Initial Submission

Investigators are responsible for ensuring IRB approval is obtained.

Timing: Investigators must submit and receive approval prior to beginning any research activity.

You cannot begin recruitment or request the written informed consent of any subject to participate before obtaining IRB approval. 21 CFR 812.110; ICH 3.3.6.

Forms
thumbnail_image048.jpg
 
Federal regulations give us various levels of IRB review, depicted
in the image to the left. 

 

 

Online access to the forms can be found below:

Form

Training on Submitting the Form

Not Human Subjects Determination Form

Training, Submitting NHS Form

Exempt Form

We recommend starting with the exempt form to determine if exemptions apply to your study. Based on your answers, you will be alerted if exemptions do not apply to the study and will be forwarded to the next form.

Training, Submitting Exempt Form

Human Subjects Form for Expedited/Full Board Studies

Training, Submitting Expedited or Full Board Study

Initial Submission Frequently Asked Questions

Generally, the earlier the better. Submissions are reviewed on a first-come-first-serve basis. The IRB usually sees an increase in submissions around the beginning of each semester and the beginning of summer session I. Please check our IRB schedule for suggested submission deadlines.

It depends. The complexity of the study and what activities you have planned will determine the IRB review path. Incomplete or inconsistent submissions will cause delays in your review.