34 C.F.R. PART 97--PROTECTION OF HUMAN SUBJECTS
TITLE 34--Education
Subtitle A--OFFICE OF THE SECRETARY, DEPARTMENT OF EDUCATION
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)
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| To what does this policy apply?
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| Assuring compliance with this policy--research conducted or supported by any Federal Department or Agency.
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| IRB functions and operations.
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| Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.
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| Criteria for IRB approval of research.
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| Suspension or termination of IRB approval of research.
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| General requirements for informed consent.
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| Documentation of informed consent.
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| Applications and proposals lacking definite plans for involvement of human subjects.
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| Research undertaken without the intention of involving human subjects.
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| Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal Department or Agency.
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| Early termination of research support: Evaluation of applications and proposals.
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Subparts B-C--[RESERVED]
Subpart D--ADDITIONAL ED PROTECTIONS FOR CHILDREN WHO ARE SUBJECTS IN RESEARCH
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| To what do these regulations apply?
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| Research not involving greater than minimal risk.
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| Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects.
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| 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.
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| Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.
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| Requirements for permission by parents or guardians and for assent by children.
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