DUHS as the sIRB

  1. You need to get permission for the DUHS IRB to serve as the sIRB for relying sites. This should happen prior to submitting your grant proposal if you plan on the DUHS IRB being the sIRB. To ask for permission, please complete this sIRB request form.  In this form, you will be asked to provide a brief synopsis of the study, indicate the primary grant holder, level of risk, number of relying sites and the duration of the study.  Sharon Ellison and/or Joe Austin will respond to your request and you should receive an email indicating their decision.
  2. It is important that the DUHS Lead PI and Lead Study team understand the additional responsibilities they have when the DUHS IRB is the Single IRB.  Please navigate to the PI and Study Team Responsibilities document for more information.
  3. Once you receive permission from the DUHS IRB to serve as the sIRB, you will submit your new study application as usual. However, please put "sIRB” at the end of your title in iRIS and be sure to upload the email from the DUHS IRB agreeing to serve as the sIRB.
  4. While you are waiting for the protocol to go through all the HRPP reviews in iRIS, please reach out to Minna Pak (minna.pak@duke.edu) and she will train you on how to add on relying sites via amendments after the initial new protocol is approved.  Minna will train you on the applicable reliance agreements needed (SMART IRB Cede letter or IAA) and other required documentation and tools for on-boarding relying sites.
    • The IREx platform which supports sIRB documentation and coordination is the preferred tool to use when collecting reliance agreements and other required on-boarding documentation when the DUHS IRB serves as the sIRB. If your relying sites have completed profiles in IREx and have signed onto the SMART IRB Master Reliance Agreement, IREx is a very efficient tool to use. If you are a current IREx user, you can find out if  your relying sites have completed their IREx profiles and have signed the SMART IRB Master Reliance Agreement by navigating here. Otherwise, please contact Minna Pak and she can work together with you to look up this information.
      • We also encourage you to navigate to the User Trainings for IREx. Please view the training called "Coordinating Center Staff/Lead Study Team".
      • Minna Pak has to initiate the process in IREx before study team members are added to the IREx platform.
      • There may be situations in which it is not ideal to use IREx (for example, relying sites don't have completed profiles in IREx already). In these cases, Minna Pak has relying documentation that she will send to you by email with instructions.  Please reach out to her with questions.

Other important resources: