Informed consent and clinical research involving children and adolescents: implications of the revised APA ethics code and HIPAA.

In 2003, 2 new sets of rules and regulations affecting the conduct of clinical research involving children and adolescents went into effect: the revised American Psychological Association's (APA) Ethical Principles of Psychologists and Code of Conduct (APA, 2002; effective June 1, 2003) and the Privacy Rule (45 CFR Part 160 and A and E of Part 164; effective April; 14, 2003) of the Health Insurance Portability and Accountability Act (HIPAA: Public Law 104-191). This article highlights those APA ethical standards and HIPAA regulations relevant to clinical research involving children and adolescents and discusses how psychologists can apply these rules in ways that will ensure ethical and legal compliance.