When IRBs Disagree: Waiving Parental Consent for Sexual Health Research on Adolescents

Adolescents have unique health risks, and adolescent health is an important area of research, but one that raises notoriously difficult questions about informed consent. Adolescents' developing ability to understand the goals and risks of research motivate the requirement that adolescent participants assent to taking part in studies. Concurrent parental consent is normally required as a proxy for fully informed consent because of the wide variation in adolescent development. On the other hand, adolescents are developing as autonomous individuals with needs for privacy and confidentiality. Recognizing these needs as paramount in special cases, federal regulations 45 CFR 46.116(d) and 45 CFR 46.408(c) permit the waiver of the requirement of parental consent, thereby elevating the adolescent's assent to de facto consent on his or her own behalf. The emergence of sexual maturity, with its associated emotional, psychological, and social developments, deepens the concerns about privacy, autonomy, and parental authority. Research on adolescent sexuality and sexual health is thus fraught with moral ambiguities.