Title: Outcome Statement: INCOME DISTRIBUTION FROM NIHR ADOPTED INDUSTRY SPONSORED STUDIES To ensure that income distribution from work undertaken within the Trust for National Institute for Health (NIHR)-adopted Industry-sponsored studies is distributed in accordance with NIHR CRN policy. Written By: In Consultation With: Approved By and Date: With Reference To: Associated Trust Policies: Applicable To: For Use By: Reference Number: Version: 1.0 Published Date: 28 th July 2011 Review Date: 28 th July 2012 Impact Assessment: Reason for Development/Review Implementation and Monitoring Bonnie Teague, Manager Governance Committee Members, CLRN, DeNDRoN, MHRN. Finance Governance Committee 28 th July 2011 Income Distribution from NIHR CRN Industry Portfolio Studies (NIHR CRN Industry Team, V1, April 2011) Industry-sponsored portfolio-adopted research studies taking place in Norfolk and Waveney Mental Health NHS Foundation Trust. and Development, Finance Department, DeNDRoN, MHRN R&D029 N/A To support the new national NIHR Income distribution model To be implemented by the and Development Department (with approval from the Manager) for all UKCRN portfolio-adopted Industry Studies taking place in the Trust. To be revised by the and Development Department in accordance with national policy changes as required. Page 1 of 5
Introduction The Department of Health considers the support and delivery of industry-funded and sponsored research to be a priority. To support that priority, it is crucial that all stakeholders are incentivised to participate in industry-sponsored research. Benefits of commercial research to the NHS and the UK health research system include: Wealth generation for the UK economy Income generation for NHS Trusts Access to novel compounds, new practices and procedures Access to large-scale international clinical trials Access to well-managed and monitored clinical trials for investigators and patients The principles that underpin the NIHR income distribution model are that: Departments and individuals are recognised for their contribution to commercial NIHR CRN portfolio studies run within Trusts and are incentivised fairly All costs incurred by the NHS, and where relevant, Universities are fully recovered Commercial research continues to afford investigators and Trusts the opportunity to fund additional research related activities; funding arrangements between stakeholders should be cognisant and pragmatic in managing this important benefit of commercial research Income from commercial research can be distributed and carried over in line with the finance control procedures of individual Trusts and in accordance with the research priorities agreed between research departments, service support departments, individual investigators and senior Trust management NHS Trusts include the NIHR Local Networks (LRNs) in their consultations when: o Managing current Network supported research resources o Assessing local research needs across the whole spectrum of activities and departments which may require Network support o Setting research priorities across the Trust o Planning for the future of research locally and how this can be supported by the Networks o Growing research capacity for the long-term to meet national research ambitions Overly onerous itemisation and invoicing of study costs at any level are avoided Purpose This policy details arrangements for income distribution from work undertaken within the Trust for National Institute for Health (NIHR)-adopted Industry-sponsored studies Definitions and Abbreviations NIHR National Institute of Health : The body of the Department of Health which manages its work through four strands: Infrastructure,, Systems and Faculty. CRN/LRN NIHR Clinical/Local Network: Part of the NIHR Infrastructure Strand. The CRN is comprised of 6 Topic-specific research Networks: Mental Health, Dementia and Neurodegenerative Diseases, Cancer, Medicines for Children, Stroke, Diabetes, in addition to the Primary Care Network and a Comprehensive Local Network (CLRN) which covers the running of the outstanding studies. The Networks support the set-up and delivery of studies in NHS Trusts. R&D and Development: The NWMHFT department responsible for all research-related activities in the Trust. mcta- model Clinical Trial Agreement: The National Contract template for Industry-sponsored studies as agreed nationally and signed by the Trust, the Industry Sponsor and the Clinical Organisation. NIHR Portfolio Publicly accessible database of national clinical research studies which have been adopted/supported by the NIHR CRN. Page 2 of 5
1. Trust Income Distribution Model The Trust s income distribution model for NIHR-adopted Industry-sponsored studies is based on the model recommended by the NIHR 1 and makes use of the different elements for the NIHR Industry Costing Template (figure 1) to quantify different components of the income and define how they should be allocated. The core elements identified on the costing template are: Per patient budget consisting of: o Direct staff costs (+70% overhead +20% capacity building overhead) o Investigation costs (+20% capacity building overhead) Pharmacy costs R&D and other trial related costs Note that this model does not apply to Industry studies undertaken within the Trust that: Are not adopted onto the NIHR portfolio, or have been adopted onto the NIHR portfolio but for which the local Investigator and relevant LRN have agreed in advance that the study will be set up and run without any form of Network support Income element (from costing template) Allocation of income Staff costs Direct staff costs Retained by Trust passed through to relevant department or to LRN when NIHR funded staff involved 70% overhead Half Retained by trust (indirect overhead) Half allocated to local Investigator 20% capacity building Allocated to relevant LRN Investigations Investigation costs Retained by Trust - passed through to support service depts 20% capacity building Allocated to relevant LRN Pharmacy Pharmacy costs Retained by Trust - passed through to pharmacy (payment for work performed by LRN funded staff passed onto the LRN or used to build capacity to support NIHR adopted research R&D R&D and other costs Retained by Trust Figure 1: Schematic representation of the key elements of the NIHR Industry costing template and how the income from these elements will be distributed. 1.1. Direct Staff Costs All direct staff costs are paid direct to the Trust as per the arrangements of the model Clinical Trials Agreement (mcta). Where these costs are incurred by individual departments or external providers, the corresponding income is paid / passed through from the Trust as per local agreement. The costs associated with NIHR CRN staff working on the delivery of a study are paid / passed through to the relevant LRN. The amounts passed through to departments, external providers and LRNs will be considered on a study-by-study basis once monies have been recovered from the sponsor in 1 Income Distribution from NIHR CRN Industry Portfolio Studies NIHR Clinical Network Coordinating Centre, CRN Industry Team, Version 1.0, April 2011. Page 3 of 5
proportion to the relative contributions of the different staff involved, the study s recruitment and the agreed financial arrangements for staff costs within the mcta. 1.2. Investigation Costs The Industry costing template includes standard tariffs for a wide range investigations (e.g. for CT scans, laboratory tests, ECGs, etc). These tariffs already include an Institutional overhead element. Therefore, only the 20% capacity building element is charged over and above the total tariff for the investigations. 1.3. Pharmacy Costs These costs reflect the work involved in the set-up, maintenance and close-down of the study for the Pharmacy department, which is not wholly dependent on the number of patients or study design. The income for these activities is retained within the Trust and passed through to the Pharmacy Department. In cases where the work for Industry-sponsored NIHR-adopted studies is undertaken by clinical trials pharmacists whose posts are funded by one or more LRNs, the income will be used either to pay a proportion of the salary costs for those post-holders or to pay for additional members of staff to expand the department s capacity to support NIHR-adopted research. 1.4. R&D and Other Trial Related Costs The income for these activities is retained within the Trust to support the activities of the R&D department and to cover other trial related expenditure as detailed in this section of the costing template. 1.5. Overhead Element Half of the 70% overhead on direct staffing costs is retained by the Trust to cover indirect costs and any variability between the negotiated prices. The other half of the overhead element is designated for the Principal Investigator. This amount will be allocated to a suitable cost centre in the Trust finance system, through which the Principal Investigator has a decision making capacity in the use of the funds in line with Trust practices and finance control procedures. 1.6. Capacity Building Element A capacity building rate of 20% is added to both staff costs and investigations. This element of the income is ring-fenced for building research capacity in the local research community, to ensure a greater volume of research can be delivered in the future. According to prior agreement with each of the NIHR Comprehensive or Topic Specific Networks on a study-by-study basis, the Capacity building income is either: Paid to the NIHR Clinical Networks Or Retained within the Trust in designated cost centres for the relevant NIHR Clinical. Expenditure of this income is agreed through discussion between the Trust and the relevant NIHR Clinical Network Board in line with the recommendations set out in with the NIHR guidance document. 1.7. Agreement and Administration of Income Distribution Model The Income Distribution Model will be implemented by the and Development department on a study-by-study basis for Industry-sponsored studies applying for approval to conduct research in the. The distribution model for each study will require authorisation by the Manager, with additional agreement by the LRNs as appropriate. and Development will be responsible for fully informing the Finance department of the distribution of study income and invoicing arrangements. Page 4 of 5
Monitoring Statement Aspects of the policy to be monitored Distribution of key elements of income Monitoring method Details to be monitored in accordance with published NIHR CRN policy. Individual/Team responsible for monitoring Manager ( and Development) Frequency Annually Findings: Group/Committee that will receive the findings/monitoring report Governance Committee Action: Group/Committee responsible for ensuring actions are completed Governance Committee Page 5 of 5