Revised model agreements to support faster, standardised research contracting

The Health Research Authority (HRA) has published some changes to model agreements that should be used in health and social care research across the UK.

From today the Model Commercial Chief Investigator Agreement (mCCIA) and the Model Confidential Disclosure Agreements (mCDAs) should be used without modification across the UK. 

The changes are part of 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.

The agreements have been developed by the Four Nations Contract Leads following feedback from the research industry and the NHS. 

Model Commercial Chief Investigator Agreement (mCCIA)

In November 2024 the HRA published a draft of the Model Commercial Chief Investigator Agreement (mCCIA) for comment and the feedback received was used to update the agreement. The changes have standardised certain areas of the agreement, addressed concerns raised by stakeholders and make the agreement easier to understand and use. 

Using the new mCCIA without modification will reduce negotiation times and ensure that only project-specific elements are tailored in the template.

The HRA has also received requests for a contract research organisation (CRO) version of this agreement. Whilst that has not been published, the HRA is committed to publishing a CRO-mCCIA as soon as possible.

Until then, if sponsors and CROs prefer to use an agreement to include the CRO as a party to the agreement, they should use the mCCIA as the template and modify it accordingly. 

They are also considering developing chief investigator agreement templates for other study types. 

Model Confidential Disclosure Agreements (mCDAs)

The Model Confidential Disclosure Agreements are legal agreements that are often used in commercial contract research to govern the sharing of confidential information from the commercial sponsor to the prospective participating NHS or HSC organisations prior to the site agreement.

Using either the mCDA or the model Master Confidential Disclosure Agreement will help streamline the commercial contracting process and reduce unnecessary negotiation. 

This a priority for the government and the Health Research Authority as part of ongoing work to streamline and reform clinical research set-up. 

To find out more about how agreements like this can help make the UK a great place to do research visit the UKCRD website.