prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject’s disorder or condition.
Section 407. Research not otherwise approvable that presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.
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Appendix D: Glossary, Acronyms, and Laws and Regulations ."
The Ethical Conduct of Clinical Research Involving Children . Washington, DC: The National Academies Press,
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