What are the requirements of NIH's sIRB policy effective January 25, 2018?
The NIH policy requires that all domestic sites participating in multi-site studies involving non-exempt human subjects research funded by NIH use a single Institutional Review Board (sIRB).
What is the NIH definition of "multi-site research"?
NIH defines a multi-site study as one that uses the same protocol to conduct human subjects research at more than one site. A site is considered to be conducting human subjects research if it is "engaged" in the research. In general, an institution is engaged in research when:
For additional help determining if a site is engaged in human subjects research, including limited exceptions to the above examples, see Engagement in Human Subjects Research Worksheet.
If you are unsure whether or not your NIH study qualifies as multi-site research, please contact the NYU IRB Office at email@example.com or (212)998-4808.
What to do for NIH multi-site studies when...
NYU is the Lead Site
When NYU is designated as the Lead Site, it will be using the BRANY IRB, not the NYU IRB, as the sIRB.
Please see the NYU OSP Wiki for instructions on budgeting for the cost of using BRANY IRB as the sIRB and for guidance on the other information to include in your NIH proposal regarding sIRB.
NYU is a Participating Site
When NYU is designated as a Participating Site, the Lead Institution will determine the single IRB of record.
Please see the NYU OSP Wiki for instructions on budgeting for the cost of sIRB and for guidance on the other information to include in your NIH proposal regarding sIRB.