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DOD D 3216.2

2002 Edition, March 25, 2002

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PROTECTION OF HUMAN SUBJECTS AND ADHERENCE TO ETHICAL STANDARDS IN DOD-SUPPORTED RESEARCH

Includes all amendments and changes through Change/Amendment , March 25, 2002


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Description / Abstract:

This Directive:

Applies to the Office of the Secretary of Defense, the Military Departments, the Chairman of the Joint Chiefs of 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 in the Department of Defense (hereafter referred to collectively as "the DoD Components").

Applies to research involving human subjects, as defined herein, conducted by a DoD Component (i.e., intramural) and other research that is supported by a DoD Component (i.e., extramural) through a contract, grant, cooperative agreement, or other arrangement.

Does not apply to the use of investigational new drugs, biological products, or devices for purposes of Force Health Protection. Such use is not research and is governed by DoD Directive 6200.2 (reference (d)).

Does not apply to accepted medical practice, including the use of investigational products in such practice, undertaken for purposes of treatment, not research. Such medical practice is not research and is not subject to this Directive.

PURPOSE. This Directive:

Reissues reference (a) to update policies for protecting the rights and welfare of humans as subjects of study in Department of Defense (DoD)-supported research, development, test and evaluation, and other related activities hereafter referred to as "research."

Implements 10 U.S.C. 980 (reference (b)).

Supports implementation of 32 CFR Part 219 (reference (c)), referred to as the "Common Rule."

Establishes other DoD policies for the ethical conduct of research.