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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




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


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.

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