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.
§ 97.406 - 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.