After you submit your NIH application and peer review is completed, you may be asked to provide certain information
electronically using the Just-In-Time feature of the eRA Commons found in the
Commons Status section. For more information see: Submit JIT
and eRA Commons.
For studies involving non-exempt human subjects, you must submit the following
Your Institution’s Federalwide Assurance (FWA) Number
The Federalwide Assurance (FWA) is the only type of assurance currently accepted and approved by
the Office of Human Research
Protections (OHRP).
Through the FWA, an institution commits to HHS that it will comply with the requirements in the HHS Protection of
Human Subjects regulations at 45 CFR part 46.
IRB Date
The official notification of IRB review and approval for your research protocol must be
submitted. Pending or out-of-date approvals are not acceptable. *NIH-funded sites in the United States cannot accept
or rely on a non-U.S. IRB.
Protection of Human Subjects Education
Provide certification that all key personnel involved in human subjects research have completed
the
education
requirement in the protection of human subjects. Studies involving exempt human subjects research must also
provide certification education in the protection of human subjects.
Name of the Single IRB of record
Provide the name of the single IRB of record when required to use a single IRB. Providing the
name of the single IRB of record at Just-in-Time submission suffices to fulfill the NIH Policy on the Use of a
Single Institutional Review Board for Multi-Site Research requirement to provide an sIRB plan for NIH grants. Note
that NIH expects the NIH funded domestic sites in a multi-site study to rely on a U.S. sIRB.
Learn more about considerations for human subjects research in the next phase of the grants process