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Update and Renewal of an IORG-IRB/IEC Registration

Version Date 06/06/2005

Whenever there is a change in information on file with the Office for Human Research Protections (OHRP) regarding your Institutional Review Board/Independent Ethics Committee (IRB/IEC) organization (IORG) registration(s), an update to the registration(s) must be submitted to OHRP. Your IORG-IRB/IEC registration(s) must be renewed at least every 3 years.

LIST OF APPROVED ASSURANCES AND REGISTERED IRBs/IECs
(http://ohrp.cit.nih.gov/search/asearch.asp#ASUR)

Tracking the Status of an IORG-IRB/IEC Registration Submission

Once you have submitted an update or renewal to an IORG-IRB/IEC registration, you may track the progress of your document until the update or renewal is processed. All registered IORG-IRBs/IECs, with their expiration date, are listed on the OHRP website at http://ohrp.cit.nih.gov/search/asearch.asp#ASUR.

Methods for Submitting an Update or Renewal to an IORG-IRB/IEC

There are two methods for submitting an update or renewal to an IORG-IRB/IEC registration to OHRP:

1) electronic submission, or 2) hard copy submission.

*NOTE:

1. Changes in the legal name of the organization registering the IRB/IEC must be accompanied with a letter from the IORG-IRB/IEC Head Official explaining the details leading to the change (e.g., acquisition, change in legal organization, merger, etc.).

2. When an IRB/IEC is being deactivated/disbanded, a letter should be sent to OHRP signed by the Head Official of the IORG-IRB/IEC or the Signatory Official of the FWA (if the IRB/IEC is internal to an FWA institution). The letter should state something like “No human subjects research that is conducted or supported by the U.S. Dept of Health and Human Services is active under the IRB/IEC registration being deactivated.”

I. Electronic Submission

When you use the OHRP Electronic Submission System (ESS) to “update” your IORG-IRB/IEC registration, you are really renewing the registration. That is, before submitting the electronic record to OHRP for review and processing, you are responsible for ensuring that the entire IORG-IRB/IEC registration record is complete and accurate. You must have an e-mail address in order to use the OHRP ESS. Submission of documents using the ESS will expedite processing the update/renewal of your IORG-IRB/IEC registration. You will be guided through the electronic submission process at http://ohrp.cit.nih.gov/efile.

II. Hard Copy Submission

There are two types of updates that may be submitted in hard copy: 1) a complete update, or 2) a limited update, as described below. Any complete update submitted to OHRP will be considered a renewal of the IORG-IRB/IEC registration, and when processed, will begin a new 3-year effective period. Limited updates will retain the expiration date assigned.

A. Instructions for Hard Copy Submission of a Complete Update (Renewal) of an IORG-IRB/IEC Registration

In the upper right-hand corner, indicate by an [x] that this IORG-IRB/IEC registration is an "Update or Renewal" and provide your institution's IORG number. Also, if you are registering additional IRB/IECs with this update (renewal), please check the box indicating this action.
Follow the instructions for completing and submitting an IORG-IRB/IEC registration found at http://www.hhs.gov/ohrp/humansubjects/assurance/regirbi.htm. Link to the IORG-IRB/IEC registration form is provided below.
Please submit the IORG-IRB/IEC registration update (renewal) form single-sided. You may fax OR mail the registration to OHRP; however, please do not do both.

FAX: 240-453-8202

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

B. Instructions for Hard Copy Submission of a Limited Update of an IORG-IRB/IEC

In the upper right-hand corner, indicate by an [x] that this IORG-IRB/IEC registration is an "Update or Renewal" and provide your institution's IORG number. Also, if you are registering additional IRB/IECs with this update (renewal), please check the box indicating this action.
Complete paragraph 1. Then complete those sections of the IORG-IRB/IEC registration form where changes are to be made. Follow the instructions for completing and submitting an IORG-IRB/IEC registration found at http://www.hhs.gov/ohrp/humansubjects/assurance/regirbi.htm. Link to the IORG-IRB/IEC registration form is provided below.
Please submit the IORG-IRB/IEC registration update (renewal) form single-sided. You may fax OR mail the registration to OHRP; however, please do not do both.

FAX: 240-453-8202

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

The current IORG-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)

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