The PIF is the first step to engage with the NJRO for studies requesting NuTH Sponsorship or support with the costs for NHS involvement. The information requested via the PIF process provides a starting point to engage with relevant teams to craft and support an application at the pre-award stage.

Sponsorship and funding are commonly confused. A research ‘Sponsor’ refers to the organisation which takes legal responsibility for the safety, efficacy, conduct, resourcing, outcome and outputs of a research study, which includes ensuring the appropriate funding arrangements are in place to deliver the study. NuTH commonly acts as research Sponsor for clinical research studies with patient involvement.

Sometimes funders can request evidence of Sponsorship as part of a funding application. In these scenarios a letter of provisional support may be required. It is important to know that full Sponsorship will only be granted upon evidence of adequate funding arrangements and therefore Sponsorship can only be fully confirmed post award.

This is the organisation that takes financial responsibility for the grant and as signatory will receive the funds should the grant be awarded. The lead will approve the final grant envelope which are the collated costs from all relevant organisations and third parties. The lead is usually the substantive employer of the lead applicant. NuTH can act as a research Sponsor for a NuTH or Newcastle University (NU) led grant.

Cost attribution in line with AcoRD guidance is a primary function of the FDT as this informs the costs to be funded by a grant and those which are met separately by government funding under certain conditions. There are four types of NHS costs in non-commercial research: research, service support, standard care and excess treatment costs. The Schedule of Events Cost Attribution Template (SoECAT) is a document which exists to outline and confirm cost attributions including calculation of excess treatment costs (ETCs). Further information can be found in the NJRO FAQs.

The SoECAT is now hosted by the Central Portfolio Management System (CPMS). Some funding applications require a SoECAT to be submitted as a supporting document. This document serves to validate the cost attributions to ensure that the research costs are appropriately outlined to the funder. It can also calculate ETCs where these are relevant, however it is not a costing tool. It is helpful for applicants to highlight to the FDT when a SoECAT is required to allow sufficient time for its completion and validation. Further information on the SoECAT can be found here and in the NJRO FAQs.

Investigator Initiated Trials (IITs) are clinical studies developed by individual clinical/academic investigators and managed/sponsored by non-commercial researcher institutions (NHS, HEI), and funded by a commercial company.

IITs are defined as unsolicited, independent research where the investigator’s associated institution serves as the Sponsor and a commercial company provides support in the form of funding and/or a product/drug. 

IITs enable clinical academics to enhance patient care as they often identify new ways of using existing treatments, whilst simultaneously advancing the product knowledge, including safety.

Due to their commercial funding, the costs for these studies are subject to overheads, and the Contracts and terms are reviewed and negotiated by the non-commercial grants team and Business Development Managers.

The NIHR Research Support Service (RSS) works in partnership with the NIHR Research Delivery Network (RDN) and supports researchers to develop applications to national, peer-reviewed research programmes including NIHR programmes, UK Research Councils and national health and care charities. Studies eligible for RSS support are likely to be eligible for Portfolio adoption.

To find out more about how the Newcastle RSS Hub can help you horizon scan for funding opportunities, develop your research idea or input into your grant application, they can be contacted via the following:

• contact form
• or, for general enquiries: nihr-rss@newcastle.ac.uk

All high-quality research studies eligible for NIHR Research Delivery Network (RDN) support in England are included on the NIHR Portfolio. Participant recruitment to Portfolio studies automatically counts as accrual activity and therein represents a nationally recognised research metric. In addition to the prestige that Portfolio status represents, there are numerous benefits that can apply to Portfolio studies including funding for eligible costs such as ISRCTN registration and access to the Study Support Service (SSS) for study delivery.

In terms of funding, Portfolio studies are eligible for service support meaning that certain activities qualify to be funded separately and do not represent research costs to be funded by the funder/included in the grant. See AcoRD guidance and NJRO FAQs for further information.

Awards need to be notified to the lead organisation (NuTH or Newcastle University) so that the assessment, acceptance and contracting process can begin. Please notify the FDT or Newcastle University costing team accordingly i.e. who supported you with costings at the application stage. The funding team of the lead organisation will then notify and email the relevant documents (award letter and associated costs) to the Awards team. For studies seeking NuTH Sponsorship, a request for R&D registration and Sponsorship will follow and you will be guided through the process of receiving NHS R&D approval.