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Section 46.101
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Definitions |
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Section 46.102
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Assuring compliance with this policy--research conducted or supported by any Federal Department or Agency |
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Section 46.103
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IRB membership |
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Section 46.107
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IRB functions and operations |
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Section 46.108
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IRB review of research |
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Section 46.109
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Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved |
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Section 46.110
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Criteria for IRB approval of research |
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Section 46.111
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Review by institution |
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Section 46.112
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Suspension or termination of IRB approval of research |
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Section 46.113
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Cooperative research |
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Section 46.114
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IRB records |
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Section 46.115
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General requirements for informed consent |
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Section 46.116
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Documentation of informed consent |
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Section 46.117
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Applications and proposals lacking definite plans for involvement of human subjects |
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Section 46.118
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Research undertaken without the intention of involving human subjects |
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Section 46.119
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Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal Department or |
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Section 46.120
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Use of Federal funds |
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Section 46.122
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Early termination of research support: Evaluation of applications and proposals |
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Section 46.123
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Conditions |
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Section 46.124
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To what do these regulations apply? |
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Section 46.201
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Definitions |
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Section 46.202
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Duties of IRBs in connection with research involving pregnant women, fetuses, and neonates |
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Section 46.203
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Research involving pregnant women or fetuses |
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Section 46.204
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Research involving neonates |
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Section 46.205
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Research involving, after delivery, the placenta, the dead fetus or fetal material |
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Section 46.206
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Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem |
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Section 46.207
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Applicability |
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Section 46.301
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Purpose |
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Section 46.302
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Definitions |
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Section 46.303
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Composition of Institutional Review Boards where prisoners are involved |
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Section 46.304
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Additional duties of the Institutional Review Boards where prisoners are involved |
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Section 46.305
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Permitted research involving prisoners |
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Section 46.306
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To what do these regulations apply? |
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Section 46.401
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Definitions |
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Section 46.402
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IRB duties |
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Section 46.403
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Research not involving greater than minimal risk |
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Section 46.404
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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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Section 46.405
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Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to |
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Section 46.406
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Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem |
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Section 46.407
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Requirements for permission by parents or guardians and for assent by children |
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Section 46.408
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Wards |
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Section 46.409
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What IRBs must be registered? |
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Section 46.501
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What information must be provided when registering an IRB? |
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Section 46.502
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When must an IRB be registered? |
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Section 46.503
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How must an IRB be registered? |
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Section 46.504
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When must IRB registration information be renewed or updated? |
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Section 46.505
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Authority |