4.  POLICY. It is DoD policy that:

a.  All research involving human subjects that is conducted or supported by the Department of Defense shall comply with part 219 of Reference (c), which incorporates the ethical principles of respect for persons, beneficence, and justice, as codified in page 23192 of the Federal Register (also known as “The Belmont Report” (Reference (e)).

b.  Certain categories of human subjects in research are recognized as vulnerable populations, groups, or individuals and are afforded additional protections as specified in section 7 of Enclosure 3 of this Instruction.

c.  Research involving human subjects for testing of chemical or biological warfare agents is generally prohibited by section 1520a of title 50, United States Code (U.S.C.) (Reference (f)), subject to possible exceptions for research for prophylactic, protective, or other peaceful purposes.

d.  DoD-appropriated funds shall not be used to support research involving a human being as an experimental subject, as defined in this Instruction, without the prior informed consent of the experimental subject or in accordance with section 980 of title 10, U.S.C. (Reference (g)) and this Instruction (see section 9 of Enclosure 3 of this Instruction for details). The definitions of research involving a human being as an experimental subject and research involving human subjects are different; see the Glossary for an explanation.

e.  Research involving human subjects covered under this Instruction shall also comply with applicable Federal and State laws and regulations. When the research is conducted outside of the United States, it must also comply with applicable requirements of the foreign country and its national laws and requirements. In the event of an unresolved conflict between this Instruction, including its references, and other applicable laws and requirements such that compliance with both is impossible, the requirements most protective of the human subjects shall be followed. When there is an unresolved conflict, DoD Components shall consult with legal counsel and seek guidance from the Assistant Secretary of Defense for Research and Engineering (ASD(R&E)).

5.  RESPONSIBILITIES. See Enclosure 2.

6.  PROCEDURES. See Enclosure 3.

7.  RELEASABILITY. UNLIMITED. This Instruction is approved for public release and is available on the Internet from the DoD Issuances Website at http://www.dtic.mil/whs/directives.

8.  EFFECTIVE DATE. This Instruction is effective upon its publication to the DoD Issuances Website.



1. References

2. Responsibilities

3. Procedures


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