Reference:USA 45 CFR Part 46 09-Apr-2025 Subpart B
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| Document information | |
|---|---|
| Reference | USA 45 CFR Part 46 09-Apr-2025 |
| Validity area | USA |
| Scope(s) | G |
| Document name | 45 CFR Part 46 |
| Version / Revision | 09-Apr-2025 |
| Status | Current |
| Document type | Legal act |
| Language(s) | EN |
| Description | Title 45âPublic Welfare
Subtitle AâDepartment of Health and Human Services Subchapter AâGeneral Administration Part 46 Protection of Human Subjects https://www.ecfr.gov/current/title-45 |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Scope | G |
| Document part | Subpart B |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags (EN) | |
| Tags (original language) | |
| Tags (FR) | |
| Comment | Additional protections for pregnant women, fetuses and neonates |
Content
Subpart BâAdditional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research [âŚ] § 46.203 Duties of IRBs in connection with research involving pregnant women, fetuses, and neonates. [âŚ] § 46.204 Research involving pregnant women or fetuses. [...] (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; [...] (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; [...] (j) Individuals engaged in the research will have no part in determining the viability of a neonate. [...] § 46.205 Research involving neonates. [...] § 46.206 Research involving, after delivery, the placenta, the dead fetus or fetal material. [...] § 46.207 Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates. [...]
