DUHS IRB as Reviewing IRB for Relying Site/Individual (not the sIRB)

Process for Reliance on the DUHS IRB by External Institutions or Individuals on Multi-site Studies

1.  Contact Minna Pak (minna.pak@duke.edu) with the request for an IAA (IRB Authorization Agreement), IIA (Individual Investigator Agreement) or the use of the SMART IRB Reliance Agreement. It is the preference that the SMART IRB reliance agreement be used whenever possible.

2.  However, if you are using the IAA or IIA, complete the study-specific information on pages 1 and 2. On page 3, complete the attachment A to include a brief (2-4 sentences) description of the activities to be conducted by the external site.

3.  Forward the document to the relying institution for its review and signature.  Please direct requested tracked changes to the IAA or IIA to Minna for review by Duke’s attorney.

4.  Once terms are agreed, email the partially signed IAA or IIA to Minna Pak and she will send to Sharon Ellison (IRB Executive Director) or her designee for signature on behalf of Duke.

5.  Minna will return the signed agreement to the coordinator via email with the instruction to upload it into the study record via amendment in iRIS.

6.  All Key Personnel at the site must be listed on the outside key personnel section in iRIS.  For non-Duke sites in which the DUHS IRB is the reviewing IRB under the SMART IRB Reliance Agreement, no proof of human subjects training is required.  For non-Duke sites in which the DUHS IRB is the reviewing IRB under the DUHS IRB Authorization Agreement (IAA), the site must either confirm that human subjects training is complete for their key personnel or provide the training completion reports.  Key personnel who utilize the DUHS IRB as their IRB-of-Record via an Individual Investigator Agreement (IIA), must affiliate in the CITI Program under 'Duke Health' and complete the Duke Health course modules to fulfill their human subjects training requirements.

7.  The external site’s consent form (if applicable) must be submitted via amendment for watermarking.  Generally, Duke’s consent template is used; however, exceptions can be made.

8.  The external site’s consent form must list the DUHS IRB’s contact information.