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Portfolio FAQs

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 study” 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).

Recruitment data will be collected only when new consent is given, i.e. where prospective consent is being obtained to collect samples/data for the purpose of the research study.

Where generic consent has previously been given for a sample/data to be included in a tissue bank/disease registry/data bank, etc. and the study is accessing those samples/data, recruitment data will not be recorded.

E2. 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).

E3. 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 (2013) 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

E4. 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.

E5. 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 non-commercial 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 and Social Care policy document “Eligibility for NIHR Clinical Research Network Support (April 2013)”.

E6. 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.

E7. 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 non-commercial 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.

E8. 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 for Clinical Research Network support via the non-commercial adoption process.

E9. 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.

E10. My study is funded by an overseas Government, is it eligible for NIHR Clinical Research Network support?

Studies that are funded by overseas Governments are considered for eligibility for CRN support via the non-commercial adoption process. Studies need to demonstrate that they meet the eligibility criteria set out in the Department of Health and Social Care policy document “Eligibility for NIHR Clinical Research Network Support (April 2013)“. 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. Such studies have a medium priority for Clinical Research Network support.

E11. 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 are considered for eligibility for CRN support via the non-commercial adoption process. Studies need to demonstrate that they meet the eligibility criteria set out in the Department of Health and Social Care policy document “Eligibility for NIHR Clinical Research Network Support (April 2013)“. In order to meet the criteria of open competition and high quality peer review, the funding call from the non-UK charity must have been open to all qualified individuals in England. Such studies have a low priority for Clinical Research Network support.

E12. My study is being conducted within an NIHR Biomedical Research Centre (BRC), NIHR CLAHRC (Collaboration for Leadership in Applied Health Research and Care), Patient Safety Translational Research Centre (PSTRC) or Diagnostic Evidence Co-operatives (DEC) funded programme of research, is it eligible for NIHR Clinical Research Network support?

Funding for NIHR Centres 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/s in each of these NHS/University collaborations. Studies that have been funded as part of a BRC/CLAHRC/PSTRC/DEC programme will not therefore require infrastructure support from the NIHR CRN.

Multi-centre BRC/CLAHRC/PSTRC/DEC studies may require Clinical Research Network support if study activity (e.g. recruitment) is occurring in sites external to the NHS Trust/s in receipt of the BRC/CLAHRC/PSTRC or DEC award.

Applications for these studies to be considered for CRN support should be made in 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 Clinical Research Network (CRN) Support and inclusion in the NIHR Clinical Research Network Portfolio?” If deemed eligible for CRN support these studies will be added to the NIHR CRN Portfolio. Recruitment data should be provided for all UK sites (i.e. both the CRN and the NHS Partner site-BRC/CLAHRC/PSTRC/DEC).

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 support should be made to the Study Support Service Helpdesk supportmystudy@nihr.ac.uk

E13. My study is being conducted within a Clinical Research Facility for Experimental Medicine, is it eligible for NIHR Clinical Research Network support?

NIHR funding for Clinical Research Facilities (CRFs) does not include funding for research costs. All NIHR CRF supported studies therefore require external funding for research costs which will determine eligibility for 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 Network 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 NIHR CRN Portfolio. Recruitment data should be provided for all UK sites (i.e. both the CRN and the CRF sites).

Applications for “additional” NHS support from the CRN should be made in 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 Clinical Research Network (CRN) Support and inclusion in the NIHR Clinical Research Network Portfolio?” If deemed eligible for CRN support these studies will be added to the NIHR CRN Portfolio. Eligibility for Clinical Research Network Support and inclusion in the NIHR CRN Portfolio will be determined by the source of any external funding secured to cover the research costs of the study.

It is recognised that the requirement for CRN Support may change during the lifecycle of the study, for example a CRF supported 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 support should be made to the Study Support Service Helpdesk supportmystudy@nihr.ac.uk

E14. 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 support 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 Network 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 NIHR CRN Portfolio. Recruitment data should be provided for all UK sites (i.e. both the CRN and ECMC sites).

Applications for “additional” NHS support from the CRN should be made in 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 Clinical Research Network (CRN) Support and inclusion in the NIHR Clinical Research Network Portfolio?” If deemed eligible for CRN support these studies will be added to the NIHR CRN Portfolio.

It is recognised that the requirement for CRN Support may change during the lifecycle of the study, for example an ECMC supported 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 support should be made to the Study Support Service Helpdesk supportmystudy@nihr.ac.uk

E15. My study is being conducted within an NIHR Healthcare Technology Co-operatives (HTCs), is it eligible for NIHR Clinical Research Network support?

Funding for NIHR Healthcare Technology Co-operatives (HTCs) 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 a single NHS organisation, but may be transferred to additional Partner NHS Trusts. Studies that have been funded as part of a HTC programme will not therefore require infrastructure support from the NIHR CRN. Multi-centre HTC 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 HTC award and external to any Partner NHS organisations, to whom infrastructure funding has been transferred.

Applications for these studies to be considered for CRN support should be made in 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 Clinical Research Network (CRN) Support and inclusion in the NIHR Clinical Research Network Portfolio?” The need for any “additional” NHS support from the Clinical Research Network 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 NIHR CRN Portfolio. Recruitment data should be provided for all UK sites (i.e. both the CRN and the NHS Partner site-HTC).

It is recognised that the requirement for CRN support may change during the lifecycle of the study, for exmaple an HTC 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 support should be made to the Support Service Helpdesk supportmystudy@nihr.ac.uk

E16. 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).

Where it is clear from the protocol that participants will be referred to services via the NHS and where there is a clear need for CRN Support, these studies should be considered for CRN Support (subject to meeting the usual eligibility criteria), even where the research is taking place in non-NHS settings.

E17. 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 England. 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.

E18. My study does not consent participants or the activity does not meet the NIHR CRN definition of recruitment, is it eligible for NIHR CRN support?

All studies which meet the Eligibility Criteria for Clinical Research Network (CRN) Support and require Network support are included on the NIHR CRN Portfolio regardless of whether or not the study consents participants or whether the activity meets the NIHR CRN definition of recruitment. For further information on the types of informed consent that fulfil the NIHR CRN definition of recruitment please see the frequently asked questions for recruitment data R3.