Approved For Release 2003/05/15 : CIA-RDP96-00789ROO2600160005-2 DEFENSE INTELLIGENCE AGENCY STAFF SUMMARY SHEXT ROUTE TO ACTION SIGNATURE (Grade and Surname) ORI INATOR (Symbo TELEPHONE NO -DATE 1 PAC' , pnui -W PAG-TA 9 Mar 94 V A rnn-r(i 3 'PC qqq ACTION OFFICER A P..q n 6 C r_nord 7 F) D ronr_d A np q i rr n ni i -r a l TYPIST'S INITIALS ral s SUBJECT Protection of Human Subjects in Research (U) REMARKS 1. (U) PURPOSE: To provide the status of DIA's participation in the conduct or support of intramural or extramural human subject research. 2. (U) BACKGROUND: The memorandum opposite provides the DIA response to requirements set forth in ESO tasker #710. 3. (U) DISCUSSION: a. (U) DIA has determined that only one program (Project STAR GATE) falls within the definition of human subject research. This research is conducted in two areas: in-house activities conducted by DIA civilian personnel and external research activities conducted under DIA contract with the Science Applications International Corporation (SAIC). b. (SINF) 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. DIA personnel involved with in-house investigations are required to sign a Statement of Consent form approved by the DIA General Counsel. External research conducted by SAIC is in full compliance with all applicable laws, Federal regulations and DoD instructions. 4. (U) RECOMMENDATION: That DR sign memorandum opposite. CLASSIFIED BY MULTIPLE SOURCES DECLASSIFY ON OADR SECRET NOT RELEASABLE TO FOREIGN NATIONALS 3GI 3GIJ DIA FORM I OdWUMW ' KWAIMUMA91141i V414.-VPPn9h-P=9P&9.02600160005-2 D I A R 12-8 Approved For F$AgKtNJ3/Wbl.Td?ioikDI;Q$N89ROO2600160005-2 UNCLASSIMSED Validated Task Control No.: Slant No.: Subject: Subject Classification: UNCLASSIFIED 94-002605 0 PROTECTION OF HUMAN SUBJECTS IN RESEARCH Consumer. No. Of Scanned Pages. ASD/HA 2 Office Of Entry: Primary Action: Tasking Authority. Validator.- -- ESS . PC ESS F GIJ Is DIA Suspense: Consumer Suspense: Reference No.: Document Control No.: 03/15/94 03/16/94 ESO #0710 Guidance: Guidance Classification: UNCCASSIFIED 1. TASKER CONTAINS TWO PAGES SCANNED MATERIAL: OSD/ENVIRNOMENTAL AND LIFE SCIENCES MEMORANDUM ON PROTECTION OF HUMAN SUBJECTS IN RESEARCH 2. PER SCANNED MEMO, DIA HAS BEEN REQUESTED TO INDICATE WHETHER THE AGENCY CONDUCTS OR PROVIDES FUNDING SUPPORT FOR INTRAMURAL OR EXTRAMURAL RESERACH WHICH INVOLVES HUMAN SUBJECT PARTICIPATION. IF SO, A STATUS REPORT OF THE AGENCY PARTICIPATION IS REQUIRED. IF NOT, A WRITTEN NEGATIVE REPLY IS NECESSARY. 3. ESS OBTAINED THE REQUESTOR'S APPROVAL ON EXTENDING SUSPENSE FROM 4 MAR 94 TO 15 MAR 94. 3. PC SHOULD TAKE THE LEAD, AND PREPARE A CONSOLIDATED AGENCY RESPONSE FOR DR SG1J SIGNATURE. 4. ESS POCI --IF- sGIB EST SHOULD SCAN TWO PAGES. Collob: C 03/11/94 ---- DA 03/11/94 ---- J2 03/11/94 ---- MC 03/11/94 ---- DC 03/11/94 ---- PS 03/11/94 ---- SC 03/11/94 ---- Coord.- 3C 03/14/94 ---- Info: kTS CS-XO DR-XA ES ESO IG MD SG1J Tasking Aulho&y: A d@F ESS, - r qi SGI. B - pprova l l % ( IA-P Win J-/I.Cl I' Approved For Release 2003/05/15 : CIA-RDP96-00789ROO2600160005-2 PO-2A GUIDANCE ACTION: PAG SUSPENSE: 1200 10 MARCH 1994 COLLAB: PAA/PAE/PAM/PAN/PO/PGI/PGT/P-AS/P-FM SUSPENSE: 0900 08 MARCH 1994 PO-4C 1100 10 MARCH 1994 INFO: PC-HQ/PA/PG/PO-2A (FILE) GUIDANCE: PAG: 1. TAKE THE LEAD FOR PC. COORDINATE/CONSOLIDATE INPUTS FROM PC COLLABS (LISTED ABOVE) AS WELL AS INPUT FROM CC, OC, DA, PS, J2, SC AND MC. 2. PREPARE A MEMORANDUM FOR, FOR THE DR SIGNATURE, REPORTING THE STATUS OF AGENCY PARTICIPATION IN RESEARCH INVOLVING HUMAN SUBJECTS. IF RESPONSE IS NEGATIVE, A WRITTEN RESPONSE IS REQUIRED. 3. A STAFF SUMMARY SHEET, FOR DIRECTOR NMIPC SIGNATURE, SHOWING THE APPROPRIATE COORDINATION, SHOULD BE INCLUDED AS PART OF THE COMPLETED PACKAGE. 4. COORDINATE THE COMPLETED RESPONSE WITH GC PRIOR TO FORWARDING TO PO-4C. 5. FORWARD COMPLETED PACKAGE TO PO-4C FOR EDITING NLT 0900 10 MARCH. , .1 - -------------------- 6. WHEN THE PACKAGE IS RETURNED FROM PO-4C, FORWARD IT TO PC HEADQUAR- TERS FOR SIGNATURE NLT 1200 10 MARCH. SG1J 7. UPON COMPLETION, PLEASE PROVIDE CLOSEOUT INFORMATION, VIA HIGGINS, TO PO-2A CLEAR SUSPENSE: TASKER NUMBER, DATE/TIME COMPLETED, AC= TMSEN, ACTION OFFICER, AND COR- RESPONDENCE CONTROL NUMBER. PAG/PAA/PAE/PAM/PAN/PGI/PGT/PO/P-AS/P-FM: 1. PREPARE A WRITTEN RESPONSE INDICATING THE STATUS OF ANY KNOWN NMIPC PARTICIPATION IN RESEARCH INVOLVING HUMAN SUBJECTS. IF RESPONSE IS NEGATIVE, A WRITTEN RESPONSE IS REQUIRED. SG1J 2. FORWARD RESPONSES TO PAG POC,i NLT 0900 SG1B 8 MARCH. PO-4C: EDIT/FORMAT THE CONSOLIDATED DIA RESPONSE AND RETURN TO PAG NLT 1100 10 SG1J MARCH. 3MAR94)SGlB GUIDANCE FOR CC ELEMENTS TCN : 94-002605; SUBJECT: RECORDS SEARCH - PROTECTION OF HUMAN SUBJECTS IN ACTION : C-AS (C-AS2A2, F RESEARCH TAKE FOR-ACTION AS NOTED ON 311. PC SGIJ POC TO BE DETERMINED (CONTACTI I NEGATIVE REPORTS ARE SG1B Approved For Release 2003/05/15 : CIA-RDP96-00789ROO2600160005-2 Approved For Release 2003/05/15 : CIA-RDP96-00789ROO260016 REQUIRED; ORAL REPLIES NOT ACCEPTABLE. SEARCH REPORTRORTIT INCLUDE FILtS SEARCHED, PARAMETERS, AND THE PERSON(S) RESPONSIBLE FOR THE SEARCH. SEARCH SHOULD FOCUS ON, BUT NOT BE LIMITED TO SPECAT/RODCA TRAFFIC HELD. SAFE SEARCH IS NOT REQUIRED. S: 10 MAR 94 COLLAB C-AS/C-FM/CMO/CL/CH PROVIDE NAME/TELEPHONE NUMBER OF ACTION SG1B SG1J OFFICER TO C-AS2A2 F_ I JUPON RECEIPT. EACH COLLAB (TO INCLUDE C-AS) IS REQUIR PROVIDE A WRITTEN RESPONSE IN THE FORMAT OUTLINED IN THE TASKER. FORWARD SIGNED RESPONSES TO SG1j I NEGATIVE RESPONSES ARE REQUIRED IN WRITING. VERBAL RESPONSES OR RESPONSES FROM COLLAB SUBORDINATE ELEMENTS WILL NOT BE ACCEPTED. SG1 B S: 8 MAR 94 CC/JRF/3MAR94/1004HRS@ SG1J TCN: 94-002605 SUBJ: RECORD SEARCH-PROTECTION OF HUMAN SUBJECT IN RESEARCH ACTION: C-AS2 I C-AS2B3, X0475) TAKE FOR ACTION. CC GUIDANCE REMAIN UNCHANGED FROM ABOVE. SUSPENSE: 8 MAR 94 SG1J COLLAB: C-AS1, C-AS2, C-AS2A, C-AS2B, C-AS2C, C-AS3 - EACH COLLAB (TO INCLUDE C-AS) IS REQUIRED TO PROVIDE A WRITTEN RESPONSE IN THE FORMAT OUTLINED IN THE TASKER. FORWARD SIGNED RESPONSES TO -I C-AS2B3, SG1B NEGATIVE RESPONSES ARE REQUIRED IN WRITING. VERBAL RESPONSES OR RESPONSES FROM COLLAB SUBORDINATE ELEMENTS WILL NOT BE ACCEPTED. SUSPENSE:7 MAR 94 SG1B C-AS/DJL/3MAR94/1555HRS@ PSP: PLS PROVIDE COLLAB SUPPORT FOR PS. SEE SCANNED PAGES. PROVIDE INPUT TO PC POC. SEND HIGNOTE Tol IWITH CLOSING INFORMATION. DUE: 11 MAR. P-FM GUIDANCE P-FM1/2/3 GUIDANCE SUSPENSE: 1200/7 MAR 94 DIVISIONS ARE ASKED TO PROVIDE A SHORT SUMMARY, INDICATING STATUS OF ANY KNOWN P-FM PARTICIPATION IN RESEARCH INVOLVING HUMAN SUBJECTS. SUBMIT VIA HIGGINS (WP 5.1) TO P-FM ACTION OFFICER,i I NLT SUSPENSE INDICATED ABOVE. NEGATIVE RESPONSE, IF APPLICABLR-, REQUIRED. SG1J P-FM GUIDANCE: SUSPENSE: 0900/8 MAR 94 RECEIVE, CONSOLIDATE AND FORWARD P-FM RESPONSE TOI SG1J SG1J $%$%$%$%$%$%$%$%$%$%$%$%$% PGT GUIDANCE $%$%$%$%$%$%$%$%$%$%$%$%$%$%$%$%$%$%$% PGT-1.2,3 IF THERE ARE ANY INPUTS PLEASE SEND THEM TOI VIA HIGGINS 5.1 ENCLOSURE NLT COB 7 MAR. PLEASE ROUTE A COPY TOI Ac! WELL SO SHE CAN CLOSE IT OUT ON THE ATS. SG1J Approved For Release 2003/05/15 : CIA-RDP96-00789ROO2600160005-2 Approved For Release 2003/05/15 : CIA-RDP96-00789ROO2600160005-2 DELEGATED OFFICES office Suspense Time Type -------- -------- ---- ---- P-AS 03/08/94 0900 CL P-FM 03/08/94 0900 CL PA 03/15/94 IN PAA 03/08/94 0900 CL PAE 03/08/94 0900 CL PAG 03/10/94 1100 PA PAM 03/08/94 0900 CL PAN 03/08/94 0900 CL PC-HQ 03/15/94 IN PG 03/15/94 IN PGI 03/08/94 0900 CL PGT 03/08/94 0900 CL PO 03/08/94 0900 CL PO-4C 03/10/94 1100 CL Approved For Release 2003/05/15 CIA-RDP96-00789ROO2600160005-2