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Ethical Considerations for Clinical Investigations of Medical Products Involving Children

FDA recently published a draft guidance on Ethical Considerations for Clinical Investigations of Medical Products Involving Children.

Clinical investigations in children are essential for obtaining data on the safety and effectiveness of drugs, biological products, and medical devices (collectively referred to as medical product herein) in children and to protect children from the risks associated with exposure to medical products that may be unsafe or ineffective.

Children are a vulnerable population who cannot consent for themselves and who therefore are afforded additional safeguards when participating in a clinical investigation. Such safeguards are an essential requirement for the initiation and conduct of pediatric investigations as part of a medical product development program. This guidance describes the FDA’s current thinking regarding ethical considerations for clinical investigations of medical products in children.

The ethical principles for the protection of human subjects in FDA-regulated clinical investigations are reflected in the requirements in 21 CFR parts 50 and 56; additional safeguards for children are included in 21 CFR part 50, subpart D (Additional Safeguards for Children in Clinical Investigations). 

In accordance with 21 CFR 50.50, IRBs must review clinical investigations involving children as subjects and approve only those clinical investigations that satisfy the criteria described in 21 CFR 50.51, 50.52, or 50.53 and the conditions of all other applicable sections of subpart D. 

Clinical investigations involving FDA regulated products that are not medical products may have similar ethical considerations to those discussed in this guidance but are outside the scope of this guidance.

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