Guidance

In comparison with commercial contract NHS research, the funding arrangements for non-commercial NHS research can be more complex and can involve a number of partner organisations. It is essential that both the NHS and its partner organisations understand the full cost of non-commercial research and reach a shared understanding of how costs are funded.

DoH guidance relating to the costing of Non Commercial studies include:

The above guidance helps to illustrate the difference between the cost categories described below. In addition, NUH R&D are currently collating an illustrative guide to supplement the above and this will be available in early 2011.

Broad cost categories

The definitions of the broad cost categories are as follows:

• Research Costs are the costs of the R&D itself that end when the research ends. They relate to activities that are being undertaken to answer the research questions.
• NHS Support Costs are the additional patient care costs associated with the research, which would end once the R&D study in question had stopped, even if the patient care involved continued to be provided.
• NHS Treatment Costs are the patient care costs, which would continue to be incurred if the patient care service in question continued to be provided after the R&D study had stopped.
• NHS Excess treatment costs are the patient care costs provided as part of research, that is either an experimental treatment or a service provided in a different location from where it would normally be given and it differs from the normal, standard treatment for that condition. This includes all types of patient care services including diagnostic, preventive, continuing-care, rehabilitation and health promotion.

Sources of Funding

A) Research Costs

These are met by grant funders (i.e. NiHR or Charitable Funds) through the award of a research grant. Chief Investigators include within their grant bid the costs of research to be performed at all sites. Each contributing site should therefore receive income from the Chief Investigator’s grant income to cover these costs.

NUH Finance will not approve any study where this income is not forthcoming unless other funding streams are available to cover this.

B) Support Costs

Support Costs are funded by the Comprehensive Local Research Networks. The Comprehensive Clinical Research Network consists of 25 Comprehensive Local Research Networks (CLRNs) covering the whole of England, and it is the Trent Comprehensive Local Research Network (TCLRN) that funds the support costs of Nottingham University Hospitals (NUH).

Funds however are only provided if the study is adopted by the TCLRN. Automatic adoption occurs for all studies funded by the NIHR or by most large charities (e.g. The Welcome Trust).
Funds from TCLRN are distributed in two ways:

• Prior to the start of each financial year (and at the half year for any remaining contingency), researchers bid for TCLRN funds to cover the costs of Consultant Research PAs, Research nurses, Research co-ordinators, and staff in Diagnostic departments utilised on research activities (Pharmacy, Medical Physics, Pathology etc). These funds support the research infrastructure of the trust. In addition, NUH separately fund certain posts from the trusts ‘Flexibility & Sustainability’ fund (FSF) and BRU Development fund.
• Any staff study costs not funded by the above TCLRN and FSF funds must be funded from NUH’s ‘Other Service Support’ funds. Once these funds are exhausted then an application must be made to TCLRN for funds from their contingency. In addition, where there is evidence that the funds supplied by TCLRN to support the R&D infrastructure are insufficient then applications for further funds should be performed.

C) Treatment Costs

These costs are met through the normal commissioning process.

D) Excess Treatment Costs

Excess Treatment Costs (ETC) that do not exceed £35,000 will be funded by the Trust up to a maximum of £250,000 per year.

For ETC in excess of £35,000 or where the total fund has been exhausted, it is the trust (not the researcher) who should present a business case to the commissioners for additional funding. These should be directed to the Head of Research & Evaluation for NHS Nottinghamshire County and NHS Nottingham City. This arrangement will continue until the PCT structure is replaced.

For the PCT guidance, refer to this pdf.

Costing Process

The TCLRN Non Commercial Costing Template is completed by the respective RM&G facilitator in the trust’s R&D department. The template used is a version with NUH’s staff rates incorporated into it.

Staff rates and costs of Investigations are at cost price for all NiHR and Charitable funded studies. Pharmacy costs are obtained from the Clinical Trials Pharmacist or from the Senior Oncology Pharmacist (for Oncology trials). For other investigation prices contact the R&D department who maintain a price list.

The RM&G facilitator in the R&D department is responsible for completing this template detailing all procedures and investigations as stated in the ‘Site Specific Information’ (SSI) and protocols. In addition any income received from the Chief Investigator should be completed.

The template requires establishing staff names and whether they have been funded by TCLRN or FSF funds. Contact the Non Commercial representative of the Finance team for any assistance in determining this. Where necessary, Finance will be responsible for any application to TCLRN for further funds.

The Costing template must be approved by the Corporate Finance Manager (R&D, Commercial & Education) prior to any contract agreement and commencement of research activities. Please note that studies can not be approved unless all funding sources are known.