STAFF SUMMARY SHEET

• Document Type: CREST
• Collection: STARGATE
• Document Number (FOIA) /ESDN (CREST): CIA-RDP96-00792R000600200001-9
• Release Decision: RIPPUB
• Original Classification: S
• Document Page Count: 8
• Document Creation Date: November 4, 2016
• Document Release Date: August 25, 2003
• Sequence Number: 1
• Content Type: SUMMARY

Approved For Releas 03/09/10: CIA-RDP96-007928000600200001-9
CR~1'
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 which
requests DIA to indicate whether the Agency conducts or provides
funding support for intramural or extramural research which
involves human subject participation. Response opposite
(enclosure 1) has been prepared for DR signature and forwarding
to Director, Environmental and Life Sciences, Office of the
Director, Defense Research and Engineering.
3. DISCUSSION:
a. (U) A thorough review by all elements of the 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. (S/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. DIA personnel involved with in-
house investigations are required to sign a Statement of Consent
form approved by the DIA General Counsel. The assignment 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.
c. (S/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. SAIL has
provided formal written assurance to 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) RECOMMENDATION: That DR sign memorandum opposite.
1 Enclasuire
1. DIA Ta~sker ESO #0710
T11~ V.(~ K ~ i 1~f~ ~~~:L
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~~
MEMORAND RECTOR H DEFENSE RESEARCH p,NDNENGINEERING SCIENCES, OFFICE
OF THE DI ,
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 az-eas: 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 SAIL as required by the
current contract is in full compliance with all applicable laws,
Federal regulations and DaD instructions. SAIC has provided
formal written assurance to the DIA that they are in full
compliance. In addition, all research plans/activities are
constant;ly 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
SG1J contact Chief, Technology Assessment and Support
can be
Activitr~ (PAG-TA Was ington, D.C. 20340.
SG 1 A contacted at
VIC ~ ~~ ~ ~'~ ~~~ ~,~
Approved ~~
SG1J
 Approved For Release 2003/09/10: CIA-RDP96-007928000600200001-9
OFFICE OF THE. SECRETARY OF DEFENSE
WASHINGTON, D.C. 20301
FEB l 7 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
ted by the
Protections of Human Subjects in Research was adop
Department of Defense (DoD) and publishently,TPolicy2Guidanceffor
Federal Regulations, Part 219. Subsequ lations was issued
implementation of the Human the, Assistant Secretary of Defense
Defense Researc
jointly an June 10, 1993 by
(Health Affairs)tondhehAssistantoSecretariestof~the Military
and Engineering
Departments having cognizance for research, development, testing,
and acquisition.
It 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 iserequested
compliance with current human use regulations, conducts or
.that each Director indo~~aforwintramural oreextramural research
provides funding supp anticipation. If an Agency does
which involves human subject p
conduct or support human subjects research the required
administrative package will be provided to ensure Agency
compliance with tha abOa systematiceinvestigation~rincluding
research is define
research, development, testing and evaluation, desipg,ctavities
develop or contribute to generalizable knowledge. oses of
which meet this definition constiareeconducted orrsupported under
this policy, whether or not they ur oses. For
a program which is considered research fo~ooT~s may include
example, some demonstration and service p g
researchi activities. Human subjects isrofessional orlstudent)
individual about wham an investigator (p
conduct'~ng research obtains data through intervention or rivate
interaction with the ithevindividualoused fordresearchlpurposes.
information regarding
Directors are requested to provideor~hofsintramuralgorcy
partici~,pation in the conduct or supp March 4, 1994 to
extramural human subject xesearch by
Director, Environmental and Life Sciences
Office of the DD129tor, Defense Research and Engineering
Pentagon Room 20301-3030
Washington, D.C.,
Negative responses are required.
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 Approved For Release 2003/09/10: CIA-RDP96-007928000600200001-9
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..
? , 0.--?.~,.- . -
J e V. Osterman
Edward D. Martin, M.D.
Acting Assistant?Secretary Director, Environmental
of Defense (Health ~~ffairs) and Life .Sciences
Approved For Release 2003/09/10: CIA-RDP96-007928000600200001
 UNCLASSIFIED
~-Il~a
Approved For Release 2003/0.9/10. ;~.CIA-RDP96-007928000600200001-9
TASKING CONTROL FORM-
Validated
Form BeaomeslJNCLASSIFIED
 Approved For Release 2003/09/10: CIA-RDP96-007928000600200001-9
*********************_*********** PO-2A GUIDANCE ********************,**********
ACTION: PAG SUSPENSE: 1200 10 MARCH 1994
COLLAB: PAA/PAE/PAM/PAN/PO/PGI/PGT/P-AS/P-FM
SUSPENSE: 0900
'
PO-4C
0
110
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. PR~PAR~' A~MEM,,,O~RANDUM FOR, FOR THE DR SIGNATURE, REPORTING THE STATUS
OF AGENCY PART CIP ION 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. FORWARI) COMPLETED PACKAGE TO PO-4C FOR EDITING NLT 0900 10 MARCH.
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 OSEOUT INFORMATION, VIA HIGGINS, TO
SG1J PO-2A/ (W/CY TO TO CLEAR SUSPENSE: TASKER
NUMBER, DATE/TIME C LETED, ACTION TAKE , 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
SG1J
PARTICIPATION IN RESEARCH INVOLVING HUMAN SUBJECTS. IF RESPONSE IS
NEGATIVE, A WRITTEN RESPONSE IS REQUIRED.
~2. FORWARD RESPONSES TO PAG POC,I INLT 0900
8 MARCH.
PO-4C: EDIT/FORMAT THE CONSOLIDATED DIA RESPONSE AND RETURN TO PAG NLT 1100 10
S G 1 J MARCx .
3 MARS 4 )
********************* GUIDANCE FOR~CC+,ELEMENTS *******************************
TCN 94-002605; SUBJECT: RECORDS SEARCH - PROTECTION OF HUMAN SUBJECTS IN
RESEARCH
ACTION C-AS (C-AS2A2, E FOR ACTION AS NOTED ON 311. PC
POC TO BE DETERMINED (CONTACT NEGATIVE REPORTS ARE
SG1J
Approved For Release 2003/09/10: CIA-RDP96-007928000600
SG1J
08 MARCH 1994
10 MARCH 1994
 SG1J
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 Approved For Release 2003/09/10 :CIA-RDP96-007928000600200001-9
SECRET
CON~T1ROL NUMBER
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;OBJECT
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TO BE COMPLETED BY REQUESTER
OFFICE/DESK
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:LASSIFICATION' ..-. ~
)SLIVERY INSTRUCTIONS
HOLD IFOR NORMAL DUTY HOURS
AGENCY
SG1J
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INDIVIDUALS NAME
TRANSMIT TO
DELIVER IIdMEDIATELY
SG1
A
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B~i-
OFFICE ROOM NUMBER PHONE NU118ER
Q, ~s~ Qu.,,. Pac ~
SG1J
_q ( ~ ~ ~~96-00792 00060020 001-9 SG1J
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