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Fed Regist. 2001 Nov 13;66(219):56775-80.

Protection of human research subjects. Final rule.


The Department of Health and Human Services (DHHS) is withdrawing Subpart B of its human subjects protection regulations published on January 17, 2001 and is issuing this replacement rule. These regulations provide additional protections for pregnant women and human fetuses involved in research. The final rule continues the special protections for pregnant women and human fetuses that have existed since 1975 and makes limited changes in terminology referring to neonates, clarifies provisions for paternal consent when research is conducted involving fetuses, clarifies language that applies to research on newborns of uncertain viability, and corrects technical errors.

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