R&I POLICY: SPONSORSHIP FEES R&I P02 Main Author(s): Rebecca Smith, Research Operations Manager Consultation Route: R&I Senior Team, NBT Research Committee Original Date of Issue: June 2013 Date of Review: August 2014 Current Version Reviewed By: Rebecca Smith, Research Operations Manager Ratifying Committee: Research Advisory Group Summary of changes: 1. Removal of options for sponsorship costs in section 5. Date of Next Review: August 2016 Version 2.0/August 2014/Page 1 of 7
Sponsor Fees: Meeting the costs of undertaking activities to fulfil the role of sponsor for non commercial NHS research at NBT 1. Purpose 1.1. NBT does not currently seek extra funding to cover the costs incurred by sponsorship of non-commercial research. This paper proposes a new policy for recovery of these costs, the criteria and a costing structure for NBT sponsorship of non-commercial research projects. 2. Background 2.1. The costs of undertaking activities to fulfil the role of sponsor 1 for non commercial NHS research are increasing at NBT as NBT take on sponsorship of increasing numbers and increasingly complex research studies. There is increasing financial pressure on NHS trusts and universities to ensure that all funding (clinical and research) is transparent and research costs are all identified and funded appropriately. 2.2. In May 2012 the Department of Health (DH) published new guidelines for Attributing the costs of health & social care Research & Development (AcoRD) 2. The AcoRD guidance supersedes earlier guidance contained in Attributing Revenue Costs of non-commercial research in the NHS (ARCO) and must be used to attribute the costs of research taking place in the NHS from October 2012. 2.3. If NBT is to sponsor a study safely (especially a Clinical Trial of an Investigational Medicinal Product (CTIMP)) and ensure sponsor responsibilities are undertaken appropriately NBT should have appropriately resourced systems in place in order to do so. There should be transparency in how this is resourced. 2.4. In order to produce a policy on sponsorship fees a review of AcoRD and the mechanisms for recouping costs associated with sponsorship of non-commercial research projects used by other organisations is necessary. Sponsor roles and responsibilities 2.5. The sponsor is the individual, or organisation (or group of individuals or organisations) that takes on responsibility for confirming there are proper arrangements to initiate, manage and monitor, and finance a study. 2.6. At NBT we provide the following sponsor services: Contract management - The arrangement, agreement and maintenance of contracts pertaining to the research study including funding contracts, service level agreements, sub-contracts and interparty contracts for delivery and ownership of the research. Study set up advice on protocol design, design and provision of site files and delegation logs 1 Sponsor as defined by Department of Health (2005). Research Governance Framework for Health and Social Care. 2nd edition. www.dh.gov.uk/en/aboutus/researchanddevelopment/atoz/researchgovernance/dh_4002112 2 Department of Health 2012 Attributing the costs of health & social care Research & Development (AcoRD) http://www.dh.gov.uk/en/publicationsandstatistics/publications/publicationspolicyandguidance/dh_133882 Version 2.0/August 2014/Page 2 of 7
Monitoring/audit development of monitoring plans, site visits and associated travel costs, attendance at data monitoring committees as necessary Pharmacovigilance including safety reporting Staff training - GCP Archiving Arranged externally at cost Support and advice on delivery of research plus including regulatory approvals and completion of forms (MHRA, REC) 3. Attributing the costs of health & social care Research & Development (AcoRD) 3.1. Sponsor related activities remain classified as research costs in AcoRD. This means that the cost of these activities should be covered by research funding. 3.2. Study specific central trial co-ordination and management, archiving, training and registration of trials should always be included in the grant funding. 3.3. Local trial co-ordination and management, regulatory preparation and compliance (REC, MHRA) and sponsorship fees (MHRA and CTA fees) should also be covered by grant funding except where the funder is a medical research charity that is a member of the Association of Medical Research Charities (AMRC) and the activity is undertaken by existing staff employed by the NHS, NIHR Clinical Research Network or other organisations funded by the NHS to provide patient care services. Under these circumstances, the cost of the activities will be met by DH. The DH funding is in the form of NIHR Research Capability Funding (RCF) already received by the organisation. 3.4. NBT sponsorship services should therefore be categorised as follows: Central trial co-ordination grant funded Staff training grant funding Archiving grant funding Local single site management - grant funded or RCF (where AMRC charity funded) for local site set up Monitoring/audit grant funded or RCF (where AMRC charity funded) Pharmacovigilance grant funding or RCF (where AMRC charity funded) Support and advice grant funded or RCF (where AMRC charity funded) 4. Benchmarking 4.1. A 2010 review of sponsor fees 3 indicated that 30% of those asked charged a sponsor fee. 59% charged a single one off fee, 36% charged a set-up fee and an annual fee and 5% varied their charge dependent on other aspects. 4.2. Key points from the costing structures of those who do charge a fee: Organisations charge a median basic fee of 1000 to sponsor a study. However, a large range of fees are charged ( 50 20,000) as one off or set up fee depending on the type of study. Some charge a flat rate (same fee for any 3 Sponsor Fees: Meeting the costs of undertaking activities to fulfil the role of sponsor for non commercial NHS research http://www.rdforum.nhs.uk/docs/sponsorfees2010.pdf Version 2.0/August 2014/Page 3 of 7
type of study) and others have a full range of charges for different types of studies On average organisations charge double the basic fee for CTIMPs Although the way fees are charged was different for each organisation it was clear additional fees are charged for CTIMPs/device trials (on average twice the fee than for non CTIMPs). In general, organisations charge the lowest (basic or zero) fees for student research, questionnaire and qualitative research Only four respondents provided details of the annual fees charged in two cases these were the same as the set-up fee (therefore the same fee would be charged each year), in the other two the annual fee was 30-60% of the set-up fee. 4.3. University Hospitals Bristol NHS Foundation Trust (UHBristol) have also been reviewing their sponsor fees policy and have recently commenced testing a range of charges with funding applications. They charge a basic set-up fee and then have additional premiums and annual charges on top for multicentre studies, CTIMPs, contracting and monitoring. NBT R&I Office have been collaborating on the development of a common policy. Version 2.0/August 2014/Page 4 of 7
4.4. A summary of sponsor fees charged by organisations charging a one off fee plus UHBristol costs is below: Min Max Mean 4 Median 5 charges UHBristol Basic Fee 50 5,000 1,329 1,000 756 Additional premium charged (on top of basic fee): CTIMPs (any) 650 16,608 4,608 1,000 657 Student studies (undergrad) 0 0 0 0 Student studies (postgrad) 0 300 43 0 Single centre studies 0 8,304 2,001 300 Multicentre studies 0 8,304 2,215 750 Observational studies 0 1,000 257 150 Interventional studies 0 8,304 1,651 400 Device studies 0 8,304 1,651 400 Questionnaire studies 0 500 136 50 Qualitative studies 0 500 114 0 Annual cost single site 138 per site set-up 1208/ 1510 CTIMP Annual cost additional 137/ sites 370 CTIMP Annual monitoring per site 374 Contract set up 82 per site Contracts annual single site 984 Contracts multicentre annual 82 per site 4 Mean is the mathematical average of a set of numbers. It is calculated by adding up two or more scores and dividing the total by the number of scores. 5 Median is found by arranging all the numbers from lowest value to highest value and picking the middle one. The median is often used in preference to the mean, particularly when a distribution is skewed i.e. there are outliers in the dataset that skew the mean. The median is given here as the mean is skewed by one respondent charging considerably higher fees (5 10 times) than all the others. Version 2.0/August 2014/Page 5 of 7
5. NBT sponsorship costs 5.1. All research costs should be transparent and funded appropriately and the one off costing does not achieve this. 5.2. NBT will use a project specific cost tool to allocate sponsorship costs against a project that are based around actual costs to sponsor a specific study. This method allows risk and workload to be accounted for providing actual and justifiable costs. The disadvantages are that it is more complex to apply and therefore more time is needed to include it in grant costings. Actual Cost Costing Model Task Cost Unit Basis for cost Study specific central trial coordination and management Contract management across sites 225 per site 2 day Contracts Officer (CO) Green light approval - MHRA approved study (site assessment and set up) 60 per site 5h Governance Officer (GO) Green light approval non-mhra study (site assessment and set up) 30 per site 2.5h GO SIV -MHRA approved study 200 per site 1 day Clinical Trials Officer (CTO) plus travel SIV - non-mhra study 100 per site 1/2 day CTO plus travel Close out 100 per site 1/2 day CTO plus travel Local trial co-ordination and management 0 Regulatory preparation grant staff project Governance and delivery team - MHRA approved study 100 single 4h CTO and 3h GO Governance and delivery team -non- MHRA study 25 single 2h GO Project staff 0 as required Compliance- MHRA approved study Monitoring 460 per site per year 4 days CTO Emergency contact 60 per site per year 4h CTO Safety and compliance reporting 60 per site per year 4h CTO Compliance - non-mhra study Monitoring 115 per site per year 1 day CTO Emergency contact 30 per site per year 2h CTO Version 2.0/August 2014/Page 6 of 7
Safety and compliance reporting 30 per site per year 2h CTO Archiving 152 per box Iron Mountain per staff GCP and other research Training 200 member training Trial fees (MHRA, CTA etc) as required Trial registration (ISCRTN etc) as required 5.3. Costs should be allocated according to actual planned activity so if monitoring is not required for a study then the cost of monitoring need not be included. 6. Application of the policy 6.1. This model should be applied to: All studies sponsored by NBT with external funding. Including but not limited to fellowships, staff projects and all other clinical research where a sponsoring organisation is required. The costs to cover actual sponsorship activities should be included in the grant application (see exemptions below). Where costs have not been included in an application, waiver of fee is by application to the R&I Senior Management Team. 6.2. The following exemptions to this policy apply: Studies that are not sponsored by NBT if the funding application is to be submitted by an external organisation (e.g. universities) the sponsoring organisation will need to be identified before submission by the relevant research offices. If sponsorship remains with the external organisation these costs do not apply. Student projects unless they are MHRA approved trials Small projects less than 20,000 Studies where application of the sponsorship fee takes the funds requested above the maximum limit for funding Studies that are already funded or where the application was submitted prior to 1 July 2013 Studies where the sponsorship costs were included in the application but the funding body does not award those costs as agreed during contract negotiation Projects applying to an AMRC charity for funding are exempt from the following sponsorship fees: 1) regulatory preparation, 2) trial fees and 3) pharmacovigilance. All other sponsorship fees apply (see section 3, page 2). Version 2.0/August 2014/Page 7 of 7