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.
- § 46.122— Use of Federal funds.
- § 46.123— Early termination of research support: Evaluation of applications and proposals.
- § 46.124— Conditions.
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.
Subpart C — Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
Subpart D — Additional Protections for Children Involved as Subjects in Research
- § 46.401— To what does this subpart 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.