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Title 45

Displaying title 45, up to date as of 7/09/2026. Title 45 was last amended 7/02/2026.
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Title 45Public WelfarePart / Section
Subtitle ADepartment of Health and Human Services1 – 199
Subchapter AGeneral Administration1 – 102
Part 46Protection of Human Subjects46.101 – 46.505
Subpart ABasic HHS Policy for Protection of Human Research Subjects46.101 – 46.124
Subpart BAdditional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research46.201 – 46.207
§ 46.201To what do these regulations apply?
§ 46.202Definitions.
§ 46.203Duties of IRBs in connection with research involving pregnant women, fetuses, and neonates.
§ 46.204Research involving pregnant women or fetuses.
§ 46.205Research involving neonates.
§ 46.206Research involving, after delivery, the placenta, the dead fetus or fetal material.
§ 46.207Research 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.
Subpart CAdditional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects46.301 – 46.306
§ 46.301Applicability.
§ 46.302Purpose.
§ 46.303Definitions.
§ 46.304Composition of Institutional Review Boards where prisoners are involved.
§ 46.305Additional duties of the Institutional Review Boards where prisoners are involved.
§ 46.306Permitted research involving prisoners.
Subpart DAdditional Protections for Children Involved as Subjects in Research46.401 – 46.409
Subpart ERegistration of Institutional Review Boards46.501 – 46.505
§ 46.501What IRBs must be registered?
§ 46.502What information must be provided when registering an IRB?
§ 46.503When must an IRB be registered?
§ 46.504How must an IRB be registered?
§ 46.505When must IRB registration information be renewed or updated?