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In January 2015 the HRA sought comment on a revised model Non-Commercial Agreement (mNCA)
The original mNCA was released in 2008. It was intended to be used to agree the relationship between, and the responsibilities of, non-commercial sponsors and their research sites in relation to specific studies. The body of the agreement was written for use without modification, whereas the schedules could be tailored to reflect study specifics. Use of the template thereby ensured compliance with applicable UK law and institutional arrangements whilst minimising the review required at site.
Although the mNCA has achieved wide acceptance from NHS sites, a large number of non-commercial sponsors retained their own templates whilst others adopted the mNCA with modifications, requiring sites to undertake additional review. Against this background, and aware that the research landscape has moved on since 2008, we worked with a broad range of partners to revise and update the mNCA.
The review commenced in mid-2013 with a survey of Registered Clinical Trials Units (CTUs). This identified the following main reasons for sponsors not using the unmodified mNCA:
- Inappropriate indemnity and liability clauses for non-NHS sponsors (including a lack of reciprocal indemnity)
- Inability to reflect funding terms and conditions of third-party funders (including industry and the NIHR), particularly regarding indemnities and intellectual property
- Inability to reflect common co-sponsor arrangements
- Lack of material transfer clauses and other additional site obligations (giving rise to additional material transfer agreements, etc. even in cases where the mNCA was used).
In October 2013 we established a small working group with the intention of addressing these key points in a redrafted template. Their outputs were taken to a wider group of contracting experts from research-active University and NHS institutions in March 2014, followed by additional consultation through to October 2014. Comments were collated and a final meeting held in January 2015 to finalise the current draft.
The draft we consulted on addressed the concerns most frequently raised by sponsors, in that it allows for single sponsor (NHS or University), joint-sponsor and co-sponsorship arrangements to be reflected, through the use of variant clauses without deviation from the template.
It also ensures that indemnity arrangements are appropriately described and (where appropriate) reciprocal.
Other clauses allow for funder conditions to be acknowledged without modification.
Material transfer clauses have been added and the schedule of responsibilities revised to aid clarity for all parties. Other minor changes have been made in response to feedback.
Comment was invited from 12 January to 3 February 2015 from all interested parties, particularly those responsible either for issuing agreements on behalf of non-commercial sponsors or signing agreements for NHS research sites.