The Health Research Authority (HRA), in collaboration with the devolved administrations of Northern Ireland, Scotland and Wales, and the R&D Forum, are calling for comments on the draft of a new study agreement template.
The draft Investigator Initiated Study Agreement is proposed for future use between non-commercial sponsors and commercial organisations providing support for investigator-initiated trials.
These are research studies where the research idea comes from a non-commercial sponsor but that also receive commercial support.
Although non-commercial sponsors already work with commercial companies in this way, it can take a long time to get agreement because there isn’t a standard contract available.
The Investigator Initiated Study Agreement provides a standard contract agreement template for this type of research.
The draft has been developed by the R&D Forum contracts group, who are NHS contract managers, with support from the UK Four Nations contracts leads, who are responsible for maintaining the UK model research agreements available on IRAS, the online platform used for processing research applications for approval.
The UK Four Nations contracts leads consists of the Health Research Authority, Health and Social Care in Northern Ireland, NHS Research Scotland and Health and Care Research Wales.
The development of the Investigator Initiated Study Agreement template supports the government’s commitment to making it easier to set up clinical research in the NHS and HSC through the Recovery, Resilience and Growth (RRG) programme, and its response to Lord O’Shaughnessy’s review into the set-up of commercial clinical research.
Sarah Grimshaw, Research Regulation Specialist at the HRA‘We are delighted to work with the R&D Forum contracts group and the devolved administrations to develop the Investigator Initiated Study Agreement, which will help make it easier to set up investigator initiated clinical trials.
‘We really value the input of the research community, and we are encouraging them to get involved in the development of the document. Their feedback will help us to understand what changes need to be made to the first draft of this agreement before we publish it for use. We want to make sure that it will be suitable for use by NHS and HSC organisations, universities, and commercial companies.’
To get involved, please send your comments by email to research.agreements@hra.nhs.uk by 9am on 3 June 2024.
If you need to make detailed comments, please include these in tracked changes on the Investigator Initiated Study Agreement template and attach it to your email.
HRA draft Investigator Initiated Study Agreement
You can download a Word version of the draft document and make comments on the model Investigator Initiated Study Agreement using tracked changes.
If you require the document in a different format please email research.agreements@hra.nhs.uk