DEADLINE – Monday 3 June 2024 @0900
The UK Four Nations Contracts Leads Group (including the HRA, in collaboration with the Devolved Administrations of Northern Ireland, Scotland and Wales) and the R&D Forum Contracts Group, are calling for comments on a new model Investigator Initiated Study Agreement (mIISA).
Model Investigator Initiated Study Agreement (mIISA)
We are aware that it can take a long time to agree contracts between the HSC and industry for investigator-led studies, when a HSC investigator has an idea for a research study and needs financial or other support to be provided by industry for the study to be viable. We have therefore developed the model Investigator Initiated Study Agreement.
The mIISA is designed for use as a bi-partite agreement when the HSC are sponsoring a research study; industry’s only involvement in the study is the provision of finance or products.
We have tried to ensure that the template covers as many different scenarios and arrangements for supporting this type of research as possible.
However, before this model agreement is published for use, we would like to hear from you whether we need to make any changes to the draft.
We want to make sure that the template can be used by HSC organisations, universities and industry to support clinical research sponsored by the HSC and academia. After we have received comments on the draft, we will also develop a tri-partite agreement for situations when a university is acting as a co- or joint-sponsor.
Development
The mIISA has been developed by the R&D Forum Contracts Group, who are NHS/HSC 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 development of the Investigator Initiated Study Agreement template supports the government’s commitment to making it easier to set up clinical research in the HSC through the recovery, resilience and growth programme, and its response to Lord O’Shaughnessy’s review into the set-up of commercial clinical research.
Feedback
Read the document here model Investigator Initiated Study Agreement DRAFT. Send your comments by email to research.agreements@hra.nhs.uk by no later than 9am on 3 June 2024. If you need to make detailed comments, please include these in tracked changes on the Investigator Initiated Study Agreement and attach this to your email response.
Assistance
For assistance with queries relating to model template agreements, contract drafting and negotiation for clinical trials or collaboration projects in research development and innovation, please contact ResearchContracts@innovations.hscni.net.