The people needed to complete the costs for a funding application are:

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1 Research Design Service London Guide to costing grant applications The people needed to complete the costs for a funding application are: The chief investigators and or senior researchers Your local Trust, University or Research and development finance department Your local clinical research network Your associated clinical trials unit (if your application involves a clinical trial) The role of the chief investigator and or senior researchers are to decide the level of resources needed to fulfil the aims and objectives set out to achieve the aims of the research project. A good starting point is to list all research activities. As a minimum the local finance department apportion costs to personnel and overheads required by your organisation and will need to authorise the final amount of funding requested on the Management Information System you will use to submit your application. In addition your local clinical research network will need to support your request for treatment costs and service support costs. Your clinical trial unit will only support applications that have been properly costs and approved by the unit. There are three types of costs you need to consider when applying for funding from the National Institute for Health Research (NIHR) or the Association of Medical Research Charities (AMRC): Research costs Treatment costs Service Support Costs Detailed guidance can be found at: It is always worth reading the funding guidance documents relating to your application to determine what they will and won t fund under research costs and the proportion of overheads they will cover (also known as economic costing). 1) Research costs

2 These are the costs of the research itself, these costs cease to exist when the research ends. They relate to research activities that are being undertaken to answer the research questions. Research costs are met by grant funders through the award of a research grant. Research costs do not directly contribute to patient care. All research costs are normally worked out and signed off by Research and development, Trust or University finance departments. It is useful to identify who approves grant application costs early on and to know their timelines, do not under-estimate the time it takes to obtain approvals. As a minimum they will require the information below: i) Time frame Estimated start and finish dates. ii) Research personnel information They will need either a named staff member or the grade and scale point of the researcher to be appointed and whether they full time or the part time. This is normally required as fulltime (1 or 100%) or the full-time equivalent e.g. 20% or 0.2 equals one day per week. They will also need to know the duration of time employed over the study period. Your finance department will work out direct and indirect incurred costs associated with employing staff for example National Insurance contributions and incremental rises is salaries. If you want to include any studentships and or fees, these will also need to be provided (although check with the funder if they allow for these). Sometimes this can be a good way of providing a PhD opportunity with a stipend and reducing staff costs. One off payments as honoraria or for lay people attending meetings such as steering groups and PPI groups are not staff costs, they will appear in miscellaneous costs. iii) Travel and subsistence Remember to include all potential site visits (including audit visits), travel expenses to steering groups, meetings and dissemination costs, for example conferences. iv) Equipment Check the conditions your funder has on equipment laptops and PCs, sometimes they are excluded and or limited (typically a purchase cost limit of 5,000 is set, if your needs are more consider a leasing cost for expensive items). Whatever equipment you purchase you will have to make a case for it in the Justifications for funding section of the application form. This is for research equipment i.e. equipment needed to carry out the research NOT for patient care, this section is for things like video or audio recording devices, and data collection technology. v) Consumables

3 These are research related they may include stationery, postage, vouchers, promotional material, specialist advertising for new research posts. Additional services such as transcription and other one off payments may be included here or in miscellaneous expenses If you are planning interviews and focus group remember to include cost of hiring a room (if you are paying travel expenses these will need to go in travel and subsistence) vi) Clinical Trial Units (CTU) costs If you are planning to have CTU support, you will need to include the cost of this service. You will need a separate costing meeting with your appropriate CTU. The costs of this service will depend on: The level of support you require for example the duration of the study, trial coordination and or management The risks associated with the study and the experience of the study team The number of participants in your study The complexity of the randomisation process Number of sites (for example Quality Audit visits) Data collection/input and data management and number of follow up intervals Statistical support, number of outcomes and complexity of analysis Health economic analysis and level of and complexity of analysis Archiving costs (if needed) vii) Other costs added to your application Depending on your funder you might want to include other direct costs such as open access publication and recruitment. Your finance department will also add Estates fees, and indirect costs such as the costs of providing desk space, IT support etc (these may vary with special permissions, e.g. charities might be charged less). These costs depend on any stipulations from the funder about how much the university can charge for these e.g. full economic costing or only 80%. 2 & 3) Service support costs and treatment costs Service support costs and treatment costs are paid either via the local clinical research networks and/or your health trust. A spreadsheet called ACAT (Activity Capture Attribution Template) has been developed by the Department of Health and the NIHR to help researchers consider and cost patient related care costs. More guidance and the template can be downloaded from: If the activity is a patient care costs i.e. integral to the provision of treatment, diagnosis or care regime it is a treatment cost. If the activity is related to the services treating the patient or contributes to the care needs of a patient but is

4 not integral to the provision of care it is a service support cost. These include things like identifying and screening patients to recruit into the study. There is a really useful document about attributing the costs of health and social care, it is called AcoRD and supersedes a previous guidance document which is now out of date called ARCO. Detailed information and AcoRD guidance and frequently asked questions can be found at: This guidance is relevant for England and Wales only, Scotland have their own guidance orks.html. The costs are based on activities so you need to think about who is doing them (their grade / profession and how much they cost per hour) and how long it may take them to do or complete the task. The table below shows examples of the type of activities that may need costing in each costing domain.

5 Research costs Treatment costs Service support costs Trial management/coordination Trial material Screening test to determine patient eligibility to participate Randomisation Tests/investigations needed to answer the Supplying and administering the medicine/device/therapy being studied Supplying and administering any active comparators - including medicines, devices or therapies Training of clinicians to deliver the treatment Investigations and tests which would continue to be incurred if the patient care service in question continued to be provided after the R&D study has stopped Patient follow-up where this is required as part of The processing of the patient record to identify NHS patients who may be suitable to approach to ask if they wish to participate in a research project (e.g. searching patient records, GPs screening the list to make sure inclusion and exclusion criteria are fulfilled Time spent producing invitation letters (cost of postage, paper and envelopes are a research cost) Obtaining informed consent from patients where the study is a health research study, taking place within the NHS Additional investigations, assessments and tests where the results are required by the patient s care team to ensure patient safety and where arrangements are in place to feed the results back to the clinician. E.g. Followup where the primary purpose is to monitor patient safety rather than efficacy

6 research question Follow up activity not related to normal patient care Cash payments/reimbursements to participants All costs relating to placebos and shams Trial registration fees Archiving Data analysis Dissemination of research results the clinical management of a patient Dawn Carnes August 2014

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