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Legal and Ethical Guidelines for Research in Children and Adolescents
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1. Introduction:

Research with children and adolescents is vital to promote the health of our society at large as well as to ensure that children enjoy the benefits of research. Children and adolescents are considered "vulnerable" populations deserving special protections in order to balance the risks to the adolescent and child of research with the possible benefit to them and future generations.


2.  Regulations:

Several federal regulations provide guidance to child and adolescent health care researchers.

Subpart A of 45 CFR Part 46 for the U.S. Department of Health and Human Services provides for basic human subject protections and is known as the “Common Rule” for its application to most research conducted, supported, or otherwise regulated by 17 federal agencies.

Subpart D of 45 CFR 46, applies specifically to children.


3.  Ethics

The ethical principle of respect for persons underlies the obligation to treat individuals as autonomous actors who must provide their informed and voluntary consent to participate in research. Requirements for parental permission serve the ethical obligation to respect and protect vulnerable individuals. However, provisions for involving children and adolescents in discussions about research participation and seeking their assent or consent, when appropriate, attest to the critical need to respect children and adolescents’ developing autonomy. Parental permission and minor assent/consent are the intertwined foundations of ethical research involving children and adolescents.

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