Subpart A—Basic HHS Policy for Protection of Human Research Subjects

Sections

• § 46.101
  § 46.101 To what does this policy apply?
• § 46.102
  § 46.102 Definitions for purposes of this policy.
• § 46.103
  § 46.103 Assuring compliance with this policy—research conducted or supported by any Federal department or agency.
• § 46.104
  § 46.104 Exempt research.
• § 46.105-46.106
  § 46.105-46.106 [Reserved]
• § 46.107
  § 46.107 IRB membership.
• § 46.108
  § 46.108 IRB functions and operations.
• § 46.109
  § 46.109 IRB review of research.
• § 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.
• § 46.111
  § 46.111 Criteria for IRB approval of research.
• § 46.112
  § 46.112 Review by institution.
• § 46.113
  § 46.113 Suspension or termination of IRB approval of research.
• § 46.114
  § 46.114 Cooperative research.
• § 46.115
  § 46.115 IRB records.
• § 46.116
  § 46.116 General requirements for informed consent.
• § 46.117
  § 46.117 Documentation of informed consent.
• § 46.118
  § 46.118 Applications and proposals lacking definite plans for involvement of human subjects.
• § 46.119
  § 46.119 Research undertaken without the intention of involving human subjects.
• § 46.120
  § 46.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal department or agency.
• § 46.121
  § 46.121 [Reserved]
• § 46.122
  § 46.122 Use of Federal funds.
• § 46.123
  § 46.123 Early termination of research support: Evaluation of applications and proposals.
• § 46.124
  § 46.124 Conditions.