103.24a Organization Policy on Principal Investigator Responsibilities

December 2021

The Organization requires that individuals who will serve as principal investigators (PIs) of human subjects research (HSR) studies meet certain criteria. The IRB retains the final authority to determine if an individual is appropriate to serve in the role of PI.

The following may serve as PIs of HSR studies reviewed by the JHM IRBs:

  • Faculty members of The Johns Hopkins University who are compensated from the institution (including Part Time Faculty)*;
  • Properly credentialed clinicians, employed by a JHM entity
  • The following groups of people may serve as PI if they meet the educational, experience and any additional requirements agreed upon by their departments and the OHSR, and provide a letter of support from an appropriate department representative
    • Designated senior staff members of the Johns Hopkins Applied Physics Lab;
    • Registered nurses or Nurse Practitioners in the Johns Hopkins Health System (JHHS);
    • Non-faculty pharmacists in the Department of Pharmacy at the Johns Hopkins Hospital;
    • Non-faculty physical and occupational therapists in the Department of Physical Medicine and Rehabilitation;
    • Senior staff members designated by departmental authorities

PIs bear ultimate responsibility for the conduct of HSR studies and for the safety of human subjects participating in them. PIs and their study teams must comply with federal, state, and local laws and regulations, Organization policies, and the determinations of the JHM IRBs. PIs who conduct research activities that take place at research sites outside the US must also comply with all local applicable laws and regulations in the country(ies) where the research takes place. PIs are responsible for properly training research staff in activities or procedures required for the research’s conduct.

For further explanation of PI responsibilities and requirements, see the JHM IRB guidance “Investigator Responsibilities.

(*Faculty ranks that may serve as a PI are: Professor, Associate Professor, Assistant Professor, Professor Emeritus, Instructor, Research Associate, Lecturer, and Part-Time Faculty. The listed ranks include any individuals who are at a status of pending appointment at rank.)

Exceptions to the above requirements may be approved by the Vice Dean for Clinical Investigation.