FDA Issues New Safeguards for Children in Clinical Trials

July 1, 2001

ROCKVILLE, Md-To comply with a mandate in the Children’s Health Act of 2000, the FDA has issued an interim rule implementing additional requirements to safeguard children enrolled in clinical trials. "A key aspect of the new rule sets standards and procedures for assuring that children have assented to participating in clinical trials (when possible), and that their parents or guardians are able to give fully informed consent to the child’s participation in a study," the agency said in a statement.

ROCKVILLE, MdTo comply with a mandate in the Children’s Health Act of 2000, the FDA has issued an interim rule implementing additional requirements to safeguard children enrolled in clinical trials. "A key aspect of the new rule sets standards and procedures for assuring that children have assented to participating in clinical trials (when possible), and that their parents or guardians are able to give fully informed consent to the child’s participation in a study," the agency said in a statement.