Colorado State University

Multi-Site Research and IRB Reliance

Multi-site Research refers to human subject research conducted at external sites that are not components of Colorado State University (CSU) (Fort Collins Campus and Spur Campus). There are different requirements based on whether the external site or its employees are engaged in human subject’s research conducted by a CSU investigator.

Engagement

The IRB determines whether an external site is engaged in research using guidance from the Office of Human Research Protections guidance, “Guidance on Engagement of Institutions in Human Subjects Research.” External sites may need to consult their local IRB to determine whether their institution considers them to be engaged in the research.

IRB Reliance

When the research involves multiple sites, it’s common, and often required by the funding source for institutions to rely on one another for IRB review. CSU may enter into an IRB reliance agreement or an Institutional Authorization Agreement (IAA), which documents which institution’s IRB will serve as the IRB of record, and which institutions IRB will rely on the IRB of record.

NIH Single IRB Requirements

The Final NIH Policy on Use of a Single IRB for Multi-Site Research documents the expectation that all US sites participating in non-exempt multi-site studies funded by NIH are required to use a single Institutional Review Board (sIRB).

If your research is NIH-funded multi-site research, please reach out to the CSU IRB as soon as possible, to allow sufficient time for the reliance agreement process.

Revised Common Rule

When a CSU investigator is seeking funding from a Federal department or agency that has adopted the Revised Common Rule (RCR) for the protection of human subjects in research and their research is a non-exempt, collaborative project, they must agree to use a Single IRB.

CSU only requires sIRB on projects that are funded or supported by a Federal department or agency that has adopted the RCR.

SMART IRB

CSU is a participating SMART IRB Institution. SMART IRB (Streamline, Multisite, Accelerated Resources for Trials IRB Reliance Platform) is an NIH-Funded platform designed to harmonize and streamline the IRB review process for multi-site research.

Types of Reliance Agreements

• Institutional Authorization Agreement (IAA)

  • An IAA may cover all human subjects research that engages an institution or requires IRB review between two institutions or be used to document reliance on a specific study. Each institution retains the authority to determine whether to conduct its own review on a project-specific basis.

• Individual Investigator Agreements (IIA)

  • IIAs are a formal agreement between CSU and an independent investigator collaborating on a CSU research study, by which CSU agrees to extend it’s (FWA) to the individual, and through which the independent investigator agrees to fulfill specified training and conduct while collaborating on the project. IIAs are subject to review and approval by CSU’s Institutional Official.

Please contact the CSU IRB to inquire about reliance agreements or Individual Investigator Agreements. [email protected]