Overview

The UCSD IRB has five administrative determinations it can make. These include determinations that a study is Not Human Subjects Research (NHSR), a study is Exempt, UCSD is not engaged in the human subjects research, acknowledging requests to rely on an external IRB, and Indefinite Plans/Delayed Onset which is appropriate for Just-In-Time (JIT) requests. Read on to see the steps to requesting each type of determination in Kuali IRB.

Steps to Take

1. Start by logging into Kuali IRB

2. Start a new protocol by clicking “+ New Protocol” (blue box below) in the upper right hand corner of the screen. Select “IRB” (red box below) from the drop down menu.

3. Complete the first page by filling out the study/project title and PI information (orange box below).

4. Click “Next” (green box below)

6. On the next page, under “Submission Type” select “Administrative Determination or Registration” (purple box below)

7. Then under “Submission for Administrative Determination or Registration” select one of the following depending on which type of application you want to submit: (orange box below)

• For NHSR Determinations select “Activity Not Human Subjects Research”
• For Exempt Studies select “Human Subjects Research – Exempt Registration” 
• For UCSD Not Engaged determinations select “UCSD Not Engaged in Research” 
• For requests to have an external IRB review a study select "Request to Rely on non-UCSD IRB"
• For Indefinite Plans/Delayed Onset determinations select “Indefinite Plans/Delayed Onset (IPDO)” 

8. Complete the rest of the questions on this page. Then click “Next” (green box below)

9. Complete the remainder of the application. Upload any requested documents into the Supporting Information section of Kuali. 

10. What to do next will depend on the type of application you've completed:

• For exempt studies, requests to rely on an external IRB, or Indefinite Plans/Delayed Onset determinations, click “Submit”
• For NHSR or Not Engaged determination, once the form is complete it will tell you whether the project is Not Human Subjects Research or Not        Engaged depending on the application type you selected. If you don’t need a formal determination from the IRB, you can click “Print” to save an unofficial copy of this determination for your records. If you do need an official determination, click “Submit” and OIA will review the submission and issue a formal determination.