Clinical research governance

Contents

Overview

Guidance and requirements for researchers conducting clinical research funded by the Medical Research Council (MRC).

Approvals for research

For research involving human participants, the research organisation must demonstrate to MRC on request that required approvals are in place or were in place before the trial started.

Approvals could be, for example:

  • regulatory authorisations, such as clinical trials authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA)
  • favourable opinion from the research ethics committee and Health Research Authority
  • NHS or Health and Social Care Northern Ireland Research and Development.

In addition, the chief investigator must notify MRC if a regulator or a research ethics committee requires amendments that substantially affect the research question, methodology or costs to the extent that the project is no longer the same as that approved for funding by MRC.

MRC does not require:

  • permissions to be in place when an application for funding is submitted to MRC
  • to be routinely sent copies of evidence of submissions, permissions and amendments
  • to be routinely notified of changes to the protocol requested by MHRA or research ethics committees unless they substantially change the research project approved for funding by MRC.

In cases where the research is especially sensitive, MRC may ask the principal investigator for evidence of required approvals before releasing funding.

Last updated: 31 March 2022

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