Parental Consent for Adolescent Research.

Abstract

The purpose of this article is to increase understanding about how to obtain institutional review board approval to waive parental consent for adolescent research that involves minimal risk to subjects and/or that cannot be carried out practicably without the waiver. Because of IRB guidelines, the researchers were unable to use passive parental consent for a study of adolescent nonmedical prescription drug use (NMPDU). Without knowledge of waiver 45 C.F.R. §46.116 of the U.S. Department of Health and Human Services Code of Federal Regulations regarding the protection of human research subjects, the study design required active parental consent for survey administration. This requirement limited study participation and increased costs. Using the waiver, the study design could have waived parental consent with adolescent assent. By increasing awareness of the 45 C.F.R. §46.116 waiver and its subparts, the researchers hope to inform future researchers about reducing barriers to future adolescent research. Lessons learned include how using the waiver may decrease research costs, reduce participant selection bias, increase participant response rate, and expand data available to contribute to critical, emerging adolescent health issues such as NMPDU.