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Treatment Outcome Studies With Children: Principles of Proper Practice

This article addresses ethical issues in conducting randomized clinical trials (RCTs) with youth. Ethical considerations that occur prior to treatment (matters of research design, the risk–benefit ratio, issues concerning assent/consent, the influence of payment for participation), during treatment (issues of privacy, protocol adherence, premature termination), and following treatment (needs for posttreatment referrals and/or follow-up contacts, archiving of treatment data) are reviewed. Recommendations, based on empirical evidence and clinical experience, are offered for conducting ethical treatment research with youth and future directions for carrying out research on the ethics of conducting RCTs with youth are offered.