34 CFR 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.
- § 97.107— 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.
- § 97.122— Use of Federal funds.
- § 97.123— Early termination of research support: Evaluation of applications and proposals.
- § 97.124— Conditions.
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.