PROTECTION OF HUMAN SUBJECTS IN RESEARCH

Document Type: 
Collection: 
Document Number (FOIA) /ESDN (CREST): 
CIA-RDP96-00789R002600160007-0
Release Decision: 
RIPPUB
Original Classification: 
S
Document Page Count: 
2
Document Creation Date: 
November 4, 2016
Document Release Date: 
March 3, 2003
Sequence Number: 
7
Case Number: 
Publication Date: 
February 17, 1994
Content Type: 
MF
File: 
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PDF icon CIA-RDP96-00789R002600160007-0.pdf80.3 KB
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Approved For Release 2003/05/15 : CIA-RDP96-00789R002600160007-0 SECRET DEFENSE INTELLIGENCE AGENCY 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"; CLASSIFIED BY MULTIPLE SOURCES DECLASSIFY ON OADR WARNING NOTICE-INTELLIGENCE SOURCES OR METHODS INVOLVED SECRET Approved For RR"WE2@R?R /05T.OC R06 7I QQ2600160007-0 Approved For Release 2003/05/15 : CIA-RDP96-00789R002600160007-0 SECRET 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 S G1J in research should be forwarded to my point of contact Chief, Technolo Assessment and Support Activity (PAG-TA), Washington, . 20340. 1 -1 an be contacted at WARNING NOTICE-INTELLIGENCE SOURCES OR METHODS INVOLVED Approved For FaR1T6 (29)2600160007-0