PI Responsibilities

The principal investigator (PI) is responsible for personally conducting and/or supervising the conduct of human-subjects research and for protecting the rights, safety, and welfare of the subjects enrolled in the research.

The Investigator is accountable for regulatory violations resulting from failure to adequately supervise the conduct of the study.

More Specifically, the Principal Investigator Must:

  • Design and implement ethical research, consistent with the principles outlined in the Belmont Report
  • Ensure that all research involving human subjects is submitted to and approved by the IRB before study initiation
  • Ensure that anyone delegated to conduct study-related tasks is qualified and trained appropriately
  • Ensure adequate supervision of any and all co-investigators and study staff
  • Ensure that informed consent is obtained prior to initiating study activities
  • Implement research as it has been approved by the IRB
  • Obtain prior IRB approval before implementing study changes
  • Obtain informed consent/assent in accordance with the IRB approved application
  • Document informed consent/assent as outlined in the IRB approved application
  • Report progress of the approved protocol as often as required by the IRB
  • Report any new information of risks, adverse events, unanticipated problems etc., as outlined in the IRB policies
  • Ensure that a final report is submitted to the IRB when the study is closed or completed
  • Retain research records for a minimum of 7 years (information can be stored off-site)

The investigator should develop a plan for the supervision and oversight of the study. This plan should include the following as applicable:

  • Routine meetings with staff to review trial progress, adverse events, and update staff on any changes to the protocol or other procedures
  • A procedure for the timely correction and documentation of problems identified by study personnel, outside auditors, or other parties involved in the conduct of a study
  • A procedure for documenting or reviewing the performance of delegated tasks in a satisfactory and timely manner (e.g., observation of the performance of selected assessments or independent verification by repeating selected assessments)
  • A procedure for ensuring that the consent process is being conducted in accordance with the IRB-approved protocol and applicable regulations and laws AND that study subjects understand the nature of their participation and the risks
  • A procedure for ensuring that source data are accurate
  • A procedure for ensuring that information in source documents is accurately captured on the case report forms (CRFs)
  • A procedure for dealing with discrepancies identified by staff or outside auditors