External (Non-Duke) Sites

If an external (non-Duke) site is determined to be engaged in research and added to a Duke-based study, the DUHS IRB requires the following:

  • Notice of approval from the site’s IRB; OR
  • A completed IRB Authorization Agreement (IAA) or if the site is signed onto the SMART IRB Master Reliance Agreement, a SMART IRB Cede Letter that is issued on a protocol by protocol basis

Sometimes a site will provide a letter stating that they are deferring to the DUHS IRB, but that is not sufficient. Duke must have a fully signed IAA or SMART IRB Cede letter that clearly defines site responsibilities and liability for both parties.

Contact Minna Pak in the IRB office for the templates for either agreements. Please upload your fully signed IAAs or SMART IRB Cede letter as documentation with your protocol in iRIS.

If you have a multi-site study, please pay attention to keeping the IRB approvals from the external sites current. When a DUHS investigator plans to conduct research at a site or sites external to DUHS, and the site(s) will be engaged in research according to OHRP guidance (October 16, 2008), the investigator must submit to the DUHS IRB documentation of current IRB approval at all external sites in a timely manner. This documentation belongs in the "Multi-site Research" section of your iRIS submission.