PROTECTION OF HUMAN SUBJECTS IN RESEARCH

Document Type: 
Collection: 
Document Number (FOIA) /ESDN (CREST): 
CIA-RDP96-00789R002500260004-3
Release Decision: 
RIPPUB
Original Classification: 
S
Document Page Count: 
2
Document Creation Date: 
November 4, 2016
Document Release Date: 
February 26, 2003
Sequence Number: 
4
Case Number: 
Publication Date: 
February 17, 1994
Content Type: 
MF
File: 
AttachmentSize
PDF icon CIA-RDP96-00789R002500260004-3.pdf87.77 KB
Body: 
Approved For Release 2003/O~RDP96-007898002500260004-3 DEFENSE INTELLIGENCE AGENCY WASHI~JGTON, c.c. za34o- 5100 5-64,027/PAG-TA MEMORANDUM FOR THE OFFICE OF THE DIRECTOR, DEFENSE RESEARCH AND ENGINEERING DIRECTOR, ENVIRONMENTAL AND LIFE SCIENCES SUBJECT: Protection of Human Subject;, in Research (U) Reference: OSD Memorandum, 17 Febn;iary 1994, subject as above. 1. (S/NF) Tne Defense Intelligence Agency has determined that oNy one of its program's, Project STAR GATE, falls within the definition of human subject research. This reseazch is conducted in two areas: in-pause investigations conducted b;y 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 subjE;cts. As required by Procedure 13 of DOD Directive 5240.1-R, approval for project activities hays been granted by the Deputy Secretary of Defense. All personnel involved with in-house investigalions are required to sign a Statement of Consent form approved by the DIA General Counsel. Assignment to this project is voluntary, and employees may temporazily 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 prc ject personnel beyond risks to which they would ordinarily be exposed in their daily lives. 3. (C/NFL External research conducted by SAIC, as required by the current contract, is in full compliance with all applicable laws, federa:i 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 II, (18 June L991), "Federal Policy for the Protection of Human Subjects; Notices and Rules.'? CLASSIFIED BY MULTIPLE SOURCES DECLASSIFY ON OADR NOT RELEASABLE TO FOREIGN NATIONALS Approved For Release 2003/05/15 :CIA-RDP96-007898002500260004-3 Approved For Release 200~~A-RDP96-007898002500260004-3 4. (C/NF) Formal written assurance of carn~pliance 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 laves, directives, and regulations are fully and consistently implemented. SG1J 5. (U) The administrative packa a overnin the protection of human subjects in research should be forwarded to my point of contact Chief, Technology Assessment and Support Activity SG1 J {PAG-TA), Washington, DC 20340-5100. Ocan be contacted at NOT RELEASABLE TO FOREIGN NATIONALS SG1 B Approved For Release 2003/05/15 :CIA-RDP96-007898002500260004-3