Exemption from IRB Review

Yes, only a DUHS IRB Chair/designee can make a declaration of exemption for your study.  If you believe your study qualifies for exemption, you must complete a New Study application in iRIS and indicate that you are applying for a declaration of exemption.  You cannot initiate any study activities until you have received written notice of the determination of exemption from the IRB.

OHRP has just updated its decision charts to make them consistent with the revised Common Rule requirements currently in place.  These graphic charts are intended to aid those who need to decide if an activity is research involving human subjects and whether the research might be able to be declared exempt by the IRB, under the exemption categories found at 45 CFR 46.104.

OHRP Decision Charts

Note that to obtain an authoritative determination of whether an activity is exempt from further IRB review, the Faculty/Staff Member must request confirmation from the IRB that an activity does or does not constitute research with human subjects, and whether the project involving research with human subjects qualifies for exemption from further IRB review or meets the definition of “not engaged in research”.  If you think your project may qualify for exemption, please submit the project to the IRB and choose the option “Application for exemption from IRB review” in section 400 of the submission form in iRIS.

In iRIS currently, the way to close an exempt study is to click on the "close exempt" button.

Yes.  Furthermore, any person added to a Key Personnel list on a study must complete the Duke Health CITI module training requirement.