9th January 2024

The Health Research Authority launches new updates to the commercial and non-commercial model agreements

The Health Research Authority (HRA) has launched updates to the commercial model agreements, removal of the standalone data processing agreements and new non-commercial hub and spoke agreement.

Updates to commercial model agreements

The October 2023 commercial agreements and guidance have been updated by the Four Nations Contracts Leads following feedback from commercial sponsors, contract research organisations (CROs) and NHS Trusts.

The main changes are:

•            clarifying expectations for archiving fees. Archiving fees will be a one-off cost charged by the participating NHS and health and social care (HSC) organisation to the sponsor, CRO or their agent at close-down of the study to cover retention, destruction, and reasonable access requests. The one-off archiving fee will be calculated by the participating NHS and HSC organisation at close-down.

•            adding a new clause in the financial appendix to ensure that NHS organisations can defer the use of funds into future financial years to build research capacity.

New non-commercial hub and spoke agreement

A new non-commercial hub and spoke agreement is published to support hub and spoke delivery models for non-commercial clinical trials. This can be used when using the unmodified model Non-Commercial Agreement (mNCA).

The mNCA acts as the hub agreement between the sponsor and lead trial site (participating NHS or Health and Social Care (HSC) organisation). In hub and spoke models, the lead trial site sub-contracts with other NHS and HSC trial sites using the new template. Further information about the use of hub and spoke study delivery models is available in setting up interventional research guidance on the HRA’s website.

Removal of the commercial and non-commercial standalone data processing agreements

The standalone data processing agreements were developed to be used with contracts which had been signed before the General Data Protection Regulation (GDPR) came into effect in 2018. They enabled studies to continue to be conducted in line with the requirements of the new legislation by providing GDPR compliant data processing clauses.

The HRA is receiving queries from stakeholders about the purpose of these agreements. Some organisations are incorrectly using them to contract studies where the only research activity is data processing. As the templates have now served their purpose, the HRA has removed them from IRAS.

It is expected that commercial sponsors of research where the only research activity is data processing use the mNISA or CRO-mNISA to contract with participating NHS organisations. Non-commercial sponsors of research where the only research activity is data processing should use the organisation information document to contract with participating NHS organisations.

For more information, please visit the HRA’s website.