45 C.F.R. § 46.201

To what do these regulations apply?

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(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 pre-2018 Requirements means 45 CFR part 46, subpart A, as revised October 1, 2016. The 2018 Requirements means 45 CFR part 46, subpart A, as revised October 1, 2018.

(1) For research subject to the pre-2018 Requirements and this subpart, the exemptions at § 46.101(b)(1) through (6) of the pre-2018 Requirements are applicable to this subpart.

(2) For research subject to the 2018 Requirements and this subpart, the exemptions at § 46.104(d)(1) through (8) of the 2018 Requirements may be applied.

(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.

[66 FR 56778, Nov. 13, 2001, as amended at 89 FR 84825, Oct. 24, 2024]

Notes of Decisions

Cited in 2 cases, 1995–1996 · leading case: C.K. v. Shalala, 883 F. Supp. 991 (D.N.J. 1995).

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C.K. v. Shalala, 883 F. Supp. 991 (D.N.J. 1995). “45 C.F.R. § 46.201 et seq. However, the Family Cap has no effect on the level of benefits received by a pregnant woman; moreover, the data to be garnered from the program and evaluated by HHS/DHS does not at all implicate issues and/or concerns regarding pregnant women and/or…”

C.K. v. New Jersey Dep't of Health & Human Servs., 92 F.3d 171 (3rd Cir. 1996). “5 constitutes experimentation involving pregnant women and fetuses in contravention of HHS regulations that set forth additional protections for research, development, and other activities involving pregnant women, fetuses, or in vitro fertilization.”

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