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# Guide on Pediatric Study Ethical Considerations
- URL: https://www.fdaweb.com/guide-on-pediatric-study-ethical-considerations/
- Published: 2022-09-26T12:00:00.000Z
- Updated: 2026-09-14T18:00:36.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5152814

*Federal Register* notice: FDA is making available a draft guidance entitled “Ethical Considerations for Clinical Investigations of Medical Products Involving Children.” The document explains fundamental concepts for the ethical framework that IRBs, sponsors and industry should consider when reviewing or conducting clinical trials involving children, such as scientific necessity for conducting it and risk categories for interventions or procedures that do not offer a prospect of direct benefit for children. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-09-26/pdf/2022-20720.pdf?ref=fdaweb.com).