2003 CFR Title 45, Volume 1

Title 45--Public Welfare SUBTITLE A--DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 46--PROTECTION OF HUMAN SUBJECTS
	46.101	To what does this policy apply?
	46.102	Definitions.
	46.103	Assuring compliance with this policy--research conducted or supported by any Federal Department or Agency.
	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.
	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.
	46.301	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.
	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.