Health Research Authority further updates the commercial agreements for participating NHS and Health and Social Care organisations

The Health Research Authority has made further updates to the commercial model agreements for use with participating NHS and Health and Social Care (HSC) organisations.

These have been updated to align with the model Commercial Chief Investigator Agreements published in June 2025.

This is UK-wide and affects commercial sponsors, contract research organisations (CROs), NHS and HSC organisations from July 30 this year. 

The following suite of commercial model agreements for use with participating NHS and HSC organisations has been updated: 

• 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) 

What is changing?

The definitions of ‘Agent’ and ‘Confidential Information’ in all of 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 have clarified that another party, such as a CRO, 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 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. 

What does this mean for sites currently waiting to sign mCDAs or are still in set up?

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, the HRA recommends using 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. 

Which agreement can I use?

You can find out more about which agreements you can use depending on the stage of your research project on the HRA website. 

What do you need to do?

Please share this information with the people in your organisation who agree and sign research contracts.  

View the templates needed for IRAS submissions from October 2025