An IRB Authorization Agreement (IAA) is a special agreement between two institutions who are engaged in human subjects research to establish the IRB with primary oversight. An IAA allows an institution with a Federalwide Assurance (FWA) to extend the applicability of its FWA to cover research activities at another Institution. In practice, this means Montclair’s IRB will be the IRB of Record which reviews the study. IAAs can be requested by entering information within your Cayuse IRB submission. The program outlined below provides guidance on building allowable direct costs into your project budget that should be applied to all funded research activities where a reliance agreement is needed.
Effective Date: June 1, 2021
Applicability:
The fee schedule and program below applies to all non-exempt human subject research wherein the proposed activities associated with serving as an single IRB (sIRB) are the responsibility of Montclair IRB.
How do I plan for sIRB requests in my proposal?
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 create an SP event notifying the IRB office that a researcher expects to be engaged in human subjects research involving an sIRB. The consultation process may take up to 10 business days to complete. Based on the consultation the researcher and OSP will be able to integrate the sIRB fee schedule into direct costs where applicable. If a letter of support is required the IRB will need up to 10 business days from initial request of consultation on sIRB.
sIRB fee schedule* (*the fee schedule is subject to change based and will be evaluated on an annual basis):
- Expedited
- Initial $1,100/site that will rely on Montclair
- Modification $500/yr (Includes up to 5 modifications)
- Renewal $500/ two yr
- Full Board
- Initial $1,600/site that will rely on Montclair
- Modification $750/yr (Includes up to 5 modifications)
- Renewal $500/yr
- 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
YES!
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.
No, at this time fees will only apply to projects initiating a reliance agreement plan after the effective date of 6/1/2021.
Yes, 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.
