Attributing the costs of health Research & Development – AcoRD Elizabeth Coote Head of Non-Commercial Research Services TASC NRS – delivering research excellence

Session will cover …. reasons for change implementation of AcoRD basic principles behind the guidance process for attribution examples of costs Q&A NRS – delivering research excellence

Reasons for change attribution practice hasn’t always reflected guidance change in overall funding landscape improving the consistency of cost attribution and research funding encourage researchers to consider the total cost of the research they plan NRS – delivering research excellence

Implementation

NRS – delivering research excellence applies to grant applications submitted after 1 October 2012 Agreed by working group of AMRC, CSO, DH Does NOT apply to Commercially Sponsored research i.e. all costs are research costs

Principles

Research costs –relate to activities required to answer research question –end when research ends –met by funder through grant AMRC exceptions NRS – delivering research excellence Principles of AcoRD (1) No changes of definitions from ARCO

NHS Treatment costs –patient care costs (prevention/diagnosis/drug/therapy) –would continue even after research finished –met by NHS from general budget –if disproportionately expensive, subvention (Excess Treatment Costs (ETCs)) can be applied for NRS – delivering research excellence Principles of AcoRD (2)

NHS Support costs –additional patient care costs associated with research –end when research ends, even if patient care service would continue –met from NRS allocation to Boards OR through support from Scottish Networks NRS – delivering research excellence Principles of AcoRD (3)

Guidance documents NRS – delivering research excellence 3 sections main Guidance that covers the background, principles and attribution process annex A provides an Exemplar lists of activities and where they should be attributed annex B provides a set of Frequently Asked Questions (FAQs) – FAQs are updated periodically

Annex A Exemplars split into 3 sections – research, support and treatment costs Research costs fall into 2 categories Part A costs met by all grant funders Part B costs met by grant funders except where the funder is a member of the AMRC, where HBs expected to pick up cost NRS – delivering research excellence

AcoRD Attribution process

Attribution principles Attribution driven by Primary Purpose, so “why?” not “who?” or “where?” SSC must be a patient care service if an activity does not contribute to patient care then it is a Research cost “ a service provided by, or on behalf of, the NHS where that service treats, or contributes to, the care needs of a patient” NRS – delivering research excellence

AcoRD section 3.12 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 NRS – delivering research excellence

Attribution Step 1 identify activities being carried out with primary purpose of answering research question (by definition these will end when the research ends) these are RESEARCH COSTS examples of Research Costs are listed in Annex A NRS – delivering research excellence

Attribution Step 2 activities that are NOT research costs, i.e. patient care costs, must be split between treatment and NHS support costs TREATMENT COST –activity integral to provision of clinical service/care, whether standard or experimental –would be incurred if treatment/service was provided out with the context of research NRS – delivering research excellence

Treatment costs for attribution purposes you should assume that an experimental intervention/service being tested will continue after the end of the study most interventions that are being tested or compared as part of a study will be treatment costs (even if they are experimental, unlicensed for the condition or not approved and even if there are no plans to continue with the intervention after the study has ended) Placebo/sham treatments are NOT treatment costs NRS – delivering research excellence

Attribution cont NHS SUPPORT COST –patient care activity which would not occur if treatment/service was being provided out with the context of research –activity driven by the NHS duty of care to a patient (e.g. to ensure safety of research participant) OR –patient care activity primarily undertaken to facilitate research NRS – delivering research excellence

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’ The activity is a patient care cost. Is the activity integral to the provision of a treatment (or diagnostic) regime? The activity is a Research Cost because it is not directly contributing to patient care The activity is a Treatment Cost The activity is a Service Support Cost Yes No Yes No If funder is an AMRC member Attribute costs between Part A and Part B

Research costs Part B NRS – delivering research excellence Non-AMRC funders must meet the costs of Part A and B activities If funder is an AMRC member, and activities can be undertaken by existing staff, PART B costs will be met through NRS funding –Networks, NRS infrastructure, NRS researcher support where activity is of a level that cannot be accommodated by existing staff then it must be met by funder

NRS – delivering research excellence local study coordination/management data collection to answer research question (includes completion of CRF) regulatory preparation and compliance time taken by CI/PI to explain study to colleagues Research costs Part B

Costing NHS staff time in applications Based on activity not person What is the purpose of what they are doing? Administering treatment Ensuring safety Will it continue? Answering research question? Can this be done by existing staff? May be split in time depending on activities –Attribute, estimate and request from funder if necessary NRS – delivering research excellence

Examples

For example (1) …… Intervention Study involved 3 blood samples from participant: 1 sample for bio bank; 1 sample routine clinical care and 1 sample to assess baseline biochemistry Current - Funded through support costs AcoRD – Sample 1 = research cost Sample 2 = treatment cost Sample 3 = support cost NRS – delivering research excellence

Current A randomised placebo controlled CTIMP –Randomisation is research cost –Pharmacy costs assigned as support costs AcoRD –All Placebo costs are research costs –Pharmacy set up/close down is research cost –IMP dispense is treatment cost –Individual IMP accountability is support cost For example (2) …… NRS – delivering research excellence

Specific issues

Invitation to participate NRS – delivering research excellence Q How is contacting an individual to invite them to participate attributed? A This is a research cost as the primary purpose (recruitment) is in relation to answering the research question –comes under Part A so should be requested from the funder

Costs of repackaging Q. I know that the cost of dispensing the intervention medicine for a study is a NHS Treatment Cost, but the drug has to be repackaged locally at each recruitment site specifically for the trial. Is the repackaging a NHS Treatment Cost even though it would not need to repackage the drug once the study ended even if we continued to dispense the drug to patients? A. The repackaging of an intervention drug is a research activity where it is performed centrally either by a single NHS organisation or by a non-NHS supplier for use by all recruitment centres. However, where a NHS organisation repackages a drug locally for its own use, the activity is a NHS Support activity. NRS – delivering research excellence

New diagnostic tests NRS – delivering research excellence Q I intend to analyse pathological samples with the long term aim of introducing a new diagnostic process – how should I attribute the costs? A Analysis of samples to see if they are able to inform diagnosis is too far downstream to be considered a treatment and therefore is a research cost. If there is then a further study (or second phase) where you e.g. compare whether the (same) analysis is better than standard diagnosis then at this point the activity would be considered a treatment cost.

Imaging NRS – delivering research excellence Q As part of my study scans will be carried out after every cycle of chemotherapy to look for drug efficacy A As the primary purpose of the scan is to determine efficacy, the scans should be classified as research. Even if the scan also looks at potential toxicity and/or is put on the patient record, this does not over-ride the primary purpose

Staff time NRS – delivering research excellence Q As part of my intervention study a nurse will consent the patient, administer a QoL questionnaire and take patient BP – how are these costs attributed. A Consent – NHS support Questionnaire – Research BP – depends why it’s being done – if it is a research data item then it’s Research (Part B), if it is a study of a BP lowering drug then Research (Part A), or if it is to check intervention doesn’t affect BP then NHS support

Hints and tips

Tips NRS – delivering research excellence researchers should seek to minimise costs by efficient study design, not by omission researchers should seek appropriate advice in good time before grant submission –support from all available sources (funder, R&D office, CTU, network etc OR CSO) Individuals involved in attribution/costing need to understand the detail of the study –relevant information included in application form

Potential problems NRS – delivering research excellence Not referring back to the definitions of the 3 types of costs Not considering primary purpose of activity Assuming because an activity takes place in the NHS it must be a NHS cost – not true Assuming that funding for NHS costs works in the same way as funding for research costs

NRS – delivering research excellence Boards/networks have limited resources and may not be able to support your study appropriately if the cost attribution has been inaccurate

Any questions?