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Attributing the costs of health Research & Development –
AcoRD
Elizabeth CooteHead of Non-Commercial Research Services
TASCLiz.Coote@nhs.net
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
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Implementation
Implementation
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• 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
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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
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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
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Principles of AcoRD (3)
Guidance documents
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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
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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”
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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
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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
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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
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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
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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
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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
NoYes
No
If funder is an AMRC member
Attribute costs between Part A and Part B
Research costs Part B
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• 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
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• 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
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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
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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) ……
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Specific issues
Invitation to participate
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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.
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New diagnostic tests
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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
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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
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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 supportQuestionnaire – ResearchBP – 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
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• 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
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• 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
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Boards/networks have limited resources and may not be able to
support your study appropriately if the cost attribution has been inaccurate
Any questions?
Liz.Coote@nhs.net
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