f ; = ben. B55 GIP RWG E ac ire ER Os 1807 BB ROO 400440034-6 ADUrOUVveU © - CONTROL NUMBER COMMAND GROUP APPROVAL/RELEASE SHEET SUBJECT Establishment of INSCOM Human Use Review Committee OFFICE SYMBOL [DATE (GRILL FLAME) (U) TAFM-OPS~ HU-SA 1G March 1980 ACTION REQUIREO To obtain approval for establishing a Human ACTION-OF FICER-PHONE Use Review Committee for in-house Project GRILL FLAME LTC Watt, (AV)923-~7829 MEMORANDUM FOR RECORD (Describe briefly the requirement, bockground ond action taken or recommended, Must be sufficiently detailed to identify the action without reesourse to other sources.) 1. REQUIREMENT: To establish a Human Use Review Committee to oversee the activities of INSCOM's GRILL FLAME Project. This committee will meet on a quarterly basis to reviey the status of the program and to provide recommendations/observations as appropriate, Proposed membership of this committee is indicated at TAB A, 2. (S) BACKGROUND: a. In mid-January 1980, the DCG-I directed that a formal review of the GRILL FLAME Program be provided NLT: 1 July 1980 (TAB B). b. On 20 November 1979, the Surgeon General's Human Sub jects Research Review board made the recommendation that "credible Human Use Review processes or committees in action agencies for review of protocols" be established (TAB C). d. By creating a Human Use Review Committee to oversee the INSCOM GRILL FLAME Program we will insure that our work is being monitored by the most appropriate echelon of DOD, That the DCG-I, USAINSCOM, approve this proposed Human Use Review Committee as indicated at TAB A for immediate implementation by signing this 3 RESOURCE IMPLICATIONS YES NO 3 Incl as A. Personnel + Space Authorization - Operating Costs (OMA) + Investment Costs (OPA & MCA) RDTE Costs Environment Ooo0o000 Oo00000 ™"moonogo (If “YES"* coordinate action thru the Command Environmentalist ODCSLOG) HEAD Ge Me tht a ow oh A.) EE a 19 ALLAN R. STERN, COLONEL, GS, DcSoPS | FUROGL1 G04 40034-8203 7 ALY IA(H 32 (ARPS EPs for Reteesemy pais a ee ee De oe aaa ei, Aue 76) 32 | rit oole cy Ky itis a | RRERSON py ET gf FO
Nate etree carmen par me - Approved For Release 2003/09/16 : CIA-RDP96-00788R001100440034-6 tren -. DEPARTMENT OF THE ARMY OFFICE OF THE SURGEON GENERAL WASHINGTON, Dus. 203.10 ; Pe sor AEWZS® ey FN) eee Bis YS < REPLY. TO Set ATTENTION OF 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 The Surgeon General Headquarters, Department of the Army - Washington, DG 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 32368 in the Pentagon on 20 November 1979 to consider human use issues yepresented in protocols presented by SRI International [Proposed Grill Flame Protocol: . Task IL (U) PRELILPLFRRHONREPNTS (U) —- 15 November 1979] and the US Army Missile Commai:.. (MICOM) [RPT (U) - 7 November 1979]. a. Members present were: GOL Edward L. Buescher, MC, Chairman,. HSRRB. COL Harry Holloway, MC, Professor and Chairman, Department of Psychiatry, USUHS 2-1 Hoc Member, HSRRB De. Ke GC. Revrson, Ph.D., Consultant Ad Hoc Member, HSRRB Dr. Herbert ul. ley, M.D., Goosultant Ad Hoc Member, HSRRB Dr. Chris J. D. Agrafonetis, v.D., Gonsultant Ad Hoc Member, HSRRB Ms. Annie L. Young, Systems Analyst, AMSAA, Ad Hoc Meuber, HSRRB LTG Richard W. Severson, MSC, C, Human Use Review Of ice, USAMRDC, Recorder CPT (P) Steven M. Porter, JAGC, Judge Advocate, USAMR0C, and Member, HSRRB b. Observers/Investigators  cesent were: Dr. Billy Z. Jenkins, Ph.D., Grili flame Principal Investigator, USAMICOM Dr. Edward May, Ph.D., Grill Flame *roject Leader, SRI International, Menlo Park, CA (contractor) Dr. Hal Puthoff£, Ph.D., SRI International, Menlo Park, CA Dr. Russell Targ, PheD., SRI International, Menlo Park, CA Mx. John Kramar, Assistant Director, ‘my Materiel Systems Analysis Activity, Abexdeen Proving Ground, HD Approved For Release 2003/09/16 : CIA-RDP96-00788R001100440034-6 Ty fa
oi re - Approved For Release 2003/09/16 : CIA-RDP96-00788R001100440034-6 - 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 1973 2. Mx. Kramar. presented a resume of the progress to date on the AMSAA Grill Flame Protocel [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: ae 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 yt 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 unprepar=1 to address all anticisated, problems. Specifically, the concerns include: (1) provision for ahomate whe scientific review of research protocols, (2) provision for collabesating behavioral scientists in execution of protocols, and (3) provision fer credible Human Use Review processes or committees in action agencies ‘sr =" review of protocols." b. There clearly is no ~ixed and formally appointed professional oversight for work being dome under "Grill Flame"; rather, oversight appears to be ad hoc, incomplate 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. ¢. The subcommittee recommends thead hoc supervision of the Grill Flame.s:cogram.be discontinued and +i 2 command responsibility for the program *« identified. - 3. Dr. May presented the SRI International protocol to the Ad Hoc Subcommitree. Dr. Jenkins presented the MICOM variations of the same protocol. Subsequent to discussions, the following is the unanimous consensus of the subcommittees members: , a» The SRI International and MICOM protecols do indeed constitute research i:valving human subjects. The immediate risks to the subjects appear to minimal; however, there are potential latent related effects which deserve explanation “in the subject con wnt form. Recommend the consent form be amended to include: ~ Approved For Release 2003/09/16 : CIA-RDP96-00788R001100440034-6
so - Approved For Release 2003/09/16 : CIA-RDP96-00788R001100440034-6 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 a (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 Bie knowledge -of-the-—investtcaters no-one has suffered such career damage from a Grill Flame—relatad activity, but the potential for such is brought to your attention. (2) "Some participating subjects may come to believe that thay can possess the capacity. to use and/or powers for 3 personal profit in risk-taking situations (Example: participating in * games of chance or speculative investment) .YSome 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 net 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 2% 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 piuslic and political sensitivity of human subjects participating in such a classified project: _ (L) Scientific review. (2) Command and control of the Grill Flame program needs to be delineated and liability concerns properly addressed. + eet ie (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 DeD needs to ba 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 approvriate. ved For Release 2003/09/16 : CIA-RDP96-00788R001100440034-6 pies INURE SDSS Ln ALT Sata Beastie ciara tc tek it eect re epee Eee Soca NE Ve Mae na deReel retard mettre re Ten . hea) Pe EES STS Meg me kre nde c gent og PON cen repo gt Spa ent same.) bu cere tr eaeira h Vle a oni ane Nae Se a eR
Sel ome . Approved For Release 2003/09/16 : CIA-RDP96-00788R001 1904400346 SGRD-HR anuary 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 exciuding any group of subjects that might be especially sensitive to the effects of stress. so 5. The ad hoc subcommittee recommends approval of the protocols pending receiptof a new revised consent form which addresses the an- . ticipated risks mentioned above. 6. There being no further business, the meeting was adjourned atc 1550 hours. Oi ne Li lieben RICHARD W. SEVERSON - . 4 LTC, MSC ‘ Recorder APPROVED/DESAPEROVED: . APPROVEDLDESAPD ROWED : | , | _ ala , ELLEK GD (Ss LEE EDWARD L. BUESCHER CHARLES C. PIN2Y ( . Colonai, MC Lieutenant Gec-ral . Chairman, Human Subjects The Surgeon General Research Review Board 4 . Re Approved For-Release.2003/09/1.6.:, CA-RP PIANO 7ZEBROOt1 0044 00SAEB are TET TAT