E1. I receive funding from an NIHR non-commercial Partner which supports the establishment / running of a tissue bank, a disease registry, data bank, cohort or other resource which underpins a number of research studies, is this eligible for NIHR Clinical Research Network support?
No, a “research project” is defined as a structured activity which is intended to provide new knowledge which is generalisable. 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 Clinical Research Network 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 Clinical Research Network support (subject to meeting the other eligibility criteria).
E2. My study has been deemed a Service Evaluation by the NHS Research Ethics Service does this mean that it is not eligible for NIHR Clinical Research Network support?
Service evaluations looking at local needs assessment would not be considered research (section 2.1 of Eligibility Criteria) and therefore would not be eligible for NIHR Clinical Research Network support. However, a study which involves service evaluation may be eligible for consideration for NIHR Clinical Research Network support if it fulfils the Eligibility Criteria definition of research (section 2.1). It would be expected that the study would be attempting to derive generalisable new knowledge to be eligible.
As stated in section 2.2 of the Eligibility Criteria it is the Study Sponsor (as defined by the Research Governance Framework for Health and Social Care) and not the NHS Research Ethics Service, that has the formal responsibility for confirming that a study is research. Therefore, if the Study Sponsor confirms the study meets the Eligibility Criteria definition of research, an application can be made for consideration for NIHR Clinical Research Network support. It should be noted that once a study is defined as research it would then require full NHS Permissions, including review by a committee within the UK Health Departments Research Ethics Service (where it meets the criteria for requiring such review).
E3. My study involves recruitment of NHS patients in a non-NHS setting, is it eligible for NIHR Clinical Research Network support?
Yes, the purpose of the NIHR Clinical Research Network is to ensure that all high quality research, funded by the NIHR and its Partners that involves NHS patients, their data or tissues/samples or their carers and/or NHS resources (i.e. staff, premises or facilities) has access to NHS infrastructure for research, including NHS Support Costs. Studies which include NHS patients, some or all of whom are being cared for in a private (or other non-NHS) settings, and whose care is being funded by the NHS, are eligible for Clinical Research Network support (providing they meet all other eligibility criteria).
E4. My study is funded by a non-commercial (non profit making) organisation, is it eligible for NIHR Clinical Research Network support?
Non-commercial studies are automatically eligible for consideration for NIHR Clinical Research Network support if the non-commercial organisation / funder is an NIHR non-commercial Partner with respect to the funding stream supporting the study and the study meets the Eligibility Criteria definition of research (see section 2.1). NIHR 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; and
- Take appropriate account of the priorities, needs and realities of the NHS in making decision about the research they fund
E5. My study is funded by a university, college or local healthcare organisation, is it eligible for consideration for NIHR Clinical Research Network support?
No, UK universities, colleges and local healthcare organisations (including NHS Trusts) do not fulfil the criteria for NIHR non-commercial Partner status. Studies funded by these organisations are therefore not eligible for NIHR Clinical Research Network support.
E6. My not for profit UK organisation / charity funds medical research in the UK, can I be considered for NIHR non-commercial Partner Status?
Yes, non-commercial organisations which have not previously been deemed an NIHR noncommercial Partner can apply to be become an NIHR non-commercial Partner by completing the self-declaration form available on the NIHR Clinical Research Network website. By signing the self-declaration, funding organisations are confirming that they meet the NIHR non-commercial Partner criteria as set out in the Department of Health policy document “Eligibility for NIHR Clinical Research Network Support (April 2013)”.
E7. My non-commercial organisation is currently considered an NIHR non-commercial Partner. What impact does the new NIHR non-commercial Partner Self-declaration process have on my organisation?
Existing NIHR non-commercial Partner organisations will only be required to complete a self-declaration form if a study funded by a funding stream not already assessed against the NIHR non-commercial Partner criteria applies for Clinical Research Network support. At this time, the funding organisation would be asked to self-declare with respect to this new funding stream and all other funding streams.
E8. My study is funded as part of a programme or centre grant, is it eligible for NIHR Clinical Research Network support?
Individual studies funded as part of programme or centre grants are required to have undergone protocol peer review before they can be considered for NIHR Clinical Research Network support. Appendix 1 of the Eligibility Criteria (April 2013) policy document outlines the standard of peer review required. It is a Study Sponsor's responsibility to provide confirmation of appropriate peer review. Please note: For those individual studies funded as part of a NIHR Programme Grant for Applied Research, confirmation that appropriate peer review has been undertaken will not be required if the study commences within two years of the start of the parent programme. This is because the individual studies detailed in the programme application have been peer reviewed by the NIHR prior to the award of the programme.
E9. My study is funded as part of a Research Training Award; can the work I do be supported by the NIHR Clinical Research Network?
Individual studies funded as part of Research Training Awards are required to have undergone protocol peer review before they can be considered for Clinical Research Network support. Eligibility for NIHR Clinical Research 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 won in open national competition from the NIHR Trainees Coordinating Centre or an NIHR non-commercial Partner, and the specific project which you are working on underwent protocol peer review then the project is automatically eligible for consideration for Clinical Research Network support (providing it meets all other eligibility criteria). If your project was not peer reviewed as part of the grant award process, this will be required before a study can be considered for Clinical Research 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 adoption 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 (April 2013) policy document will be required.
E10. My study is supported by several non-commercial funding organisations, how is eligibility determined?
A non-commercial study supported by multiple funders is automatically eligible for consideration for NIHR Clinical Research Network support if one of the funders is the NIHR, other area of central Government or an NIHR non-commercial Partner. If none of the funders include the NIHR, other area of Central Government or an NIHR noncommercial Partner then the study may be eligible for formal consideration via the adoption process.
E11. My non-commercial study is supported by a funding stream which has multiple funding partners; how is eligibility determined?
The eligibility of studies that are supported by a funding stream which has multiple funding partners will be determined by the organisation who has managed the funding competition, specifically the peer review process. For example, the Stroke Association and the British Heart Foundation operate a joint programme grant funding stream. The Stroke Association manage the funding competition, including the peer review process and so it is the Stroke Association who would be required to self-declare with respect to this funding stream.
E12. My study is funded by an overseas Government, is it eligible for NIHR Clinical Research Network support?
Studies that are funded by overseas Governments require formal consideration through an adoption process prior to consideration for Clinical Research Network support. Studies need to demonstrate that they meet the eligibility criteria set out in the Department of Health policy document “Eligibility for NIHR Clinical Research Network Support (April 2013)”. Such studies have a medium priority for Clinical Research Network support.
E13. My study is funded by a non-UK, non-commercial (non profit making / charitable) organisation, is it eligible for NIHR Clinical Research Network support?
Studies that are funded by a non-UK charity require formal consideration through adoption process prior to consideration for NIHR Clinical Research Network support. Studies need to demonstrate that they meet the eligibility criteria set out in the Department of Health policy document “Eligibility for NIHR Clinical Research Network Support (April 2013)”. Such studies have a low priority for Clinical Research Network support.
E14. My study is being conducted within an NIHR Biomedical Research Centre (BRC), NIHR Biomedical Research Unit (BRU), NIHR CLAHRC (Collaboration for Leadership in Applied Health Research and Care) or Patient Safety Translational Research Centre (PSTRC) funded programme of research, is it eligible for NIHR Clinical Research Network support?
Funding for NIHR Centres and Units 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 NHS partner in each of these NHS/University collaborations. Studies that have been funded as part of a BRC/BRU/CLAHRC/PSTRC programme will not therefore require infrastructure support from the NIHR CRN. Whilst not eligible for the NIHR Clinical Research Network Portfolio, such studies should apply for NHS Permission through the NIHR Coordinated System for gaining NHS Permission (NIHR CSP) which is accessed via the Integrated Research Application System (IRAS).
Multi-centre BRC/BRU/CLAHRC/PSTRC studies may require Clinical Research Network support if study activity (e.g. recruitment) is occurring in sites external to the NHS Trust in receipt of the BRC/BRU/CLAHRC or PSTRC award. Applications for these studies to be considered for CRN support should be made via CSP (NOTE: by selecting No to question 5a on the IRAS Project Filter form question 5b in generated. Select Yes to Question 5b "Do you wish to make an application for the study to be considered for NIHR Clinical Research Network (CRN) Portfolio?"). If deemed eligible for CRN support these studies will be added to the Portfolio Database. Recruitment data should be provided on a monthly basis for all UK sites (i.e. both the CRN and the NHS Partner site-BRC/BRU/CLAHRC/PSTRC). It is recognised that the requirement for CRN support may change during the lifecycle of the study, for example a BRC study may need to open in new CRN supported sites to achieve the study's recruitment target. Should this situation arise an application for CRN should be made to the Network providing the Coordinated Network Support Service.
E15. My study is being conducted within a Clinical Research Facility for Experimental Medicine, is it eligible for NIHR Clinical Research Network support?
NIHR Funded CRFs
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 clinical research network support and inclusion in the NIHR CRN 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 Clinical Research Networks should be considered on a case-by-case basis at a local level. If deemed eligible for CRN support these studies will be added to the Portfolio Database. Recruitment data should be provided on a monthly basis for all UK sites (i.e. both the CRN and the CRF sites).
E16. My study is being conducted within an Experimental Medicine Cancer Centre, is it eligible for NIHR CRN support?
Experimental Cancer Medicine Centres (ECMCs) are funded jointly by Cancer Research UK (CR-UK), the NIHR in England, and the Health Departments for Scotland, Wales and Northern Ireland. In England the CR-UK/NIHR ECMCs are joint University/NHS partnerships. The purpose of funding is to meet the costs of research infrastructure (via the CR-UK 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 CR-UK is an NIHR Non-commercial Partner, all studies supported by an ECMC award are technically eligible for consideration for NIHR Clinical Research Network and hence inclusion in the NIHR CRN Portfolio. However, as NIHR funding for ECMCs includes some funding for NHS Support, "additional" NHS support from the Clinical Research Networks will be considered on a case-by-case basis at a local level. If deemed eligible for CRN support these studies will be added to the Portfolio Database. Recruitment data should be provided on a monthly basis for all UK sites (i.e. both the CRN and ECMC sites).
E17. My study is public health research, is it eligible for NIHR Clinical Research Network support?
The purpose of the NIHR Clinical Research Network is to ensure that all high quality research, funded by the NIHR and its Partners, that involves NHS patients (or their data or tissues/samples) or their carers, NHS staff and / or resources has access to NHS infrastructure for research (including NHS Support Costs). If the public health intervention takes place in an NHS setting, or involves subjects who are recruited in their capacity as NHS patients, or NHS staff, then the study is eligible for Clinical Research Network support (subject to meeting all other eligibility criteria).
E18. My study is funded by an award (fellowship / studentship) from an overseas government/charity, is this eligible for NIHR CRN support?
Research funded following open international competition and high quality peer review by overseas governments or charities is considered for eligibility for CRN support via the non-commercial adoption process. In order to meet the criteria of open international competition, the funding call must have been open to all qualified individuals in the UK. Therefore, where a foreign government has funded one of its nationals to conduct research or training overseas without any element of international competition, the study funded by this award will not be eligible for CRN support.
E19. If I have further queries about eligibility who should I contact?
Please contact the Portfolio Helpdesk via portfolio.helpdesk@nihr.ac.uk
