New Submission Information for Exempt Reviews
Exempt submissions are submitted in IRBnet and assigned to a committee member for review to ensure the study meets the one or more of the exemption categories defined from the Common Rule, 45 CFR 46. The committee member will either approve the exempt study or request it be resubmitted as an expedited study using the full protocol application. Exempt studies are assigned every Tuesday and Thursday. The turnaround time for exempt submissions is approximately one week from when the submission is assigned to a committee member.
Exempt submissions should include the following:
- Exempt Self-Determination Form
- Exempt Study Participation Sheet
- Description of Project (1-2 pages that summarizes research question, recruitment method, study procedures).
- Any Recruitment Materials
- Any Measurement Tools (surveys, etc.)
- CITI Training Certification for all researchers
To submit an Exempt study in IRBnet, follow these steps:
Step 1: The Faculty Research Advisor / Principal Investigator submits the Exempt Self Determination Form, Study Participant Sheet, and other required documents via IRBNet, with electronic signatures completed by ALL involved researchers.
Please Note: Submissions MUST be made by a Brenau Faculty Member. Applications will NOT be accepted if ALL investigators have not electronically signed the submission. Partially completed IRB applications will NOT be accepted.
Submitted applications must meet the following criteria:
- Each item must be uploaded into the IRBNet Application package as a separate document in its original file format.
- ALL sections on the Exempt Self-Determination Form and Exempt Study Participant Information Sheet must be filled out.
- Must include the contact information for both the Institutional Review Board AND the Faculty Principal Investigator.
- Each researcher/investigator on the project must have or create an IRBNet account linked to Brenau University and upload their CITI Certification under Training and Credentials in their User Profile.
- Brenau’s CITI Policy and Requirements can be reviewed in the Brenau CITI Policy.
- CITI Registration and Certification can be completed at http://www.citiprogram.org.
- When uploading your CITI certification to your IRBNet User Profile:
- Choose “Other” as the Document Type and Enter CITI Training Certification as the Description.
- Make sure you enter the Effective and Expiration Dates.
- Don’t forget to hit “Submit”
- SIGNATURES ARE REQUIRED. Be sure that all applicants (research advisor/principal investigator, and when applicable, co-investigators) have electronically signed the application package before submitting your application for review.
Step 3: Submit your project. Your project will not be assigned for review until you submit.