Title 16

PART 1028

Part 1028 - Protection Of Human Subjects

PART 1028 - PROTECTION OF HUMAN SUBJECTS Authority:5 U.S.C. 301; 42 U.S.C. 300v-1(b). Source:82 FR 43460, Sept. 18, 2017, unless otherwise noted.

16:2.0.1.1.17.0.1.1SECTION 1028.101
   1028.101 To what does this policy apply
16:2.0.1.1.17.0.1.2SECTION 1028.102
   1028.102 Definitions for purposes of this policy.
16:2.0.1.1.17.0.1.3SECTION 1028.103
   1028.103 Assuring compliance with this policy - research conducted or supported by any Federal department or agency.
16:2.0.1.1.17.0.1.4SECTION 1028.104
   1028.104 Exempt research.
16:2.0.1.1.17.0.1.5SECTION 1028.105-1028.106
   1028.105-1028.106 [Reserved]
16:2.0.1.1.17.0.1.6SECTION 1028.107
   1028.107 IRB membership.
16:2.0.1.1.17.0.1.7SECTION 1028.108
   1028.108 IRB functions and operations.
16:2.0.1.1.17.0.1.8SECTION 1028.109
   1028.109 IRB review of research.
16:2.0.1.1.17.0.1.9SECTION 1028.110
   1028.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.
16:2.0.1.1.17.0.1.10SECTION 1028.111
   1028.111 Criteria for IRB approval of research.
16:2.0.1.1.17.0.1.11SECTION 1028.112
   1028.112 Review by institution.
16:2.0.1.1.17.0.1.12SECTION 1028.113
   1028.113 Suspension or termination of IRB approval of research.
16:2.0.1.1.17.0.1.13SECTION 1028.114
   1028.114 Cooperative research.
16:2.0.1.1.17.0.1.14SECTION 1028.115
   1028.115 IRB Records.
16:2.0.1.1.17.0.1.15SECTION 1028.116
   1028.116 General requirements for informed consent.
16:2.0.1.1.17.0.1.16SECTION 1028.117
   1028.117 Documentation of informed consent.
16:2.0.1.1.17.0.1.17SECTION 1028.118
   1028.118 Applications and proposals lacking definite plans for involvement of human subjects.
16:2.0.1.1.17.0.1.18SECTION 1028.119
   1028.119 Research undertaken without the intention of involving human subjects.
16:2.0.1.1.17.0.1.19SECTION 1028.120
   1028.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal department or agency.
16:2.0.1.1.17.0.1.20SECTION 1028.121
   1028.121 [Reserved]
16:2.0.1.1.17.0.1.21SECTION 1028.122
   1028.122 Use of Federal funds.
16:2.0.1.1.17.0.1.22SECTION 1028.123
   1028.123 Early termination of research support: Evaluation of applications and proposals.
16:2.0.1.1.17.0.1.23SECTION 1028.124
   1028.124 Conditions