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.

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

16:2.0.1.1.17.0.1.1	SECTION 1028.101	1028.101 To what does this policy apply
16:2.0.1.1.17.0.1.2	SECTION 1028.102	1028.102 Definitions for purposes of this policy.
16:2.0.1.1.17.0.1.3	SECTION 1028.103	1028.103 Assuring compliance with this policy - research conducted or supported by any Federal department or agency.
16:2.0.1.1.17.0.1.4	SECTION 1028.104	1028.104 Exempt research.
16:2.0.1.1.17.0.1.5	SECTION 1028.105-1028.106	1028.105-1028.106 [Reserved]
16:2.0.1.1.17.0.1.6	SECTION 1028.107	1028.107 IRB membership.
16:2.0.1.1.17.0.1.7	SECTION 1028.108	1028.108 IRB functions and operations.
16:2.0.1.1.17.0.1.8	SECTION 1028.109	1028.109 IRB review of research.
16:2.0.1.1.17.0.1.9	SECTION 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.
16:2.0.1.1.17.0.1.10	SECTION 1028.111	1028.111 Criteria for IRB approval of research.
16:2.0.1.1.17.0.1.11	SECTION 1028.112	1028.112 Review by institution.
16:2.0.1.1.17.0.1.12	SECTION 1028.113	1028.113 Suspension or termination of IRB approval of research.
16:2.0.1.1.17.0.1.13	SECTION 1028.114	1028.114 Cooperative research.
16:2.0.1.1.17.0.1.14	SECTION 1028.115	1028.115 IRB Records.
16:2.0.1.1.17.0.1.15	SECTION 1028.116	1028.116 General requirements for informed consent.
16:2.0.1.1.17.0.1.16	SECTION 1028.117	1028.117 Documentation of informed consent.
16:2.0.1.1.17.0.1.17	SECTION 1028.118	1028.118 Applications and proposals lacking definite plans for involvement of human subjects.
16:2.0.1.1.17.0.1.18	SECTION 1028.119	1028.119 Research undertaken without the intention of involving human subjects.
16:2.0.1.1.17.0.1.19	SECTION 1028.120	1028.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal department or agency.
16:2.0.1.1.17.0.1.20	SECTION 1028.121	1028.121 [Reserved]
16:2.0.1.1.17.0.1.21	SECTION 1028.122	1028.122 Use of Federal funds.
16:2.0.1.1.17.0.1.22	SECTION 1028.123	1028.123 Early termination of research support: Evaluation of applications and proposals.
16:2.0.1.1.17.0.1.23	SECTION 1028.124	1028.124 Conditions