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: (1) the student is working with a Principal Investigator (PI) from another institution or (2) the PI is adding you as a student investigator to an existing, 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 to the IRB Office email address at email@example.com an Administrative Amendment Application for Changes to Minor Research to add you as a student investigator to the study team. The PI should include evidence that you have completed human subjects research ethics training and an Investigator Agreement signed by the student.
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)
· Human Subjects Research (HSR) Exempt from IRB review
· Human Subjects Research (HSR) requiring IRB review
To Get Started:
1. If you are a MPH student working on a capstone project, review the MPH Capstone Calendar (2017-2018 - Calendar - Academics - Johns Hopkins Bloomberg School of public Health) on the MPH website (Master of Public Health - Degree Programs - Academics - Johns Hopkins Bloomberg School of Public Health).
2. There is a guidance posted on the IRB Guidance and Policies page called “What needs review by IRB?” The MPH office has converted this guidance into a Survey Monkey program called “IRB Worksheet” which is available to everyone.
3. Complete the IRB Worksheet if you would like to see what the likely outcome may be.
4. Whether or not you complete a worksheet, you will need to complete an IRB Office Determination Request Form. There are two types of determination forms. Select the one that best describes your project.
a. 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.
b. 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.