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Update and Renewal of an IORG-IRB RegistrationVersion Date 07/09/2009 Whenever information on file with the Office for Human Research Protections (OHRP) changes regarding the contact person who provided the IRB registration information or the IRB chairperson, an update/renewal to the registration(s) must be submitted within 90 days after the changes occur. The update/renewal function also must be used to register an additional IRB before it is designated under an FWA and reviews research conducted or supported by HHS. In addition, an IRB registration also should be updated when there are changes to the IRB membership roster. At a minimum IORG-IRB registration(s) must be renewed every 3 years. LIST OF APPROVED ASSURANCES AND REGISTERED IRBs Tracking the Status of an IORG-IRB Registration Submission Once you have submitted an update or renewal to an IORG-IRB registration, you may track the progress of your document until the update or renewal is processed.� All registered IORG-IRBs, with their expiration date, are listed on the OHRP website at http://ohrp.cit.nih.gov/search/. Methods for Submitting an Update or Renewal to an IORG-IRB You must update/renew the registration of your institution's or oranization's IRB(s) electronically using the Electronic Submission System (ESS) at http://ohrp.cit.nih.gov/efile/, unless your institution or organization lacks the ability to register its IRB(s) electronically. If an institution or organization lacks the ability to register an IRB electronically, that institution must send the IRB registration information in writing: to OHRP, if the IRB reviews research regulated by OHRP only or reviews research regulated by FDA and OHRP; or, to FDA, if the IRB reviews research regulated by FDA only. See below for information on where to fax or mail written IRB registration information to OHRP and FDA. When using the ESS to "update" your IORG-IRB registration, you are really renewing the registration. That is, before submitting the electronic record to OHRP for review and acceptance , you are responsible for ensuring that the entire IORG-IRB registration record is complete and accurate. You must have an e-mail address in order to use the OHRP ESS. You will be guided through the electronic submission process at http://ohrp.cit.nih.gov/efile. *NOTE: 1. Changes in the legal name of the organization registering the IRB must be accompanied with a letter from the IORG-IRB Head Official explaining the details leading to the change (e.g., acquisition, change in legal organization, merger, etc.). 2. An institution's or organization's decision to disband a registered IRB must be reported in writing within 30 days after permanent cessation of the IRB's review of research. 3. If an IRB decides to review new 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. Written information can be submitted to OHRP or FDA OHRP:
FAX: 240-453-8202 FDA:
The Good Clinical Practice Program (HF-34) Step-by-Step Instructions for Registering an IRB can be accessed at: The current IORG-IRB registration form (click below) should be used when submitting an update or renewal to OHRP. IRB REGISTRATION INSTRUCTIONS |
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