Department of Defense
INSTRUCTION

NUMBER 3216.02
November 8, 2011
USD(AT&L)

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SUBJECT:    Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research

References: See Enclosure 1

1.  PURPOSE. This Instruction reissues DoD Directive (DoDD) 3216.02 (Reference (a)) as a DoD Instruction in accordance with the authority in DoDD 5134.01 (Reference (b)) to establish policy and assign responsibilities for the protection of human subjects in DoD-supported programs to implement part 219 of title 32, Code of Federal Regulations (CFR) (also known and hereinafter referred to as “the Common Rule” (Reference (c)).

2.  APPLICABILITY

a.  This Instruction applies to:

(1)  OSD, the Military Departments, the Office of the Chairman of the Joint Chiefs of Staff and the Joint Staff, the Combatant Commands, the Office of the Inspector General of the Department of Defense, the Defense Agencies, the DoD Field Activities, and all other organizational entities within the Department of Defense (hereinafter referred to collectively as the “DoD Components”).

(2)  All DoD-conducted or -supported research involving human subjects as defined in the Glossary. All such activities must include both systematic investigation designed to develop or contribute to generalizable knowledge AND involve a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual or about whom identifiable private information is obtained. All activities meeting both of these conditions will hereinafter be referred to as “research involving human subjects” in this Instruction.

(3)  Activities such as research, development, testing, and evaluation (RDT&E) that meet the definition of research involving human subjects (as defined in the Glossary), as well as clinical investigations or medical activities regulated by the Food and Drug Administration (FDA) in parts 50, 56, 312, 600, and 812 of title 21, CFR (Reference (d)). DoDI 3216.02, November 8, 2011

b.  Applicability is not dependent upon the budget activities funding the research, the mission of the DoD organization conducting or supporting the research, the security classification of the research, the location of the research in the United States or a foreign country, or whether the research is conducted or supported under a program that is not considered research for other purposes.

3.  DEFINITIONS. See Glossary.



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