Department of Defense
INSTRUCTION
NUMBER 3216.02
November 8, 2011
USD(AT&L)
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)).
