May 17, 2006

The FDA has issued a draft guidance for clinical investigators, institutional review boards (IRBs), sponsors and others concerning the agency's review process for clinical trials involving children.

The draft guidance, published in the Federal Register, notes that IRBs must review clinical trials that use children as subjects and approve them only if they meet a detailed risk-benefit calculus and the consent of both the children and their parents or guardians is obtained. These requirements may be set aside only if the IRB is able to document that the proposed study would help in the understanding, prevention or alleviation of a serious children's health or welfare problem. Also, the FDA commissioner must concur and be able to determine that the study will be conducted under ethical principles and with the consent of the children and their parents or guardians.

When an IRB refers a clinical trial involving children to the FDA, the agency's Pediatric Ethics Subcommittee of the Pediatric Advisory Committee is to review it at a public meeting (if the documentation is complete) and make a recommendation to the commissioner, who has final decision-making power. The agency encourages the relevant IRB to send a representative as well as the study's principal investigator to attend the subcommittee meeting. Public review and comment are required.