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How Thick Is the Ice?

Jeremy Sugarman, MD, MPH, MA

JAMA. 2004;291:494-496.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

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.^1-3 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.

Three pillars support the rights and interests of all persons enrolled in clinical research, including investigators and sponsors, institutional review boards (IRBs), and informed consent by participants. Investigators and sponsors are responsible for designing and conducting ethically sound research.⁴ Institutional review boards are charged with oversight of research through prospective and continuing review to ensure . . . [Full Text of this Article]

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.

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