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Code of Federal Regulations (Last Updated: April 5, 2024) |
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Title 34 - Education |
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Subtitle A - Office of the Secretary, Department of Education |
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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 for purposes of this policy. |
| § 97.103 - Assuring compliance with this policy - research conducted or supported by any Federal Department or Agency. |
| § 97.104 - Exempt research. |
| § 97.105 - [Reserved] |
| § 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. |
| §§ 97.104--97.106 - [Reserved] |
| Subparts B--C - XXX |
| 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. |
| § 97.407 - 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. |