Planning & Funding: Discuss sponsorship and agreements

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Introduction

Sponsorship is required for all studies in the NHS that are within the scope of the UK policy framework for health and social care research (see 1st resource). It may take some time to secure a sponsor(s), so it’s a good idea to start early in the planning process.

The 2nd resource below was developed by the NHS R&D Forum to outline the principles of sponsorship, and to answer some frequently asked questions about sponsorship.

For studies where more than one party has sponsorship responsibilities, collaborative agreements outlining the role and responsibilities of each party should be developed. For organisations that regularly collaborate, it may be possible to develop a generic framework agreement that can be tailored to specific arrangements for individual studies. Model Agreements have also been developed (available from the UKCRC website - 3rd resource below) which are intended for use in unmodified format by representatives of the NHS and universities.

For multi-centre research, agreements between the sponsor(s) and each centre are needed to ensure local investigators understand their responsibilities and agree indemnity arrangements.  Examples of these agreements are available from the 3rd resource below.

Depending on the study and whether services from external organisations will be required (e.g. sample assays) Service Level Agreements or contracts with these providers will be needed.

For transfer of tissue samples to or from other organisations, certain standards should be followed, these are available in the 4th resource below.  In some cases, a formal Material Transfer Agreement may be required, particularly if there are issues relating to Intellectual Property (see also Transfer of Data/Tissues).

Resources

  • 1. UK policy framework for health and social care research

    The UK policy framework for health and social care research (which replaces the 4 Research Governance Frameworks of England, Wales, Scotland and N. Ireland) is available to download from this site.

    Good practice for specific research projects Date added: 4 September 2007
  • 2. NHS R&D Forum Sponsorship Principles

    NHS R&D Forum document outlining sponsorship principles.

    Good practice for all research Date added: 4 September 2007
  • 3. UKCRC Model agreements

    A series of model agreements drawn up by the UKCRC partners and stakeholders.

    Standard process for all research Date added: 1 May 2009
  • 4. MRC Guidance: Standards for transfer of human tissues

    MRC guidance on transfer of human tissue samples, developed for MRC research units but applicable to all.

    Good practice for tissues Date added: 5 September 2007