Guidance

Attributing the costs of health and social care research (AcoRD)

Updated 15 April 2024

Applies to England

In April 2024 this document was republished in an accessible format. The guidance itself remains the same since it was last updated on 8 August 2019 - it will be fully updated later in 2024.

Purpose

Health and social care research is a core NHS activity and as such, the NHS is committed to supporting a portfolio of commercially and non-commercially funded research. This guidance provides a transparent and consistent basis for attributing the costs of health and social care research studies.

Background

In England, the NHS constitution confirms research as a core function of the NHS. It reaffirms the commitment of the NHS, throughout the UK, to promote and conduct research to improve health and social wellbeing and to improve NHS patient^{[footnote 1]} care services. The Health and Social Care Act reaffirms this – for instance through the powers and duty it will place on the Secretary of State and others to support and promote research. While the NHS must play its full part in supporting research, it is important that the cost of that research is identified and properly funded.

This guidance provides a framework for the NHS and its partners to identify, attribute and recover the various costs associated with research in the NHS, in a transparent, robust and consistent manner. It applies to all NHS research covered by the Research Governance Framework for Health and Social Care. While the principles of cost attribution are similar across all 4 nations of the UK, because of the differences in certain aspects of the funding mechanisms operating in England, Northern Ireland, Scotland and Wales, including the provision of research infrastructure, this guidance applies to England only.

This guidance builds on the original health service guidance (97)32, ‘Responsibilities for Meeting Patient Care Costs associated with Research and Development in the NHS’ but replaces the ‘Attributing revenue costs of externally funded non-commercial research in the NHS’ (ARCO) 2005 document. The new guidance reflects significant change in the research landscape over recent years. The revised attribution process places more emphasis on the primary purpose of an activity and less on where that activity takes place or on who undertakes an activity. It is recognised that, in some instances, the clarification provided by this guidance may result in changes to previous cost attribution practice. Department of Health and Social Care (DHSC) will monitor the impact of this new guidance to ensure there are no unforeseen consequences.

Basic principles

Research studies comprise a number of component activities, which, for the purpose of agreeing funding arrangements, are attributed to one of 3 broad cost categories^{[footnote 2]}:

• research costs - the costs of the research and development (R&D) itself that end when the research ends. They relate to activities that are being undertaken to answer the research questions
• NHS treatment costs - 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 support costs - 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

While cost attribution follows clear principles, the application of those principles, in complex clinical circumstances, can be challenging. Equally, the potential challenge of recovering attributed costs is also acknowledged. The funding of non-commercial research frequently involves a number of partner organisations who collaborate to support and undertake clinical research. This may introduce a greater degree of complexity than is encountered in commercially-funded research where the relationship between cost attribution and cost-recovery is more absolute. While DHSC expects non-commercial funding partners to respect the outcomes of the cost attribution process, we recognise that there may be specific circumstances that require compromise and, in some instances, the adoption of pragmatic solutions to cost recovery. Annexes A and B distinguish degrees of flexibility that reflect the different research support and infrastructure initiatives that DHSC has pursued. In particular, the department’s support for research infrastructure for charity-funded research now has similarities with the charity research funding stream of quality-related funding, that supports the full economic cost of charity research in universities.

Commercial contract studies

The funding arrangements for commercial contract research studies are straightforward. The NHS is required to recover, from industry, all costs over and above the standard NHS treatment cost. The attribution of costs is, therefore, not an issue for commercial contract research.

To further simplify the process of cost recovery, industry costing templates have been developed to provide transparency, greater consistency and predictability in deriving research study costs. A variety of industry costing templates, based on the principles of the NHS Finance Manual, are available for commercial contract research undertaken in the NHS involving pharmaceutical clinical trials, biotechnology agents, and medical devices. Specific templates are also available for NHS primary and secondary care settings. Further information on industry costing templates is available on the National Institute for Health and Care Research (NIHR) website.

Although initially developed for studies intended for adoption by the clinical research networks in England, the templates are freely available to companies interested in running trials anywhere in the NHS and their use is recommended by the 4 health departments of the United Kingdom for commercial contract studies involving the NHS. Given the success of the commercial costing templates, the possibility of developing equivalent non-commercial costing templates is being explored.

It is important to note that research studies are not automatically considered to be ‘commercial contract research’ simply because they attract industry funding. Commercial companies also work collaboratively with NHS bodies or non-NHS research funders to support non-commercial research. If a study is primarily for the public benefit, rather than the direct commercial benefit of the company concerned, it may be considered non-commercial. Specific guidance on NHS collaboration with commercial companies is available on the NIHR website.

Non-commercial contract studies

In comparison with commercial contract NHS research, the funding arrangements for non-commercial NHS research can be more complex, often involving a number of partner organisations. It is essential that both the NHS and its partner organisations identify and quantify the full cost of non-commercial research and reach a shared understanding of how these costs are recovered through appropriate funding arrangements.

For non-commercial studies the normal funding arrangements for research, NHS treatment and NHS support costs are:

• research costs - usually met by grant funders through the award of a research grant, though there are some specific research activities where, in England, the costs will be met by DHSC (these are outlined in annexes A and B)
• NHS treatment costs - met through the normal commissioning process (Annex B, which is published on the NIHR website, outlines the arrangements in England)
• NHS support costs - met from the R&D budget by the health departments of the United Kingdom (Annex B outlines the arrangements in England)

The attribution process

The application of the cost definitions, set out above, has over time led to divergence in interpretation and practice. The following section provides revised guidance on the attribution process and is augmented by exemplar lists of common research-related activities attributed to each of the 3 cost categories. These lists (see Annex A, below) are not exhaustive and are intended to assist interested parties to understand the attribution process.

The attribution decision for a specific research-related activity is driven by the primary purpose of the activity but must also recognise the context within which the activity takes place.

To help arrive at the correct attribution decision and to help differentiate between these cost categories it is helpful to refer to the concept of NHS patient care services and the premise that the NHS bears the cost of caring for its patients even when they are involved in a research study. This may provide a more intuitive approach to cost attribution.

An NHS patient care service is defined as ’a service provided by, or on behalf of, the NHS where that service treats, or contributes to, the care needs of a patient’. The service may include all types of patient care services, including diagnostic, preventive, therapeutic, continuing care and rehabilitative care services, as well as health promotion. It also includes activity that measures or monitors the health of a patient receiving an experimental treatment regime where that activity is assuring the safety of the patient.

A 2-step approach to cost attribution is recommended. The first step differentiates between research costs and the costs of NHS patient care services. The second splits NHS patient care services into NHS treatment costs and NHS support costs.

Step 1 - determine if the activity is a patient care cost or research cost

In the context of this study, is the activity a “service provided by, or on behalf of, the NHS where that service treats or contributes to the care needs of a patient”?

If the answer is yes, the activity is a patient care cost (go to step 2 below).

If the answer is no, the activity is a research cost because it is not directly contributing to patient care.

Research costs

Research costs are derived from the core research activities that are being undertaken to answer the research questions. They end when the research ends. In practice, it is easier to identify research costs by exclusion. If an activity is not directly contributing to an NHS patient care service, then it is attributed as a research cost. Annex A, below, provides a list of common research activities that fall into the research cost category

Where the grant funder is a member of the Association of Medical Research Charities, research costs must be further attributed between those activities that fall within part A of Annex A and those that fall within part B.

Step 2 - if the activity is a patient care cost

Activity that is regarded as part of an NHS patient care service must be split between NHS treatment costs and NHS support costs. The differentiation between these 2 categories is again driven by primary purpose. Annex A, below, provides a list of common research activities that fall into NHS treatment costs and NHS support costs categories

NHS treatment costs

If an activity is integral to the provision of a treatment (or diagnostic) regime, whether this is standard or experimental, then it is attributed as an NHS treatment cost.

A research study may result in an NHS patient care service that differs from standard treatment, or is delivered in a different location from where it would normally be given. The associated NHS treatment costs may be less, or may be greater, than the cost of standard treatment. If greater, the difference between the NHS treatment costs and the cost of the standard treatment is referred to as the NHS excess treatment costs. These excess costs are nonetheless part of the NHS treatment costs, not an NHS support cost, and are not normally funded from DHSC R&D budgets. However, there are country-specific arrangements in place across the United Kingdom to provide some subvention support from departmental R&D budgets. These arrangements for England are outlined in the FAQs document (Annex B, which is published on the NIHR website).

NHS support costs

If a patient care activity is primarily undertaken to facilitate research or is driven by the NHS duty of care to a patient, for example, to ensure the safety of a patient participating in research then it is attributed as a NHS support cost.

Determining the primary purpose of an activity

Common research activities attributed to research costs, NHS treatment costs and NHS support costs are listed in Annex A, below. While these lists attempt to encompass the common research activities, they can never be exhaustive. As considerable reliance may be placed on these lists they will be augmented as experience in implementing this guidance is gained and they will be provided online alongside the FAQs document (Annex B, published on the NIHR website). Users are advised to always refer to the up-to date version of this document.

It is apparent from the exemplar lists that investigations, assessments or tests present a group of activities that maybe attributed as research costs, NHS treatment costs or NHS support costs. Indeed, the same activity (for example, blood pressure reading) may, in a single research study, fall into all 3 cost categories depending on the primary purpose of undertaking the activity at a specific point in the research study. Therefore, the primary purpose of an investigation, assessment or test must be carefully considered and explained in the research protocol to facilitate correct attribution.

Where the primary purpose of an activity is to generate data to answer the research question then the activity is not primarily concerned with patient care and is regarded as a research cost even where it is a clinical activity. The split between NHS treatment costs and NHS support costs is, in some instances, less obvious. Both provide different aspects of an NHS patient care service. However, a key delineator is the residual consequence arising from the cessation of a research study. NHS treatment costs would continue to be incurred as long as the treatment regime continued to be delivered, extending beyond the completion or cessation of the particular research study. In contrast, NHS support costs would cease with the completion or cessation of the research study as they are not an integral part of the treatment regime. For the purposes of the attribution process it can be assumed that an experimental intervention or service being tested will continue after the end of the study.

The rationale of using primary purpose to determine the attribution of research activity therefore raises the possibility that an individual involved in a research study - a research nurse, for example - may carry out a range of activities, some of which will be research costs, some of which will be NHS support costs and some of which will be NHS treatment costs. The funds required to cover the cost of this one member of staff may therefore need to come from a range of funding sources.

NHS research is increasingly complex and challenging. It may involve a variety of people and a variety of organisations. Attempts to classify research activity inevitably impose what must always be an artificial classification on a real world situation. Therefore no matter how elaborate the classification system it can never accommodate every reality. There is often a need to compromise, and the particular circumstances of individual research studies need to be considered within the overall classification rationale set out in this guidance.

Annex A: list of common research activities attributed to the research costs, NHS treatment costs and NHS support costs

Activities that are attributed to research costs

The costs of activities listed in Part A should be funded in full by all grant funders.

The costs of activities listed in Part B will also need to be funded in full by grant funders except where the funder is a medical research charity that is a member of the Association of Medical Research Charities 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 in Part B will be met by DHSC.

Part A

Part A activities include:

• any screening tests or assessments to determine whether a patient is eligible to participate in a study, performed after the patient has been approached to ask if they wish to participate in the study, but before they are accepted onto the study
• study-specific central trial co-ordination and management
• patient randomisation
• investigations, assessments and tests relating to if, how, why and when an intervention or procedure works - in other words, activity which is intended to answer the research question
• investigations, assessments and tests where the results are anonymous and unlinked to a patient identifier, or where the individual results will not be reported back to study participants or their clinicians, since such information is collected primarily for the purpose of answering the research question. However, exceptional circumstances may arise where there is an overwhelming clinical need to convey results to the clinician providing care. The possibility of such exceptional circumstances does not change the primary purpose
• patient follow-up where the follow-up is not a part of individual patient clinical management
• cash reimbursements or payments to volunteers to participate in the study
• all costs associated with placebos, including but not limited to producing, formulating, disguising, shipping, storing and dispensing placebos, including administering sham treatments, since these costs do not form part of the patient’s care and would not continue to be incurred once the study is finished
• registration of trials, including Medicines and Healthcare products Regulatory Agency (MHRA) clinical trial authorisation fees
• data storage archiving of clinical research records
• costs associated with making the results accessible
• training where new skills are required to carry out the R&D activity, but not training in obtaining informed consent, or training to deliver the treatment under investigation
• data analysis needed to answer the questions that the research study is addressing

Part B

Part B activities include:

• local study trial co-ordination and management
• data collection needed to answer the questions that the research study is addressing (including collecting data for and completing the report)
• regulatory preparation and compliance including obtaining ethical approval and complying with the Medicine for Human Use (Clinical Trials) Regulations 2004
• the time taken by Chief and Principal Investigators (CI and PI) to explain the study to professional colleagues, and to understand, the research elements of a study - for example the time taken to explain the criteria for patient eligibility or to explain the randomisation protocol

Activities that are attributed to NHS treatment costs

Activities that are attributed to NHS treatment costs include:

• supplying and administering the medicine, device or therapy being studied
• supplying and administering any active comparators - including medicines, devices or therapies, but not placebo or sham treatments
• 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 clinical management of a patient. If the primary purpose of the follow up is to inform the long-term evaluation of an experimental treatment, the activity should be attributed as a research cost. If the primary purpose of the follow-up is to monitor patient safety rather than efficacy, the activity should be attributed as an NHS support cost

Activities that are attributed to NHS support costs

Activities that are attributed to NHS support costs include:

• 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
• 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

1. The term ‘patient’ is used in its generic sense to include all types of NHS service user ↩

2. The original definitions of the cost categories were set out in health service guidance (97)32, ‘Responsibilities for Meeting Patient Care Costs associated with Research and Development in the NHS’ and remain unchanged. ↩