" and the NHS Research Governance Framework. It is expected that this confirmation will be provided by the sponsor via email.

2.6.18. Peer review undertaken as part of an unsuccessful grant application cannot be considered.

2.6.19.  As part of the self-declaration as an NIHR RDN Non-commercial Partner, funding organisations are required to confirm that the research they fund is of clear value to the NHS, social care or public health. For non-commercial research studies funded by ‘potentially eligible’ funding streams, as per the UK Policy Framework for Health and Social Care Research, the funder is responsible for assessing (or arranging for assessment of) the scientific quality, the relevance of the research to the target population, and, if appropriate, the value for money of the research as proposed. Additionally, ethical implications will be addressed as part of gaining a favourable opinion from a Research Ethics Committee.

• For further clarity around the meaning of clear value to the NHS, social care or public health the following can be considered:

Will the investment the NHS, social care or public health will be required to make in answering the question (including treatment costs, service support costs, patient and NHS, social care or public health time/effort etc.) be hugely disproportionate to the value of the evidence that will be gained? If so, the study would not meet this criteria.

• For further clarity around the meaning of whether the priorities, needs and realities of the NHS, social care or public health are taken, in making funding decisions the following can be considered:

Will the study be examining an intervention that is highly unlikely to be taken up by the NHS social care or public health even if it is proven to have some efficacy? If so, the study would not meet this criteria.

To suggest a change to this document please contact the Portfolio Eligibility team: portfolio.applications@nihr.ac.uk. Requests will be discussed on a 6 monthly basis. Any changes made to the document will be communicated alongside the reissued document.

⁶ Small single-centre studies and investigator-initiated commercial collaborative studies still require expert and independent peer review but this might be arranged through the institutions R&D office (as required by the NHS Research Governance Framework for England and Wales).

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 (DHSC) Eligibility Criteria for NIHR Clinical Research Delivery Network Support policy.

These FAQs are publicly available on the NIHR website.

This guidance document is an Annex to the Eligibility Criteria for NIHR RDN Support: Policy  - Implementation Guidance Document.

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 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 NIHR RDN 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).

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 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 (i) involves services delivered in more than one NHS / care organisations (e.g. 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 would be considered eligible (subject to meeting the other eligibility criteria) since the activity is generating generalisable or transferable new knowledge.

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’.

Non-commercial studies are eligible to receive NIHR Research Delivery Network support (RDN) 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 decisions about the research they fund.

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

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.

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 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. 

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.

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.

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 areas 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.

The eligibility of studies that are supported by a funding stream which has multiple funding partners will be determined by the organisation who 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.

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 high quality 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. 

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.

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. awarded 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.

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:

• 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.

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 RDN.

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). 

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 RDN.

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 RDN.

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 RDN.

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 NIHR 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). 

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 NIHR Research Delivery Network’s Study Support Service if they meet the 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)

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 here.

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

• Discussed your study with your regional RDN, through our Study Support Service

• Confirmed the sponsorship arrangements for your study

• Obtained an IRAS ID for your study by following these steps 

• 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.

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 that there is enough time left for the RDN to provide benefit to the delivery of the study.

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.

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).”

1.1. The purpose of this document is to outline the NIHR RDN Non-commercial Partner Self-Declaration process. This process is managed by the NIHR RDN Portfolio Eligibility Team of the Research Delivery Directorate in the RDN Coordinating Centre. This guidance document is an Annex to the Eligibility Criteria for NIHR RDN Support Implementation Guidance Document.

1.2. The Department of Health and Social Care policy document ‘Eligibility for NIHR Research Delivery Network Support (October 2024)’ [Eligibility Criteria] defines NIHR RDN Non-commercial Partners as those organisations that:

1. Award research funds as a result of open competition across England with high-quality peer review (definitions are set out in Appendix 1 of the  ‘Eligibility for NIHR Research Delivery Network Support; and

2. Fund research that is of clear value to the NHS, social care or public health; and

3. Take appropriate account of the priorities, needs and realities of the NHS, social care or public health, in making decisions about the research that they fund.

1.3. NIHR RDN Non-commercial Partners are required to sign a Self-Declaration detailing which of their funding streams meet the NIHR RDN Non-commercial Partner criteria (as defined above) and which do not.

1.4. A list of current NIHR RDN Non-commercial Partners is maintained by the RDNCC Portfolio Eligibility Team and updated fortnightly on the NIHR website by the RDN Comms Team.

1.5. This document is exclusively a list of NIHR RDN Non-commercial Partners (generally, charitable organisations) who manage automatically eligible funding streams. It is not a list of all funders that manage automatically eligible funding streams. The NIHR and other areas of central Government, including Non-Departmental Public Bodies and the Research Councils, do not appear in this list, but do administer automatically eligible funding streams.

1.6. A disclaimer appears as a footnote on the NIHR RDN Non-commercial Partner list to state that “the research funders on this list denoted by (‡) have  “self-declared” that at least one funding stream they administer meets the NIHR RDN Non-commercial Partner criteria as stated in the Department of Health and Social Care policy document Eligibility for NIHR Research Delivery Network Support. The NIHR Research Delivery Network has included these organisations in good faith."

2.1. The purpose of the NIHR Research Delivery Network (RDN) is to support high quality research that is of value to the NHS, social care and public health. The manner in which research funding is awarded is used as a marker of quality. Only the highest quality research studies will secure funding following a highly competitive, open, national call, that includes high quality peer review of the study protocol, in the selection process.

2.2. Non-commercial organisations that operate across England and have their headquarters in the UK (usually charities or professional bodies) and which award funding through dedicated funding streams, on a recurrent basis, using consistent processes, may become NIHR RDN Non-commercial Partners. 

2.3. By self-declaring their funding streams, NIHR RDN Non-commercial Partners are confirming that all research studies in receipt of such funding are high-quality and of 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. Studies funded by self-declared ‘eligible’ streams are, therefore, automatically eligible to receive NIHR RDN support, subject to meeting all other requirements of the Department of Health and Social Care Eligibility Criteria.

2.4. If a funder declares that a funding stream is an ‘exception’, e.g. one-off funding, or if the funder’s primary focus is not to fund research, the study may be considered through section 3.16 of the Eligibility Criteria, “certain other high-quality studies”. However, an organisation cannot become an NIHR RDN Non-commercial Partner if they only fund through ‘exceptions’.

2.5. Section 3.6 of the Eligibility Criteria states that non-commercial funding organisations that self-declare as NIHR RDN Non-commercial Partners may be audited to ensure that they meet the Partner criteria. If the NIHR RDNCC Portfolio Eligibility Team is concerned that a funding organisation that has self-declared does not meet the Partner Criteria their concerns will be referred to the Department of Health and Social Care.

2.6. The Eligibility Criteria section 3.7 states that individual studies funded as part of programme grants or centre grants, or as part of research training awards are required to have undergone protocol peer review before they can be considered for NIHR RDN support. NIHR RDN Non-commercial Partners that fund programme grants or centre grants or research training awards are therefore required to confirm as part of their Self-Declaration that the funding process for their programme grants or centre grants or research training awards includes a protocol peer review. If protocol peer review is not undertaken as part of the grant award process, this will be noted by the RDNCC Portfolio Eligibility Team. Confirmation of protocol peer review will be required from the study sponsor before a study can be considered for RDN support.

2.7. The Eligibility Criteria section 3.9 states that studies where the funder providing the research costs is different from the funder managing the funding competition, including the peer review process, will have their eligibility determined by the funder responsible for managing the funding competition. Therefore, for funding streams supported by multiple funders, so called joint funding streams (e.g. the Stroke Association and British Heart Foundation joint programme grant funding stream), it is only the funding partner who is managing the funding competition, including the peer review process, who should self-declare with respect to this funding stream.

3.1. The following processes are used to determine whether or not a funder is eligible to become an NIHR RDN Non-commercial Partner and to determine the eligibility of individual funding streams.

3.2. Following the identification of a new funder or funding stream: New funders or funding streams are identified in one of the following ways:

• IRAS submission

• Non-commercial Portfolio Application via CPMS

• Email-based application for a study led by one of the Devolved Administrations

• Email query or a request from the Welsh Portfolio team to undertake a funder assessment on their behalf

• A proactive approach from a Funder seeking to become an NIHR Non-commercial Partner

3.3. A preliminary assessment of the funder and relevant funding stream is undertaken using information from the grant award letter and publically available resources including the organisation’s website and data from the Charity Commission and/or Companies House.

3.4. If the new funding organisation and funding stream is assessed as meeting the NIHR RDN Non-commercial Partner criteria, the organisation is sent an email inviting them to become an NIHR RDN Non-commercial Partner along with the Self-Declaration form and guidance on how to complete the form. The Funder is asked to complete and return the Self-Declaration form, within two-working weeks, indicating the eligibility of each stream they administer i.e. whether they are automatically eligible, not eligible or conditionally eligible (automatically eligible subject to specific conditions being satisfied e.g. confirmation from the study sponsor of post-award peer review in line with the Eligibility Criteria, for programme, centre and research training awards).

3.5. Where the eligibility of an organisation and the funding streams they administer is unclear following the preliminary assessment, a standard email is sent requesting clarification of the processes used to award funds before the funder is asked to complete a Self-Declaration form.

3.6. If the funder ‘self-declares’ as an NIHR RDN Non-commercial Partner organisation, it is added to the NIHR RDN Non-commercial Partner list. 

3.7. If the funder declines to ‘self-declare’ then it will be presumed that they do not meet the NIHR RDN Non-commercial Partner Criteria and any studies they fund will be deemed not eligible for NIHR RDN support. 

3.8. If a funder doesn’t respond within two weeks, by which time the information has been requested twice, a final reminder email is sent copying the CI, giving them another week to respond with the required information. If there is still no response received, any studies currently awaiting an eligibility decision which are supported by this funder will be deemed not eligible for NIHR RDN support. 

3.9. The Self-Declaration form contains the following statement, which is signed by the NIHR RDN Non-commercial Partner: “I agree to inform the NIHR Research Delivery Network of any new funding streams established by my organisation and to provide an updated self-declaration form incorporating these new streams”. We, therefore, expect our Non-commercial Partners to approach the Portfolio Eligibility Team with any new funding streams to self-declare these. 

3.10. The RDN may also find out about new funding streams, when an application is received for a study that is funded by a new stream. A preliminary assessment is undertaken of the funding stream using information from the grant award letter and publically available resources including the organisation’s website. 

3.11. When the new funding stream has been assessed, the organisation is sent an email, including a copy of the Self-Declaration form, pre-populated with details of any previously self-declared funding streams, and guidance on how to complete the form. The Funder is asked to update the Self-Declaration form, with respect to all of the existing funding streams it administers including the newly identified stream and return this within two-working weeks.

3.12. Where the eligibility of a new funding stream is unclear, a standard email is sent requesting clarification of the processes used to award funds, before updates to the Self-Declaration form are requested.

3.13. If the funder ‘self-declares’ the new funding stream eligible, the study is considered automatically eligible for RDN support (providing they meet all other Eligibility Criteria). 

3.14. If the funder declines to ‘self-declare’ a new funding stream it will be presumed that it does not meet the required criteria and any studies funded by that stream will be deemed not eligible for RDN support. 

3.15.  If a funder doesn’t respond within two working weeks, by which time the information has been requested twice, a final reminder email is sent copying the CI in, giving them another week to respond with the required information. If there is still no response received, any studies currently awaiting an eligibility decision which are supported by this funder will be deemed not eligible for NIHR RDN support. 

3.16. The Portfolio Eligibility Team maintains a list of all NIHR RDN Non-commercial Partners and their self-declared funding streams, within the ‘Funders and Funding Streams’ tab of the Central Portfolio Management System (CPMS). Access to this data is restricted to staff within the NIHR RDN Coordinating Centre¹.

3.17. The Department of Health and Social Care is notified every two weeks, on a Wednesday, of any new Partner organisations who have self-declared and their associated funding streams. An email is sent to the Department of Health and Social Care (specifically the Research Policy Senior Manager for the Department of Health and Social Care, Anna Kramer), copying in the NIHR RDN Non-commercial Research Initiatives Manager.

3.18. Should the RDNCC Portfolio Eligibility Team have any concerns about the suitability of an organisation, which has self-declared as an NIHR RDN Non-commercial Partner, a report detailing their concerns will be submitted to the Department of Health and Social Care for consideration.

3.19. Non-commercial funding organisations that self-declare as NIHR RDN Non-commercial Partners may be audited to ensure that they continue to meet the criteria.

¹ This is a Department of Health and Social Care requirement

AcoRD: Attributing the Costs of health and social care Research & Development 

AMRC: Association of Medical Research Charities 

ARC: Applied Research Collaboration

BRC: Biomedical Research Centre

CRN: Clinical Research Network, (now the Research Delivery Network (RDN)

ECMC: Experimental Cancer Medicine Centre

CPMS: Central Portfolio Management System 

CRF: Clinical Research Facilities 

DHSC: Department of Health and Social Care

GAfREC: Governance Arrangements for Research Ethics Committees  

HEI: Higher Education Institution

HIC: Health Informatics Collaborative 

HRA: Health Research Authority 

HSG: Health Service Guidelines 

HTC: Healthcare Technology Co-operative 

ICB: Integrated Care Boards

ICS: Integrated Care Systems

ICP: Integrated Clinical & Practitioner Academic Programme

IIT: Investigator Initiated Trial

IRAS: Integrated Research Application System 

MIC: Medtech and In vitro diagnostic Co-operative

NDPB: Non-Departmental Public Bodies 

NICE: National Institute for Health and Care Excellence

ODP: Open Data Platform

PSTRC: Patient Safety Translational Research Centre

RDN: Research Delivery Network

RDNCC: Research Delivery Network Coordinating Centre

REC: Research Ethics Committee

RRDN: Regional Research Delivery Network 

RTP: Research Tissue Bank

STP: Sustainability and Transformation Partnership 

TRC: Translational Research Collaboration 

Version number: Version 2.4

Effective from date: 1 October 2024 

Marietta Müller

Portfolio Eligibility Manager

Email: marietta.muller@nihr.ac.uk