Clinical research governance - MRC

Contents

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.

There is a different policy for sponsorship of clinical trials of medicines.

Requirements for MRC-funded research by other organisations

UKRI expects the host institution, the 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.

Sponsorship of clinical research in MRC institutes and requirements for directors

UKRI will accept sponsorship responsibilities under the UK policy framework for clinical research led by UKRI employees at MRC institutes.

Institute directors are authorised to accept sponsorship responsibilities on behalf of UKRI. An MRC institute should not accept sponsorship responsibilities if they rightly belong elsewhere.

There is a different policy for sponsorship under the clinical trials regulations.

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.

Institute directors may agree to co-sponsor clinical research projects with another 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 and accept responsibilities for the design or conduct (or both) 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.

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

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

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.

Naming UKRI as sponsor on ethics committee applications

If the conditions are met, MRC institutes should:

  • name UKRI as the sponsor on Research Ethics Committee applications;
  • 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 and indemnity page.

Contact the MRC Regulatory Support Centre

Email: info@rsc.mrc.ukri.org

Last updated: 6 October 2021

NOTE Council web content is being transitioned to this website – let us know if you have feedback or would like to help us test new developments.