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Required Training and References

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 Adobe Reader.

Training

Information Resource Material Location
DoD Minimum Education Requirements DoD Memo Regarding Minimum Education Requirements
DON HRPP-Provided Online Training Access DON HRPP-provided CITI training

References

Information Resource Material Location
10 USC 980 Limitations on the use of humans as experimental subjects
DoDI 3216.02 DoD's unique and additional requirements for protection of human subjects - Revision dtd 15 Apr 2020 (.pdf, 285KB)
32 CFR 219 DoD version of subpart A of 45 CFR 46
SECNAV Instruction 3900.39E CH-1 Secretary of the Navy Instruction: Human Research Protection Program (HRPP)
Marine Corps Order 3900.18 Marine Corps Commandant: Human Research Protection Program (HRPP)
Belmont Report Ethical principles that provide the foundation for the protection of human research subjects
45 CFR 46 Department of Health and Human Services (DHHS) regulations for the protection of human subjects, containing four (4) subparts
21 CFR 50 FDA regulations on informed consent in clinical investigations
21 CFR 56 FDA regulations on the composition, operation, and responsibility of an Institutional Review Board (IRB)
21 CFR 312 FDA regulations on investigational new drugs
21 CFR 600 FDA regulations on biologics
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)