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Electronic Code of Federal Regulations

blue pill

e-CFR Data is current as of July 24, 2014

TITLE 34—Education

Subtitle A—OFFICE OF THE SECRETARY, DEPARTMENT OF EDUCATION

PART 97—PROTECTION OF HUMAN SUBJECTS

rule

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.
rule

Subparts B-C [Reserved]

rule

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.


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