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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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