Clinical research governance - MRC

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MRC policy on the UK policy framework for health and social care research

To ensure that health and social care research in the NHS is conducted to high scientific and ethical standards, the UK policy framework for health and social care research defines broad principles of good research governance. The UK policy framework was released in October 2017 by the Health Research Authority to replace the previous research governance frameworks of England, Wales, Scotland and Northern Ireland.

MRC’s policy on the UK policy framework details our requirements of MRC-funded researchers in universities or other research organisations undertaking work in the NHS or with NHS partners.

These requirements, which focus mainly on research sponsorship, are part of MRC’s terms and conditions for research funding. They are consistent with our policy on sponsorship under the UK Clinical Trials Regulations.

Requirements for MRC-funded research by other organisations

MRC, or more accurately UKRI, does not accept sponsorship responsibilities under the UK policy framework for the research that it funds. UKRI expects the host institution – research organisation – to nominate itself as sponsor or to make alternative arrangements.

All new grant and fellowship applications for clinical research funding must include details of the sponsorship arrangements made by the research organisation.

UKRI may agree to co-sponsor projects with a research organisation under certain circumstances, subject to appropriate agreements and controls, and providing that:

  • another organisation is not better placed to undertake the sponsor’s duties
  • one or more UKRI employees act as principal investigator(s) and accept responsibilities for the design and/or conduct of the study
  • the research proposal has been peer reviewed and approved for funding by the MRC
  • an MRC institute is able to exercise the sponsor’s duties.

Requests by Research Organisations for co-sponsorship with UKRI will be assessed for eligibility on a project-by-project basis.

UKRI will not be a co-sponsor for studentships or other training awards, or other ‘block grant’ awards.

Requirements for MRC institute staff

UKRI is willing to accept the responsibilities of sponsor under the terms of the UK policy framework, for research that is initiated and managed by MRC institutes. In these cases, the MRC will have assessed the quality of the research and the risks to the MRC and UKRI.

Directors of MRC institutes are authorised to accept sponsorship responsibilities on UKRI’s behalf.

Under the UK policy framework sponsorship is project-specific and does not automatically extend to new work which has not been assessed by the MRC. However, it does accommodate reasonable changes within the scope and duration of the approved project or those required by research ethics committees.

MRC institute directors may agree to accept sponsorship responsibilities for other projects managed by MRC institutes, subject to appropriate agreements and controls, providing that:

  • another organisation is not better placed to undertake the sponsor’s duties
  • one or more UKRI employees act as principal investigator(s) and accept responsibilities for the design and/or conduct of the study
  • the research proposal has been peer reviewed and approved for funding by the MRC or by a funder with equivalent assessment standards
  • the MRC institute is able to exercise the sponsor’s duties.

An MRC institute should not accept sponsorship responsibilities if they rightly belong elsewhere.

Directors of MRC institutes must ensure that quality, risk management and monitoring systems are in place.

Directors of MRC institutes must ensure that there is clear and systematic documentation of all projects for which the institute has sponsorship responsibilities, including approvals of the study and any amendments by regulatory authorities and research ethics committees. This information should be immediately available on request.

MRC institutes should have appropriate research governance systems, in which responsibilities are allocated, accepted and carried out within a sound research and project management framework.

Agreements and systems should be in place and documented with NHS organisations and other collaborative or partner organisations, including commercial organisations.

Research Ethics Committee Applications

If the conditions are met, MRC institutes should name UKRI as the sponsor on Research Ethics Committee applications; and provide relevant details for a member of staff within the institute who is responsible for sponsorship (the sponsor representative).

Further guidance on how MRC institutes should implement sponsorship responsibilities can be found on the MRC Regulatory Support Centre’s Sponsorship & indemnity page.

MRC Regulatory Support Centre

Email: info@rsc.mrc.ukri.org

Last updated: 17 August 2021

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