Section 3.2 Single IRB Plan

  1. Study Information

Title:[Study Title]

PI:[Name of Lead PI]

NIH Grant Number:[#]

  1. Compliance

We plan to comply with the NIH sIRB policy pursuant to NOT-OD-16-094 by designating a single IRB of record.

  1. Single IRB of Record

Although a single IRB of Record has not yet been chosen for this study, the lead institution is dedicated to identifying a single IRB of Record for all sites in this study.[RR1]The following participating sites have expressed their willingness to rely upon the review of a single IRB of Record for this study: [List Relying Institutions].

  1. Presently-Identified Participating Sites

All presently-identified participating sites, as listed above, have agreed to rely on a single IRB of record for the above study/studies, to be determined in the future[RR2]. Any potential participating sites included after the submission of this application shall be required to rely on the chosen single IRB of record for the above-named study/studies as a condition of their participation, unless they meet the NIH criteria for exemption from using a single IRB.

  1. Communication Plan

Please see the attached Communication Plan which shall be implemented by all participating sites. (Use Division of Responsibilities Tableas a guide and see our sample completed Table. Collaborate with the chosen sIRB,if any, to ensure agreement.)

  1. Individual Authorization Agreement

All presently-identified participating sites shall enter into and sign an individual authorization agreement (IAA) prior to the initiation of the study, or shall use the SMART IRB reliance agreement. Said IAA shall include, but not be limited to, the division of responsibilities in Section E.

  1. Recordkeeping

Specifically, lead institution shall be responsible for maintaining records related to the fully executed IAA. Lead institution shall be responsible for maintaining records related to the Communication Plan.

Emory University
1599 Clifton Road, 5th Floor - Atlanta, Georgia 30322
Tel: 404.712.0720 - Fax: 404.727.1358 - Email: - Web:
An equal opportunity, affirmative action university

[RR1]If a single IRB is already agreed upon by all sites (NOT Emory IRB unless confirmed in advance with us), you may state that here instead.

[RR2]Remove if an sIRB has already been selected