Approved For Release 2003/05/15
: CIA-RDP96-00789R002500260002-5
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
On Auaust
11,
1991,
the Federal Common Policy for the
protection of Human Subjects
in Research was
f
ISbU^tS^oil^^ance for
^?^rofJSne1o
th
I 9rSthe
3Is^s?a?fK=reLrof
SKIense
(Health Affairs)
ana the Office of
the Director,
and Enaineering
to the Assistant Secretaries
of
.
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.
?S enLL
that
all Department of Defense Agencies are
in
compliance with current human use regulations,
it
is requeste
JEJP
„ach Director indicate whether his Agency conducts or
provide?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
g
®jJ ^
romoliance 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 Hying
individual about whom an investigator
(professional or student)
conducting research obtains data through intervention
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
y
'
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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: CIA-RDP96-00789R002500260002-5
Approved For Release 2003/05/15
: CIA-RDP96-00789R002500260002-5
Your
Mv 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
Regulation
in the area of human subject protection
in research
is
appreciated*
Edward D.
Martin,
M.D.
Acting Assistant Secretary
of Defense
(Health Affairs)
Osterman
Director,
Environmental
and Life Sciences
O
Approved For Release 2003/05/15
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SUBJECT
Protection of Human Subjects in Research (U)
REMARKS
1.
(C/NF) 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.
(S/NF) 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.
External research conducted by
SAIC is in full compliance with all applicable laws, Federal regulations and DoD instructions.
c.
(S/NF) This matter was coordinated throughout all of DIA, and no other programs were determined to fall within
the definition of human subject research.
4.
(U) RECOMMENDATION :
1 Enclosure
OSD Memorandum,
dtd 17 Feb 94, sab (U)
CLASSIFIED BY MULTIPLE SOURCES
DECLASSIFY ON OADR
Request the Director sign the memorandum opposite.
I
)HN TT BERBRICH
( Director
National Military Intelligence
Production Center
NOT RELEASABLE TO FOREIGN NATIONALS
*0'
N
r*
AT
DIA FORM 1 OCTOBER 1962
(Previous edition will bo used until exhausted)
Approved For Release 2003/05/15
: CIA-RDP96-00789R002500260002-5
DIAR 1?