National Directive on Commercial Contract Research Studies

National Directive on

Commercial Contract

Research Studies

Version 3.0, 3 December 2021

Changes highlighted in Yellow from version 2 first published 26 September 2018,

updated 25 April 2019. (Publishing approval number: 08486)

Classification: Official

Publication approval reference: PAR1195

1 | National Directive on Commercial Contract Research Studies

Contents

Document Title: National Directive on Commercial Contract Research Studies……….

Subtitle: NHS England and NHS Improvement in partnership with the National

Institute for Health Research and the Health Research Authority…………………........

Contents………………………………………………………………………………….… 1

1 Introduction..…………………………………………………………………………….. 2

2 Mandated use of Unmodified Model Agreements only……………………………... 3

3 Mandated use of the Standard Costing Methodology………………………………. 3

4 Introduction of the National Contract Value Review process………………………. 4

Annex A: NHS Standard Contract wording item Service Condition 26.4……………. 5

2 | National Directive on Commercial Contract Research Studies

Introduction

The NHS Standard Contract requires that from 1 October 2018, all NHS providers

in England will use the new commercial contract research set-up and reporting

processes. This National Directive sets out what these processes involve. It will

continue to be reviewed and revised throughout 2019 and onwards, building on

learning gained during the introduction phase of the single/national contract value

review process as discussed in section 4.

A commercial contract research study is a research project that is fully sponsored

and fully funded by a commercial company, regardless of National Institute for

Health Research Clinical Research Network (NIHR CRN) portfolio status. For the

avoidance of doubt, this excludes Investigator-initiated Trials (defined as studies

sponsored by a non-commercial entity e.g. University or NHS, with some level of

funding being provided by a commercial organisation) and other industry

collaborative studies not solely sponsored by a commercial entity, which are

considered non-commercial studies.

NHS England’s Twelve Actions to Support and Apply Research in the NHS

recognise that the NHS is a vibrant research environment but that more should be

done to facilitate research and innovation in the NHS. In 2017 a public consultation

set out joint options from NHS England and NHS Improvement, the National

Institute for Health Research (NIHR) and the Health Research Authority (HRA) to

simplify arrangements for research in the NHS in England and associated changes

to the terms of the NHS Standard Contract in England. The response, which was

published in May 2018, sets out specific actions to simplify and standardise

processes for commercial contract research set up and reporting. The Standard

Contract has been modified as a result, to place a contractual obligation on NHS

providers in England to adhere to the new streamlined processes set out in this

National Direction, specifically:

1 https://www.england.nhs.uk/publication/12-actions-to-support-and-apply-

research-in-the-nhs/

● mandated use of an unmodified model agreement,

● mandated use of standard costing methodology,

● introduction of a national contract value review process.

The twelve actions are supported by both the Second Life Sciences Sector Deal,

which was published in December 2018, and the NHS Long Term Plan, which was

published in January 2019. Both reinforce a long-term commitment to creating the

best environment for clinical research and making the UK one of the best places in

the world to do biomedical, clinical and medical innovation research. The national

contract value review is set out in Saving and Improving Lives; The future of UK

3 | National Directive on Commercial Contract Research Studies

Clinical Delivery

, which was published 23 March 2021 and is overseen via the

Research Recovery, Resilience and Growth (RRG) programme board.

https://www.gov.uk/government/publications/the-future-of-uk-clinical-research-

delivery/saving-and-improving-lives-the-future-of-uk-clinical-research-delivery#our-

strategy-and-plans-for-delivery

2 Mandated use of Unmodified Model Agreements only

All providers (and, by extension, commercial sponsors and Contract Research

Organisations (CRO)) are required to comply with HRA expectations

to use of up-

to-date model site agreement for sponsor (and, where applicable, CRO) to site

contracting (e.g. Model Clinical Trial Agreement [mCTA] and CRO-mCTA) including

as specified in the HRA and Health and Care Research Wales (HCRW) initial

assessment letter and letter of HRA and HCRW Approval.

HRA and HCRW Approval to carry out commercial contract research studies in the

NHS will be conditional upon use of only an unmodified model site agreement to

contract with the sites, unless the HRA & HCRW Approval waives that requirement

where appropriate (e.g. where no template relevant to the study design exists).

More details on HRA and HCRW assessment and waiver process will be available

on HRA’s website.

https://www.hra.nhs.uk/planning-and-improving-research/best-practice/model-

agreements/

3 Mandated use of Standard Costing Methodology

The Standard Contract requires providers (and thereby commercial sponsors and

Contract Research Organisations) to use a standard “methodology for setting prices

payable by research sponsors to NHS providers for their participation”. The

standard methodology currently used is the NIHR interactive Costing Tool (NIHR

iCT).

This NIHR iCT provides for the national contract value review. The template reflects

the latest financial year values for:

● national NIHR tariff elements for investigations,

● hourly rates for procedures, based upon NHS Employers costs,

● prescription charges based upon NHS England values,

● NHS inflator/deflator value for investigations,

● Market Forces Factor values,

● overhead components built from both indirect cost (for labour activities) and

capacity building for both labour activities and investigations.

Operational guidance to support the use of the NIHR iCT is located on the NIHR

costing template page

4 | National Directive on Commercial Contract Research Studies

The NIHR iCT will continue to be subject to review and providers are encouraged to

raise any issues with the template methodology.

4 Introduction of the National Contract Value Review Process

The mandated use of the unmodified model site agreement and the standard

costing methodology (iCT) were the next steps on the road to a national contract

value review process. Providers using these templates and the process set out

below will have the opportunity to provide feedback to NIHR and raise awareness of

issues identified. NHS England and NHS Improvement and NIHR will work with key

stakeholders to review the new process including its impact. The national contract

value review process and its principles of upfront fixed costs and increased system

transparency will become mandatory following the review of this introduction phase.

This national contract review process is a nationally co-ordinated contract value

negotiation process. It builds on what has been achieved with the NIHR Industry

Costing Template, to create a single contract value review with an assigned

national co-ordinator for each commercial contract study.

Individual contracts will still be executed with each site, in line with nationally

derived contract values, e.g. the NIHR iCT costing and hourly rates (modified as

necessary for local circumstances, within the scope of the process) and HRA

directions as to model contract clauses. Cost variations will be available to all

parties at the outset of the costing process for a study via a costing list. Provider

organisations are responsible for stipulating the variation in costing and will adhere

to this costing list.

The initial proposed national contract value review process is set out on the NIHR

website and will ensure efficiencies for the conduct of commercial contract research

by:

● assigning a national co-ordinator who is empowered to work on behalf of all

NHS providers and act as a single point of contact for negotiation with the

sponsor on resource required,

● NHS providers publishing to commercial sponsors either a confirmation that

they adhere to the national costs or setting out all the provider-specific

adjustments to the national costs along with justifications,

● providing assurance that the NIHR Interactive Costing Tool captures all

Sponsor and NHS requirements to deliver the study,

● capturing predefined NHS provider-specific adjustments to the national

coordinator negotiated study template as part of the model agreement

financial appendix.

NHS providers will not deviate from the published provider-specific costs in place at

the time the commercial sponsor approached the site and will accept the

requirements to deliver the study set out in the national coordinator-negotiated

NIHR Interactive Costing Tool.

NHS providers will have the opportunity to nominate commercial research costing

experts to act as the National Co-ordinators. These individuals will need to meet

necessary criteria to ensure the successful and efficient costing and negotiations for

5 | National Directive on Commercial Contract Research Studies

commercial contract research. It is acknowledged that NHS providers will have

varying levels of expertise across location and/or therapy area which will mean that

National Co-ordinators will not be equally dispersed across England. It is expected

that providers work towards including the requirements of the national co-ordinator

role in their local job descriptions for staff costing commercial contract research.

A peer-to-peer community of national coordinators, will be developed to build

confidence and efficiencies in the role and process.

Information on progress will be available on the AAC Website.

Annex A: NHS Standard Contract wording item Service Condition 26.4

If the Provider chooses to participate in any Commercial Contract Research Study

which is submitted to the HRA for approval on or after 1 October 2018, the Provider

must ensure that that participation will be in accordance with the National Directive

on Commercial Contract Research Studies, at a price determined by NIHR for each

Provider in accordance with the methodology prescribed in the Directive and under

such other contractual terms and conditions as set out in the Directive.

Commercial Contract Research Study a research project that is fully sponsored

and fully funded by a commercial company

National Directive on Commercial Contract Research Studies the mandatory

requirements governing participation by Providers in Commercial Research

Studies, published jointly by NHS England and NHS Improvement, the National

Institute for Health Research and the Health Research Authority from time to time,

including;

(i) a methodology for setting prices payable by research sponsors to Providers for

their participation; and

(ii) other contractual terms and conditions to apply to Provider participation.

6 | National Directive on Commercial Contract Research Studies

Contact details: england.research@nhs.net