Welcome to the Electronic Submission System for FWAs and IRB Registrations
Institutions must submit all FWAs, including new FWAs, electronically using the electronic submission system available through the OHRP website at http://ohrp.cit.nih.gov/efile/, unless an institution lacks the ability to do so electronically. If an institution believes it lacks the ability to submit its FWA electronically, it must contact OHRP by telephone or email (see http://www.hhs.gov/ohrp/assurances/contact/index.html) and explain why it was unable to submit its FWA electronically.
This system also allows an institution or organization (IORG) to submit documents for registering a new institutional review board (IRB) and to update or renew an existing IRB registration. Using the electronic system for registration of an IRB that reviews research conducted or supported by the Department of Health and Human Services (HHS) is required unless an institution or organization lacks the ability to register an IRB electronically via this system.
To determine if your institution has an approved FWA, or if your institution or organization has a registered IRB, please see our website at http://ohrp.cit.nih.gov/search/search.aspx.
||This icon indicates that a particular information field must be completed.
||More information displayed in pop-up or new window.
||Delete record button
||This "Note" icon encourages the user to read the displayed information for more clarification.
||This "Warning/Alert" icon is used to alert the user to important information before proceeding.
A new FWA application
A "new" FWA application may be submitted to OHRP if
- your institution has never submitted an FWA to OHRP for approval,
A new IRB registration
A "new" IRB registration should be submitted to OHRP when your institution or organization has never been assigned an IORG number and never registered an IRB. If your institution or organization has an IRB registered with OHRP, you should use the "update/renewal" feature through this electronic submission system to update or renew an existing IRB registration or to register an additional IRB.
An update/renewal to an OHRP-approved FWA
An institution must update its FWA within 90 days after changes occur regarding the legal name of the institution, the Human Protections Administrator, or the Signatory Official. The FWA is effective for 5 years and must be renewed every 5 years, even if no changes have occurred, in order to maintain an active FWA. Any renewal or update that is submitted electronically, and approved by OHRP, begins a new-5-year effective period.
An update/renewal to an OHRP-registered IRB
An "update/renewal" to your institution’s or organization's registered IRB(s) must be submitted within 90 days after changes occur regarding the contact person who provided the IRB registration information or the IRB chairperson. 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. An IRB registration also should be updated when there are changes to the IRB membership roster. At a minimum, an IRB registration must be renewed every 3 years.
To begin your electronic submission, please select the appropriate tab menu at the top of this page.
Note: You may begin entering information for an electronic submission and then find you are not ready to submit it to OHRP for review. In this case, you may save the data entered and return at a later time to complete the submission.