Institutional Review Board (IRB)
The Institution that operates the IRB is responsible for its registration. Prior to intiating the IRB Registration process, VA sites, should be familiar with VHA Handbook 1058.03 Assurance of Protection for Human Subjects in Research.
To Register a New IRB:
1. To begin the process of IRB Registration, go to the following website: http://ohrp.cit.nih.gov/efile/
2. If your VA Facility has NEVER operated an IRB in the past and your facility is establishing an IRB at your VA Facility, select NEW IRB.
3. Upon initial registration your Facility will receive an IRB Organization Number (IORG0000___) and a separate number for each IRB you establish (IRB0000___)
4. If your VA Facility has operated an IRB in the past that was deactivated and your VA Facility wishes to restart the IRB, please contact Priscilla Craig in ORO at 202 266-4572 or firstname.lastname@example.org for instructions.
To Renew/Update the IRB Registration:
An "update/renewal" to the IRB Registration must be submitted when there are changes in your institution's IRB information on record with OHRP (e.g., change in Roster, contact person, Institutional Official, addition/deletion of an IRB, or changes in mailing addresses). VHA Handbook 1058.03 requires that changes be submitted within 30 days of a change. The IRB Registration must be renewed every 3 years.
1. Go to the following website: http://ohrp.cit.nih.gov/efile/.
2. Select IRB on the tab at the top of the screen.
3. Select RENEWAL IRB on the Left side of screen.
4. Select I NEED ELECTRONIC SUBMISSION NUMBER.
5. Follow instructions to obtain a submission number and a password. The submission number and password will be used one time. The password is created each time you update.
6. In July 2009 the Food and Drug Administration (FDA) mandated the filing of the IRB Registration for institutions engaged in FDA-regulated research. Each time the IRB Registration is updated, the information on your Facility’s FDA research must be reviewed and updated.
7. If your VA Facility has no FDA-regulated research at present, please be aware that FDA requires that the FDA related information must be completed on the IRB Registration PRIOR to initiating any FDA regulated research.
8. Make the necessary changes to the IRB Registration. Once all entries are made, please proofread all fields of the form to ensure the accuracy of the data. Your updates will be shown on a summary screen.
9. At the prompt on the summary screen select SAVE AND EXIT.
10. Contact Priscilla Craig via phone or email for review of the submission. After ORO review, you may go back into the system and submit. Click on SUBMIT. You will be prompted to print a copy of your submission for your records. NOTE: FDA has requested copies of past updates on site visits. OHRP does not maintain past submissions in their database.
NOTE: There are no signatures required to update the IRB Registration.
For questions about electronic filing or about the IRB Registration please contact Priscilla rather than OHRP.