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Policies and Guidance

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

JHU Policy on Enrolling Employees in Human Subjects Policy (GEN010)

JHU Policy on Enrolling Students in Human Subjects Research Policy (GEN011)

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

 

What are the levels of review possible for HSR applications?

                Exempt Determination – 104.01

                Expedited Review – 110.01

                Convened Review – 111.01

What policies apply to the submission and content of research applications?

Conflict of Interest – 103.11

Submission – 103.26

Vulnerable Populations, including Students and Employees – 111.04, 111.08, 111.09, B203, C304, D403

Recruitment – 111.04, 111.1

Informed Consent/Assent Process – 116.01, 116.04, D403

Documentation of Informed Consent – 116.02, 116.04, 116.05, 117.01, D403, SL2

Risk Assessment – 111.10

Protecting Participant Privacy and Data Confidentiality – 111.12

Scientific Review – 111.05

Sample Size – 111.07

Payment to Participants – 111.02

Ancillary Reviews (COI, Biosafety, Radiation, etc.) – 103.10, 103.19, 103.21, 103.22

Data Safety Monitoring – 103.13

Local IRB approvals/permissions – 103.23

What rules apply to IRB reviews and meetings?

IRB members, reviewers, and Chairs – 103.04, 107.01, 107.02, 107.03, 111.11

IRB meeting operations – 103.05, 103.15, 108.01, 109.02

Undue Influence over the JHSPH IRB – 109.04

HSR involving FDA regulated products - FDA 312/812, FDA 50.1

           Drugs – 103.19, 103.19a, 103.20, 103.22

           Devices – 103.27

What other requirements are there in addition to JHSPH IRB initial approval?

Clinicaltrial.gov registration and account management – 103.25

Disclosing Research Lab Test Results – 101.02

IRB monitoring after approval – 109.08

Amendments – 103.09, 109.05

Continuing Review/Progress Reports – 109.06, 109.07

Problem Event Reports

           Unanticipated Problems Posing Risk to Subjects or to Others – 103.06

           Reports of Protocol Non-Compliance and Protocol Deviations – 103.07

           Reports to OHRP, FDA, Sponsors – 103.08

Complaints from Participants/Others – 109.03

Suspension/Termination – 113.01

Record Retention – 115.02

Faculty Departures – 103.14

Can the Institution disapprove HSR approved by the JHSPH IRB? – 112.01

What rules apply to the IRB Office? – 107.01, 115.01, SL1

Can the JHSPH IRB enter into Reliance Agreements with other Institutions? 103.03

                Reliance Agreements (sIRB and non sIRB) – 114.02