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Code of Federal Regulations Title 34
Department of Education
PART 97 - Protection of Human Subjects


Subpart A--Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects)

97.101 To what does this policy apply?
97.102 Definitions.
97.103 Assuring compliance with this policy -- research conducted or supported by any Federal Department or Agency.
97.104 - 97.106 [Reserved]
97.107 IRB membership.
97.108 IRB functions and operations.
97.109 IRB review of research.
97.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.
97.111 Criteria for IRB approval of research.
97.112 Review by institution.
97.113 Suspension or termination of IRB approval of research.
97.114 Cooperative research.
97.115 IRB records.
97.116 General requirements for informed consent.
97.117 Documentation of informed consent.
97.118 Applications and proposals lacking definite plans for involvement of human subjects.
97.119 Research undertaken without the intention of involving human subjects.
97.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal Department or Agency.
97.121 [Reserved]
97.122 Use of Federal funds.
97.123 Early termination of research support: Evaluation of applications and proposals.
97.124 Conditions.

Subpart B--[Reserved]

Subpart C--[Reserved]

Subpart D--Additional ED Protections for Children Who are Subjects in Research

97.401 To what do these regulations apply?
97.402 Definitions.
97.403 IRB duties.
97.404 Research not involving greater than minimal risk.
97.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects.
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.
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.
97.408 Requirements for permission by parents or guardians and for assent by children.
97.409 Wards.

Authority: 5 U.S.C. 301; 20 U.S.C. 1221e-3, 3474; 42 U.S.C. 300v-1(b).

Link to Protection of Human Subjects Page

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Last Modified: 10/24/2005