HRPP Document: PRO105
Revision Date: 5/12/11, 12/16/13, 4/9/14
Subject: Procedure for Determination of Exemption from Human Subjects Regulations; Ethical Review
This procedure describes how UAB reviews human subjects research to determine if it qualifies for exemption from the human subjects regulations in accordance with 45 CFR 46.101 and 21 CFR 56.104. This procedure also describes how research exempt from human subjects protection regulations may undergo ethical review. This procedure is not to be used to grant exemptions under the FDA category 21 CFR 56.104(c) for emergency use of a test article in a life-threatening situation (see Attachment A, FDA exemptions applicable to research, Category (c)).
An investigator submits one copy of the following materials to the OIRB:
This information must be included with the application.
Chair or designee:
Approved on December 10, 2014, by:
Ferdinand Urthaler, MDIRB Chair
Jonathan Miller, MPPA, CIPOIRB Director
ATTACHMENT A TO PRO105:
OHRP Decision Trees for Determination of Exemption: