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103.24a Organization Policy on Principal Investigator Responsibilities

September 2020

The Organization requires that individuals who will serve as principal investigators (PIs) of human subjects research (HSR) studies meet certain criteria.  The following may serve as PIs of HSR studies reviewed by the JHM IRBs:

  • Faculty members of The Johns Hopkins University *;
  • Designated senior staff members of the Johns Hopkins Applied Physics Lab;
  • Registered nurses in the Johns Hopkins Health System (JHHS) who meet the education, work and research experience, and additional requirements set forth by the JHHS Department of Nursing;
  • Non-faculty pharmacists in the Department of Pharmacy at the Johns Hopkins Hospital who meet the criteria agreed upon by the Office of Human Subjects Research (OHSR) and the Department of Pharmacy;
  • Non-faculty physical and occupational therapists in the Department of Physical Medicine and Rehabilitation who meet the criteria agreed upon by the OHSR and the Department of Physical Medicine and Rehabilitation;
  • Senior staff members designated by departmental authorities; and,
  • Properly credentialed clinicians at one of the JHM hospitals as designated by a local Research Review Committee (RRC) or the JHM ACH IRB.

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, Adjunct Professor, Professor Emeritus, Instructor, Research Associate, Lecturer, and Part-Time Faculty.)