Adolescent drug users in behavioral and social research studies: Ethical and regulatory considerations

Background: Adolescent drug users, 11-17 years old, are at risk for bloodborne and sexually transmitted infections. Including adolescent drug users in behavioral and social research is important for developing prevention and treatment interventions. More than 90% of studies with drug users report a mean age of mid-to-late 30s with lower age limits of 18 years. Findings from these studies may not be applicable to adolescent drug users.

Methods: We reviewed the scientific, ethical, and regulatory literature of the past 15 years to shed light on barriers and strategies to increase studies with adolescent drug users.

Results: Many adolescents are classified as children by federal regulations for protecting research participants. This classification depends on state and local laws which vary by state according to its definition of age of majority or legal age of adulthood. Regulatory requirements for study participation include consent or assent of adolescents depending on the regulatory classification of age and parental or guardian permission. Waiver of documents or documentation is permissible under certain conditions, such as minimal-risk studies, and selection of a youth advocate to assist adolescents in their role as research participants. Such conditions can also apply to emancipated minors or those who are homeless.

Conclusions: The ethical principles of respect, beneficence, and justice call for increasing the number of studies with adolescent drug users. Increasing our understanding of the regulations for enrolling adolescent drug users in behavioral and social research would facilitate the implementation of these studies and the compatibility of science, ethics, and regulations.