IRB Office Preliminary Determinations for MPH and Other Degree Students
All student-initiated projects must have a preliminary review by the IRB Office to determine whether they are human subjects research requiring IRB oversight unless the JHSPH PI is adding you as a student investigator to an existing, JHSPH IRB-approved study.
- If your student project falls within the general scope and aims of an existing, active, JHSPH IRB-approved study, the PI for that study must submit an Administrative Amendment Application through the PHIRST system to add you as a student investigator to the study team. You will need to submit evidence that you have completed human subjects research (HSR) ethics training (and HIPAA or GCP training, if needed) through the PHIRST system as part of the PHIRST registration process.
All other students must submit an IRB Office Determination Request Form to the IRB Office even if you have IRB approval for your project from another institution’s IRB.
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 from IRB review
- Non-exempt HSR requiring 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 JHSPH IRB may consider entering into a reliance agreement deferring JHU review responsibilities to that external institution’s IRB.
- 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 JHSPH IRB may accept the Exempt determination made by the external U.S. research institution’s IRB.
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. Please complete the tool for guidance about the process.
- Whether or not you complete the tool, you must submit an IRB Office Determination Request Form to obtain documentation from the IRB about the determination outcome. There are two types of determination forms. Please select the one that best describes your project.
- If you are using secondary data for analysis, complete the IRB Office Determination Request Form for Secondary Data Analysis in collaboration with your advisor and submit it to the JHSPH IRB Office e-mail address firstname.lastname@example.org. Be sure to include your advisor in your e-mail submission.
- If you are collecting primary new data, complete the IRB Office Determination Request Form for Primary Data Collection in collaboration with your advisor and submit it to the JHSPH IRB Office e-mail address email@example.com. Be sure to include your advisor in your e-mail submission.
The IRB Office will review the form and let you and your advisor know whether or not 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.