SG1J SG1A Approved For Release SECT : CIA-RDP96-00792R000600200001-9 WORKING PAPER MEMORANDUM FOR THE DIRECTOR, ENVIRONMENTAL AND LIFE SCIENCES) OFFICE OF THE DIRECTOR, DEFENSE RESEARCH AND ENGINEERING SUBJECT: Protection of Human Subjects in Research Reference: OAASD Memorandum, 17 Feburary 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. SAIC has provided formal written assurance to the DIA that they are in full compliance. 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. 4. (U) The administrative package governing the protection of human subjects in research should be forwarded to my point of contact| ‘| chief, Technology Assessment and Support Activity (PAG=TA), Washington, D.C. 20340. [sean be SG1J contacted at WURKING PAPER Approved SECRET” ty 792R000600200001- ZL
deena in TE Approved For Release 2003/09/10 : CIA-RDP96-00792R000600200001-9 OFFICE OF THE SECRETARY OF DEFENSE WASHINGTON, p.c. 20301 FEB 17 1994 MEMORANDUM TO DIRECTORS OF THE DEFENSE AGENCIES SUBJECT: Protection of Human Subjects in Research On August 11, 1991, the Federal Common Policy for the Protection of Human Subjects in Research was adopted by the Department of Defense (DoD) and published in Title 32, Code of Federal Regulations, Part 219. Subsequently, policy Guidance for implementation of the Human Subjects Regulations was issued jointly on June 10, 1993 by the Assistant Secretary of Defense (Health Affairs) ana the Office of the Director, Defense Research and Engineering to the Assistant Secretaries of the Military Departments having cognizance for research, development, testing, and acquisition. Tt has been brought to our attention that at least one Defense Agency has recently initiated a- program in medical technology. To ensure that all Department of Defense Agencies are in compliance with current human use regulations, it is requested that each Director indicate whether his Agency conducts or provides funding support for intramural or extramural research which involves human subject participation. If an Agency does conduct or support human subjects research the required administrative package will be provided to ensure Agency compliance with the above Federal Regulation. For clarity, research is defined as a systematic investigation, including research, development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For ‘example, some demonstration and service programs may include research activities. Human subjects is defined as a living individual about whom an investigator (professional or student) conducting research obtains data through intervention or interaction with the individual, or obtains identifiable private information regarding the individual used for research purposes. Directors are requested to provide the status of Agency participation in the conduct or support of intramural or extramural human subject research by March 4, 1994 to Director, Environmental and Life Sciences Office of the Director, Defense Research and Engineering Pentagon Room 3D129 Washington, D.C... 20301-3030 Negative responses are required. Approved For Release 2003/09/10 : CIA-RDP96-00792R000600200001/
Approved For Release 2003/09/10 : CIA-RDP96-00792R000600200001-9 My point of contact for this action is Captain John F. Jemionek, MSC, USN, who may be contacted at (703) 697-1494. Your assistance in ensuring total DoD compliance with Federal Regulation in the area of human subject protection in research is appreciated. Edward D. Martin, M.D. Jpge v. Osterman Acting ‘Assistant - Secretary Director, Environmental of Defense (Health Affairs) and Life Sciences Approved For Release 2003/09/10 : CIA-RDP96-00792R000600200001
| Approved For Release 2003/09/10 :-CIA-RDP96-00792R000600200001-9 Roe, Sb 4 Mo. we . TASKING CONTROL FORM UNCLASSIFIED. Validated Task Control No.: Slant No.: Subject: Subject Classification: UNCLASSIFIED 94-002605 PROTECTION OF HUMAN SUBJECTS IN RESEARCH - Consumer: No. Of Scanned Pages: Office Of Entry: Primary Action: Tasking Authority: Validator: DIA Suspense: Consumer Suspense: ; Reference No.: Document Control No.: Guidance: Guidance Classification: UNCLASSIFIED 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 SIGNATURE. SG1 ** EST SHOULD SCAN TWO PAGES. ** Collab: C 03/11/94 ---- DA 03/11/94 ---- ~ J2 03/11/94 ---- MC 03/11/94 ---- OC 03/11/94 ---- PS 03/11/94 ---- SC 03/11/94 ---- Info: TS SG1J SG1A Tasking Authority: pproved For Releasy 2003/09/10 : CIA-RDP96-00792R000600200001-9 DIA Form 311 Form BecomesUNCLASSIFIED CS-X0 DR-XA ES ESO IG MD
Approved For Release 2003/09/10 : CIA-RDP96-00792R000600200001-9 KKK KEKE KEKE KER RERERERERERKERERER PO-2A GUIDANCE KKK EKER ERE REREREREREREREESR ‘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. — — — meee er — —— ‘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 (SC- PO-4C. —_—_—— (L$. FORWARD COMPLETED PACKAGE 10 PO-4C FOR EDITING NLT _0900_10 MARCH. ena 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 PROVID SEOUT INFORMATION, VIA HIGGINS, TO Sct) PO-2A/ (W/CY TO TO CLEAR SUSPENSE: TASKER NUMBER, DATE/TIME COMPLETED, ACTION TAKEN, 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 SG1j “NEGATIVE, A WRITTEN RESPONSE IS REQUIRED. coAe-2. ronwany Responses to vas woe|_ NT 0900 8 MARCH. PO-4C: EDIT/FORMAT THE CONSOLIDATED DIA RESPONSE AND RETURN TO PAG NLT 1100 10 SG1J MARCH. a ies KEKKKEKRKERERE RRR RKKKEK GUIDANCE FOR_CC ELEMENTS KOK KEKE KEE RIK RRR RRR EEK ARER ERE REE qa TCN : 94-002605; SUBJECT: RECORDS SEARCH - PROTECTION OF HUMAN SUBJECTS IN RESEARCH ACTION : C-AS (c-AS2A2,(__sd E FOR ACTION AS NOTED ON 311. PC Poc TO BE DETERMINED conmmér|SSSSS*dS NEGATIVE REPORTS ARE SG1J : SG1J Approved For Release 2003/09/10 : CIA-RDP96-00792R0006002000 ae
SG1J Approved For Release 2003/09/10 : CIA-RDP96-00792R000600200001-9 Approved For Release 2003/09/10 : CIA-RDP96-00792R000600200001-9
Approved For Release 2003/09/10 : CIA-RDP96-00792R000600200001-9 SECRET CONTROL NUMBER OO | ‘ SG1J ' . TO BE COMPLETED BY REQUESTER “ROM ; DAE » / AA OFFICE/DESK 1 PHONE wge{ SUBJECT SLASSIFICATION —— Ry PAGES SG1 YELIVERY INSTRUCTIONS HOLD FOR NORMAL DUTY HOURS DELIVER IMMEDIATELY ns enna TRANSMIT TO SGI AGENCY DIVIDUALS NAME | orerce | ROOM NUMBER PHONE NUMBER i ee S senarks| re bree perteter Drst oral Uy 4+ Aofy ine halt Satage lamer pst aot Wainecandun for DR SG1J SG1J SG1 A