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January 28, 2004

Determining the Appropriateness of Including Children in Clinical ResearchHow Thick Is the Ice?

Author Affiliations

Author Affiliation: Center for the Study of Medical Ethics and Humanities, Departments of Medicine and Philosophy, Duke University Medical Center, Durham, NC. Dr Sugarman is now with the Phoebe R. Berman Bioethics Institute, Johns Hopkins University, Baltimore, Md.

JAMA. 2004;291(4):494-496. doi:10.1001/jama.291.4.494

There are multiple reasons to mandate the inclusion of children in clinical research, yet concomitant ethical tensions related to this research must be satisfied. In simple terms, for medical practice to be based on sound evidence, and for all children to receive optimal medical care, research that includes children is vital.13 However, as a group, children are inherently vulnerable in several respects and the ethical justification for this research rests on thin ice. Consequently, there must be careful scientific and ethical sanction before moving forward with proposed research with children.

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