' fill='%23ffffff'%3E%3Cpath d='M283.94,167.31l386.39,516.64L281.5,1104h87.51l340.42-367.76L984.48,1104h297.8L874.15,558.3l361.92-390.99 h-87.51l-313.51,338.7l-253.31-338.7H283.94z M412.63,231.77h136.81l604.13,807.76h-136.81L412.63,231.77z'%3E%3C/path%3E%3C/g%3E%3C/svg%3E%0A){kind=small}
Health Research Authority announce further updates to commercial agreements for participating NHS and Health and Social Care organisations
The agreements have been updated to align with the model Commercial Chief Investigator Agreements published in June 2025
The following suite of commercial model agreements for use with participating NHS and Health Social Care (HSC) organisations has been updated. Please share this information with the people in your organisation who agree and sign research contracts:
- Model Clinical Trial Agreements (mCTAs) including:
- The Primary Care mCTAs (PC-mCTAs)
- The Advanced Therapy Medicinal Product mCTAs (ATMP-mCTAs)
- Model Clinical Investigation Agreements (mCIAs)
- Model Non-Interventional Study Agreements (mNISAs)
- Model Commercial Participant Identification Agreement (mC-PICA)
- Model Commercial Hub and Spoke Agreement
- Model Confidential Disclosure Agreements (mCDAs)
The definitions of ‘Agent’ and ‘Confidential Information’ in all these agreements have been updated to align with the recent changes made to the model Commercial Chief Investigator Agreements (mCCIAs).
Confidential information can now be shared by the chief investigator with potential and participating NHS and HSC organisations. The Health Research Authority (HRA) has clarified that another party, such as a Contract Research Organisation, can sign the agreement on behalf of the sponsor, not just an affiliate. Corrections have also been made after feedback was received on the previous versions.
The HRA recommends that sponsors use the July 2025 versions of these agreements in their Integrated Research Application System (IRAS) submissions as soon as possible. The July 2025 versions of the agreements will only be accepted in new IRAS submissions from 1 October 2025.
The May 2025 versions of the mCTAs, mCIAs, mNISAs, mC-PICA and the model Commercial Hub and Spoke Agreement will not be accepted in new IRAS submissions after 30 September 2025.
Any agreement not already exchanged (signed by both parties and notified or returned to the sponsor) can continue to be exchanged using the April 2024 version of the mCDAs or the May 2025 version of the participating organisation agreement. There is no need to move to use the latest templates if you have already started negotiations.
However, if a June 2025 version of the model Commercial Chief Investigator Agreements has been used to contract with the NHS or HSC, it is recommended to use the July 2025 version of the participating NHS organisation agreements. This will support chief investigators sharing confidential information about individual studies with participating NHS organisations, when needed.
If sponsors prefer to use the July 2025 version of the relevant agreement to contract with NHS and HSC organisations, there is no need to submit an amendment to use the revised contract template. You can find out more about which agreements you can use depending on the stage of your research project on the HRA website.
Publication date: 7th August 2025
