Required Training and References
In response to a Department of Defense (DoD)-wide initiative to raise awareness of and improve compliance with human research protections, Department of Navy (DoN) personnel, DoD/DoN collaborators and DoN extramural performers have initial and continuing research protections training standards to maintain.
Documents on this page with a .pdf extension, may require the Adobe Reader.
Training
References
| Information |
Resource Material Location |
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10 USC 980
|
Limitations on the use of humans as experimental subjects
|
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DoDI 3216.02
|
DoD's unique and additional requirements for protection of human subjects (.pdf, 161KB)
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32 CFR 219
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DoD version of subpart A of 45 CFR 46
|
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SECNAV Instruction 3900.39D
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Secretary of the Navy Instruction: Human Research Protection Program (HRPP)
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Marine Corps Order 3900.18
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Marine Corps Commandant: Human Research Protection Program (HRPP)
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Belmont Report
|
Ethical principles that provide the foundation for the protection of human research subjects
|
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45 CFR 46
|
Department of Health and Human Services (DHHS) regulations for the protection of human subjects, containing four (4) subparts
|
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21 CFR 50
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FDA regulations on informed consent in clinical investigations
|
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21 CFR 56
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FDA regulations on the composition, operation, and responsibility of an Institutional Review Board (IRB)
|
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21 CFR 312
|
FDA regulations on investigational new drugs
|
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21 CFR 600
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FDA regulations on biologics
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21 CFR 812
|
FDA regulations on investigational devices
|
|
63 FR Nov 1998
|
Categories of minimal risk research eligible for expedited review
|
| DODD 6200.02 |
Application of Food and Drug Administration (FDA) Rules to Department of Defense Force Health Protection Programs (.pdf, 3.48KB) |
| DODI 3210.7 |
DoD's policy on research integrity and misconduct (.pdf) |