Lib deve oorsonoossooteooena . DEPARTMENT OF THE ARMY SECURITY SUPPORT DETACHMENT USAINSCOM, 902D MILITARY INTELLIGENCE GROUP FORT GEORGE G. MEADE, MARYLAND 20755 Approved For Release sananviit REPLY TO ATTENTION OF: IAGPA-F-SD 26 March 1984 i pames MEMORANDUM THRU otiae-BDek-Toroys~ ABCSOPS=AUM: : 30 bf COL Kirk, Cofs 1 /y fe BG Scanlon, .DCG-S Ged ot / FOR MG Stubblebine, CG, INSCOM Cogent 3 ae SUBJECT: CENTER LANE Human Use Review (S/CL-1/NOQFORN) 1. (U) References: a. (U) 45 Code of Federal Regulations, Part 46, "Protection of Human Subjects" (incl 1) b. (U) Procedure 13, DOD Directive 5240.1-R (incl 2) c. (U) AR 381-10, paragraph 2-18 (incl 3) d. (U) USAINSCOM Regulation 15-3, "Boards, Commissions and Committees: HIGH PERFORMANCE REVIEW PROCEDURES" (incl 4) 2. (S/CL=2/NOFORN) Background. In February 1979, the Army General Counsel determined that GRILL FLAME activities involved testing on human subjects, and FOIAB5 ARMY In March 1979, The Surgeon General's WARNING NOTICE: CENTER LANE SPECIAL ACCESS PROGRAM RESTRICT DISSEMINATION TO THOSE WITH VERIFIED ACCESS TO CATEGORY TWO (2) SENSITIVE INTELLIGENCE SOURCES AND METHODS INVOLVED NOT RELEASABLE TO FOREIGN NATIONALS CLASSIFIED BY: CDR, INSCOM DECLASSIFY ON: OADR ARMY review(s) completed. Approved For Release NE re 3 60002-8 J
3 VE : be S Approved For Release 2004/86 T seccoreoncotsoreonen8 “s t IAGPA-F-SD 26 March 1984 SUBJECT: CENTER LANE Human Use Review (S/CL-~1/NOFORN) Human Subjects Research Review Board reviewed the GRILL FLAME protocol and concluded that it represented technology transfer and validation of the technology transfer, rather than research or clinical investigation, and as such, GRILL FLAME activities did not require approval for human use. However, the Board expressed concerns that future Army follow-on work might be classified as research, and as such, plans should be considered to establish credible human use review procedures to oversee GRILL FLAME activities. In April 1979, Army General Counsel determined that the Army could continue/proceed with GRILL FLAME activities as long as HEW guidelines and other appropriate precautionary measures were taken. In April 1980, the Under Secretary of the Army approved the continuation of GRILL FLAME activities. In October 1980, the OSD, DIA, and Army General Counsels jointly agreed that it would be prudent to obtain written approval from the Deputy Secretary of Defense to conduct GRILL FLAME activities. ACSI, DA concurrently initiated action to obtain Secretary of the Army approval to conduct GRILL FLAME activities. In September 1982, INSCOM GRILL FLAME activities ceased because of NFIP restrictions; INSCOM psychoenergetic activities were reinitiated in December 1982, under the INSCOM CENTER LANE Project (ICLP), an S&IA activity. Secretary or Under Secretary approval for GRILL FLAME/ICLP activities has been granted on 14 January 1981, 1 February 1982 and 1 September 1983. Approvals are generally valid for one year. 3. (S/CL-2/NOFORN) Discussion. Paragraph l references require an agency internal review board to insure compliance with human use guidelines. Operating originally as an ACSI-directed project, GRILL FLAME/ICLP activities in the past were reviewed by HQ, DA components to insure compliance with human use directives. With the transfer of program management from OACSI to INSCOM on 14 January 1981, and the promulgation of the INSCOM Human Technology Review Board (HTRB) on ll January 1984, human use review and subsequent approval action of ICLP is now an INSCOM responsibility. 4. (S/CL-2/NOFORN) Recommendations. Recommend that the ICLP Protocol now be reviewed by the e— INSCOM HTRB to determine if ICLP constitues human use. If that O74 review results in a determination that ICLP still constitutes Approved For Release 2004/0, NeitdeP 96-00788R001500160002-8 ;
Approved For Release 2004/@6; ey [ Topse-oorssnootsooteo002. TAGPA-F-SD 26 March 1984 SUBJECT: CENTER LANE Human Use Review (S/CL-1/NOFORN) human use, then approval to continue ICLP activities will have to be obtained from the Secretary of the Army. In order to review the ICLP protocol, voting members of the INSCOM HTRB will auc have to receive a ICLP indoctrination. The préparation of a new ICLP protocol, its review, and submission of required approval documents will be accomplished by 1 September 1984, the anniversary date of the last Secretary of the Army approval of ICLP. 4 Incl BRIAN BUZBY Vy as LTC, MI CENTER LANE Project Manager Approved For Release 2004/06/29 ix - 6-00788R001500160002-8 . | ‘ a