|
Update and Renewal of an IORG-IRB/IEC RegistrationVersion 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 Tracking the Status of an IORG-IRB/IEC Registration SubmissionOnce 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: *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
FAX:� 240-453-8202
Division of Policy and Assurances B.� Instructions for Hard Copy Submission of a Limited Update of an IORG-IRB/IEC
FAX:� 240-453-8202
Division of Policy and Assurances The current IORG-IRB/IEC registration form (click below) should be used when submitting an update or renewal to OHRP. IRB REGISTRATION INSTRUCTIONS |