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What Government Agencies Protect Children in Clinical Trials?

The physical and psychological health needs of children differ significantly from those of adult populations, due to body size, hormonal and cognitive development, nutritional requirements and unique exposures and risks. Clinical trials provide a way to better understand the health needs and best treatment options for children. While conducting medical experiments on a young and vulnerable population may sound alarming, several governmental agencies have legal and practical frameworks in place to protect children's health and best interests.

  1. Office for Human Research Protections

    • The main governmental agency that protects children enrolled in clinical trials is the Office for Human Research Protections. Administered by the U.S. Department of Health and Human Services, OHRP protects the "rights, welfare and well-being" of subjects involved in both biomedical and behavioral research. OHRP has elaborated a set of legal and ethical standards explicitly for the participation of children in clinical research to ensure the most favorable balance of risk and benefit, and to protect the rights and health of a vulnerable population.

    Food and Drug Administration

    • The U.S. Food and Drug Administration is one of the biggest federal funding sources for clinical research, and helps sponsor studies for the development of pharmaceuticals, natural therapies and medical devices. Like OHRP, the FDA has a set of stringent criteria for the protection of children in trials, which are especially attentive to issues of voluntary consent and assent, minimizing risk and protecting children from positions of undue harm and vulnerability.

    Joint Agencies

    • The Department of Health and Human Services, along with the National Institutes of Health and the National Heart, Blood and Lung Institute, has recently formed a children-centered coalition to educate the public about the important role of children in clinical research. As government agencies are required to maintain a similar set of standards with regard to the protection of human subjects, this newly-formed division provides a clear outline of general trial processes and the rights and protection of all participants. The recently launched website, Children and Clinical Studies (see Resources), offers an informative overview of the benefits to research participation, and the specific ways researchers and institutions maintain federal standards to protect children.

    Institutional Review Board

    • All institutions that receive federal funding for clinical trials in either behavioral or biomedical research are required to form an Institutional Review Board. An IRB is responsible for regulating the ethical and legal standards of research, and as a body, is accountable to federal regulations and audits. For clinical trials involving children, an IRB serves on the behalf of governmental agencies to ensure that research institutions, such as hospitals, schools and corporations, comply with federal standards and protect the health and well-being of participating minors.

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