datamatters24/research-document-archive huggingface dataset:
Approved Vorf^^pf^7QlQ(V^fWCF^f^SQ7mRQQ2&Q& itOlSfi
C / / //**'Validated
Siant No):
Subject:
Subject Classification:
UNCLASSIFIED
PROTECTION OF HUMAN SUBJECTS IN RESEARCH
Task Control No.:
Slant No
94-002605
>
Consumer:
No. Of Scanned Pages:
ASD/HA
Office OfEntiy.
Primary Action:
ESS
PC
DIA Suspense:
Consumer Suspense:
03/15/94
03/16/94
Tasking Authority:
Validator:
ESS
Reference No.:
Document
ESO #0710
Guidance Classification:
UNCLASSIFIED
Guidance:
Document Control No.:
.
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 ,
.
ESS OBTAINED THE REQUESTOR ' S APPROVAL ON EXTENDING SUSPENSE FROM
4 MAR 94
TO 15 MAR 94.
PC SHOULD TAKE THE LEAD ,
AND PREPARE A CONSOLIDATED AGENCY RESPONSE FOR D
SIGNATURE,
r
SGI J
4.
ESS POC:
!
i
SG1B
** EST SHOULD SCAN TWO PAGES.
**
Collab:
:c 03/11/94
?C 03/11/94
DA 03/11/94
PS 03/11/94
J2 03/11/94
SC 03/11/94
MC 03/11/94
Coord:
7C 03/14/94
CS-XO
DR-XA
ES
SGI J
Tasking Authority:
DIA Form 311
(Rev. 2/93)
05/15
: CIA
UNCLASSIFIED
89R00260Q
orm Becomes UNCLASSIFIED
Upon Removal OfAttachments
Approved For Release 2003/05/15
: CIA-RDP96-00789R0026QQ16QQQ3-4
********************* GUIDANCE
FOR
CC
ELEMENTS ***********************m*m^
TCN
•
94-002605;
SUBJECT:
RECORDS SEARCH
-
PROTECTION OF HUMAN SUBJECTS
IN
RFSEARCH,
COLLAB
SGI J
SGI J
ACTION
:
C-AS
(C-AS2A2,
PC
POC TO
BE DETERMINED
(CONTACT
I
REQUIRED;
ORAL REPLIES NOT ACCLPIABLt
„ . n
i i-n
r> n rt M
ft a rTrnr*
Akin
Till-
Pi
1 TAKE
FOR ACTION AS NOTED ON
311,
;j
|
I.
NEGATIVE REPORTS ARE
KtuuiKtu-
ukml
mu.
.hull, "SEARCH REPORTS MUST
INCLUDE
FILES 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.
SGI J
SG1B
S:
10 MAR 94
C-AS/C-FM/CMO/CL/CH
PROVIDE NAME/TELEPHONE NUMBER OF ACTION
nPFTPFR TO G-AS2A?
I
I
| UPON RECEIPT.
EACH CULLAd
(TO
INCLUDE C-AS)
I S REQUIR ED TO PkOVIDE A WRITTEN RESPONSE
IN
THE
FORMAT OUTLINED
IN THE TASKER.
FORWARD SIGNED RESPONSES TO
SG1B
|
THE
F0RHAI
|
NEGATIVE RESPONSES ARE REQUIRED
IN WRITING.
ti VERBAL
RE'SFOTTSLS
(JR RESPONSES
FROM COLLAB SUBORDINATE ELEMENTS WILL NOT BE
ACCEPTED.
S:
8 MAR 94
CC/JRF/3MAR94/1004HRS/[
SG1B
Approved For Release 2003/05/15
: CIA-RDP96-00789R0026001 60003-4
Approved For Release 2003/09/08 : CIA-RDP96-00789R002600160004-3 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 4 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. NO REFERRAL REQUIRED Approved For Release 2003/09/08 : CIA-RDP96-00789R002600160004-3
Approved For Release 2001/03/07
: CIA-RDP96-00789R003300350004-4
*2-£_
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—
Date
Time
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Phone No.
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Number
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Approved For Release 2001/03/07
: CIA-RDP96-00789R003300350004-4
Approved For Release 2003/09/08
: CIA-RDP96-00789R0026001 60004-3
OFFICE OF THE SECRETARY OF DEFENSE
WASHINGTON. D.c.
20301
FEB
1994
MEMORANDUM to directors of the defense agencies
SUBJECT:
Protection of Human Subjects
in Research
*
4-ii
i qqi
the Federal Common Policy for the
On August
11,
xS9
>
Rocearch was adopted by the
Protection of Human Subjects
i
.
,
,
- n -T^tle
32,
Code of
Department
of Defense
(DoD^ an
P^bl
ently>
policy Guidance for
Federal Regulations,
Part 219.
Regulations was issued
implementation of'the
.Human SubD
As l istant secretary of Defense
jointly on June
10,
199
Y
of
the Director,
Defense Research
(Health Affairs)
and the Oltic
Q
tar
: es
D f the Military
and Engineering to the Assis
research,
development,
testing,
Departments having cognizance
for researcn,
and acquisition.
“
^has
b
recently
9 initiated fpSgrS in^edicirSchnology
.
?rSSure
S
that all Department of
^requested
compliance with current ^an use reRations
ducts
or
that each Director indicate whether his Age
kamurai research
provides
funding support for ^ramural
Agency does
which involves human su^ect Participation.^ required
conduct or
?uPPor
^v^
a”
i il
b
Je provided to ensure Agency
administrative package will
P
ecmlat ion.
For clarity,
compliance with the above Fe
investigation,
including
research
is defined as
designed to
research,
to gene?alizable knowledge
.
Activities
develop or contribute
no gentle*
research for purposes
of
which meet this^he^o^nSt they are conducted or supported under
this policy,
whether or n
vocoarrh
for other purposes.
For
a program which
is considere
.
urograms may include
example,
some demonstration and service programs
Uving
research activities.
Human subjects
.
£
slonal or student)
individual about whom an “v||“9
Jhroug£ intervention or
conducting re?^
r^e°^ividuS,
or obtain* identifiable private
information TegarSSg“he individual used for research purposes.
Pirectors are
research by March
4,
1994 to
Of f ice°of S^toSSoS SSfens|
eRese“cS
S
and Engineering
Washington?°D. 0^^20301-3 030
Negative responses are required.
NO REFERRAL REQUIRED
Approved For Release 2003/09/08
: CIA-RDP96-00789R0026001 60004-3
Approved For Release 2003/09/08
: ClA-RDP96-00789R002600 160004-3
Your
My point
of contact
for this action
is Captain John
F.
Jemionek,
MSC,
USN,
who may be contacted at
(703)
697
1494.
assistance
in ensuring total DoD compliance with Federal
.
Je^laKon in the are? o£ human subject protection in research as
appreciated.
Sbj±XAcL
Edward
D.
Martin,
M.D.
Acting Assistant Secretary
of Defense
(Health Affairs)
vj.
V.
Osterman
Director,
Environmental
and Life Sciences
Approved For Release 2003/09/08
: CIA-RDP96-00789R0026001 60004-3
Approved For Release 2001/03/07 : CIA-RDP96-00789R003300350008-0 teense peainten meena enmnamaerndie amine ieee iene nt Wy, / Approved For Release 2001/03/07 : CIA-RDP96-00789R003300350008-0
Approved For Release 2003/05/15 : CIA-RDP96-00789R002600169098-2 REQUIRED; ORAL REPLIES NOT ACCEPTABLE. SEARCH REPORT T INCLUDE ‘ PILES 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 UPON RECEIPT. EACH COLLAB (TO INCLUDE C-AS) IS REQUIRED TO PROVI WRITTEN RESPONSE IN THE FORMAT OUTLINED IN THE TASKER. FORWARD SIGNED RESPONSES TO SG1J [____] NEGATIVE RESPONSES ARE REQUIRED IN WRITING. VERBAL RESPONSES OR RESPONSES FROM COLLAB SUBORDINATE ELEMENTS WILL NOT BE ACCEPTED. SG1B 5s: 8 MAR 94 CC/IRF/3MAR94/1004HRSJ_ SG1J KKRKKEKEKIEKEKRREEEREREEKEREECH-AS GUIDANCE 888 RRR RK KK KKK RR IR RRR RK RIK KR RK KKK E PCN: 94-002605 SUBJ: RECORD SEARCH-PROTECTION OF HUMAN SUBJECT IN RESEARCH ACTION: C-AS2 [.___} 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[_______},_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 C~AS/DIL/3MAR4/1555HRS/[ | SG1B KKK KEKE GUIDANCE R&R RK RRR K KKK EKER KKK EERE REE K PSP: PLS PROVIDE COLLAB SUPPORT FOR PS. SEE SCANNED PAGES. PROVIDE INPUT TO PC POC. SEND HIGNOTE TO WITH CLOSING INFORMATION. DUE: 11 MAR. RARER ERE K RRR KER K ERE RK EK EY SKK II III IK RR III KI IKKE IKKE KIRKE KER REREREEE 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, cane —EEOUTRL NLT SUSPENSE INDICATED ABOVE. NEGATIVE RESPONSE, IF APPLICABLE, D. SG1J P-FM GUIDANCE: SUSPENSE: 0900/8 MAR 94 RECEIVE, CONSOLIDATE AND FORWARD P-FM RESPONSE TO[_ SG1J SG1J SESS SR SSSSSSS3SESSSSSS$3H% PGT GUIDANCE $B$%$3SSSSSSSSBSBSFSBHBGHVSZGBGESBGSHS PGT-1,2,3 IF THERE ARE ANY INPUTS PLEASE SEND THEM TO VIA HIGGINS 5.1 ENCLOSURE NLT COB 7 MAR. PLEASE ROUTE A COPY TO [SASS WELL SO SHE CAN CLOSE IT OUT ON THE ATS. SG1J Approved For Release 2003/05/15 : CIA-RDP96-00789R002600160005-2
nein ———————_—ee Approved For Release 2003/05/15 : CIA-RDP96-00789R002600160005-2 DELEGATED OFFICES Office Suspense Time Type aaa eee See eee eee ee 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-RDP96-00789R002600160005-2
Approved For Release 2000/08/08 : CIA-RDP96-00789R002900070001-3 qainha=al===, VIEWER e. REMOTE 1. Receives tasking from Operations Officer through Project Officer. 2. Usually views once a day but no more than three times a day. 3. Provides a summary of information obtained per session to the Project Officer. Summary will contain at least the following: Project number, date, start time, end time, viewer identification number, session number, physical inclemencies noted, summary of information from session, sketches and appropriate classification markings. 4. Does not discuss session results with other viewers. 5. May be selected to act as trainer/teacher for a new member of the unit. 6. Should the Remote Viewer serve as Monitor or Project Officer, he/she will not perform remote viewing activities on those Monitor or Project Officer tasks. 9 aguamempmes / NOFORN ApprovediberReleasrs2 000108 HBR KAK-RDR96r00789R0G29000 7000 lay
COLLAB
SGI J
SGI J
Approved For Release 2003/05/15
: CIA-RDP96-00789R00260016Q0Q5-2m
TMriTTTIW
REQUIRED;
ORAL REPLIES NOT ACCEPTABLE.
SEARCH REPORTS MUST INCLUDE
FILES 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
r_ Aq/r-FM/CMO/CL/CH PROVIDE NAME/TELEPHONE NUMBER OF ACTION
SG1B
JL
I
II
1 UPON RECEIPT.
EACH COK
OFFTp-piR
ipQ Q—AS2A2
n
i — —
(TO INCLUDE C-AS)
IS REQUIRED TO PROVIDE A WRITTEN RESPONSE IN
THE FORMAT OUTLINED IN THE TASKER.
FORWARD SIGNED RESPONSES TO
_
I
NEGATIVE RESPONSES ARE REQUIRED IN WRITING.
VERBAL
RESPONSES OR RESPONSES FROM COLLAB SUBORDINATE ELEMENTS WILL NOT BE
ACCEPTED.
SG1B
S;
8 MAR
CC/JRF/3MAR94/1004HRS/1
***************************C-AS GUIDANCE***********************************
TCN:
94-002605,
SUBJ:
RECORD SEARCH-PROTECTION OF HUMAN SUBJECT _INJESEARCH
ACTION;
C-AS 2
REMAIN UNCHANGED FROM ABOVE.
SUSPENSE:
8 MAR
j,
C-AS2B3 ,
X0475)
TAKE FOR ACTION.
CC GUIDANCE
SGI J
rnTTAR*
C-AS1
C-AS 2
,
C-AS2A,
C-AS2B,
C-AS2C,
C-AS 3
- EACH COLLAB
(TO
INCLUDE C-AS)
IS REQUIRED TO PROVIDE A WRITTEN RESPONSE
IN THE FORMAT OUTLINED
IN THE TASKER.
FORWARD SIGNED RESPONSES TO
|
l
C-AS 2 B3
,
|
J
c' r
NEGATIVE RESPONSES ARE REQUIRED IN WRITING.
VERBAL RESPONSES OR RESPONSES
FROM COLLAB SUBORDINATE ELEMENTS WILL NOT BE ACCEPTED.
SG1B
SUSPENSE: 7 MAR 94
C-AS/DJL/3MAR94/1555HRS/
*********************** ****** *Ffc>
PSP:
PLS PROVIDE COLLAB SUPPORT
PC POC.
SEND HIGNOTE TO
SG1B
GUIDANCE*************************************
FOR PS.
SEE SCANNED PAGES.
PROVIDE INPUT TO
~IWITH CLOSING INFORMATION.
DUE:
11 MAR.
********************************************
******************** ****^5^**!*****
5blJ
P-FM GUIDANCE
p-pmi/ 9 /i
rTTTDANCE
SUSPENSE:
1200/7 MAR 94
DIVISIONS ARE ASKED TO PROVIDE A SHORT SUMMARY,
INDICATING STATUS OF ANY J)N°WN
p.pm PARTICIPATION IN RESEARCH INVOLVING HUMAN SUBJECTS.
SUBMIT VIA HIGGINS
“
1 NLT SUSPENSE INDICATED
(WP 5.1)
TO P-FM ACTION OFFICER,
,
ABOVE.
NEGATIVE RESPONSE,
IF APPLICABLE,
REQUIRED.
P-FM GUIDANCE:
RECEIVE,
CONSOLIDATE AND FORWARD P-FM RESPONSE TO
SGI J
SUSPENSE:
0900/8 MAR 94
SGI J
SGI J
$%$%$%$%$%$%$%$%$%$%$%$%$% pgt guidance $%$%$%$%$%$%$%$%$%$%$%$%$%$%$%$*$ % $ % $ %
VIA HiGGINS 5.1 ENCLOSURE NLT COB
7 MAR.
WELL SO SHE CAN CLOSE
IT OUT ON THE ATS
.
SEND THEM TO
PLEASE ROUTE A COPY TO Q
SGI J
IFAS
Approved For Release 2003/05/15
: CIA-RDP96-00789R0026001 60005-2
Approved For Release 2003/05/15
: ClA-RDP96-00789R002600 160005-2
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-RDP96-00789R0026001 60005-2
Approved For Release 2003/09/08 : CIA-RDP96-00789R002600160006-1 OFFICE OF THE SECRETARY OF DEFENSE WASHINGTON, D.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) 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. NO REFERRAL REQUIRED Approved For Release 2003/09/08 : CIA-RDP96-00789R002600160006-1
En ...rrrrrrrrrrrrrrrreeee Approved For Release 2003/09/08 : CIA-RDP96-00789R002600160006-1 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. Fdward D. Martin, M.D. Joge Vv. Osterman Acting ‘Assistant: Secretary Director, Environmental of Defense (Health Affairs) and Life Sciences Approved For Release 2003/09/08 : CIA-RDP96-00789R002600160006-1
Approved For Release 2003/09/08
: CIA-RDP96-00789R0026001 60006-1
OFFICE OF THE SECRETARY OF DEFENSE
WASHINGTON. D.C. 20301
FEB
1994
memorandum to directors of the defense agencies
SUBJECT:
Protection of Human Subjects
in Research
~
iqQi
the Federal Common Policy for the
SE5M S3S1M: of
Department
of Defense
(DoD)
a
subseauently,
Policy Guidance for
Federal Regulations,
Part 219.
Subsegentry^Js waJ issued
implementation of the Human Subj ects^J^s^retary of Defense
jointly on June
10,
office of
the Director,
Defense Research
(Health Affairs)
and the Office o£
tne
fche Military
and Engineering
to the Assistant
S
research,
development,
testing,
Departments having cognizance for researcn,
and acquisition.
«
brought to
attention ^^least^^efenoe
offense Agencieo afr
rn
uested
compliance with current humanuseregulatl.
the? each Director indicate whether^
research
provides
funding support
f
. na rion
If an Agency does
which involves human sublet participation.
adm^nistrativ^package^illbeprovidedtoensure^Agency^^
SSfflf«*2S?!IiSSa«si^
SCr ^tSSe'.to ae"“Si^
erSeSlh
|or pS^osefof
which meet this definition con
conducted or supported under
this policy,
whether or,^Ld %sea?ch^o^ other purposes.
For
a program which
is considere
.
programs may include
example,
some demonstration a^^^
C
fs
P^f iSed as
a living
research activities.
Human subjects
^fassional or student)
cSnducSng «siLch°obSin?2«a ^
r°S?ains“S5Sif iSble private
information ^^g^SiiaSL^or research purposes.
sffiS
Sfl?ce°oi
Sfens^ReSISofand Engineering
Pentagon Room 3D129
Washington,
D.C.,
20301-3030
Negative responses are required.
NO REFERRAL REQUIRED
Approved For Release 2003/09/08
: CIA-RDP96-00789R0026001 60006-1
Approved For Release 2001/03/07 : CIA-RDP96-00789R003300350008-0 ore DD ae O25 5 Sf Y/ O49 5 Sk / 0? chor 4 of FL r Sot 9/ = CS. OF2. G Aeserew <1 om acreage Approved For Release 2001/03/07 : CIA-RDP96-00789R003300350008-0
Approved For Release 2003/05/15 : CIA-RDP96-00789R002600160007-0 SECRET DEFENSE INTELLIGENCE AGENCY WASHINGTON, D.c. 20340- 0001 S-64,027/PAG-TA MEMORANDUM FOR THE DIRECTOR, ENVIRONMENTAL AND LIFE SCIENCES, OFFICE OF THE DIRECTOR, DEFENSE RESEARCH AND ENGINEERING SUBJECT: Protection of Human Subjects in Research (U) Reference: OAASD Memorandum, 17 February 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, 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 Experimenta] Subjects"; Cc. DoD Directive 3216.2 (January 2, 1983), "Protection of Human Subjects in DoD-supported Research"; CLASSIFIED BY MULTIPLE SOURCES DECLASSIFY ON OADR WARNING NOTICE-INTELLIGENCE SOURCES OR METHODS INVOLVED SECRET Approved For Release 2283 //4 StoCHORED ER GNPASNROG2600 160007-0
SG1J SG1J Approved For Release 2003/05/15 : CIA-RDP96-00789R002600160007-0 SECRET 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 subjects an research should be forwarded to my point of contact Chief, SG1J Technology Assessment and Support Activity (PAG-TA), Washington, D.U. 20340. Cc pan be contacted at[ WARNING NOTICE-INTELLIGENCE SOURCES OR METHODS INVOLVED noproves For Rega ages eee otoeRs260010007