CIA-RDP96-00792R000600200001-9

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WORKING PAPER
4
1
STAFF SUMMARY SHEET
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. SAIC 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 Enclosure
1. DIA Tasker ESO #0710
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92R000600200001-9

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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.
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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.
contacted at
can be
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INT OF
STATES OF
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OFFICE OF THE SECRETARY OF DEFENSE
WASHINGTON, D.C. 20301
FEB 1 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
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) and 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.
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 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.
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.
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. Martino
Edward D. Martin, M.D.
Acting Assistant Secretary
of Defense (Health Affairs)
Joseph V. Osterman
Director, Environmental
and Life Sciences
C
.
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Roccal 4Ma
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TASKING CONTROL FORM
UNCLASSIFIED
Validated
Task Control No .:
94-002605
Slant No .:
0
Subject:
Subject Classification: UNCLASSIFIED
PROTECTION OF HUMAN SUBJECTS IN RESEARCH
Consumer:
ASD/HA
No. Of Scanned Pages:
2
Office Of Entry:
ESS
Primary Action:
PC
Tasking Authority:
ESS
Validator:
VALID1
DIA Suspense:
03/15/94
Consumer Suspense:
03/16/94
Reference No .:
ESO #0710
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.
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SG1
A
** EST SHOULD SCAN TWO PAGES. **
Collab:
CC 03/11/94
pc 03/11/94
DA 03/11/94
PS 03/11/94
J2 03/11/94
SC 03/11/94
MC 03/11/94
Coord:
GC 03/14/94
--
Info:
ATS
CS-X0
DR-XA
ES
ESO
IG
MD
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Tasking Authority:
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DIA Form 311
Form BecomesUNCLASSIFIED

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**
****
***
******** PO-2A GUIDANCE
******
SUSPENSE: 1200 10 MARCH 1994
ACTION: PAG
COLLAB: PAA/PAE/PAM/PAN/PO/PGI/PGT/P-AS/P-FM
PO-4C
SUSPENSE: 0900 08 MARCH 1994
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.
GC
VV
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.
6. WHEN THE PACKAGE IS RETURNED FROM PO-4C, FORWARD IT TO PC HEADQUAR-
TERS FOR SIGNATURE NLT 1200 10 MARCH.
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, UPON COMPLETION, PLEASE PROVIDE CLOSEOUT INFORMATION, VIA HIGGINS, TO
PO-2A/
(W/CY TO
TO CLEAR SUSPENSE: TASKER
SG1J
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
NEGATIVE, A WRITTEN RESPONSE IS REQUIRED.
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2.
FORWARD RESPONSES TO PAG POC,
NLT 0900
8 MARCH.
PO-4C: EDIT/FORMAT THE CONSOLIDATED DIA RESPONSE AND RETURN TO PAG NLT 1100 10
SG1J
MARCH.
(3MAR94)
*
GUIDANCE FOR CC ELEMENTS
********
TCN
: 94-002605; SUBJECT: RECORDS SEARCH - PROTECTION OF HUMAN SUBJECTS IN
RESEARCH
ACTION : C-AS (C-AS2A2,
TAKE FOR ACTION AS NOTED ON 311. PC
POC TO BE DETERMINED (CONTACT
NEGATIVE REPORTS ARE
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SECRET
*
INTELLIGENCE
* *
*
DEFENSE
*
AGENCY
UN
ERICA
D
STATES OF
CONTROL NUMBER
001
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TO BE COMPLETED BY REQUESTER
FROM
PAG-TA
OFFICE/DESK
PHONE NUMBER
SUBJECT
Protection
2 Human Subjects in Research
CLASSIFICATION'
SECRET /NOFORM
PAGES
1+6/7
DELIVERY INSTRUCTIONS
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HOLD FOR NORMAL DUTY HOURS
X
DELIVER IMMEDIATELY
A
TRANSMIT TO
A
AGENCY
INDIVIDUALS NAME
OFFICE
ROOM NUMBER
PHONE NUMBER
DIA
GC
DE-238 PENTAGON
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As for discussion enclosed in a copy of the
REMARKS
litter from Diretor, Environmental and Life Lernen; a
draft Stoff Summary Sheet and Memorandum for DR
signature. We must have the into typing NCT 0900 th, 10 Mailt
Also includeal is a copy of facing JASKER. Our POC is
thanks
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STA-FDP96-00792000600200001-9
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