Eligibility for NIHR support

All studies in England must comply with the Department of Health 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 (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:

  • Automatically eligible
  • Potentially eligible
  • Ineligible

1. Automatically eligible 

Studies which are automatically eligible for consideration for CRN support are those that:

  • fulfil the Eligibility Criteria definition of a ‘research study’ which is “the attempt to derive generalisable (i.e. of value to others in a similar situation) new knowledge by addressing clearly defined questions with systematic and rigorous methods”.
  • have some of their research funding provided by the NIHR, other areas of central Government and 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
  • take appropriate account of the priorities, needs and realities of the NHS in making decisions about the research that they fund.

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.

 

2. Potentially eligible studies 

Studies which are potentially eligible for consideration for CRN support are those that fulfil definition of research and are:

  • commercially funded and commercially sponsored (i.e. commercial contract research)  or
  • non-commercial studies
    • Investigator initiated trials (i.e. commercial collaborative research)
    • Funded by overseas Governments
    • Funded by overseas charities.

Non-commercial studies

All potentially eligible non-commercial studies are considered for eligibility for CRN support via the non-commercial process. Those that require adoption are either:

  • initiated by non-commercial investigators (e.g. University or NHS staff) with the majority of the research funding being provided by a commercial organisation (e.g. a pharmaceutical, biotechnology or devices company) specifically to support that study
  • funded by overseas Governments
  • funded by overseas charities.

These studies must be considered via the non-commercial adoption process to ensure the quality of the studies and their value to the NHS prior to confirmation of eligibility for consideration for CRN support. If eligible, these studies will be given a medium priority (investigator initiated trials and overseas Governments) or low priority (overseas charities) for CRN support.

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

  • clear value to the NHS
  • ensuring the study takes account of the priorities, needs and realities of the NHS.

Commercially funded, commercially sponsored studies

Industry sponsored studies that have been submitted for network feasibility services at www.submitmystudy.nihr.ac.uk 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.

 

3. Studies that are not eligible 

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

  • do not meet the relevant commercial or non-commercial eligibility criteria definition of a ‘research study’ which is “the attempt to derive generalisable (i.e. of value to others in a similar situation) new knowledge by addressing clearly defined questions with systematic and rigorous methods”. This excludes: Audits, Needs assessments, Quality improvements, Other local service evaluations & Banking of biological samples or data except where this activity is integral to a self-contained research project designed to test a clear hypothesis
  • 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 an NIHR Biomedical Research Centre (BRC), NIHR Biomedical Research Unit (BRU), NIHR CLAHRC (Collaboration for Leadership in Applied Health Research and Care), Patient Safety Translation Research Centre (PSTRC) or Experimental Medicine Cancer Centre (ECMC). Please see our frequently asked questions for further information.