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Office of Research Compliance and Integrity:  Reducing the need for Duplicate IRB Review

By Jeanette Gommel

Although the regulations allow one IRB to carry out the review for multiple sites, it is common for a single study conducted at multiple sites or by researchers from multiple institutions to have several IRBs separately reviewing the study. This makes the IRB review process considerably more difficult for the researchers with little evidence to indicate that it improves the protection of human subjects.

The use of an IRB Authorization Agreement (IAA) can make the IRB review process much simpler for collaborative and/or multi-site research. If two or more federally assured* institutions collaborate on human subjects research, the institutions may rely on a single IRB (an “IRB of record”) for review and continuing oversight of the research, in order to avoid having the same project be reviewed by two or more IRBs. In order to do this, an IAA must be put in place between the IRB of record and the IRBs of those institutions who will rely on it for review.

The policy at NIU is that, in general, if the primary or lead investigator is from NIU, the NIU IRB should review the project. NIU would provide IRB oversight for the project, and the IRBs of the collaborating researchers’ institutions could initiate an IAA with NIU, rather than reviewing the project again through their own IRBs.

If NIU faculty, students, or staff are involved in a collaborative project with researchers from another institution but are not the lead investigator, NIU may ask to initiate an IAA with the lead investigator’s IRB, allowing that IRB to provide oversight for the project.

Investigators are encouraged to ask about the possibility of using an IAA when they are involved in collaborative projects with other institutions. The agreements are initiated by the IRB administrators of the institutions. At NIU, IRB administration takes place in the Office of Research Compliance and Integrity (ORCI).

If your research is externally funded, always be sure to discuss your sponsor’s IRB requirements with the Office of Sponsored Projects to ensure that all sponsor IRB requirements are met.

To inquire about the use of an IAA, you may call (815)753-8588 or email jgommel@niu.edu.

*”federally assured” means that the institution has committed to the U.S. Department of Health and Human Services (HHS) that it will comply with the requirements set forth in 45 CFR part 46, the federal regulations governing human subjects research, as well as other terms of assurance.