To access NIHR Clinical Research Network (CRN) support in England, and be included on the NIHR CRN Portfolio, studies must satisfy the requirements of the Department of Health and Social Care established Eligibility Criteria.
Once accepted onto the NIHR CRN Portfolio, all studies must adhere to the expected actions and requirements set out in the Terms and Conditions for NIHR Clinical Research Network Support. These represent good portfolio management practice and enable effective allocation of the CRN's resources to help to support the delivery of as many studies as possible.
Studies are required to meet the Eligibility Criteria for NIHR CRN support to be accepted onto the NIHR CRN Portfolio and throughout the duration of its delivery.
All studies, regardless of type, must:
- Meet the definition of research (as outlined in the Department of Health and Social Care Eligibility Criteria as follows:
"Research can be defined as the attempt to derive generalisable or transferable new knowledge to answer or refine relevant questions with scientifically sound methods. This excludes: audit; needs assessments; quality improvement and other local service evaluations. It also excludes 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."
- Have appropriate ethical approval; and Health Research Authority (HRA) Approval where required
- Have full research cost funding for non-commercial studies (i.e. funding to meet all Research Costs in compliance with the AcoRD guidance) or full funding for all costs for commercial contract studies in compliance with the AcoRD guidanceThe source of research funding is the principal determinant of eligibility:
Automatically eligible funding streams
Non-commercial studies funded through open and nationally competitive grant calls administered by the NIHR, other areas of central Government (including the UK Research and Innovation Research Councils) and NIHR Non-commercial Partners are ‘automatically eligible’ for NIHR CRN support if they meet the conditions above.
NIHR Non-commercial Partners are organisations that:
- award research funds as a result of open competition across England with high quality peer review;
- 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.
The NIHR Non-commercial Partner list details all of the funding organisations that meet the NIHR Non-commercial Partner criteria.
Potentially eligible funding streams
Non-commercial studies which meet the conditions above but are not funded by the NIHR, other areas of central Government or an NIHR Non-commercial Partner (e.g. Investigator-initiated, commercial-collaborative studies (Industry-funded, non-industry sponsored), and studies funded by overseas governments or charities) are required to to undergo additional eligibility checks, via the non-commercial extended review process, to ensure they meet the eligibility criteria.
A study is not eligible if it:
- Does not meet the eligibility criteria definition of a ‘research study’, eg. if it is one of the following activities:
- Audit, needs assessment, quality improvement or other local service evaluation.
- Banking of biological samples or data except where this activity is integral to a self-contained research project designed to test a clear hypothesis.
- Does not have appropriate ethical approval, or HRA Approval where required
- Does not have full Research Cost funding for non-commercial studies or full funding for all costs for commercial contract studies
- Is funded by a training award that is not a recognised part of a research career pathway or by another funding source that does not meet the eligibility criteria.
- Is fully funded by and conducted within another NIHR research infrastructure e.g.. Biomedical Research Centre (BRC), Applied Research Collaboration (ARCs) Please see our eligibility frequently asked questions for further information.
To maintain access to NIHR Clinical Research Network support in England, and for continued inclusion on the NIHR CRN Portfolio, studies must adhere to the Terms and Conditions for NIHR Clinical Research Network Support.
Eligibility for infrastructure support in other UK administrations
Each of the four UK Health Administrations have developed their own criteria for determining which studies can be supported and included in their respective portfolios. Details of the eligibility criteria for Scotland, Wales and Northern Ireland can be found via the links below:
- Scotland: NHS Research Scotland (NRS)
- Wales: Health and Care Research Wales (HCRW)
- Northern Ireland: Northern Ireland Clinical Research Network (NICRN)
Portfolio Terms and Conditions
Once eligible, all studies must adhere to the Terms and Conditions for NIHR Clinical Research Network Support to maintain access to NIHR Clinical Research Network support in England, and for continued inclusion on the NIHR CRN Portfolio. These Terms and Conditions apply at the point of acceptance onto the NIHR CRN Portfolio until a study closes to recruitment. The expected actions and requirements set out represent good portfolio management practice which supports the effective monitoring of the Portfolio and allocation of resources.
The study sponsor has overall responsibility for compliance with these Terms and Conditions. Sponsors may delegate the actions necessary to comply with them to suitably qualified parties but retain overall responsibility for all aspects of the study and its delivery.
The study sponsor or their delegate must:
- Ensure that the NIHR CRN is provided with contact details of the appropriate study management contact (where the sponsor has delegated activities) and that this information is maintained during the study lifecycle.
- Ensure that a response is provided to requests for data items by the CRN in order to complete the requisite minimum data set for creating a study record in the Central Portfolio Management System (CPMS).
- Inform the NIHR CRN of any changes to funding, sponsor arrangements or key milestones. This includes but is not limited to study status, study recruitment target, planned open date, actual open to recruitment date, planned closure to recruitment date, actual closure to recruitment date and incorrect recruitment activity data.
- Oversee the recruitment data provided by sites and inform the NIHR CRN of any inaccuracies via CPMS.
- Notify the NIHR CRN when a UK site achieves the first global or European recruit for a commercial study via email.
- Close studies where the study recruitment target has been met for the UK, or, inform the NIHR CRN of the updated recruitment target and revised planned closure dates if the recruitment is to be extended. For non-commercial studies, confirmation that appropriate funding is in place to cover the increased cost must be provided.
- Confirm the progress of a study against its planned milestones and work with research sites to address any barriers to progress.
If the Terms and Conditions are not adhered to by sponsors or their delegate, the study will be removed from NIHR CRN Portfolio and NIHR CRN support will be withdrawn. Studies withdrawn from the NIHR CRN Portfolio will not be able to access support costs, and Excess Treatment Costs for studies where these are provided by integrated care boards (ICBs).