NEW FWA
    (institution does not     have an FWA #)

NEW IORG
    (organization does     not have a     registration #)


UPDATE/RENEWAL     FWA (institution has     an assigned FWA #)

UPDATE/RENEWAL     IORG (organization     has an assigned     registration #)



Welcome to the Electronic Submission System for Federalwide Assurances and IRB/IEC Registrations

Office for Human Research Protections (OHRP)

Submission of documents for a new Federalwide Assurance (FWA) or to update/renew an existing FWA may be done using this electronic submission system. Additionally, the system allows an organization to submit documents for registering a new institutional review board/independent ethics committee (IRB/IEC) organization (IORG), as well as for updating/renewing an existing IORG-IRB/IEC registration. Using the electronic submission system will expedite processing by OHRP.

To determine if your institution has an approved FWA or your organization has a registered IRB/IEC(s), please see our website at http://ohrp.cit.nih.gov/search/asearch.asp#ASUR.

Using this web page you can electronically submit:

   1) A new FWA application - A "new" FWA application may
       be submitted to OHRP if:

      a) Your institution has never submitted an FWA to OHRP
           for approval,

      b) Your institution currently holds an approved Multiple
           Project Assurance (MPA), or

      c) Your institution currently holds an approved Cooperative
           Project Assurance (CPA).

   2) A new IORG-IRB/IEC registration - A "new" IORG-
      IRB/IEC registration should be submitted to OHRP when
      your organization has never been assigned an IORG
      number and never registered an IRB/IEC
. If your
      organization has an IRB/IEC registered with OHRP, you
      should use the "update" feature through this electronic
      submission system to make changes or to register an
      additional IRB/IEC(s)
.

   3) An update/renewal to an OHRP-approved FWA - An
      "update/renewal" to an FWA should be submitted when there
      are changes in your institution's assurance information on
      record with OHRP (e.g., change in Signatory Official, addition
      of an IRB/IEC, change is mailing addresses). At a minimum,
      the FWA must be renewed every 3 years.

   4) An update/renewal to an OHRP-registered IRB/IEC -
      An "update/renewal" to your organization's registered IORG-
      IRB/IEC(s) should be submitted when there are changes to
      your organization's registration information (e.g., addition of
      an IRB/IEC(s), new roster of members, a change in IRB
      Chair). At a minimum, an IORG-IRB/IEC registration must
      be renewed every 3 years.

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.

To proceed, please select the appropriate action on the toolbar at the left margin.

 

General regulatory questions re: human subjects research, contact ohrp@osophs.dhhs.gov
Click here for assistance in completing these various documents

© 2005 Office for Human Research Protections. All Rights Reserved.