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OHRP Guidance – FWA Instructions – U.S. Institutions
For federally-conducted or –supported research covered by the FWA, the department or agency that conducts or supports the research retains final authority for determining whether the Institution complies with the Terms of Assurance. If HHS receives an allegation or indication of noncompliance related to human subjects research that is covered by the FWA and is conducted or supported solely by a Common Rule department or agency other than HHS, HHS will refer the matter to the other department or agency for review and action as appropriate. Please note that if an institution voluntarily extends the Common Rule or the Common Rule and the HHS subparts (B, C, and D) to all research regardless of support, OHRP will have the authority to ensure that the institution complies with this commitment for all research to which the FWA applies that is not federally-conducted or –supported.
ITEM #5 - Designation of Institutional Review Boards (IRBs)
Designate your institution’s Institutional Review Boards (IRBs) of record for this Assurance. You must indicate at least one IRB in this section. Please ensure that all designated IRBs are registered, or are in the process of registering, with OHRP prior to submitting an FWA form to OHRP. OHRP does not take action on an FWA form until at least one of the designated IRBs is registered and assigned an IRB Registration number. If the registration of the IRB is in process when you submit your FWA, OHRP will insert the IRB Registration number. Any IRB relied upon by the institution for review of human subjects research to which the FWA applies must be registered with HHS and must be designated under the institution’s FWA. An FWA may be updated at any time to designate additional IRBs.
To determine if an IRB is registered with OHRP, you should go to the OHRP website at http://ohrp.cit.nih.gov/search/asearch.asp#ASUR and search for it. If an IRB(s) needs to be registered, go to the IRB Registration materials on the OHRP website at http://www.hhs.gov/ohrp/assurances/.
List on the FWA form the IRB Registration number for each designated IRB [not the IRB Organization number (IORG number)] and the name of the IRB(s) as registered on this website.
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