Institutional Review Board

IRB Reliance Procedures – Investigator Responsibilities
(Authorization Agreements)

Brief Overview

The University of Missouri engages in agreements in which an IRB relies on the review of a designated IRB known as the “IRB of Record” in multi-site research studies. These agreements may be altered and vary in scope and terms. They are designed to reduce duplication of review efforts and increase efficiency by designating an IRB of Record with one IRB initial and continuing review process.

Not every multi-site study requires a reliance agreement and these determinations are made by the IRB. The institutions entering into an agreement must be engaged in research. In general, an institution is engaged when its employees or agents for the purposes of the research project obtain: (1) data about the subjects of the research through intervention or interaction with them; (2) identifiable private information about the subjects of the research; or (3) the informed consent of human subjects for the research. Contact the IRB for assistance with this determination.

Office of Human Research Protections Guidance on Engagement: http://www.hhs.gov/ohrp/policy/engage08.html

Text Box: How the Appropriate IRB of Record is Selected: •	Must have an approved FWA •	Accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) •	Take into consideration the site of the overall Principal Investigator and the role of each investigator(s) •	IRB expertise - select an IRB with sufficient knowledge of the community from which the subjects are drawn •	Funding agency requirements, prime grantee site •	Consult with the Institutional Official and IRB from each organization to determine the appropriate IRB of record

 

 

 

 

 





Click on the Appropriate Scenario to view Instructions and Responsibilities:

Scenario 1: MU IRB is the IRB of Record – Submission Process
Scenario 2: MU IRB Relying on Another IRB – Submission Process   
Scenario 3: Adding an Individual with No IRB Affiliation