Title 34

PART 97

Part 97 - Protection Of Human Subjects

PART 97 - PROTECTION OF HUMAN SUBJECTS Authority:5 U.S.C. 301; 20 U.S.C. 1221e-3, 3474; 42 U.S.C. 300v-1(b). Source:56 FR 28012, 28021, June 18, 1991, unless otherwise noted.

34:1.1.1.1.31.1SUBPART A
Subpart A - Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects)
34:1.1.1.1.31.1.121.1SECTION 97.101
   97.101 To what does this policy apply
34:1.1.1.1.31.1.121.2SECTION 97.102
   97.102 Definitions for purposes of this policy.
34:1.1.1.1.31.1.121.3SECTION 97.103
   97.103 Assuring compliance with this policy - research conducted or supported by any Federal department or agency.
34:1.1.1.1.31.1.121.4SECTION 97.104
   97.104 Exempt research.
34:1.1.1.1.31.1.121.5SECTION 97-97.106
   97-97.106 [Reserved]
34:1.1.1.1.31.1.121.6SECTION 97.107
   97.107 IRB membership.
34:1.1.1.1.31.1.121.7SECTION 97.108
   97.108 IRB functions and operations.
34:1.1.1.1.31.1.121.8SECTION 97.109
   97.109 IRB review of research.
34:1.1.1.1.31.1.121.9SECTION 97.110
   97.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.
34:1.1.1.1.31.1.121.10SECTION 97.111
   97.111 Criteria for IRB approval of research.
34:1.1.1.1.31.1.121.11SECTION 97.112
   97.112 Review by Institution
34:1.1.1.1.31.1.121.12SECTION 97.113
   97.113 Suspension or Termination of IRB Approval of Research.
34:1.1.1.1.31.1.121.13SECTION 97.114
   97.114 Cooperative Research.
34:1.1.1.1.31.1.121.14SECTION 97.115
   97.115 IRB Records.
34:1.1.1.1.31.1.121.15SECTION 97.116
   97.116 General Requirements for Informed Consent.
34:1.1.1.1.31.1.121.16SECTION 97.117
   97.117 Documentation of informed consent.
34:1.1.1.1.31.1.121.17SECTION 97.118
   97.118 Applications and proposals lacking definite plans for involvement of human subjects.
34:1.1.1.1.31.1.121.18SECTION 97.119
   97.119 Research undertaken without the intention of involving human subjects.
34:1.1.1.1.31.1.121.19SECTION 97.120
   97.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal department or agency.
34:1.1.1.1.31.1.121.20SECTION 97.121
   97.121 [Reserved]
34:1.1.1.1.31.1.121.21SECTION 97.122
   97.122 Use of Federal funds.
34:1.1.1.1.31.1.121.22SECTION 97.123
   97.123 Early termination of research support: Evaluation of applications and proposals.
34:1.1.1.1.31.1.121.23SECTION 97.124
   97.124 Conditions.
34:1.1.1.1.31.2SUBPART B
Subparts B-C [Reserved]
34:1.1.1.1.31.3SUBPART D
Subpart D - Additional ED Protections for Children Who Are Subjects in Research
34:1.1.1.1.31.3.121.1SECTION 97.401
   97.401 To what do these regulations apply
34:1.1.1.1.31.3.121.2SECTION 97.402
   97.402 Definitions.
34:1.1.1.1.31.3.121.3SECTION 97.403
   97.403 IRB duties.
34:1.1.1.1.31.3.121.4SECTION 97.404
   97.404 Research not involving greater than minimal risk.
34:1.1.1.1.31.3.121.5SECTION 97.405
   97.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects.
34:1.1.1.1.31.3.121.6SECTION 97.406
   97.406 Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition.
34:1.1.1.1.31.3.121.7SECTION 97.407
   97.407 Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.
34:1.1.1.1.31.3.121.8SECTION 97.408
   97.408 Requirements for permission by parents or guardians and for assent by children.
34:1.1.1.1.31.3.121.9SECTION 97.409
   97.409 Wards.