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