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FEDERAL · 45 CFR

Part 46 — Protection of Human Subjects

50 sections · Title 45: Public Welfare

§ 46.101To what does this policy apply?
§ 46.102Definitions for purposes of this policy.
§ 46.103Assuring compliance with this policy—research conducted or supported by any Federal department or agency.
§ 46.104Exempt research.
§ 46.105-46.106§ 46.105-46.106 [Reserved]
§ 46.107IRB membership.
§ 46.108IRB functions and operations.
§ 46.109IRB review of research.
§ 46.110Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.
§ 46.111Criteria for IRB approval of research.
§ 46.112Review by institution.
§ 46.113Suspension or termination of IRB approval of research.
§ 46.114Cooperative research.
§ 46.115IRB records.
§ 46.116General requirements for informed consent.
§ 46.117Documentation of informed consent.
§ 46.118Applications and proposals lacking definite plans for involvement of human subjects.
§ 46.119Research undertaken without the intention of involving human subjects.
§ 46.120Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal department or agency.
§ 46.121§ 46.121 [Reserved]
§ 46.122Use of Federal funds.
§ 46.123Early termination of research support: Evaluation of applications and proposals.
§ 46.124Conditions.
§ 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.
§ 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.
§ 46.401To what does this subpart apply?
§ 46.402Definitions.
§ 46.403IRB duties.
§ 46.404Research not involving greater than minimal risk.
§ 46.405Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects.
§ 46.406Research 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.
§ 46.407Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.
§ 46.408Requirements for permission by parents or guardians and for assent by children.
§ 46.409Wards.
§ 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?