Authorization Agreement Process

Working with External Collaborators

The U-M IRBs have regulatory oversight responsibility for the human subject research activities of U-M faculty, students, and staff.  The research activity of an external collaborator engaged in a U-M human subjects study must also be reviewed by either the:

• IRB at the collaborator's institution, or
• Applicable U-M IRB

An Authorization/Collaborative Agreement may be established between the parties to cede regulatory oversight to one of the IRBs as the IRB-of-Record. This same process may be used when a U-M investigator engages in human subjects research as an external collaborator.

If two or more federally-assured institutions collaborate on human subjects research supported by a Common Rule agency, the institutions may rely on a single IRB (an "IRB-of-Record") for review and continuing oversight of the research, in order avoid duplicate review.   ~ National Academies:  Federal Demonstration Partnership (FDP)  

Agreement Process

U-M investigators should not initiate an Authorization/Collaborative Agreement with another institution without first checking with the applicable U-M IRB (see contact information below) to:

• Verify that the collaborator's research activity meets the definition of "engaged" in research
• Identify the appropriate type of IRB agreement
• Facilitate the signing of the agreement by U-M's Institutional Official, as applicable.  At U-M, signatory responsibility is delegated to the Assistant Vice President for Research – Research Policy and Compliance.  
• Implement and manage the agreement

 IRB staff may request changes to the listed study team members on the IRB application in eResearch based upon their initial review of your request for an agreement. 

IRB Agreement Types

1.  IRB Authorization Agreement (IAA)​

An IAA is an agreement between U-M and another institution that holds a Federal Wide Assurance (FWA) with the Office of Human Research Protections (OHRP) of the U.S. Department of Health and Human Services (HHS). Any institution (e.g., university, medical centers, NGOs, community organization, survey research organization) receiving funds from HHS must have an FWA.  This agreement type is used to establish the IRB-of-Record (whether that's U-M or the other institution).  The IAA is signed by the Institutional Officials at each institution.  

2.  Individual Investigator Agreement (IIA)

An IIA is an agreement between U-M and an individual collaborator who is not affiliated with an FWA institution (e.g., former student working after graduation with their faculty mentor, professional in the community with specific expertise, community partners).  This agreement type outlines the responsibilities of the individual investigator for the protection of human subjects.  The IIA is signed by the:

• Individual investigator
• U-M Principal Investigator (PI)
• U-M Institutional Official (federally-sponsored projects) or IRB Chair (all other sponsors)

3.  Collaborating Institution Agreement (CIA)

A CIA is an agreement between U-M and an institution/organization that does not have an FWA.  This agreement type is typically used for non-federally sponsored research projects involving multiple collaborators who are affiliated with the organization (e.g., research assistants affiliated with a non-profit agency, teachers offering educational interventions in a public school).  It outlines the responsibilities of the collaborating institution for the protection of human subjects.  A CIA is signed by a representative who has the authority to make commitments on behalf of the organization and by the U-M Institutional Official.