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.

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Training

Information Resource Material Location
Human Research Protection Program (HRPP) Training and Education Guidance (March 23, 2013)
DoD Minimum Education Requirements DoD Memo Regarding Minimum Education Requirements
DON HRPP-Provided Online Training Access DON HRPP-provided training
Directions for online training – intramural

Directions for accessing Collaborative Institutional Training Initiative (CITI) - intramural existing users

Directions for accessing Collaborative Institutional Training Initiative (CITI) - intramural new users

Directions for online training – extramural

Directions for accessing CITI - extramural existing users

Directions for accessing CITI - extramural new users

Guidance

Information Resource Material Location
Handbook for DON Commands DON HRPP Handbook dtd 16 May 2015

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 (.pdf, 161KB)

32 CFR 219

DoD version of subpart A of 45 CFR 46

SECNAV Instruction 3900.39E

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)

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