Development of an electronic reliance (authorization) agreement toolkit

Thursday, October 11, 2012 — Poster Session IV
2:00 p.m. – 4:00 p.m.	Natcher Conference Center, Building 45	NIAID	RSCHSUPP-7

Authors

• B.R. Herpin
• G.G. Kelly
• M Michael

Abstract

Much has changed in the design, conduct and complexity of clinical research since requirements for Institutional Review Boards (IRBs) were established, including a marked increase in the number of multi-site clinical studies. With the increasing number of multi-site studies have come increasing administrative burden, redundancy and delays in IRB protocol review processes. A reliance agreement is a formal, written document that provides a mechanism for an institution engaged in research to delegate IRB review to an independent IRB or an IRB of another institution. Reliance agreements are commonly used when a study is conducted at multiple sites, when a participating research entity does not have its own IRB, when study implementation is time sensitive (public health emergency, seasonal flu, etc.), when a study involves special populations, or when a study requires specialized IRB expertise. In preparation for the increasing and ongoing use of alternative models of IRB review for multi-site studies, NIAID has developed an electronic reliance agreement toolkit as a resource. The toolkit contains general information and customizable tools related to clinical research review by IRBs, both for those institutions providing review for another institution and those delegating review.

back to top