September 2020

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 reviewing IRB.
• PIs are responsible for properly training research staff in activities or procedures required for the research’s conduct.
• PIs are responsible for providing the reviewing IRB any with requested information about local requirements, policies, and/or local research context issues.
• PIs are expected to notify the reviewing IRB or EC when local policies that impact IRB or EC review are updated.
• PIs are expected to cooperate in the reviewing IRB’s responsibility for initial and continuing review, record keeping, and reporting; additionally all information requested by the reviewing IRB must be provided in a timely manner.
• PIs are responsible for reporting promptly to the reviewing IRB any proposed changes to the research. A PI cannot implement changes to the research (including changes in the consent document) without prior reviewing IRB approval (except where necessary to eliminate apparent immediate hazards to the participants).
• PIs cannot not enroll participants in research prior to review and approval by the reviewing IRB.

For further explanation of PI responsibilities and requirements when relying on an external IRB, see the JHM IRB document “Statement of PI Responsibilities when Relying on an External IRB.”

(* 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.)