Approved For Release 2003/09/09 : CIA-RDP96-00792ROO0500600026-9 SECRET S-64,027/PAG-TA MEMORANDUM FOR THE DIRECTOR, ENVIRONMENTAL AND LIFE SCIENCES, OFFICE OF TB111RECTOR, DEFENSE RESEARCH AND ENGINEERING SUBJECT: Protection of Human fubjects in Research (U) Reference: OAASD Memorandum, 17 February 1994, subject @Ls above. 1. (SINF) 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. (CINF) 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"; WARNING NOTICE-INTELLIGENCE SOURCES OR METHODS INVOLVED SECRET Approved'NTRMUINMDR: FOR696-WeRMWO0600026-9 Approved For Release 2003/09/09 : CIA-RDP96-00792ROO0500600026-9 SECRET CLASSIFIED BY MULTIPLE SOURCES DECLASSIFY ON OADR 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 siihinnt-cz in -rpmpa-rch should be forwarded to my point of SG1J contact Chief, Technology Assessment and Support Activity (PACr) w hi on, D.C. 20340. an be SG1J SG1J contacted at I WARNING NOTICE-INTELLIGENCE SOURCES OR METHODS INVOLVED SECRET Approved KTR9RP@N*A/WR Approved For Release 2003/09/OSECUORDP96-00792ROO0500600026-9 2. (U) Alpha Desynchronization. a. (SINF) It is an established neurological fact that a brain in "idle" generates alpha waves at approximately 10 Hz and that these waves diminish significantly whenever the brain's idle state is interrupted by an external stimuli. EEG experiments conducted by SAIC seems to have demonstrated, for the first time in AC research, that reception of an AC signal by the brain does, in fact, interrupt the alpha rhythm in the same manner as would any other external signal. This is called event-related desynchronization (ERD). b. (SINF) The potential "value-added" of this experimental result is the potential use of ERD to improve AC functioning analogous to the method in which biofeedback can be used to train a person to alter his physiological responses. 3. (U) Remote Observation Experiment. a. (SINF) This experiment demonstrated that changes in the electrical properties of one person's skin could be effected according to the intent of an isolated operator and indicates that AMP can be used to remotely influence biological systems. SG1 B 4. (CINF) A complete report covering these experiments will be delivered to PAG-TA in June 1994 per contract requirements. At that time a full technical report will be developed by this Activity. 5. (U) PAG-TA POC is I Enclosure Preliminary Research (SINF) 1 Cy Results Chief. PAG-TA 2 SG1 Approved For Release 2003/09/04;P~MRDP96-00792ROO0500600026-9 NOT RELEASABLE TO FOREIGN NATIONALS