NOT-OD-20-058 informs the research community that effective January 20, 2020, Career Development (K) and Fellowship (F) awards that obtain initial IRB approval on or after January 20, 2020 are subject to the sIRB policy.
- Not included are studies for which NIH approved an exception from the sIRB policy before January 20, 2020. Exempted studies conducted under ongoing, non-competing awards (with receipt dates prior to January 25, 2018) that received an initial IRB approval before January 20, 2020 will continue to use multiple IRBs for the duration of the exemption but no later than the next competing award.
- K and F applications submitted on or after January 20, 2020 must follow revised instructions to complete the PHS Human Subjects and Clinical Trials Information form, Section 3.2 is this a multi-site study that will use the same protocol to conduct non-exempt human subjects research at more than one site?
- K and F applications with studies approved on or after January 20, 2020 must select either “Yes” or “No” to indicate if it is a multi-site study that will use the same protocol to conduct non-exempt human subjects research at more than one domestic site. “N/A” may not be used.
Please direct questions regarding the additional policy guidance to [email protected].
Questions regarding application forms and instructions should be directed to [email protected].