Single IRB(sIRB) Fee Schedule

In preparing a research proposal with the OSP staff, researchers are responsible for notifying the OSP team that Montclair will be involved in multi-site non-exempt human subjects research. The OSP team will notify the Office of Research Compliance and Regulatory Programs that a researcher expects to be engaged in human subjects research involving an sIRB. The researcher and OSP will be able to integrate the sIRB fee schedule into direct costs where applicable.

Fees are charged to cover a number of tasks, including but not limited to:

• Coordination, management, and liaison activities with outside institutions for reliance documentation and negotiation of reliance agreements
• The costs associated with the IRB staff time spent screening and reviewing the IRB submission and the associated site materials
• Supporting the committee in their sIRB reviews
• Educating outside researchers on sIRB process and procedures
• Education and support of researchers to enable compliance specific to multi-site research

The single IRB (sIRB) mandate is a set of complementary federal policies that require certain types of federally-funded research that involve multiple institutions to use one IRB to accomplish IRB review and approval for all of the institutions conducting the study/trial. The Single IRB Model allows multiple institutions that conduct the same protocol to cede to a single IRB for review. The NIH Single IRB Policy and Common Rule Cooperative Research Requirement are the two policies that require the use of a Single IRB.

Effective January 25, 2018: All competing NIH grant applications (new, renewal, revision or re-submission) for multi-site studies with NIH receipt dates on or after January 25, 2018, must include a plan describing the use of a sIRB for the study.

• Applies to: Domestic sites of NIH funded studies where each site will conduct the same protocol involving non-exempt human subjects research, whether supported by grants, cooperative agreements contracts or the NIH Intramural Research Program.
• Exceptions: VA sites; international sites; sites involving tribal nations.

Effective January 20, 2020: Projects sponsored by signatories of the revised Common Rule, involving multiple research locations conducting human subjects research, with IRB approval dates on or after January 20, 2020, must use a sIRB. This is mandated by the Cooperative Research provision which expands upon and supersedes the NIH’s Single IRB policy.

• Applies to: All sites in the United States participating in a federally funded cooperative research study (involves more than one site).
• Exceptions: 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 Research for which any Federal department of agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate.

If your study involving a reliance agreement was approved prior to the effective date of 6/1/2021, then fees do not apply to your agreement and retroactive pay is not required. 

At this time, fees will only apply to projects where this cost is allowable by the funding agency, and the project is initiating a reliance agreement plan after the effective date of 6/1/2021. Please email reviewboard@montclair.edu to confirm an exemption applies.