Summary of the responsibilities of the Principal Investigator (PI)

A single individual must be designated as the Principal Investigator for any research undertaken within your organisation involving NHS patients. This person may well be the lead person for the whole study. Sometimes you will be hosting research that’s happening across multiple sites. In this instance there will be a Chief Investigator who will hold overall responsibility for the study. It is your Principal Investigator’s responsibility to link with the Chief Investigator.

The Principal Investigator is responsible for ensuring the following:

  • The study is run in accordance with the Research Governance Framework Guidelines for Good Research Practice
  • That tasks delegated from the Chief Investigator are completed; it is the responsibility of the Principal Investigator to manage tasks as required within the organisation
  • Maintain and update the number of research participants recruited into the study
  • Compliance of the Research Governance Framework is followed
  • Co-operation in any audit inspection of the project files which could occur
  • All staff adhere to the protocol as approved by the Research Ethics Committee
  • The research complies with the Data Protection Act 1998
  • Reports of any serious adverse events are submitted to the Sponsor
  • That the patient is free to participate in the study and there are no obligations which may restrict participation