Title 49

PART 11

Part 11 - Protection Of Human Subjects

PART 11 - PROTECTION OF HUMAN SUBJECTS Authority:5 U.S.C. 301; 42 U.S.C. 300v-1(b). Source:82 FR 7274, Jan. 19, 2017, unless otherwise noted.

49:1.0.1.1.9.0.3.1SECTION 11.101
   11.101 To what does this policy apply
49:1.0.1.1.9.0.3.2SECTION 11.102
   11.102 Definitions for purposes of this policy.
49:1.0.1.1.9.0.3.3SECTION 11.103
   11.103 Assuring compliance with this policy - research conducted or supported by any Federal department or agency.
49:1.0.1.1.9.0.3.4SECTION 11.104
   11.104 Exempt research.
49:1.0.1.1.9.0.3.5SECTION 11.105-11.106
   11.105-11.106 [Reserved]
49:1.0.1.1.9.0.3.6SECTION 11.107
   11.107 IRB membership.
49:1.0.1.1.9.0.3.7SECTION 11.108
   11.108 IRB functions and operations.
49:1.0.1.1.9.0.3.8SECTION 11.109
   11.109 IRB review of research.
49:1.0.1.1.9.0.3.9SECTION 11.110
   11.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.
49:1.0.1.1.9.0.3.10SECTION 11.111
   11.111 Criteria for IRB approval of research.
49:1.0.1.1.9.0.3.11SECTION 11.112
   11.112 Review by Institution
49:1.0.1.1.9.0.3.12SECTION 11.113
   11.113 Suspension or Termination of IRB Approval of Research.
49:1.0.1.1.9.0.3.13SECTION 11.114
   11.114 Cooperative Research.
49:1.0.1.1.9.0.3.14SECTION 11.115
   11.115 IRB Records.
49:1.0.1.1.9.0.3.15SECTION 11.116
   11.116 General Requirements for Informed Consent.
49:1.0.1.1.9.0.3.16SECTION 11.117
   11.117 Documentation of informed consent.
49:1.0.1.1.9.0.3.17SECTION 11.118
   11.118 Applications and proposals lacking definite plans for involvement of human subjects.
49:1.0.1.1.9.0.3.18SECTION 11.119
   11.119 Research undertaken without the intention of involving human subjects.
49:1.0.1.1.9.0.3.19SECTION 11.120
   11.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal department or agency.
49:1.0.1.1.9.0.3.20SECTION 11.121
   11.121 [Reserved]
49:1.0.1.1.9.0.3.21SECTION 11.122
   11.122 Use of Federal funds.
49:1.0.1.1.9.0.3.22SECTION 11.123
   11.123 Early termination of research support: Evaluation of applications and proposals.
49:1.0.1.1.9.0.3.23SECTION 11.124
   11.124 Conditions.