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Institutional Review Board

Navigating JHU and JHSPH IRB Human Subjects Research Policies

JHU has authorized the JHSPH IRB to review and approve human subjects research applications conducted by its faculty, students, and staff. Our common objective is to protect human participants and to do so in a way that is compliant with federal, state, and local laws. The JHSPH IRB Policies in support of that effort are numbered to align with the regulatory code provisions of 45 CFR 46. While this structure helps us organize the policies for compliance purposes, it isn’t very user friendly. Please see the topics below to help find the policy number associated with the information you need, then search for that number in the Policy document. In addition, check our IRB website’s Compliance Training page (https://www.jhsph.edu/offices-and-services/institutional-review-board/training/), guidance page (https://www.jhsph.edu/offices-and-services/institutional-review-board/policies-and-guidance/guidance/), HIPAA page (https://www.jhsph.edu/offices-and-services/institutional-review-board/hipaa/), and Reliance Agreement information (https://www.jhsph.edu/offices-and-services/institutional-review-board/reliance-agreements-and-single-irb/).

JHU Policy on IRB Authority

JHSPH IRB Policies 

 

Independent authority of the Institutional Review Board (“IRB”) – 103.01, 103.03, 109.01, 109.04

What are the institutional obligations to support the IRB? – 103.16

Who runs the IRB? – 103.01, 103.18, 109.01

What is “human subjects research” (“HSR”)? – 101.03

Are there activities that are clearly NOT HSR? – 101.04, 102.01, 102.02, 102.03

What does “engaged” in HSR mean? – 101.03

What are the responsibilities of the Principal Investigator (“PI”)? – 103.24, SL2

How are student investigators/post-doctoral trainees managed? – 102.02, 102.03, 103.02

What training is required for investigators and research teams? -103.12