Title 6

PART 46

Part 46 - Protection Of Human Subjects

PART 46 - PROTECTION OF HUMAN SUBJECTS Authority:5 U.S.C. 301; Pub. L. 107-296, sec. 102, 306(c); Pub. L. 108-458, sec. 8306. Source:82 FR 7269, Jan. 19, 2017, unless otherwise noted.

6:1.0.1.1.17.0.1.1SECTION 46.101
   46.101 To what does this policy apply
6:1.0.1.1.17.0.1.2SECTION 46.102
   46.102 Definitions for purposes of this policy.
6:1.0.1.1.17.0.1.3SECTION 46.103
   46.103 Assuring compliance with this policy - research conducted or supported by any Federal department or agency.
6:1.0.1.1.17.0.1.4SECTION 46.104
   46.104 Exempt research.
6:1.0.1.1.17.0.1.5SECTION 46.105-46.106
   46.105-46.106 [Reserved]
6:1.0.1.1.17.0.1.6SECTION 46.107
   46.107 IRB membership.
6:1.0.1.1.17.0.1.7SECTION 46.108
   46.108 IRB functions and operations.
6:1.0.1.1.17.0.1.8SECTION 46.109
   46.109 IRB review of research.
6:1.0.1.1.17.0.1.9SECTION 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.
6:1.0.1.1.17.0.1.10SECTION 46.111
   46.111 Criteria for IRB approval of research.
6:1.0.1.1.17.0.1.11SECTION 46.112
   46.112 Review by institution
6:1.0.1.1.17.0.1.12SECTION 46.113
   46.113 Suspension or termination of IRB approval of research.
6:1.0.1.1.17.0.1.13SECTION 46.114
   46.114 Cooperative research.
6:1.0.1.1.17.0.1.14SECTION 46.115
   46.115 IRB records.
6:1.0.1.1.17.0.1.15SECTION 46.116
   46.116 General requirements for informed consent.
6:1.0.1.1.17.0.1.16SECTION 46.117
   46.117 Documentation of informed consent.
6:1.0.1.1.17.0.1.17SECTION 46.118
   46.118 Applications and proposals lacking definite plans for involvement of human subjects.
6:1.0.1.1.17.0.1.18SECTION 46.119
   46.119 Research undertaken without the intention of involving human subjects.
6:1.0.1.1.17.0.1.19SECTION 46.120
   46.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal department or agency.
6:1.0.1.1.17.0.1.20SECTION 46.121
   46.121 [Reserved]
6:1.0.1.1.17.0.1.21SECTION 46.122
   46.122 Use of Federal funds.
6:1.0.1.1.17.0.1.22SECTION 46.123
   46.123 Early termination of research support: Evaluation of applications and proposals.
6:1.0.1.1.17.0.1.23SECTION 46.124
   46.124 Conditions.