Research is a core activity of the NHS and therefore needs to be funded appropriately in order to ensure that organisations can successfully deliver study activities. The Department of Health published the ‘Attributing the costs of health and social care Research and Development (AcoRD)’ guidance in 2012 to provide a transparent and consistent basis for attributing the costs of health and social care research studies.
The basic principle outlined by the guidance is that activities carried out as part of a research study are attributed into one of three categories.
Research Costs
These are the costs of the R&D themselves and will end when the research ends. These activities will end when the research ends. Activities that fall into this category include;
Study trial coordination and management
The costs associated with inviting participants to take part in research
Investigations, assessments and tests where the results are intended to answer the research question
Data collection needed to answer the research question
The costs associated with any placebos used
These costs are usually met by grant funders through awards made to the Chief Investigator and the team, and will normally be paid to you directly by the sponsor. Information on these costs and reimbursement of them can be found in your contract or OID.
Treatment Costs (including Excess Treatment Costs)
Treatment costs are patient care costs that would continue to be incurred if the patient care service being studied were to continue into standard of care once the research ends. These costs are funded by the commissioners and include the following activities;
Supplying and administering medicine/device/therapy being studied, including any comparators
Training of clinicians to delivery the treatment or intervention
Investigations or tests that would continue to be incurred if the treatment being studied continued after the research ends
Patient follow up associated with their clinical management
These costs are calculated using the SoECAT and are divided into a per participant amount based on the recruitment target for the study. Payments are made to practices based on recruitment that is recorded and confirmed on Local and Central Portfolio Management Systems used by RDN and study staff.
There are multiple payment models for ETC’s, the most commonly used being payment model 1 whereby the per participant ETC costs are paid to the recruiting site. Payments are calculated on a quarterly basis using the data cut dates set nationally, and are made to RRDNs to pay to sites twice annually, providing they meet the minimum payment trigger of £500. Once this trigger is reached in a financial year, ETC payments would continue to be paid for the remainder of the financial year. If by the end of Q4 in a financial year the £500 trigger has not been reached then the outstanding amount of ETCs incurred would be paid to the practice. The schedule for payment of ETC’s can be found using this link.
Service Support Costs
NHS Support Costs are the additional patient care costs associated with the research that would end once the study has stopped, even if the patient care involved continued to be provided. These activities are primarily concerned with the safety of the participants.
These costs are funded by the Department of Health and Social Care and are paid to practices via RRDNs. Activities included in this category include;
The processing of the patient record to identify patients suitable to approach about participation in a study
Obtaining informed consent
Investigations, assessments or tests where the results are required by the patients care team to ensure patient safety and where arrangements are in place to feed back to their clinician
Payments for these activities are requested by your ROC/ROO and are paid by the RRDN's host organisation (The Newcastle upon Tyne Hospitals NHS Foundation Trust) to practices on a monthly basis. In order to process these payments, your organisation needs to have a contract in place with the host organisation.