University Safety and Assurances

Steps to Submitting a Study for Review


To view a flowchart of the review process  click here.

To register for "Introduction to the UWM IRB" training session click here to access our training page and scroll down to the "User Guides and Training Information" section.

 

1. Determine if your study involves Human Subjects Research and if UWM is engaged.  If you are unsure, please see the Determination of UWM IRB Submission Form.

**Note: If your study involves activities occurring at or in partnership with another institution with their own IRB or research review process please contact the IRB office before preparing any paperwork to determine the most efficient way to move forward with study review.  (see the Pre-submission section of the Forms and Templates page of our website for more information)

2.

Complete Human Subjects Training. All PIs and Student PIs are required to complete CITI training. The IRB tracks completions.

3. Understand the IRB's Guidelines and Procedures.   
4.

Studies being reviewed under Exempt and Expedited status may be submitted at any time. The turnaround time for:

  • Exempt submissions are approximately 2-3 days;
  • Expedited submissions are approximately 2 weeks; and
  • Full Board  must follow the deadlines for submission based on when the IRB meeting dates occur.
5.

All IRB submissions must be submitted through the IRBManager. User accounts, user guides, and registering for training sessions can be done here: http://www4.uwm.edu/usa/irb/researchers/irbmanager.cfm

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.

7. Plan ahead as there are multiple steps to the IRB process. The basic steps are outlined below:
    1. Complete a new study xform in IRBManager (click here to see a PDF of the form) and;
    2. Attach all supporting documents (e.g., IRBManager Protocol Form, Consent Form(s), data collection instruments, questionnaires, advertisements, etc.).
    3. Only UWM faculty or staff may serve as the Principal Investigator (PI) on the study. If someone other than the PI submits through IRBManager, the PI listed on the study will receive a notice requiring them to log in, review the submission, and sign-off on the form which will "submit" the study to the IRB.
    4. The IRB office will review your submission for completeness and will either: (a) request revisions, or (b) forward the submission for IRB member(s) review.
    5. 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 but by designated IRB reviewers.
    6. You may be required to revise your submission based on the IRB member's review.
    7. After the study meets the approval criteria, you will receive a letter "Approval" via email. Only after you have received a letter of approval can you begin your research study.
8. If your study currently has IRB approval, keep track of the expiration date of IRB approval. Your study must be reviewed by the IRB before the expiration date, so allow adequate time for submission, review, and approval. The recommend submission due date is no later than three weeks before the date of expiration.