Multi-Site Research And 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. 

SMART IRB

MSU is Now 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 SMART IRB at https://smartirb.org/

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.

Process

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

Contact

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.