For most types of research project, it is expected that an agreement between the sponsor and each participating NHS organisation will be in place before the research commences at the NHS organisation.
This agreement formally confirms the capacity and capability of the NHS organisation to deliver the research project. It should be agreed in advance by the sponsor and participating NHS organisation whether the contract execution means that research activity may start immediately, or whether it only triggers site initiation and sponsor green-light processes.
For projects under HRA and HCRW Approval, the HRA Initial Assessment Letter (and HRA Approval letter) will specify the appropriate agreement for each site type in a project. The document might be an unmodified Organisation Information Document, or another unmodified model UK agreement.
Commercial contract research
For all commercial contract research, the National Directive on Commercial Contract Research sets a policy mandate that only the appropriate and unmodified UK template agreements are used.
HRA and HCRW Approval will usually be issued conditionally upon such use. In exceptional circumstances a waiver may be granted.
These agreements should be used as set out in their accompanying guidance. Use of the unmodified model agreement, without additional side agreements, simplifies and speeds up the study setup process.
The suite of UK template agreements are long established and drafted to work across the UK. Each of the devolved nations has an equivalent policy position on the use of only the appropriate and unmodified UK template.
Using a modified model agreement, an agreement not based on a model template, or an additional side agreement for a commercial contract project may be possible, primarily if no UK template agreement exists for the type of project. Such use requires an explicit waiver, which would usually form part of the HRA and HCRW Approval conditions.
Waivers
Sponsors should be aware that a waiver request is liable to add many months of central negotiation, is unlikely to be agreed, and even where it is agreed only removes from participating organisations the obligation to use an unmodified template. It would free them to consider the sponsor proposals, as well as to propose their own. In the exceptional circumstances where a waiver is issued, we encourage participating NHS organisations to seek independent legal advice, at sponsor expense, if they do not have access to appropriate in-house legal expertise.
Non-commercial research
Whilst there is no equivalent to the National Directive for non-commercial research, there is a policy expectation that the appropriate UK template will be used without modification and failure to do so may result in prolonged central and participating NHS organisation review.
Modifying a template
If a sponsor chooses to propose modifications to a UK template, or provide a bespoke template, this must be clearly set out in the IRAS application (cover letter) with a tracked-change version of the template (if modified) provided and a detailed, change by change, rationale given. If the rationale is that no UK template agreement exists for the project type, this should be clearly stated and justified, as this may expedite the review.
There are several different model agreements, and you should use the one that is most appropriate for your study type and sponsorship arrangements.
For more information visit the IRAS website.
Will you be seeking HRA Approval?
If you will be seeking HRA Approval for your study, you may also find it useful to refer to the HRA assessment criteria and standards document as this includes considerations around the use of model agreements. You can find the document on our dedicated HRA Approval page.