C.F.R. » Title 45 » SUBCHAPTER A—GENERAL ADMINISTRATION › PART 46—PROTECTION OF HUMAN SUBJECTS › Subpart B—Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research

45 C.F.R. § 46.204

Research involving pregnant women or fetuses

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Pregnant women or fetuses may be involved in research if all of the following conditions are met:

(a) Where scientifically appropriate, preclinical studies, including studies on pregnant animals, and clinical studies, including studies on nonpregnant women, have been conducted and provide data for assessing potential risks to pregnant women and fetuses;

(b) The risk to the fetus is caused solely by interventions or procedures that hold out the prospect of direct benefit for the woman or the fetus; or, if there is no such prospect of benefit, the risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge which cannot be obtained by any other means;

(c) Any risk is the least possible for achieving the objectives of the research;

(d) If the research holds out the prospect of direct benefit to the pregnant woman, the prospect of a direct benefit both to the pregnant woman and the fetus, or no prospect of benefit for the woman nor the fetus when risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge that cannot be obtained by any other means, her consent is obtained in accord with the informed consent provisions of the pre-2018 Requirements or the 2018 Requirements, as applicable;

(e) If the research holds out the prospect of direct benefit solely to the fetus then the consent of the pregnant woman and the father is obtained in accord with the informed consent provisions of the pre-2018 Requirements or the 2018 Requirements, as applicable, except that the father's consent need not be obtained if he is unable to consent because of unavailability, incompetence, or temporary incapacity or the pregnancy resulted from rape or incest;

(f) Each individual providing consent under paragraph (d) or (e) of this section is fully informed regarding the reasonably foreseeable impact of the research on the fetus or neonate;

(g) For children as defined in § 46.402(a) who are pregnant, assent and permission are obtained in accord with the provisions of subpart D of this part;

(h) No inducements, monetary or otherwise, will be offered to terminate a pregnancy;

(i) Individuals engaged in the research will have no part in any decisions as to the timing, method, or procedures used to terminate a pregnancy; and

(j) Individuals engaged in the research will have no part in determining the viability of a neonate.

[66 FR 56778, Nov. 13, 2001, as amended at 89 FR 84825, Oct. 24, 2024]
Notes of Decisions
Cited in 12 cases, 1994–2020 · leading case: Sherley v. Sebelius, 644 F.3d 388 (D.C. Cir. 2011).
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Sherley v. Sebelius, 644 F.3d 388 (D.C. Cir. 2011). · cites it 8× “The Amendment's incorporation of 45 C.F.R. § 46.204 (b)—HHS's own regulation—relates to "[r]esearch involving pregnant women and fetuses," as section 46.”
James Sherley v. Kathleen Sebelius, 689 F.3d 776 (D.C. Cir. 2012). · cites it 2× “The Dickey-Wicker Amendment prohibits NIH from funding “(1) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed…”
Planned Parenthood of Grt TX v. Courtney Ph, 981 F.3d 347 (5th Cir. 2020). · cites it 2× “at § 289g-1(c)(4) (requiring researchers to certify that they “had no part in any decisions as to the timing, method, or procedures used to terminate the pregnancy made solely for the purposes of the research”); 45 C.F.R. § 46.204 (i) (requiring that “[i]ndividuals engaged” in…”
Planned Parenthood of Greater Tex. Fam. Plan. & Preventative Health Servs., Inc v. Smith, 913 F.3d 551 (5th Cir. 2019). · cites it 2× “§ 289g-1(c)(4) (requiring researchers to certify that they “had no part in any decisions as to the timing, method, or procedures used to terminate the pregnancy made solely for the purposes of the research”); 45 C.F.R. § 46.204 (i) (for research involving pregnant women or…”
Planned Parenthood of Greater Texas Fam. Plan. & Preventative Health Servs., Inc. v. Smith, 236 F. Supp. 3d 974 (W.D. Tex. 2017). · cites it 2× “Specifically, HHSC cites 45 C.F.R. § 46.204 as prohibiting researchers from performing abortions and.”
Sherley v. Sebelius, 704 F. Supp. 2d 63 (D.D.C. 2010). “The Dickey-Wicker Amendment provides that no federal funds shall be used for “research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in útero under 45 C.F.R. §…”
Sherley v. Sebelius, 776 F. Supp. 2d 1 (D.D.C. 2011). “” That Amendment, reenacted every year since 1996 without alteration, prohibits the NIH from funding: (1) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk…”
Doe v. Shalala, 862 F. Supp. 1421 (D. Maryland 1994). “See 45 C.F.R. § 46.204 (d). Because prior presidential administrations apparently chose not to appoint an EAB, no funding for such research had in fact been approved.”
Planned Parenthood of Grt TX v. Courtney Ph (5th Cir. 2020). · cites it 2× “14 The panel also held that the district court abused its discretion by reviewing the agency’s decision de novo rather than applying the arbitrary and capricious standard and by considering factual matters beyond those contained they “had no part in any decisions as to the…”
Planned Parenthood of Grt TX v. Courtney Ph (5th Cir. 2020). · cites it 2× “14 The panel also held that the district court abused its discretion by reviewing the agency’s decision de novo rather than applying the arbitrary and capricious standard and by considering factual matters beyond those contained they “had no part in any decisions as to the…”
Planned Parenthood of Grt TX v. Courtney Ph (5th Cir. 2020). · cites it 2× “14 The panel also held that the district court abused its discretion by reviewing the agency’s decision de novo rather than applying the arbitrary and capricious standard and by considering factual matters beyond those contained they “had no part in any decisions as to the…”
Sherley v. Sebelius (D.D.C. 2010). “The Dickey-Wicker Amendment provides that no federal funds shall be used for “research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 C.F.R. §…”
— 45 C.F.R. § 46.204(b) — 3 cases
Sherley v. Sebelius, 644 F.3d 388 (D.C. Cir. 2011). “The Amendment's incorporation of 45 C.F.R. § 46.204 (b)—HHS's own regulation—relates to "[r]esearch involving pregnant women and fetuses," as section 46.”
James Sherley v. Kathleen Sebelius, 689 F.3d 776 (D.C. Cir. 2012). “The Dickey-Wicker Amendment prohibits NIH from funding “(1) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed…”
Sherley v. Sebelius, 776 F. Supp. 2d 1 (D.D.C. 2011). “” That Amendment, reenacted every year since 1996 without alteration, prohibits the NIH from funding: (1) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk…”
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