HRA Now - further updates to the commercial agreements for participating NHS and HSC organisations

Health Research Authority sent this bulletin at 30-07-2025 03:24 PM BST

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HRA Now - further updates to the commercial agreements for participating NHS and HSC organisations

What: the commercial model agreements for use with participating NHS and HSC organisations have been updated to align with the model Commercial Chief Investigator Agreements published in June 2025

Who: commercial sponsors, contract research organisations (CROs), NHS and HSC organisations

Where: UK wide (England, Northern Ireland, Scotland and Wales)

When: Wednesday 30 July 2025

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. We 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.

We recommend 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, we recommend 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

Your feedback is important 

We have had lots of feedback about these agreements over the last couple of years. We haven’t been able to address everything we’ve heard about for this update, because we wanted to make key changes to align with the recent, urgent updates to the mCCIAs.  

If you have already sent us feedback but your proposed changes haven’t been made this time, we still have your feedback and will review it in due course. 

You can find out how to share new feedback on the contracts in IRAS Help. 

All contracts are reviewed every six months and updated as needed, based on feedback. Please do continue to tell us what you think. 

Making a more efficient and streamlined single UK standardised commercial contracting process

The changes made to these agreements are part of our work on the UK Clinical Research Delivery (UKCRD) programme which is committed to developing and mandating an efficient and streamlined single UK standardised commercial contracting process to reduce unnecessary negotiation.

You can read more about our work as part of the programme on the HRA website.

HRA Now brings you important operational updates from the HRA - including changes to guidance or processes which might affect you.