Comment from Anita Tibau

Summary: Anita Tibau is submitting a formal petition to the Office for Human Research Protections (OHRP) regarding the Casa Pia Children's Amalgam Trial. She argues that the study violated federal regulations and ethical principles, specifically regarding the protection of vulnerable children, and requests a formal determination of noncompliance, suspension of federal reliance on the data, and remedial measures for the participants.