HUMAN USE REVIEW OF PROJECT GRILL FLAME

• Document Type: CREST
• Collection: STARGATE
• Document Number (FOIA) /ESDN (CREST): CIA-RDP96-00788R001100440028-3
• Release Decision: RIPPUB
• Original Classification: C
• Document Page Count: 13
• Document Creation Date: November 4, 2016
• Document Release Date: June 17, 1998
• Sequence Number: 28
• Publication Date: January 24, 1980
• Content Type: MEMO

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SUBJECT: Human Use Review of Project GRILL FLAME
1. The Office of the Army General Counsel, at the request of ACSI,
reviewed Project GRILL FLAME to determine if "human use" issues were
involved per Executive Order, HEW, DoD and DA guidelines, particularly
AR 70-25, Use of Volunteers as Subjects of Research. On 15 Feb 79,
the Army General Counsel advised ACSI (Incl 1) that:
a. Project GRILL FLAME could be classified as one involving
testing on human subjects.
+~t b. Immediate contact should be established with The Surgeon General
to establish a human use testing committee to review GRILL FLAME
activities.
c. Current Army activities should be discontinued until The
Surgeon General review was completed.
AMSAA GRILL FLAME activities ceased on 23 Feb 79 upon notification of
sG,. the Army General Counsel recommendations (Incl 2).
.N1
2. In response to the Army General Counsel recommendations, a protocol
for the AMSAA sponsored GRILL FLAME work was developed with the
assistance of COL Garrison Rapmund, MC, Director, Walter Reed Army
Institute of Research. The AMSAA protocol was presented to the
Ad Hoc Subcommittee of The Surgeon General's Human Subjects Research
Review Board (HSRRB) on 26 Mar 79.
3. As reported to you by LTG Pixley on 2 Apr 79 (Incl 3), the HSRRB
found the AMSAA protocol to represent technology transfer and valida-
tion of the technology transfer rather than research or clinical in-
vestigation and, as such, did not require approval for human use.
However, the HSRRB expressed concerns that future Army follow-on work
might be classified as research and, as such, plans should be considered
to provide for the following:
a. Adequate scientific review of research protocols.
b. The collaboration of behavioral scientists in execution of
protocols.
c. The establishment of credible human use review processes or
committees in action agencies for review of protocols.
AMSAA GRILL FLAME in-house activities and contractual efforts recom-
menced in Apr 79 upon notification of The Surgeon General's decision
and signing of consent forms by all participants as stipulated by and
included as part of the approved protocol.
REGRADED UNCLASSIFIED
A tovpk F T
W1' Ile r ar to(~ fro I1 c assif:ied inclos,!
lease 2004/12/17 : CIA-RIP00788R001100440028-3
ARMY review(s) completed.
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SUBJECT: Human Use Review of Project GRILL FLAME
4. In June 1979, it was suggested by Dr. LaBerge, then Under Secretary
of the Army, that a Scientific Evaluation Committee (SEC) be appointed
to review the Army's GRILL FLAME efforts. In July 1979, Dr. Ruth Davis
recommended that, because of the special interest of the Secretary of
Defense, the SEC review the total DoD GRILL FLAME posture and report
directly to the DoD GRILL FLAME Oversight Committee. The eight member
committee was organized by the Chairman, Mr. Manfred Gale, in July 1979.
It should be noted that one member of the SEC, COL Harry Holloway, MC,
Professor and Chairman, Dept. of Psychiatry, Uniformed Services University
of the Health Sciences, is also a member of The Surgeon General's HSRRB.
5. The MICOM GRILL FLAME program proceeded to develop the hardware re-
quired for their initial efforts and additionally developed a protocol
for human use review. The MICOM protocol was presented to The Surgeon
General's HSRRB 20 Nov 79. At that same time, AMSAA presented a resume
of their progress to date on the AMSAA GRILL FLAME protocol, to include
their ongoing efforts in response to Dr. LaBerge's tasking of May 79.
6. As reported to you by LTG Pixley on 11 Jan 80 (Incl 4), the HSRRB
found the MICOM protocol indeed constituted research involving human
subjects, although the risks to the subjects appear minimal. The HSRRB
recommended the consent form for participants, as included in the MICOM
protocol, be amended to include two concerns:
a. The risks and responsibilities subjects may face if they come to
believe they possess the capability to use their "powers" for personal
profit.
b. The possibility subjects may lose esteem or respect from col-
leagues because of the nature of GRILL FLAME activities and potentially
suffer career damage.
The concerns surfaced during the previous meeting of the HSRRB, as sum-
marized in paragraph 3 above, were again surfaced as being applicable
to both the MICOM and AMSAA protocols. The HSRRB did recommend
approval of the MICOM protocol pending receipt of a revised consent
form which incorporates the above concerns.
7. The HSRRB felt that the ongoing AMSAA GRILL FLAME efforts appeared
to involve human experimentation. Thus, in keeping with the HSRRB's
recommendations on the MICOM protocol, AMSAA is now in the process of
revising its consent form for participants to reflect the two specific
concerns of the HSRRB as detailed in paragraph 6 above.
2
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Next 2 Page(s) In Document Exempt
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FOR OFFICIAL USE ONLT'.
DRXSY-DS 23 February 1979
SUBJECT: Preliminary Guidance on GRILL FLAME Experiments
1. No further experiments are to be conducted until actions are taken to
comply with Army guidelines on testing per reported guidance from the Army
General Council. Necessary actions include:
a. Development and signing of consent forms (ADSE&JSA to obtain from
ACSI).
b. ACSI to contact TSG to set up a committee.
2. More detailed guidance will be provided as it becomes available.
-?''?J(~HN W. KRAMAR
ADSE&JSA
CF:
GRILL FLAME Participants
"FOR OFFICIAL USE 02241 4.1".
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DEPARTMENT OF THE ARMY
OFFICE OF THE SURGEON GENERAL
WASHINGTON, D.C. 20310
REPLY TO
ATTENTION OF
1
tea., n. y
'2 APR 1979
MEMCRAIMUM FOR GENERAL JOHN R. GUTHRIE, CI NDER, US ARMY MATERIEL
DEVELOPMENT AND READINESS COMMAND
1. Attached are the minutes of a meeting of the Human Subjects Research
Review Board held to consider protocols from Stanford Research Institute
and Army Materiel System Analysis Activity in Project Grill Flame.
2. It is my opinion that the specific reviewed protocols are technology
transfer and phenomenology validation of the technology transfer rather
than research or clinical investigation, and,'as such, do not require
approval for human use.
3.. Anticipating future requirements, the Board expressed concern about
possible follow-on research. Your attention is directed to paragraphs
3 and 4 of the minutes.
1 Incl
The Surgeon General
as Lieutenant General
CF:
USA
ACSI
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 DEPARTMENT OF THE ARMY
OFFICE OF THE SURGEON GENERAL
WASHINGTON. D.C. 20310
SGRD-HR 29 March 1979
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SUBJECT: Minutes of Ad Hoc Subcommittee of The Surgeon
General's Human Use Review Committee Meeting -
26 March 1979
The Surgeon General
Headquarters, Department of the Army
Washington, DC 20310
1. Under the provisions of AR 70-25 and OTSG Reg 15-2,
a special meeting of an Ad Hoc Subcommittee of the Human
Subjects Research Review Board (HSRRB) was convened at
1100 hours in Room 2E465 in the Pentagon on 26 March 1979
to consider human use issues of protocols presented by
Stanford Research Institute (SRI) [TDSIILADREVGPL (U) -
23 March 1979] and the Army Materiel System Analysis Ac-
tivity (AMSAA) [PDAAADREVGPL (U) 23 March 1979].
COL Edward L. Buescher, MC, Chairman, HSRRB..
COL Harry Holloway, MC, Professor and Chairman, Department
of Psychiatry, USUHS, Ad Hoc Member, HSRRB.
Dr. K. E. Emerson, PhD, 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 Mem-
ber, HSRRB.
Ms Annie L. Young, Systems Analyst, AMSAA, Ad Hoc Member,
HSRRB.
MAJ Frank Arness, JAGC, Judge Advocate, USAMRDC, and Mem-
ber, HSRRB.
MAJ Richard W. Severson, MSC, C, HURO, Recorder for HSRRB.
b. Also present were:
Dr. Hal Puthoff, PhD, Stanford Research Institute, Menlo
Park, CA.
Mr. Russell Targ, Stanford Research Institute, Menlo Park, CA.
-Mr. John Kramar, Assistant Director, Army Materiel Systems
Analysis Activity, Aberdeen Proving Ground, MD.
COL Garrison Rapmund, MC, Director, Walter Reed Army Insti-
tute of Research, Washington, DC.
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SGRD-HR 29 March 1979
SUBJECT: Minutes of Ad Hoc Subcommittee of The Surgeon
General's Human Use Review Committee Meeting -
26 March 1979
2. Mr. Targ and Dr. Puthoff presented the SRI protocol to
the Ad Hoc Subcommittee. Mr. Kramar presented the AMSAA
protocol. Subsequent to discussions, the following is the
unanimous consensus of the Subcommittee members:
a. The Stanford Research Institute protocol was iden-
tified as technology transfer rather than research or test-
ing. Similarly, the Army Materiel System Analysis Activity
protocol was judged to be phenomenological validation of
the technology to be transferred by SRI. Descriptions of
procedures and modes of evaluation are straightforward and
do not present any known hazard to the persons involved.
b. For reasons stated above, Federal guidelines and
Army regulations on the use of human subjects do not apply.
3. While the Ad Hoc Subcommittee judged the current proto-
cols as other than research or clinical investigations in-
volving human subjects, sometime in the future it is possible
that follow-on work may be categorized as research, and may
involve human subjects. If any follow-on research should
involve human subjects, the Ad Hoc Subcommittee felt that
the Army sponsors and action agencies are presently unprepared
to address all anticipated problems. Specifically, the con-
cerns include:
a. Provision for adequate scientific review of research
protocols.
b. Provision for collaborating behavioral scientists
in execution of protocols.
c. Provision for credible Human Use Review processes
or committees in action agencies for review of protocols.
4. The Ad Hoc Subcommittee recommended that the Army spon-
sors and action agencies make plans to provide for solutions
to the deficiencies listed in paragraph 3,'above, in the
event that follow-on work is planned.
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SGRD-HR 29 March 1979
SUBJECT: Minutes of Ad Hoc Subcommittee of The Surgeon
General's.Human Use Review Committee Meeting -
26 ,March 19 79
5. There being no further business, the meeting was ad-
journed at 1550 hours.
RICHARD W. SEVERSON
MAJ, MSC
Recorder
APPROVED/D'I` A"F ROBED APPROVED/DISAPPROVED":
87(
EDWARD L. BUESCHER "CHARLES CL_P"IXL
Colonel, MC Lieutenant Genetv_?
Chairman, Human Subjects The Surgeon General
Research Review Board
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 147: 4C,$I4 A-RX0Sc~0q(01g4&" -3
UY ed Fd le ,Q~F4f,17/
- 88 j- 1 4V1 e
DEPARTMENT OF THE ARMY
OFFICE OF THE SURGEON GENERAL
WASHINGTON. D.C. 20310
REPLY TO
ATTENTION OF
11 JAN 1980
MEMORANDUM FOR GENERAL JOHN R. GUTHRIE, COMMANDER, US ARMY MATERIEL
DEVELOPMENT AND READINESS COMMAND
1. Attached are the minutes of a meeting of the Human Subjects Research
Review Board (HSRRB) held to consider protocols from SRI International'
and the US Army Missile Command in Project Grill Flame. Comments are
also included on a retrospective review of the Army Materiel Systems
Analysis Activity (AMSAA) study in Project Grill Flame, previously con-
sidered by the HSRRB.
2. It is my opinion that the specific reviewed protocols constitute
research involving human subjects.
3. The concerns expressed previously about the use of human subjects
in research studies in the Grill Flame program and delineated in the
29 March 1979 minutes of the HSRRB considering the SRI International
and AMSAA protocols, are applicable to these protocols. Your attention is
directed to paragraph 3b of the minutes.
1 Inc1 L-" 1 L$S C
as Lieutenant'`Gener
The Surgeon Gen'ral
CF:
USA
ACSI
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DEPARTMENT OF THE ARMY
OFFICE OF THE SURGEON GENERAL
WASHINGTON, D.C. 20310
REPLY TO
ATTENTION OF
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 OTSG 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) PDSIILPLFRRHONREPNTS (U) - 15 November 1979] and the US Army Missile
Command (MICOM) [RPT (U) - 7 November 19791-
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 if. Porter, JAGC, 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
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SGRD-HR
SUBJECT:
2 January 1980
Minutes of ".ieeting-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 belt
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:(l) 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 MICOM 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:
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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 L979
(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 &s knowledge a?-the--invp?t4ga= s 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 subjects may come to believe that they
can possess the cap4fclty to, use and/or powers for
personal profit in risk-taking sitit ations'(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
_Q, the-program is vague and needs definition. The reviewing
'direction
suttee 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.
(4) 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.
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1S'~'.t~`"~~-r~*.n~~';~.'+~w"/'+tB.~tFi:i $"s~'~,.tu+~.~'~}7~.e,~~'. r'y~..~i~"r~';'y~'~?*y;~..i~`Fw'A''. ~?.?.oe'4?.~}^.:~''~c'`~'~ f4+~iti ,~~',-~"'? `~Iw?~v'~""C'.y~j".~n ..; s.L,~'~~pwa",~?. "'!.
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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.
A RICHARD W. SEVERSON
LTC, MSC
Recorder
APPROVED/D=LAPP JED:
EDWARD L. BUESCHER
Colonel, MC
Chairman, Human Subjects
Research Review Board
APPROVEDSkPZAQ;tED:
CHARLES C. PIXLEY
Lieutenant General.
The Surgeon General
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