Part 97 - PROTECTION OF HUMAN SUBJECTS  


Subparts B-C [Reserved]
Subparts B–C [Reserved]
Subparts B-C [Reserved]
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.
§ 97.107 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]
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).

Source

56 FR 28012, 28021, June 18, 1991, unless otherwise noted.