Update and Renewal of an IRB or IEC Registration

Whenever there is a change in information on file with the Office for Human Research Protections (OHRP) regarding your Institutional Review Board (IRB)/Independent Ethics Committee (IEC) Registration, an update to the registration must be submitted to OHRP. There are two ways to update your IRB/IEC Registration: 1) a complete update and 2) a limited update, as described below.

Renewal of your IRB/IEC Registration is required at the end of the 3-year effective period. Any complete update or renewal that is submitted to, and approved by, OHRP begins a new 3-year effective period.

If your IRB Organization already has an IRB(s) registered with OHRP and you are creating or adding a new IRB, complete the IRB/IEC Registration form as an update. However, in this situation your filing of a new IRB must be made clear to OHRP. Therefore, please attach a brief note clearly indicating that the update to your IRB Organization is providing a filing of the new IRB and the new total of IRBs operated by your organization.

The electronic form may not be used at this time to update or renew an IRB. Institutions that have already registered an IRB or been assigned an IORG number by OHRP (this includes all MPA institutions) must update or renew their IRB Registration by submitting a hard copy of the completed form.

The current IRB/IEC Registration form (click below) should be used when submitting an update or renewal to OHRP.

IRB REGISTRATION INSTRUCTIONS
SAMPLE IRB REGISTRATION DOCUMENT - Rich Text Format(RTF)
SAMPLE IRB REGISTRATION DOCUMENT - HyperText Markup Language Format (HTML)

• Complete Update or Renewal
  
  

  In the upper right-hand corner, indicate by an [x] that this IRB/IEC Registration is an "Update or Renewal", and provide your IRB Organization (IORG) Number.

Type or print the full legal name of your organization and address in Item #1 and proceed in completing all items. With a complete update or renewal, please attach a short note indicating which item(s) was updated in your registration.

If you choose to submit an update or renewal to your IRB/IEC Registration with the form completely filled out, the expiration date of your registration will be set for 3 years from OHRP's processing of your submission.

• Limited Update
  
  

  In the upper right-hand corner, indicate by an [x] that this IRB/IEC Registration is an "Update or Renewal", and provide your IRB Organization (IORG) Number.

  Type or print the full legal name of your organization and address in Item #1. Then proceed to complete only the fields which have been updated. Please attach a short note indicating that the item(s) completed is the only change(s) made since your last registration filing.

  If you choose to submit an update to your IRB/IEC Registration with only the portions of the form completed with items that were updated, the expiration date of your organization's IRB/IEC registration will remain the same.

Submitting an Update or Renewal of the IRB Registration to OHRP

All updates and renewals to IRB/IEC Registrations may be sent via fax (301) 402-0438, regular mail, express mail, or hand delivery to OHRP at:

Division of Policy and Assurances
Office for Human Research Protections
The Tower Building
1101 Wootton Parkway, Suite 200
Rockville, MD 20852

If you have any questions, please do not hesitate to contact the Division of Policy and Assurances, OHRP, at (301) 496-7005 or within the U.S., 1-866-447-4777.

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