Guidance - Benign Behavioral Interventions

The Secretary's Advisory Committee on Human Research Protections (SACHRP) has drafted and the Office for Human Research Protections (OHRP) has published, "A Guidance and Educational Tool for Benign Behavioral Interventions."  The document outlines questions to ask to determine if the benign behavioral intervention proposed in a research study will meet the criteria for exemption under the new Exemption Category 3 in the Revised Common Rule (effective 1/21/2019).  The document describes several examples of behavioral interventions and whether or not they would be considered exempt or non-exempt under the new common rule.