Multi-Site Research and IRB Reliance
Multi-Site Research
Multi-site research refers to human subject research conducted at external sites, which are considered to be locations external to Michigan State University (MSU) (e.g., not on MSU campus, not within an MSU facility, location not under the jurisdiction or control of MSU). There are different requirements based on whether the external site or its employees are engaged in the human subject research conducted by an MSU investigator.
Engagement
The IRB determines whether an external site is engaged in the research using the U.S. Office for Human Research Protection (OHRP) guidance, “Guidance on Engagement of Institutions in Human Subjects Research.” However, external sites may also require IRB review based on their institutional requirements. It is important to check with each external site to determine if the site requires IRB approval based on the specific human research project.
IRB Reliance
For multi-site research with engaged external sites, arrangements may be made for institutions to rely on one another for IRB review. MSU may enter into a written agreement (Institutional Authorization Agreement (IAA) or IRB reliance agreement) to rely on another institution’s IRB review or to allow another institution to rely on MSU’s IRB review. Such agreements are made to help reduce duplicate IRB review when appropriate.
NIH Single IRB Requirements
The Final NIH Policy on Use of a Single IRB for Multi-Site Research establishes the expectation that all domestic sites participating in multi-site studies involving non-exempt human subjects research funded by NIH will use a single Institutional Review Board (sIRB).
We highly recommend that you contact the HRPP early and as soon as possible, as the decision of which IRB should serve as IRB of record may require discussions between the institution’s IRBs.
For more information, visit the Single IRB webpage.
Revised Common Rule Single IRB Requirements
Projects seeking funding from a Federal department or agency that has adopted the Revised Common Rule for the protection of human subjects in research are now required to identify and use a Single Institutional Review Board when certain criteria are met. Any institution located in the United States that is engaged in cooperative non-exempt research must rely upon approval by a Single IRB for that portion of the research that is conducted in the United States, with limited exceptions.
At MSU, this requirement only applies to projects funded or supported by a Federal department or agency that has adopted the Revised Common Rule for the protection of human subjects.
We highly recommend that you contact the HRPP early and as soon as possible, as the decision of which IRB should serve as IRB of record may require discussions between the institution’s IRBs.
For more information, visit the Single IRB webpage.
SMART IRB
MSU is a Participating Institution in SMART IRB! SMART IRB (Streamlined, Multisite, Accelerated Resources for Trials IRB Reliance platform) is funded by NIH and is designed to harmonize and streamline the IRB review process for multi-site research. It allows institutions to minimize duplicate IRB review while maintaining appropriate oversight and is in line with the Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research. MSU is now a participating institution in SMART IRB. Learn more about SmartIRB.org
Types of Agreements for Reliance
Process
Each IAA is situation and context-dependent and the process may vary, depending upon the type of reliance agreement. The HRPP office coordinates the IRB reliance process and the MSU Institutional Official retains final authority to determine whether MSU may enter into an IAA.
In addition, MSU has institutional reliance agreements with multiple institutions.
If you are conducting research at multiple institutions or entities, please feel free to contact the HRPP to determine the possibility of reliance. Kim Hess, IRB Administrator III, coordinates the reliance processes and can assist in the process.