Research

MRC policy on the UK health departments' research governance framework

Key facts about the UK policy framework

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).

The 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 the 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

The MRC does not accept sponsorship responsibilities under the UK policy framework for all of the research that it funds. The MRC 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.

The MRC 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 MRC 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 unit / institute is able to exercise the sponsor’s duties.

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

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

Requirements for MRC unit / institute staff

The MRC 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 units / institutes. In these cases, the MRC will have assessed the quality of the research and the risks to the MRC.

Directors of MRC units / institutes are authorised to accept sponsorship responsibilities on the MRC’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.

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

  • Another organisation in not better placed to undertake the sponsor’s duties.
  • One or more MRC 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 unit / institute is able to exercise the sponsor’s duties.

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

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

Directors of MRC units / institutes must ensure that there is clear and systematic documentation of all projects for which the unit / 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 units / 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.

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

Contact

MRC Regulatory Support Centre info@rsc.mrc.ac.uk