IRB Office Preliminary Determinations for MPH and Other Degree Students | Johns Hopkins

All student-initiated projects must have a preliminary review by the BSPH IRB Office to determine whether they are human subjects research requiring IRB oversight unless: the BSPH PI is adding you as a student investigator to an existing, BSPH IRB-approved study, or the IRB Office determines that the project involves human subjects and we need a new PHIRST application.

To add a student to an existing, active, BSPH IRB-approved study: the PI for that study may add a student investigator to the study team if the student’s project falls within the scope of that study. The PI may submit an Administrative Amendment Application through the PHIRST system to add the student to the study. The student must be registered in PHIRST so the PI can find the student’s name in the PHIRST system.
Students who have IRB approval or an exempt determination from an external, U.S.-based IRB should submit a BSPH IRB Office Determination Request Form to allow the IRB to review the approval/determination and decide whether to rely upon the external IRB’s approval/determination. The BSPH IRB cannot rely upon an approval/exempt determination from an external IRB outside the U.S.
Students conducting research projects (primary data collection and secondary data analysis) outside of an IRB-approved study who are not submitting a new PHIRST application must submit a BSPH IRB Office Student Determination Request Form to the IRB Office email address at bsph.irboffice@jhu.edu to obtain documentation that a PHIRST submission is not needed. The IRB will review the Determination Request Form to determine whether a PHIRST submission is required.

Students may use the IRB Pre-Determination Tool or the IRB guidance flowchart to help guide them through the IRB process.

To Get Started:

If you are a MPH student working on a capstone project, review the MPH Capstone Calendar on the MPH website.
There is a guidance posted on the IRB Guidance and Policies page called “What needs review by IRB?” A Survey Monkey program called “IRB Pre-Determination Tool” is available to everyone to help navigate the decision-making process.
Whether or not you complete the tool, you must submit a BSPH IRB Office Student Determination Request Form to obtain documentation from the IRB about the determination outcome. Please complete the section(s) that best describe your project in collaboration with your advisor and submit it to bsph.irboffice@jhu.edu. Be sure to include your advisor in your email submission.

The IRB Office will review the form and let you and your advisor know whether a new PHIRST application is required. If a new PHIRST application is not required, the IRB Office will provide you and your advisor with formal documentation of its determination. If a PHIRST application is required, the IRB Office will provide guidance and the IRBNav@jh.edu of the IRB Navigator who will offer some assistance with your PHIRST application.

OUTCOME:

The IRB Office could determine the project to be one of the following:

Not Research (NR) or Public Health Practice
Not Human Subjects Research (NHSR)
HSR Exempt and a PHIRST application is required for the Exempt determination.
Non-exempt HSR requiring a PHIRST application and IRB review.
Non-exempt HSR to be conducted at an external U.S. research institution with IRB approval by that institution’s IRB. The research activity must include adequate student supervision. In such cases, the BSPH IRB may consider entering into a reliance agreement deferring JHU review responsibilities to that external institution’s IRB; a PHIRST Reliance application is required.
Exempt HSR with an Exempt determination from an external U.S. research institution’s IRB. The research activity must include adequate student supervision. In such cases, the BSPH IRB may accept the Exempt determination made by the external U.S. research institution’s IRB; a PHIRST Reliance application is required.