Does the study involve more than minimal risk?




Exemption Review: See page 65 (in Section 9) of the IRB Guidebook for the categories that may be exempt from review, further information, and forms. The following types of research cannot be exempted from review even if they meet the exemption criteria otherwise:

         Human in-vitro fertilization;

         Review of records if the information gathered from those records is recorded in such a way that it can be linked back to the subject either directly or indirectly through the use of a code;

         Surveys or interviews given to minors;

         Any procedure that may cause a subject either physical or psychological discomfort or is perceived as harassment above and beyond what the person would experience in daily life;


         Observation of minors if the investigator participates in the activities being observed unless there is a federal statute covering the activity.

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Expedited Review: See page 71 (in Section 10) of the IRB Guidebook for the criteria that a proposal must meet in order to be considered for Expedited Review, further information, and forms. Any protocol that involves more than minimal risk must go to the Board for Full Review.

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Full Review: The IRB must review protocols involving investigational drugs or devices and where certain vulnerable subject populations will be participating. See Section 11 of the IRB Guidebook for additional requirements, guidelines, and forms.

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