Multi-Site Research And Reliance
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.
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.
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.
Types of Agreements for Reliance
There are two main types of IRB authorization agreements:
Individual investigator agreements are another type of agreement through which non-MSU personnel that are not otherwise covered by another institution are covered under MSU's FWA.
Each IAA is situation and context-dependent and the process may vary, depending upon the type of reliance agreement: institutional, project specific or other, or individual investigator. 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. For a list, visit http://hrpp.msu.edu/institutional-authorization-agreement
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.