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DEFENSE INTELLIGENCE AGENCY 5W
WASHINGTON. D.C. 20340- 0001
S-64,027/PAG-TA
MEMORANDUM FOR THE DIRECTOR, ENVIRONMENTAL AND LIFE SCIENCES, OFFICE OF THE
DIRECTOR, DEFENSE RESEARCH AND ENGINEERING
SUBJECT: Protection of Human Subjects in Research (U)
Reference: OAASD Memorandum, 17 February 1994, subject as above.
1. (S/NF) The Defense Intelligence Agency has determined that only one of
its program's, Project STAR GATE, falls within the definition of human subject
research. This research is conducted in two areas: in-house investigations
conducted by DIA civilian personnel and external research activities conducted
under DIA contract with the Science Applications International Corporation
(SAIC).
2. (C/NF) Both the DIA and DoD General Counsels have determined that the
STAR GATE Project constitutes experimentation on human subjects. As required
by Procedure 13 of DoD Directive 5240.1-R, approval for project activities has
been granted by the Deputy Secretary of Defense. All personnel involved with
in-house investigations are required to sign a Statement of Consent form
approved by the DIA General Counsel. Assignment to this Project is voluntary
and employees may temporarily choose not to participate in the project at
specific times, or permanently discontinue participation at any time. There
have been no demonstrated risks of permanent or temporary injury (including
physical or psychological) to project personnel beyond risks to which they
would ordinarily be exposed in their daily lives.
3. (C/NF) External research conducted by SAIC as required by the current
contract is in full compliance with all applicable laws, Federal regulations
and DoD instructions, specifically:
a. 45 CFR 46 Health and Human Services (HHS) Regulation, "Protection of
Human Subjects";
b. 10 U.S.C. Section 980, "Limitations on Use of Humans as Experimental
Subjects";
C. DoD Directive 3216.2 (January 2, 1983), "Protection of Human
Subjects in DoD-supported Research";
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d. Federal Register Part II, (June 18, 1991), "Federal Policy for the
Protection of Human Subjects; Notices and Rules".
4. (C/NF) Formal written assurance of compliance with the above has been
provided by SAIC to DIA. In addition, all research plans/activities are
constantly monitored by SAIC's Institutional Review Board to ensure that all
applicable Federal laws, directives, and regulations are fully and
consistently implemented.
5. (U) The administrative package governing the protection of human subjects
in research should be forwarded to my point of contactl Chie , SG1 J
SG1J Technoloa"Assessment and Support Activity (PAG-TA), Washington, 20340.
SG1J _F an be contacted at
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