The Health Research Authority (HRA) in conjunction with the Four Nations Contracting Leads Group have recently published the following updates to the commercial and non-commercial model agreements.
- Updates to the October 2003 commercial agreements and guidance
In October 2023 an unmodifiable financial appendix for use in commercial agreements that removed local contract and contract-value negotiation from the NCVR process, along with guidance, was released. Following feedback from commercial sponsors, CROs and HSC Trusts these have been updated.
The main changes to be aware of are;
- clarifying expectations for archiving fees. Archiving fees will be a one-off cost charged by the participating HSC organisation to the sponsor, CRO or their agent at close-down of the study to cover retention, destruction, and reasonable access requests. The one-off archiving fee will be calculated by the participating HSC organisation at close-down.
- adding a new clause in the financial appendix to ensure that HSC organisations can defer the use of funds into future financial years to build research capacity.
It is recommended that sponsors and CROs use the new December 2023 versions of the agreements to ensure that there is clarity of expectation between the parties. However, the October 2023 versions of the agreements will continue to be accepted in IRAS submissions for six months from today as part of a grace period.
The agreement templates and accompanying guidance can be found at IRAS Help-Preparing & submitting applications-Templates for supporting documents.
- New non-commercial hub and spoke agreement
A new non-commercial hub and spoke agreement is now available to support hub and spoke delivery models for non-commercial clinical trials. This can be used when using the unmodified model Non-Commercial Agreement (mNCA).
The mNCA acts as the hub agreement between the sponsor and lead trial site (participating HSC organisation). The lead trial site will sub-contract with other HSC/NHS trial sites using the new hub and spoke template. Further information about the use of hub and spoke study delivery models is available in our setting up interventional research guidance.
It is expected that both the mNCA and non-commercial hub and spoke agreement will be used unmodified for maximum speed and benefit during the set up phase. Applicants should submit both the mNCA and the non-commercial hub and spoke agreement with their IRAS submission or amendment, if being introduced after approvals are in place. It should be clear in the application or amendment that a hub and spoke arrangement is being used for your study.
- Removal of the commercial and non-commercial standalone data processing agreements.
The standalone data processing agreements were developed to be used with contracts which had been signed before the General Data Protection Regulation (GDPR) came into effect in 2018. They enabled studies to continue to be conducted in line with the requirements of the new legislation by providing GPDR-compliant data processing clauses.
Studies that were initially contracted without GDPR-compliant data processing clauses should have been re-contracted by now. There have been enquiries from stakeholders about the purpose of these standalone data processing agreements, with some organisations incorrectly using them to contract studies where data processing is the only research activity. Therefore, as they have now served their purpose, the decision has been made to remove them from IRAS.
It is expected that commercial sponsors of research where the only research activity is data processing use the mNISA or CRO-mNISA to contract with participating NHS organisations. Non-commercial sponsors of research where the only research activity is data processing should use the organisation information document to contract with participating NHS organisations.
Feedback
Questions and/or feedback from HSC/NHS organisations on these agreements and their use should be provided to HSC Innovations at ResearchContracts@innovations.hscni.net, whereby these will be raised directly with the “Four Nations Contracts Leads”.
Assistance
For assistance with queries relating to model template agreements, contract drafting and negotiation for clinical trials or collaboration projects in research development and innovation, please contact ResearchContracts@innovations.hscni.net.