Understanding Research Service Support Costs and Excess Treatment

CostsReshma Raycoba

NISCHR AHSC R&D Costing Manager

20th May 2014

Scope

• The content of this discussion covers non commercial portfolio research studies ONLY

• Discusses Wales-specific arrangements• For commercial research, ALL additional elements

above standard care are covered by reimbursement from the commercial sponsor

• For non commercial non portfolio studies, alternative sources of funding or support must be identified

Definitions

• For all NHS non commercial portfolio research studies, the AcoRD policy applies (from October 2012)http://www.wales.nhs.uk/sites3/page.cfm?orgid=952&pid=62653

• AcoRD is a UK wide policy, with country specific documents in place to reflect local arrangements

AcoRD Outline

• Policy framework that facilitates the attribution of activities into the correct category in order to identify the source of funding to cover that activity

• It is important to ensure that the Primary Purpose of the activity is clear

• Must assume that the intervention being tested will be adopted as standard care for the purpose of accurate attribution

• Budgets in question:• Grant funder budget (e.g. Research charity, NISCHR

RfPPB, MRC, etc)• Usual NHS Commissioning Budgets• NHS Research-specific budgets from NISCHR, Welsh

Government:– NHS Support Cost Budgets – Primary Care, Public Health and

Emergency Care (centralised in Wales); Secondary Care (included in NHS R&D Organisations’ Allocations from NISCHR, WG annually)

– NHS Research Staff – e.g. NISCHR CRC Research Nurses, research staff funded through NHS R&D allocations

– NHS Excess Treatment Cost Budget (centralised in Wales)

Definitions cont...

• Research cost activity– An activity that is only happening in order to

answer the research question – No direct impact on patient care

• Examples: – Randomisation; – Collecting data and filling in Case Report Forms for a study; – Holding focus groups to ask participants about their

experience of being in the research project

Definitions cont...

• NHS Support Cost Activity– An activity that is only happening for the

duration of the research project that impacts on patient care, but would not continue to be provided if the intervention being tested became standard care – usually safety related

• Examples: – Informed consent (agreed attribution with funders); – Searching the NHS patient record (e.g. Database searches); – Additional blood tests to check patients’ safety only for

the duration of the study (results fed back to the patient’s clinical care team)

Definitions cont...

• NHS Treatment Cost Activity– An activity that is an integral part of the

intervention being tested, which would be what the patient experiences if you assume that this intervention will be adopted as standard care

• Examples: – Administration of study drug (NOT placebo – placebos are

always covered by research costs)– Provision of interventions, e.g. Cognitive Behaviour

Therapy sessions

• Ideally, attribution of these activities should be done by the Chief Investigator when applying for a grant from a funder that is a portfolio eligible partner

• Funders will scrutinise the attribution, particularly for NIHR and NISCHR funded studies – more funders coming on board with the pilot of the Activity Capture and Attribution Template (ACAT)

• This means that each site can quickly identify the resources required to deliver the study at set up stage

• This is the ambition and your R&D Office will be able to advise on this as part of the permissions process – contact them at the earliest opportunity

Attribution Flow Chart

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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’?STEP 1

This is a patient care cost activity

This is a research cost activity

Will the activity still be required if the

intervention being tested becomes standard care?

Is the funder a NIHR partner

AMRC member?

This is a treatment

cost activity

This is a NHS support cost

activity

Attribute research activities between Part A and Part B

STEP 2Yes No

Yes No

Yes

ATTRIBUTION EXAMPLES

• Example 1 (Examples based on real studies):Participants will be randomised to take a course of IMP, or a matched placebo, for one week.

Q: How would you attribute the following:• Randomisation• The cost of the steroid• The cost of the placebo

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• Example 2:After written informed consent is given, the following assessments must be performed:

• Complete medical history check against inclusion/exclusion criteria• Report on concomitant medications

After completion of the baseline procedures, the patient will be randomised.

Q: How would you attribute the following:• Informed consent• The check against inclusion / exclusion criteria

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• Example 3:This study aims to contact smokers over the age of 18 who have attempted to stop smoking twice in the last 2 years but have not been successful.

• 40 GP surgeries will be approached and asked to conduct mail outs to send the study details to those patients on their list that might fit the criteria.

Q: How would you attribute the following:• The Practice Manager’s time taken to conduct the database search• The stationery and postage costs and time taken to stuff envelopes and

do mail merges etc

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ACCESSING RESEARCH COSTS, SUPPORT COSTS AND TREATMENT COSTS

Research Costs

Central Research Costs e.g. Salary costs for

research team

Site Level Research Costs e.g. To cover NHS clinical time collecting

data etc

Submission to Grant Funder as

part of application

Application Successful –

Grant awarded

Funding provided to

Sponsor (funding schedule

provided as part of the

contract process)

Sponsor pays Central

Research Costs either

to NHS organisation or University

Sponsor pays each site for the Research Cost Activities undertaken, as agreed at the study set

up stage *

* Note that for some charities that invest in the NHS research infrastructure, some research costs will be covered by the NHS R&D budgets – see AcoRD for further details

NHS Support Costs & Resources

NISCHR, WG

NHS R&D Allocations

Research Support & Governance Funding,

Support Cost FundingResearcher Support & Portfolio

Development Funding

NHS R&D Office assesses each study to identify level of support required

Based on activity from the previous year

Secondary Care Support Cost Resources

NISCHR, WG

NISCHR CRC Research Delivery Teams

May be able to provide some staff support as identified by

R&D office at study set up stage

Where appropriate and possible, staff support provided for NHS Support Cost Activities e.g. Taking informed consent

NISCHR, WG

Centralised SSC Budget for Primary Care, Public Health and

Emergency Care Portfolio research studies

Study team to apply directly to NISCHR, WG for SSC activities

apart from those being covered by NISCHR CRC team

NISCHR, WG authorises request and invoice raised by study

teamSupporting

servicesStaff

support*

Primary & Secondary Care Delivery Resources

Centralised Support Cost Resources

NHS Treatment Costs

NHS Treatment

Cost activities identified for study

Compare to

Current Standard

CareTreatment cost activity versus

current standard care

If intervention is over current standard care, Excess Treatment Cost

If intervention is less than current standard

care, Cost Saving to the NHS

If intervention is the same as current

standard care, cost neutral

Study team and sites submit

applications to NISCHR, WG

(with R&D sign off for

Secondary Care studies)

Centralised Excess

Treatment Cost Budget

for Wales

Application approved by NISCHR, WG and invoicing arrangements

agreed

Usual NHS Commissioning Arrangements

Cost saving to be recorded

and reported in order to give a

balanced perspective on the impact of NHS research

AcoRD

Research Costs

Research Part A

Research Part B (AMRC studies)

Treatment Costs

Over and above standard care =

Excess Treatment Costs

Less than standard care = Cost Savings

Support Costs

Direct NISCHR Funding

Primary Care / Public Health Support Cost

Budget (NISCHR) or NISCHR CRC staff resource

Centralised Excess

Treatment Cost Budget

(NISCHR)

Secondary Care R&D Allocations or NISCHR CRC staff resource

Other external sources of funding

R&D Allocations from NISCHR,

Welsh Government or NISCHR CRC staff

resource

Research Grant Income (Lead site)

Research Grant Income (host site)

AcoRD and how costs are met

Centralised NISCHR budgets

Support Available

• Attribution can be complex, but there is a lot of support available:– NHS R&D Office– Costing expertise in local teams– NISCHR AHSC R&D Costing Manager– Escalation route to NISCHR if particularly

complex

Thank you

reshma.raycoba@wales.nhs.uk

02920 196816