Updates to commercial model agreements
The October 2023 commercial agreements and guidance have been updated by the Four Nations Contracts Leads following feedback from commercial sponsors, CROs and NHS Trusts.
The main changes are:
- clarifying expectations for archiving fees. Archiving fees will be a one-off cost charged by the participating NHS and health and social care (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 NHS and HSC organisation at close-down
- adding a new clause in the financial appendix to ensure that NHS organisations can defer the use of funds into future financial years to build research capacity
We recommend that sponsors and CROs use the new December 2023 versions of the agreements to ensure that there is clarity of expectation between the parties. 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.
Please continue to send us feedback about the contracts so that we can consider whether any further changes are needed.
New non-commercial hub and spoke agreement
A new non-commercial hub and spoke agreement is published 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 NHS or Health and Social Care (HSC) organisation). In hub and spoke models, the lead trial site sub-contracts with other NHS and HSC trial sites using the new 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. 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.
It is five years since the regulation became law, and any studies which were initially contracted without GDPR compliant data processing clauses should have been recontracted by now. We are receiving queries from stakeholders about the purpose of these agreements. Some organisations are incorrectly using them to contract studies where the only research activity is data processing. As the templates have now served their purpose, we have removed 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.
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