What are the requirements of the Common Rule's cooperative research single IRB requirement?

The Common Rule requires that domestic institutions engaged in federally funded, non-exempt, cooperative human subjects research use a single Institutional Review Board (sIRB).

The following research is not subject to this provision:
(i) Cooperative research for which more than single IRB review is required by law (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe); or
(ii) Research for which any Federal department or agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate for the particular context.

What is the Common Rule's definition of "cooperative research"?

Cooperative research projects are those that involve more than one institution. An institution is considered to be involved in 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 a Common Rule agency 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. (Examples include administering surveys or conducting interviews)
  4. Its employees or agents obtain informed consent of human subjects for the research.
  5. Its employees or agents obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens for research purposes.

For additional help determining if an institution 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 federally funded grant qualifies as cooperative research, please contact the NYU IRB Office at ask.humansubjects@nyu.edu or (212)998-4808.

What to do for federally funded cooperative research studies when...

NYU is the Lead Site

In most cases, when NYU is designated as the lead site, it will serve as the single IRB, with the participating sites relying on it. Some exceptions to this arrangement include studies that fall under FDA regulations or that require certain medical expertise.

Once an agency notifies you that it intends to fund a proposal for cooperative research, email the NYU IRB immediately at ask.humansubjects@nyu.edu so it can determine the appropriate single IRB and initiate contact with the other institutions’ IRB. Include the Cayuse SP proposal number and names of all other engaged sites in the email.

NYU is a Participating Site

When NYU is designated as a participating site, the lead site will determine the single IRB of record.

Once the lead site initiates the request for single IRB review, email the NYU IRB at ask.humansubjects@nyu.edu. Include the Cayuse SP proposal number and contact information for the single IRB.