HRA Update: Updates to the commercial and non-commercial model agreements
Date: 18 September 2026
The following model agreements have been updated:
- model Non-Commercial Agreement (mNCA)
- model Commercial Chief Investigator Agreement (mCCIA) and CRO-mCCIA
- model Clinical Trial Agreement (mCTA) and CRO-mCTA
- model Primary Care mCTAs (PC-mCTAs)
- Advanced Therapy Medicinal Product Agreement model Clinical Trial Agreement (ATMP-mCTA) and CRO-ATMP-mCTA
- model Clinical Investigation Agreement (mCIA) and CRO-mCIA
- model Non-Interventional Study Agreement (mNISA) and CRO-mNISA
- commercial hub and spoke agreement
The changes in the commercial agreements balance the rights of all contracting parties relating to the use of confidential information in artificial intelligence (AI) tools.
Participating NHS organisations can now use sponsor (and CRO, where relevant) confidential information in their own secure AI tools, under the conditions stated in the contract, without seeking consent.
Under the previous versions, only sponsors (and CROs) were allowed to use the participating NHS organisations’ confidential information in secure AI tools without seeking consent. Participating NHS organisations could use sponsor (and CRO) confidential information in their own secure AI tool but needed to seek consent. We received feedback from NHS organisations that this was too restrictive and administratively burdensome.
As most organisations now have a secure AI tool, such as Microsoft 365 or Google Workspace, embedded in their IT systems, this update allows all parties to use their own secure AI tools under the conditions stated in the contract without going through additional consent processes. Any use in AI tools outside of the conditions stated in the contract would still require consent of the party owning the confidential information.
Read more here:https://content.govdelivery.com/accounts/UKNHSHRA/bulletins/428c03a