Step-by-Step New Study Submission Instructions

Steps to Submitting a Study for Review

Click here for more information about the new IRB Application Form in I-Manager.

Click here to register for an in-person training session.

1. Determine if your study involves Human Subjects Research and if UWM is engaged. If you know that your study involves Human Subjects Research, then move to step 2. If you aren’t sure, please see the “Do I need to Submit to the IRB” page for more guidance.

**Note: If you’re working with a researcher from another institution, or conducting research at another institution, please contact the IRB office before preparing any paperwork (see the IRB Deferral Request Forms page and our guidance document on working with multiple IRBs).

2. Complete Human Subjects Protection Training (CITI). All PIs and Student PIs are required to complete CITI training. If you completed training at another institution, please include a copy of your completion certificate when you submit your study.

3. Understand the IRB’s Guidelines and Procedures.

4. Studies being reviewed under Exempt and Expedited status may be submitted at any time. Typical turnaround times:

Exempt submissions are reviewed by IRB office staff. You will receive either an approval letter or request for revisions within approximately 2-3 weeks, although this may take longer during our busiest times (usually Mar-Apr and Oct-Nov). Allow a minimum of 3-4 weeks total.
Expedited submissions are sent to one or more IRB members for review. You will receive either an approval letter or request for revisions within approximately 4 weeks, although this may take longer during our busiest times (Mar-Apr and Oct-Nov). Allow a minimum of 5-6 weeks total.
Full Board submissions are reviewed at the monthly IRB meeting. Click here for submission deadlines.

5. All IRB submissions must be submitted through I-Manager. To create an account, log in with your PantherID. An account will automatically be created.

6. If your study involves other sites (e.g., recruiting from Milwaukee Public Schools, accessing medical records from Froedtert, using imaging equipment from Aurora, etc.), make sure you are aware of any additional IRB’s or institutional policies beyond that of UWM’s IRB. See note under Step 1 above.

7. Plan ahead! There are multiple steps to the IRB process. The basic steps are outlined below:

    • Start an IRB Application xForm in I-Manager (click here to see a PDF of the form).
      • All application questions are shown in the PDF. However, there is programming within the form, so many questions will appear only if you answer earlier questions a certain way when you’re completing the form in I-Manager.
    • Answer the questions within the IRB Application xForm.
    • Attach all supporting documents to the xForm (e.g. Consent Form(s), data collection instruments, questionnaires, advertisements, recruitment scripts, etc.).
      • Rule of thumb: If a participant will see or hear it, submit it.
    • Only UWM faculty or staff may serve as the Principal Investigator (PI) on the study. If a student, research assistant, etc., submits a study in I-Manager, the study will first be routed to the PI. The PI must log in, review the submission, and electronically sign the form. Then the study will go to the IRB office for review.
    • The IRB office will review your submission for completeness and determine the review category. The office will either: (a) request revisions, or (b) send the study to an IRB member for review. Check the IRB’s homepage for current estimated turnaround times for IRB office reviews.
    • Submissions requiring Full Board review will be placed on the next scheduled meeting based on submission deadlines.
    • Exempt and Expedited studies are not reviewed by the Full Board; IRB staff and members review these as they are submitted.
    • The IRB office will notify you of revisions/clarifications requested by the reviewers.
    • Once the requested revisions have been satisfactorily addressed, you will receive an approval letter via email. You cannot begin your research (including recruitment, scheduling interviews, etc.) until you receive the approval letter.

8. If your study currently has IRB approval, keep track of the expiration date. You will receive automated reminders as your expiration date approaches. These reminders will include isntructions for keeping your study open or closing it. If a continuing review is required, submit a continuing review no later than three weeks before the expiration date. Your study must be reviewed by the IRB before the expiration date, so this allows adequate time for continuing review submission, review, and approval.