Revised March 2012
The National Advisory Council on Drug Abuse (NACDA) recognizes that substance abuse research involving children and adolescents is vital to understanding factors contributing to the initiation, maintenance and cessation of substance use and abuse among this population. This period of life is characterized by growth and maturation of brain and body, which potentially affects responses to drugs and treatment. Moreover, the great majority of people who develop substance use disorders (SUDs) or addiction begin to use drugs when they are young. Therefore, study of this population is crucial in order to develop effective prevention and treatment interventions, both behavioral and pharmacological, for youth.
Research on substance use and abuse among children and adolescents presents its own unique challenges. As a result, the National Advisory Council for Drug Abuse (NACDA) and the National Institute on Drug Abuse (NIDA) have developed these guidelines to assist researchers, institutional review boards and study reviewers in developing, conducting or reviewing studies involving children and adolescents. The guidelines that are provided in this document address both general issues regarding conducting research in youth as well as issues that may specifically arise when conducting drug abuse research in youth. These guidelines are not codified and do not constitute Federal regulation. These guidelines are not intended to supplant the functions of either the Institutional Review Board (IRB) or the Office for Human Research Protections (OHRP). They are advisory to applicants, IRBs, Integrated Review Groups (IRGs), and others.
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