Earlier this month 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, asked for comments on an early draft for a new model Investigator Initiated Study Agreement.

We have already had lots of feedback – thank you to those of you who have been in touch. We’ve also received some questions about the agreement, and wanted to reassure you that this is an early draft and there is still plenty of time to have your say.

The draft model Investigator Initiated Study Agreement has been developed by the R&D Forum Contracts Group to make it easier for NHS/HSC sponsors to contract with commercial organisations which only provide financial or other support such as free products to a research study. It is intended for use when an NHS/HSC investigator has had an idea and the NHS/HSC designs and manages the research themselves, independently of the commercial contributor. It is not designed for use in collaborative research where the NHS/HSC and commercial organisations are partners in designing and/or managing the research together.

Whilst we gratefully receive comments from all stakeholders, the R&D Forum Contracts Group does not have any commercial representatives so we intend to arrange a focus group to allow for more detailed engagement and would welcome any expressions of interest from commercial organisations to be involved. We’ll circulate more information through HRA Now and our website when this is arranged. We are particularly looking for input into the intellectual property clauses and how intellectual property rights can be shared equitably given the different levels of input provided by the NHS/HSC and commercial organisations into research.

We have heard from some of you that you would value more time to consider the early draft, discuss with colleagues and respond. The new extended deadline for receipt of comments is 9am on Monday 3 June 2024.

This is just the start of our engagement with you on the template. We want to make sure that the agreement works for all parties and, as well as comments via email and the focus group mentioned above, there will be other opportunities to provide feedback as we work towards a final draft.