Part 46 - Protection of Human Subjects  


Subpart A - Basic HHS Policy for Protection of Human Research Subjects
§ 46.101 - To what does this policy apply?
§ 46.102 - Definitions for purposes of this policy.
§ 46.103 - Assuring compliance with this policy - research conducted or supported by any Federal Department or Agency.
§ 46.104 - Exempt research.
§ 46.107 - IRB membership.
§ 46.108 - IRB functions and operations.
§ 46.109 - IRB review of research.
§ 46.110 - Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.
§ 46.111 - Criteria for IRB approval of research.
§ 46.112 - Review by institution.
§ 46.113 - Suspension or termination of IRB approval of research.
§ 46.114 - Cooperative research.
§ 46.115 - IRB records.
§ 46.116 - General requirements for informed consent.
§ 46.117 - Documentation of informed consent.
§ 46.118 - Applications and proposals lacking definite plans for involvement of human subjects.
§ 46.119 - Research undertaken without the intention of involving human subjects.
§ 46.120 - Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal Department or Agency.
§ 46.121 - [Reserved]
§ 46.122 - Use of Federal funds.
§ 46.123 - Early termination of research support: Evaluation of applications and proposals.
§ 46.124 - Conditions.
§§ 46.104--46.106 - [Reserved]
§§ 46.105--46.106 - [Reserved]
Subpart B - Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
§ 46.201 - To what do these regulations apply?
§ 46.202 - Definitions.
§ 46.203 - Duties of IRBs in connection with research involving pregnant women, fetuses, and neonates.
§ 46.204 - Research involving pregnant women or fetuses.
§ 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.
§ 46.208 - Activities directed toward fetuses in utero as subjects.
§ 46.209 - Activities directed toward fetuses ex utero, including nonviable fetuses, as subjects.
§ 46.210 - Activities involving the dead fetus, fetal material, or the placenta.
§ 46.211 - Modification or waiver of specific requirements.
Subpart C - Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
§ 46.301 - Applicability.
§ 46.302 - Purpose.
§ 46.303 - Definitions.
§ 46.304 - Composition of Institutional Review Boards where prisoners are involved.
§ 46.305 - Additional duties of the Institutional Review Boards where prisoners are involved.
§ 46.306 - Permitted research involving prisoners.
Subpart D - Additional Protections for Children Involved as Subjects in Research
§ 46.401 - To what do these regulations apply?
§ 46.402 - Definitions.
§ 46.403 - IRB duties.
§ 46.404 - Research not involving greater than minimal risk.
§ 46.405 - Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects.
§ 46.406 - Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition.
§ 46.407 - Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.
§ 46.408 - Requirements for permission by parents or guardians and for assent by children.
§ 46.409 - Wards.
Subpart E - Registration of Institutional Review Boards
§ 46.501 - What IRBs must be registered?
§ 46.502 - What information must be provided when registering an IRB?
§ 46.503 - When must an IRB be registered?
§ 46.504 - How must an IRB be registered?
§ 46.505 - When must IRB registration information be renewed or updated?