App, aved f-a -0 R004 *0044M4-6 CONTROL NUWBER CO*LOD GROUP APPROVAL/RELUSE SHEET SUPJECT Establishment of INSCOM Human Use Review Committee OFFICE SYMBOL IAFM-OPS- DATE (GRILL FLAME) (U) HU-SA 10 March 1980 ACTION REQUIRED To obtain approval for establishing a Human ACTION-OFFICfR-PHOME Use Review Committee for in-house Project GRILL FLAME LTC Watt,(AV)923-7829 MEMORANDUM FOR RECORD (Descvib* briefly the requirement, background and action taken or recommended. Must be sufficiently detailed to Identify the action without rerourse 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 review 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 G L FLAME Program be provided NLT@l July 1980 (TAB B). b. On 20 November 1979, the Surgeon General's Human Subjects 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). c. In June 1979, Or LaBerge, then Under Secretary of the Army, appointed a Scientific Evaluation Committee to review the Army's parapsychological activities. In July 1979, membership on this committee was expanded to give it the authority of being a DOD Review Committee. 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. 3. (U) RECOMMENDATION: That the DCG-I, USAINSCOM, approve this proposed Human Use Review C ittee as indicated at TAB A for immediate implementation by signing this Form 32. RESOURCE IMPLICATIONS YES NO 3 Incl as A. Personnel 0 B. Space Authorixotion 0 0 C. Operating Costs (OMA) 0 0 D. Invostmertt Costs (OPA & MCA) 0 0 E. RDTE Costs n 0 F. Environment 0 0 (if "YES" coordinate action thru the Command Environmonta list ODCSLOG) COORDINATION$ APPROVAL/RELEASE -OFFICE SIGNATURE PHONE SIGNATURE DA T E ctfitsSIFIED 1"'lo C H L 1) H C A[) e, p6ono and signature) A LLAN R. STERN, COLONEL, GS, IA(HQ) FORM '32 0, 0 AUG 76) "GEM1121 Approved For Release 2003/09/16 CIA-R 96-00788RO01 100440034-6 VIM el 0 4, ,,, "0, A-4.T- Approved For Release 2003/09/16: ClA4j0P.9&,&W8J4QPw&u4I6--/@ Approved For Release 2003/09/16 CIA-RDP96-00788RO01 100440034-6 Repty-lro ArrENT1014 OP SGRD-HR DEPAn -TMENT OF THE ARMY OFFICE OF THE SURGEON Gr-NERAI- WASHINGTON, D.C. 20310 2 January 1980 SUBJECT: Minutes of Meeting of the Ad Hoc Subcommittee of Tho 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 3Z368 in the Pentagon on 20 November 1979 to consider human use issues represented in protocols presented by SRI International.[Proposed Grill Flame PrOtOC01:-r-Task 11 (U) Pn-`r.11,PLFRRHONREPNTS (U) - 15 November 19791 and the US Army Missile Comma-. (MICOM) CRPT (U) - 7 November 19791. a. Members present were: COL Edward L. Buescher, MC, Chair,-nan,.HSRRB. COL Harry Holloway, MC, Professor and Chairman, Department of Psychiatry, USUHS,,.@,,@'!J Hoc Member, HSRRB Dr. K. C,F-:-@,so@, Ph.D.,, Consultant Ad Hoc Member, HSRRB Dr. Herbert, M.D., Crr,---.ultant Ad Hoc Member, HSRRB Dr. Chris J. D. larafonetis --.D., Consultant Ad Hoc Member, HSRRB n Ms. Annie L. Young, System s Analyst, AMSAA, Ad Hoc Mt--iber, HSRRB LTC Richard W. Severson, MSC, C, Human Use Review Oi.-@.ce, USAMRDC, Recorder CPT (P) Steven M. Porter, JAGC, Ju@dge Advocate, USAM"RUC, and Member, HSRRB b. Observers/Investigators resent were: Dr. Billy Z. Jenkins, Ph.D., Grili Flame Principal Investigator, USAMICOM Dr. Edward May, Ph.D.., Grill Flame :.,,.-oject Leaderl sai International, Menlo Park, CA (contractor) Dr. Hal Puthoff, Ph.D., SRI Internat!.,-,nal, I'lenlo Park, CA Dr. Russell Targ, Ph.D., SRI Invernat.,:f@@nal, Menlo Park, CA Mr. John Kramar, Assistant Director, -iny Materiel Systems Analysis Activity, Aberdeen Proving Ground, i-ID Approved For Release 2003/09/16 : CIA-RDP96-00788RO01 100440034-6 - Approved For Release 2003/09/16 : CIA-RDP96-00788RO01 100440034-6 SGRD-HR 2 January 1980 SUBJECT: Minutes of Ileeting-of the Ad Hoc Subcommittee of The Surceon 0 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. T'lle 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 Jissues. it is clearly exceeding the validation of technology, and appears to be beyond the work scope originally examinediby 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-4 to address all antic `.@.-at.ed, problems. Specifically, the concerns incl,@da:(I) provision for a'-.,uate scientific review of research protocols, (2) provision for collab@@-itirig behavioral scientists in execution of protocols, and (3) provision L,-" credible Human Use Review processes or committees in action agencies r review of protocols." b. There clearly is no `ixed and formally appointed professional oversight for work being don(,-! tinder 11C-1.11 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 emeraing evidence and. deciding which evidence is worth pursuing will be an uncoordinated effort. c. The.. subcommittee recommends the,@--! hoc supervision of the Grill Flamr,-,-zogram be discontinued and @`,a command responsibility for the program identified. 3. Dr. May presented the SRI Internatio@nal protocol to the Ad Hoc Subcommittee. Dr. Jenkins presented the 41COM variations of the same protocol. Subsequent to discussions, the following is the unanimous consensus of the subcorunittee membel.-s; a. The SRI lnter=ational and MICOM protocols do indeed constitute research LL-,I-ilving human subjects. The immediate risks to the subjects appear to minimal; there are potential latent. related effects which deserve ex I nation In Lhe subject cor-@nt form. Recommend the consent form be amended to include: 2 Approved For Release 2003/09/16 : CIA-RDP96-00788RO01 100440034-6 Approved For Release 2003/09/16 CIA-RDP96-00788RO01 100440034-6 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 (1) #You nay lose the d'steem 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 ft" knowledge no-one has suf f ered 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 capacity to use and/or powers for personal profit in risk-taki-hg situations'(Example: participating in. games of chance or speculative investrnent)."'Some individuals wh-o have served as subjects in this kind of experiment have acted on such as- sumptions to their apparent disadvantage. Thus, the risk axists that you may come to believe that you have a power that you do not possess. You are advised of this risk and warned chat you assume responsibility for any assumptions which you make about your personal powers or capa- cities." b. The concerns expressed in the minutes of March 1979 (ref. paragraph 2a above) concerning.the Grill Flame program are also appr@o- priate for these protocols and should be addressed. Responsibility seems to be aivided between multiple principal investigators and direction q _f_._the._progr@am, is vague and needs deinition. The reviewing gubcommittee felt the Army sponsors and action agencies should,-address the following concerning the Grill Flame program because of the pi_jLic 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 s@tudias 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 woNild seem appropriate. 3 Approved For Release 2003/09/16 CIA-RDP96-00788RO01 100440034-6 Approved For Release 2001/09/16 : CIA-RDP96-00788RO01 190440034-6 SGRD-HR January 1980 SUBJECT: Minutes of Meeting of the Ad Hoc Subcommittee of The Surgeon 0 General's Human Subjects Research Review Board - 20 N .ovember 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 hoe subcommittee recommends approval of the protocols pending rece@ptof a new revised consent form which addresses the an- ticipated risks mentioned above. 6. There being no further business, i-1he meeting was adjourned at 1550 hours. @_C _R ;R D / LTC, MSC Recorder APPROVED/DTSAVYOVED: Z4 @@c EDWARD L. BUESCHER Colon@21., MC Chairman, Human Subjects Research Review Board Al? P R 0 V E D.L-;_@@ &PD,'Z@ D CHARLES C. Lieutenant Gv_.@@.Xal The Surgeon General 4 YJ 60-11WO--f P P-WK. ZAM",