Ap proved For Release 2003/0-4ffgOFMWRDP96-00789ROO2500260004-3
DEFENSE 1114TELLIGENCE AGENCY 50'
WASHINGTON. D.C. 20340- 5100
S-64,027/PAG-TA
MEMORANDUM FOR THE OFFICE OF TIIE DIRECTOR. DEFENSE RESEARCH AND
ENGINEERING DIRECTOR, ENVIRONMENTAL AND LIFE
SCIENCES
SUBJECT: Protection of Human Subjects in Research (U)
Reference: OSD 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 ofliuman subject research. This research is conducted in two
areas: in-house investiga'tions 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. 'Mere have been no demonstrated risks of permanent or temporary injury
(including physical or psychological) to prcject 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, federaJ 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 (2 January 1983), "Protection of Human Subjects in DOD-Supported
Research";
d. Federal Register Part 11, (18 June 1991), "Federal Policy for the Protection of Human
Subjects; Notices and Rules."
CLASSIFIED BY MULTIPLE SOURCES
DECLASSIFY ON OADR
NOT RELEASABLE TO FOREIGN NATIONALS
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Approved For Release 2001MR"Mft-RDP96-00789ROO2500260004-3
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.
SG1J
5. (U) The administrative package governing the protection of human subjects in research should be
forwarded to my point of contact I]Chief, Technology Assessment and Support Activity
SG1J (PAG-TA), Washington, DC 20340-5100. can be contacted ati SG1 B
2
NOT RELEASABLE TO FOREIGN NATIONALS
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