Approved For Release 2003/09/16
: CIA-RDP96-00788R001 100440027-4
SGRD-HR
DEPARTMENT OF THE ARMY
OFFICE OF THE SURGEON GENERAL
WASHINGTON, D.C.
20310
2 January
1980
SUBJECT:
Minutes
of Meeting
of
the Ad Hoc Subcommittee
of The
Surgeon
General’s
Human
Subjects Research Review Board
- 20 November
1979
The Surgeon General
Headquarters,
Department
of
the Army
Washington,
DC
20310
1.
Under provisions
of AR 70-25 and 0TSG Reg
15-2,
a
special meeting
of an Ad Hoc Subcommittee
of
the Human Subjects Research Review Board
(HSRRB)
was
convened
at
0900 hours
in Room 3E368
in
the Pentagon
on
20 November
1979
to consider human use
issues
represented
in protocols
presented
by SRI
International
[Proposed Grill
Flame Protocol:
Task
II
(U) FDSIILPLFRRHONREPNTS
(U)
-
15 November
1979] and
the
US Army Missile
Command
(MIC0M)
[RPT
(U)
-
7 November
. 1979]
.
a.
Members present were:
COL Edward
L.
Buescher,
MC,
Chairman,
HSRRB
COL Harry Holloway,
MC,
Professor
and
Chairman,
Department
of Psychiatry,
USUHS,
Ad Hoc Member,
HSRRB
Dr.
K.
C.
Emerson,
Ph.D.,
Consultant Ad Hoc Member,
HSRRB
.Dr .
Herbert
L.
Ley,
M.D.,
Consultant Ad Hoc Member,
HSRRB
'•Dr.
Chris
J.
D.
Zarafonetis,
M.D.,
Consultant Ad Hoc Member,
HSRRB
Ms.
Annie
L.
Young,
Systems Analyst,
AMSAA,
Ad Hoc Member,
HSRRB
LTC Richard
W.
Severson,
MSC,
C,
Human Use Review Office,
USAMRDC,
Recorder
CPT
(P)
Steven M.
Porter,
JAGG,
Judge Advocate,
USAMRDC,
and Member,
HSRRB
b.
Observers/Investigators present were:
Dr.
Billy
Z.
Jenkins ,. Ph.D.
,
Grill
Flame Principal
Investigator,
USAMICOM
Dr.
Edward May,
Ph.D.,
Grill
Flame Project Leader,
SRI
International,
Menlo
Park,
CA
(contractor)
Dr.
Hal
Puthoff,
Ph.D.,
SRI
International, Menlo Park,
CA
Dr.
Russell
Targ,
Ph.D.,
SRI
International,
Menlo Park,
CA
.Mr.
John Kramar,
Assistant
Director,
Army Materiel
Systems Analysis
Activity, Aberdeen Proving Ground,
MD
Approved For Release 2003/09/16
: CIA-RDP96-00788R001 100440027-4
Approved For Release 2003/09/16
: CIA-RDP96-00788R001 100440027-4
SGRD-HR
January
1980
SUBJECT:
Minutes
of Meeting' of
the Ad Hoc
Subcommittee
of The Surgeon
General's Human Subjects Research Review Board - 20 November
1979
2.
Mr.
Kramar presented
a resume
of
the progress
to date on the AMSAA
, Grill Flame Protocol
[PBAAADREVGPL]
(U)
-
23 March
1979] dealing with
phenomenological validation
of
technology
to
be
transferred
by
SRI.
The
AMSAA effort
began
in March
1979.
The
following summarized committee
views
of
the review and discussions:
a.
The
study has accomplished
the
initial
objective outlined
in
Protocol PBAAADREVGPL
(U)
- 23 March
1979 and
is now exploring new issues.
It
is clearly exceeding
the validation
of
technology,
and appears
to
be
beyond
the work scope
originally examined
by HSRRB and approved by TSG.
The
basis
for
this
expanded
scope
is unclear and
the current effort appears
" to
involve human experimentation.
The concerns
of
the
ad hoc subcommittee
as detailed
in
the previous minutes
are now more relevant:
"Army
sponsors
and action agencies
are presently unprepared
to address
all anticipated
problems.
Specifically,
the concerns
include! (1)
provision
for adequate
scientific review of research protocols,
(2) provision
for collaborating
behavioral
scientists
in execution
of protocols,
and
(3) provision
for
credible Human Use Review processes
or committees
in action agencies
for
review of protocols."
b.
There clearly
is no
fixed and formally appointed professional
oversight
for work being done under "Grill
Flame";
rather,
oversight
appears
to be ad hoc,
incomplete and
by multiple groups,
resulting
in
inadequate continuing assessment.
Conclusions
and decisions based
on
data generated
from the research will
be divergent,
depending on which
ad hoc
group
is
evaluating
the
data;
evaluating emerging evidence and
deciding which evidence
is worth pursuing will
be
an uncoordinated
effort.
.
c.
The
subcommittee recommends
the ad hoc
supervision of the
Grill
Flame program be
discontinued
and
the command responsibility
for
the program be
identified.
3..
Dr. May presented
the
SRI
International protocol
to
the Ad Hoc
Subcommittee.
Dr.
Jenkins presented
the MIC0M variations
of
the
same
protocol.
Subsequent
to discussions,
the
following
is
the unanimous
consensus
of
the
subcommittee members:
a.
The
SRI
International
and MICOM protocols
do
indeed constitute
••research
involving human
subjects.
The
immediate
risks
to
the
subjects
appear
to
be minimal;
however,
there
are potential
latent
related
effects
which deserve explanation
in
the
subject consent
form.
Recommend
the
. consent
form be amended
to
include:
Approved For Release 2003/09/16
: CIA-RDP96-00788R001 100440027-4
Approved For Release 2003/09/16
: CIA-RDP96-00788R001 100440027-4
SGRD-HR
.
.2 January
1980
.SUBJECT:
Minutes
of Meeting
of
the Ad Hoc
Subcommittee
of The Surgeon
General's Human Subjects Research Review Board -
20 November
1979
*
(1)
"You may
lose
the esteem or respect
from certain colleagues
because
of
the nature
of Grill
Flame activities
since
some may consider
participation
in
such activities
as
indicating
a
belief
in
the occult
or magical.
To
the knowledge
of
the
investigators’ no-one has
suffered
such
career damage
from
a
Grill Flame-related activity,
but
the potential
for
such
is brought
to your attention.
(2)
"Some participating
sub jects
' may come
to believe
that
they
can possess
the capacity
to use
and/or
powers
for
personal profit
in risk-taking
situations
(Example:
participating
in
games
of
chance
or
speculative
investment).
Some
individuals who have
served
as
subjects
in
this kind
of
experiment have acted
on
such as-
sumptions
to
their apparent disadvantage.
Thus,
the risk exists
that
you may come
to believe
that you have
a power
that you
do not possess.
••You
are advised—of
this
risk and warned
that you
assume responsibility
for any assumptions which
you make
about your personal powers
or capa-
cities."
•
b.
The concerns
expressed
in
the minutes
of 29 March
1979
(ref.
paragraph
2a
above)
concerning
the Grill
Flame program are also appro-
priate
for
these protocols and should be addressed.
Responsibility
seems
to be divided between multiple principal
investigators
and
direction
of
the program
is vague and needs definition.
The reviewing
subcommittee
felt
the Army
sponsors and action agencies
should address
the
following concerning
the Grill Flame program because
of
the public
and political
sensitivity
of human subjects participating
in
such
a
classified project:
(1)
Scientific
review.
(2)
Command
and
control
of
the Grill Flame program needs
to be
delineated and
liability concerns properly addressed.
(3)
Public
Information Offices
for DA and DoD need
to be
knowledgeable
of
the ongoing and proposed work.
(A)
The Chain
of Command
(and responsibility)
for
the Grill
Flame program
(this protocol)
from DA
to DoD needs
to be
identified.
(5)
Security classification
of
the studies under
the Grill
Flame
program
is
perceived
to
be
a major
impediment
to continued credible
scientific
pursuit.
If
the actual
R&D effort
is biomedical/behavioral
’science,
as
it
has
been published
in
the open
literature,
the need
for
classification
is
in
question.
Classification
of
the military appli-
cation
of
the
specific
science would seem appropriate.
•-
;
• Approved For Release. 2003/09/1 6.; CLA-RDP96-00788Rp011.QjQ^^
-»
Approved For Release 2003/09/16
: CIA-RDP96-00788R001 100440027-4
SGRD-HR
2 January
1980
SUBJECT:
Minutes
of Meeting
of
the Ad Hoc Subcommittee
of The Surgeon
General's Human Subjects Research Review Board - 20 November
1979
4.
In addition,
it was recommended
that pregnant women should be ex-
cluded
from participation
in
the work carried
out under
this protocol.
This recommendation
is
in keeping with
the generally prudent policy
of
excluding any group
of
subjects
that might
be especially sensitive
to
the
effects
of
stress.
5.
The
ad hoc
subcommittee recommends
approval
of
the protocols
pending
receipt of
a new revised consent form which addresses
the an-
ticipated risks mentioned
above.
6.
There being no further business,
the meeting was adjourned at
1550
hours
RICHARD W.
SEVERSON
LTC ,
MSG
Recorder
'APPROVED/D-I-SAFFRUVED:
APPROVE Q^fiJSAP-WSSVE D
EDWARD
L.
BUESCHER
Colonel,
MC
Chairman,
Human Subjects
Research Review Board
CHARLES
C.
PIXLEY
Lieutenant General
The Surgeon General
:
i
^ Apprpyed RorRelegse 20P3/09/16
; CIA-RDR96-qp78
;aRap11pQ440027