Posted February 3, 2020 by Ashley Washburn
Effective Jan. 20, federal policy under the Common Rule requires U.S. institutions to use a single IRB of record, or sIRB, for approval of cooperative research projects.
To prepare for implementing this change, the Institutional Review Board recommends that University of Nebraska-Lincoln investigators review the following requirements.
- Cooperative research projects involve more than one institution.
- UNL IRB does not enter into sIRB agreements for exempt research, unless it falls under a category requiring limited review.
- International participating sites are not required to comply with sIRB requirements. Typically, local ethics committee review is completed and submitted to the IRB to ensure local customs and norms are addressed within the international setting.
- If an investigator will be proposing or participating in a nonexempt cooperative research project, he or she should notify the sIRB point-of-contact as soon as possible at email@example.com.
- The IRB institutional official, or that person’s designee, is the only individual allowed to enter into authorization agreements on UNL’s behalf.
- Typically the lead institution, or prime awardee, in a cooperative research project is also the reviewing IRB, or the sIRB of record.
- A request to rely on another institution’s IRB (cede review) should be submitted via a NUgrant Determination Form. All approved project documents, including the final IRB approval letter, must be provided to the UNL IRB.
- UNL holds blanket authorization agreements with the University of Nebraska Medical Center and Boys Town National Research Hospital. The agreements allow the university to meet regulatory requirements from both the U.S. Department of Health and Human Services and the Food and Drug Administration.
- UNL is a member of SMART IRB, an electronic reliance arrangement system for investigator-initiated studies that involve other academic institutions. If a partnering institution is a member of SMART IRB, UNL may require use of this system to manage the agreement process.