The named Chief Investigator (CI) takes responsibility for the conduct of the proposed research in the UK. The HRA’s policy is that the named CI should normally be a researcher who is professionally based in the UK, so that he / she is able to supervise the research effectively in the UK setting and is readily available to communicate with the Research Ethics Committee (REC) and other review bodies during the application process and, where necessary, during the conduct of the research. The appointment of a UK-based CI for the UK arm of the study need not conflict with the overriding responsibility of the coordinating investigator for the study as a whole. The UK-based CI will remain accountable to the coordinating investigator. The REC may allow a person based outside the UK to act as CI in exceptional circumstances; for example, where an overseas researcher is undertaking a clinical or academic placement in the UK, or a UK researcher will be based overseas during part of the study. The REC will require assurances about the arrangements for supervising the research when the CI is out of the UK.
Who can Act as the Chief Investigator in a Clinical Trial of an Investigational Medicinal Product (CTIMP) taking place in the UK?
The Health Research Authority (HRA) and the Medicines and Healthcare products Regulatory Agency (MHRA) have collaborated to produce a guidance paper to set out who can act as the CI for CTIMPs taking place in the UK. The document includes a definition of the term ‘Authorised Health Professional’ and examples of which professions this term would apply to.