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e-CFR data is current as of January 26, 2021

Title 45Subtitle ASubchapter APart 46Subpart B → §46.201


Title 45: Public Welfare
PART 46—PROTECTION OF HUMAN SUBJECTS
Subpart B—Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research


§46.201   To what do these regulations apply?

(a) Except as provided in paragraph (b) of this section, this subpart applies to all research involving pregnant women, human fetuses, neonates of uncertain viability, or nonviable neonates conducted or supported by the Department of Health and Human Services (DHHS). This includes all research conducted in DHHS facilities by any person and all research conducted in any facility by DHHS employees.

(b) The exemptions at §46.101(b)(1) through (6) are applicable to this subpart.

(c) The provisions of §46.101(c) through (i) are applicable to this subpart. Reference to State or local laws in this subpart and in §46.101(f) is intended to include the laws of federally recognized American Indian and Alaska Native Tribal Governments.

(d) The requirements of this subpart are in addition to those imposed under the other subparts of this part.

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