Single IRB

An Institutional Review Board that oversees all sites participating in a multi-site study. A Single IRB (sIRB) is the IRB-of-Record, selected on a study-by-study basis, which provides the ethical review for all sites participating in a multi-site, collaborative human subjects study. Common Rule agencies/funding sponsors (e.g., NIH) require a sIRB for domestic multi-site, collaborative studies.

Since January 25, 2018, the NIH required the use of a sIRB for the review of non-exempt, multi-site, domestic, human subjects research protocols funded by the NIH.

Furthermore, under the revised Common Rule governing human subjects protections approved by the DHHS in January, 2017, most U.S. government funded cooperative studies that meet the criteria for non-exempt human subjects research, and involve more than one site, will also require sIRB review. This requirement went into effect January 20, 2020.

The NIH sIRB requirement applies to all competing grant applications, including new, renewal, revision or resubmission, submitted on or after the January 25, 2018 effective date.

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 email Sharon Ellison (sharon.ellison@duke.edu) and Joe Austin (steven.austin@duke.edu) and cc Minna Pak (minna.pak@duke.edu) with the following information:

  • Brief synopsis of the study and indicating the primary grant holder
  • Level of risk
  • Number of relying sites
  • Duration of the study

Currently, the DUHS IRB does not collect fees for this service.

SMART IRB is not an IRB.  SMART IRB is a master reliance agreement to streamline the IRB review process for multi-site studies.  It enables reliance on a study-by-study basis and clearly defines roles and responsibilities of relying institutions and reviewing IRBs.  More than 900 institutions have already signed onto this master agreement and are actively using it as the basis of reliance for multi-site projects.

It is the DUHS IRB’s preference that the SMART IRB reliance agreement be used as the basis for all studies when either relying on an external IRB or when serving as the sIRB, when possible.

Navigate to the SMART IRB website and a listing of the sites that have signed on.

Relying sites are added after the initial IRB application is approved, via amendments in iRIS. Duke study teams should consult with Minna Pak (minna.pak@duke.edu). She will provide you with instructions and tools to assist with onboarding relying sites.