Title 45

PART 46 SUBPART A

Subpart A - Basic HHS Policy for Protection of Human Research Subjects Source:82 FR 7259, 7273, Jan. 19, 2017, unless otherwise noted.

5 U.S.C. 301; 42 U.S.C. 289(a); 42 U.S.C. 300v-1(b).
Source:

45:1.0.1.1.26.1.1.1	SECTION 46.101	46.101 To what does this policy apply
45:1.0.1.1.26.1.1.2	SECTION 46.102	46.102 Definitions for purposes of this policy.
45:1.0.1.1.26.1.1.3	SECTION 46.103	46.103 Assuring compliance with this policy - research conducted or supported by any Federal department or agency.
45:1.0.1.1.26.1.1.4	SECTION 46.104	46.104 Exempt research.
45:1.0.1.1.26.1.1.5	SECTION 46.105-46.106	46.105-46.106 [Reserved]
45:1.0.1.1.26.1.1.6	SECTION 46.107	46.107 IRB membership.
45:1.0.1.1.26.1.1.7	SECTION 46.108	46.108 IRB functions and operations.
45:1.0.1.1.26.1.1.8	SECTION 46.109	46.109 IRB review of research.
45:1.0.1.1.26.1.1.9	SECTION 46.110	46.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.
45:1.0.1.1.26.1.1.10	SECTION 46.111	46.111 Criteria for IRB approval of research.
45:1.0.1.1.26.1.1.11	SECTION 46.112	46.112 Review by institution.
45:1.0.1.1.26.1.1.12	SECTION 46.113	46.113 Suspension or termination of IRB approval of research.
45:1.0.1.1.26.1.1.13	SECTION 46.114	46.114 Cooperative research.
45:1.0.1.1.26.1.1.14	SECTION 46.115	46.115 IRB records.
45:1.0.1.1.26.1.1.15	SECTION 46.116	46.116 General requirements for informed consent.
45:1.0.1.1.26.1.1.16	SECTION 46.117	46.117 Documentation of informed consent.
45:1.0.1.1.26.1.1.17	SECTION 46.118	46.118 Applications and proposals lacking definite plans for involvement of human subjects.
45:1.0.1.1.26.1.1.18	SECTION 46.119	46.119 Research undertaken without the intention of involving human subjects.
45:1.0.1.1.26.1.1.19	SECTION 46.120	46.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal department or agency.
45:1.0.1.1.26.1.1.20	SECTION 46.121	46.121 [Reserved]
45:1.0.1.1.26.1.1.21	SECTION 46.122	46.122 Use of Federal funds.
45:1.0.1.1.26.1.1.22	SECTION 46.123	46.123 Early termination of research support: Evaluation of applications and proposals.
45:1.0.1.1.26.1.1.23	SECTION 46.124	46.124 Conditions.