HRA announces updates to model agreements
The changes in commercial agreements balance the rights of all contracting parties relating to the use of confidential information in artificial intelligence (AI) tools
The following model agreements have been updated by the Health Research Authority (HRA) for use from this week (Monday 7 September):
- 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
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. The HRA 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.
As part of the changes to the agreements above, the HRA has also corrected errors which were included in the April 2026 versions, for example incorrect clause referencing. More information on the corrections and updates is available in the mNCA, mCTA and PC-mCTA guidance documents.
You can still use previous versions of the agreements for 3 months from Monday 7 September. The HRA is allowing previous versions to be accepted during this short wash-out period because the changes are not linked to legislative or other major changes taking place in the sector. Previous versions of the agreements will not be accepted from 30 November 2026.
If another version of an agreement was submitted and approved with your study, you do not need to submit a modification to use the new version of that agreement with any new sites if you use it unaltered. If you've already entered into an agreement with a NHS CI Employer or NHS site, there is no need to replace this with a new version of the agreement.
The updated agreements are available on the contracting section of the IRAS Help pages. Feeback can be emailed to research.agreements@hra.nhs.uk.
Publication date: 11th September 2026
