An institution conducting research has the option to rely on the review of another institution’s IRB, per the Office of Human Research Protection (OHRP) and the Food and Drug Administration (FDA). The institution and outside IRB must enter into an agreement to delineate each party’s roles and responsibilities.
IRB Authorization Agreement (IAA)
Institutions that hold a Federalwide Assurance (FWA) use this document to agree to adhere to federal laws and regulations involving the protection of human subjects in research. Oversight provided by the IRB of record must satisfy the terms of the relying institution’s FWA.
IAAs can be signed on a study-by-study basis or they can take the form of a master reliance agreement, such as the SMART IRB Master Reciprocal Agreement, the Kaiser Permanente InterRegional agreement, the OHSU Memorandum of Understanding (MOU), and the HCSRN Reciprocal Reliance Agreement (RRA).
Individual Investigator Agreement (IIA)
Outside investigators who are collaborating with KPNW and not acting as an employee or agent of their home institution (or do not have one) must sign an IIA. This document extends KPNW’s FWA to cover the individual outside investigator. The investigator must agree to follow KPNW’s human subject protection policies and IRB oversight.