Part 11 — Protection of Human Subjects
Current through Sep 25, 2026
Authority: 5 U.S.C. 301; 42 U.S.C. 300v-1(b).
Source: 82 FR 7274, Jan. 19, 2017, unless otherwise noted.
Sections
- § 11.101 To what does this policy apply?
- § 11.102 Definitions for purposes of this policy.
- § 11.103 Assuring compliance with this policy—research conducted or supported by any Federal department or agency.
- § 11.104 Exempt research.
- §§ 11.105-11.106 [Reserved]
- § 11.107 IRB membership.
- § 11.108 IRB functions and operations.
- § 11.109 IRB review of research.
- § 11.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.
- § 11.111 Criteria for IRB approval of research.
- § 11.112 Review by Institution
- § 11.113 Suspension or Termination of IRB Approval of Research.
- § 11.114 Cooperative Research.
- § 11.115 IRB Records.
- § 11.116 General Requirements for Informed Consent.
- § 11.117 Documentation of informed consent.
- § 11.118 Applications and proposals lacking definite plans for involvement of human subjects.
- § 11.119 Research undertaken without the intention of involving human subjects.
- § 11.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal department or agency.
- § 11.121 [Reserved]
- § 11.122 Use of Federal funds.
- § 11.123 Early termination of research support: Evaluation of applications and proposals.
- § 11.124 Conditions.