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:

  1. It receives an award directly from NIH for the human subjects research (i.e. grantee institutions), even where all activities involving human subjects are carried out by another institution.
  2. Its employees or agents intervene for research purpose with any human subjects of the research by performing invasive or noninvasive procedures or manipulating their environment. (Examples include providing individual or group counseling or psychotherapy and orchestrating environmental events or social interactions)
  3. Its employees or agents interact for research purposes with any human subject of the research.
  4. Its employees or agents obtain informed consent of human subjects for the research.
  5. Its employees or agents obtain for research purposes identifiable private information or identifiable biological specimens.

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 ask.humansubjects@nyu.edu 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.