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Learn about which human subjects protection information may be requested during Just In Time.
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 Pending or out-of-date approvals are not acceptable.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.
Click below to learn more about considerations for human subjects research in the next phase of the grants process:
