Abstract
As investigators design and implement research protocols, they should be aware of the ethical and legal requirements that govern research with human participants. This is especially true of research that involves children and other vulnerable groups. The purpose of this paper is to provide a brief overview of the regulatory and ethical requirements that relate to research involving children in the emergency department (ED) setting. For research in the ED to satisfy ethical and legal requirements, it must be scientifically sound and significant, subject selection must be fair, approaching families for enrollment must avoid pressure, the risks to participants cannot be excessive and must be minimized, risks must be justified by the benefits of the research, informed consent and assent must be obtained where appropriate, enrolled subjects must be respected, and the protocol must have obtained approval of an independent ethical review board.
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