Office of Research Oversight

Institutional Review Board (IRB) Registration Requirement

U.S. Department of Veterans Affairs (VA) medical facilities that operate internal VA Institutional Review Boards (IRBs) must obtain and maintain IRB Registration from the Health and Human Services (HHS) Office of Human Research Protection (OHRP) for each IRB operated by the facility.  VA medical facilities must maintain, or have readily available access to, accurate up-to-date rosters for all IRB's designated on a VA medical facility's Federal Wide Assurance (FWA).

IRB Registration Requirement

A registration and any update/renewal are good for three years from the date of acceptance by OHRP and can be updated/renewed at any time.  A registration update must be made:

• To update within 90 days after changes regarding the contact person who provided the IRB registration information or the IRB chairperson.
• To register any additional IRB before it is designated under an FWA and reviews research conducted or supported by HHS.
• If an FDA-regulated IRB decides to review additional types of FDA-regulated products (e.g., to review device studies if it only reviewed drug studies previously) or to discontinue reviewing clinical investigations regulated by FDA, it must report this within 30 days of the change.
• An institution's or organization's decision to disband a registered IRB that is operating must be reported in writing within 30 days after permanent cessation of the IRB's review of HHS-conducted or — supported research.

The Veterans Health Administration (VHA) requires that a membership roster for all IRB(s) required by (VHA) Directive 1058.03 to be designated on the VA medical facility’s FWA must be submitted to the VHA Office of Research Oversight (ORO) FWA staff at the time of the IRB’s designation as an IRB of Record on the FWA.  The previous requirement for VA medical facilities to report IRB roster changes to the VHA Office of Research Oversight (ORO) has been eliminated.  Assurance and IRB registration requirements are also found in VHA Directive 1058.03 Assurance of Protection for Human Subjects in Research.

Study sponsors may ask for documentation of IRB registration during monitoring visits.  Most research offices maintain copies of IRB Registration updates.  Proof of registration can also be shown on the HHS-OHRP website https://ohrp.cit.nih.gov/search//irbsearch.aspx?styp=bsc.

New IRB Registration

The Institution that operates the IRB is responsible for its registration.  Prior to initiating the IRB Registration process, VA sites should be familiar with VHA Directive 1058.03 Assurance of Protection for Human Subjects in Research.

To Register a New IRB the facility must have received permission in writing form ORO and ORD:

1.  Once your facility has approval in writing from ORO and ORD, 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 orofwa@va.gov for instructions.

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 HHS-OHRP (i.e., change in contact person who provided the IRB registration information, or the IRB chairperson), VHA Directive 1058.03 requires that changes be submitted within 90 days of a change.  The IRB Registration must be renewed every 3 years.

1.  Go to the following website: https://ohrp.cit.nih.gov/efile/IrbRnwStart.aspx

2.  Select I NEED ELECTRONIC SUBMISSION NUMBER.

3.  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.

4.  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 descriptive information on your Facility's FDA research must be reviewed and updated.

5.  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.

6.  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.

7.  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, and the ORD Record Control Schedule (RCS) requires membership rosters be kept for 6 years (RCS 10-1 8300.8§b).  HHS-OHRP does not maintain past submissions in their database.

Note that the requirement for all IRBs used by a VA medical facility to be designated on the VA medical facility's FWA has been changed.  Only IRBs that are operated by the VA medical facility must be designated or, in the absence of an IRB operated by the VA medical facility, only the primary external IRB relied upon must be designated such as the VA medical facility academic affiliate IRB.

Please make sure that you can receive messages from OHRPElectronicSubmissionsSystem@mail.nih.gov.