Which studies are eligible for inclusion in the UKCRN Portfolio?
The UKCRN Portfolio comprises of the National Institute for Health Research (NIHR) Portfolio in England, and the corresponding portfolios of Northern Ireland, Scotland and Wales.
Each of the four UK nations are developing specific eligibility criteria for studies that can be included in their respective portfolios.
In England, the Department of Health has determined that studies (clinical trials and other well designed studies which involve the NHS) that are funded by NIHR, other areas of Government, and NIHR non-commercial Partners are automatically eligible to be included in the Portfolio. NIHR Partners are those 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
- have strategic direction for the research that they fund.
Full details are included in the document which can be downloaded below.
NB: The document below incorporates a small addition to the November version - additional text has been added on ‘studies agreed by CTAAC’ in section 3.1 a.
In addition other studies, such as commercially sponsored studies or those with industry funding which are led by an academic investigator, may be considered for inclusion in the Portfolio by undergoing an adoption process.
Industry sponsored studies will be reviewed by a Network specific Industry adoption panel and if accepted into the Portfolio will be classed as high priority.
Click here to find out about UKCRN's Industry Trials Adoption Process. Submission for the adoption of Industry studies will be led by the Company. The Industry contact at the relevant network Coordinating Centre will act as the first point of contact.
Click here to find out more about Network Industry contacts. Studies which fall within the Topic Specific Networks will continue with current adoption procedures. The Comprehensive Clinical Research Network (CCRN) Industry team will start to consider the adoption of Industry studies from the end of April 2008. Ongoing Industry sponsored studies will not be considered for adoption. Existing and new industry sponsored studies that are not adopted will continue to run outside the network, but will not be included on the Portfolio.
Industry funded, non industry sponsored (Investigator Initiated) studies will be required to go through a separate adoption process for non NIHR partner funded studies and if adopted will be classed as medium priority within the NIHR eligibility criteria. All non NIHR partner funded studies will need to be adopted onto the Portfolio by April 2009 to ensure continued access to service support and infrastructure funding. The adoption process for non-commercial studies is currently being developed and more information about this will be available shortly.
Frequently Asked Questions
My study is supported by several non-commercial funding bodies, how is eligibility determined? Studies that are automatically eligible and that have a high priority for NIHR Comprehensive Clinical Research Network (CCRN) support are studies that have the majority of their research funding provided by the NIHR, other areas of Government, and NIHR non-commercial Partners. You will need to provide a full list of the organisations funding the study and the amount of funding received from each. If the majority (>50%) is from NIHR and its non-commercial Partners, then the study is automatically eligible for inclusion in the NIHR CCRN Portfolio. If the proportion of funding from NIHR and its non-commercial Partners is less than 50%, then the study will require formal consideration through an adoption process prior to acceptance on the NIHR CCRN Portfolio (medium/lower priority studies).
I have a personal award, can the work I do be included in the NIHR CCRN Portfolio?
NIHR CCRN eligibility is determined on a study by study basis, rather than the activity of an individual. If you hold a personal award (eg. fellowship) won in open national competition from the NIHR (NCCRCD) or an NIHR non-commercial Partner and the specific project which you are working on was reviewed as part of the selection process for the award, then the project is automatically eligible for inclusion in the NIHR CCRN Portfolio. If this is not the case, then the study will require formal consideration (as above) prior to acceptance on the NIHR CCRN Portfolio (medium/lower priority studies).
My study involves recruitment of patients in a non-NHS setting, is it eligible for inclusion in the NIHR CCRN Portfolio? The purpose of the Portfolio is to ensure that all high quality research, funded by the NIHR and its Partners, that involves NHS patients and/or resources has access to NHS Service Support Costs, and other infrastructure support, via the NIHR’s Clinical Research Networks. Studies which include NHS patients, some or all of whom are being cared for in a private (or other non-NHS) setting, and whose care is being funded by the NHS, are eligible for inclusion in the Portfolio and will be able to access infrastructure support through the NIHR’s Clinical Research Networks. The NHS patients involved in these studies will be counted in accrual figures. Any other studies which involve patients being treated in a non-NHS setting should be discussed with the UKCRN Coordinating Centre
My study involves a workplace intervention involving NHS staff, is it eligible for inclusion in the NIHR CCRN Portfolio? Research studies which involve NHS employees, as participants, are eligible for inclusion in the NIHR CCRN Portfolio subject to assessment against the same eligibility criteria as studies involving NHS patients. The costs, eg. time commitment, associated with NHS staff members participating in a study can be met through the NIHR’s Clinical Research Networks.
My study is public health research, is it eligible for inclusion onto the Portfolio and will I be able to access infrastructure funding via UKCRN’s Networks?
The purpose of the Portfolio is to ensure that all high quality research, funded by the NIHR and its Partners, that involves NHS patients and/or resources has access to research infrastructure support, via the NIHR’s Clinical Research Networks. If the public health intervention takes place in an NHS setting, or involves subjects who are recruited in their capacity as NHS patients, or are NHS staff, then the study is appropriate for entry onto the Portfolio (subject to meeting the eligibility criteria) and will be able to access the necessary service support and other infrastructure funding through the NIHR’s Clinical Research Networks.