Eligibility for NIHR support

All studies in England must comply with the Department of Health and Social Care established eligibility criteria for commercial and non-commercial research to qualify for our free support. The other UK administration’s eligibility criteria can be accessed here.

Studies that are eligible for Clinical Research Network (CRN) support are added to the NIHR Clinical Research Network Portfolio.

The eligibility assessment for access to CRN support on behalf of the Department of Health and Social Care (in England) is performed by:

  • Our CRN Eligibility Team and Speciality subject specific experts for non-commercial studies
  • Our Specialty subject specific experts for commercial studies

Studies are identified as being either one of the following types:

  • Non-commercial studies funded by automatically eligible funding streams
  • Non-commercial studies funded by potentially eligible funding streams
  • Commercial contract research
  • Studies which are ineligible for CRN Support.

 

All studies, regardless of type, must:

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 funding (i.e. funding to meet all Research Costs in compliance with the AcoRD guidance

 

From 1 January 2018, the NIHR Clinical Research Network (CRN) extended support into health and social care research taking place in non-NHS settings. The Department of Health and Social Care has agreed an important change to the criteria that describes which clinical research studies can benefit from CRN support. The change to the policy means the CRN can support research conducted outside of NHS settings, such as studies running in care homes or in hospices. Read the full announcement and view the new policy which became effective on 1 January 2018.

 

1. Non-commercial studies funded by automatically eligible funding streams

These include studies with some or all of their research funding provided by:

  • The NIHR
  • Other areas of central Government
  • NIHR non-commercial Partners

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
  • 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. Non-commercial studies funded by potentially eligible funding streams

These include studies with research funding provided by:

  • Industry: Investigator-initiated, commercial-collaborative research (Industry-funded, non-industry sponsored) studies

  • Overseas governments

  • Overseas charities.

All non-commercial studies funded by potentially eligible funding streams undergo additional eligibility checks to ensure the study meets the eligibility criteria  via the non-commercial extended review process.

This is to ensure the quality of the studies and their value to the NHS, social care or public health prior to confirmation of eligibility for consideration for CRN support.

The non-commercial extended review process involves review by subject-specific experts against specific criteria focused on:

  • Clear value to the NHS, social care or public health

  • Ensuring the study takes account of the priorities, needs and realities of the NHS, social care or public health.

Commercially funded, commercially sponsored studies

Industry sponsored studies that have been submitted for Network feasibility services and confirmed as both eligible and feasible for inclusion into the NIHR CRN Portfolio as part of this process will be classed as high priority.

 

Commercial contract research

Studies supported by the life sciences industry must meet the definition of research and must have appropriate ethical approval; and Health Research Authority approval where required, prior to initiation at individual sites.  If the study is deemed eligible, the NIHR CRN will determine feasibility across England via its Study Support Service to confirm site interest and/or initiate an assessment of site capacity and capability to participate. If the study is both eligible and feasible within England, it will continue to receive NIHR CRN support.

3. Studies that are not eligible

Studies which are not eligible for NIHR CRN support are those that:

  • Do not meet the eligibility criteria definition of a ‘research study’

  • Do not have full research funding

  • Are funded by training awards that are not a recognised part of a research career pathway.

  • Are fully funded and conducted within other NIHR research infrastructure i.e. Biomedical Research Centres (BRCs), NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC), Patient Safety Translation Research Centres, Experimental Cancer Medicine Centres, Clinical Research Facilities for Experimental Medicine, Medtech and In Vitro Diagnostics Cooperatives. Please see our frequently asked questions for further information.