CENTER LANE 'HUMAN USE' PROCEDURES

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The document is a memorandum discussing the "Human Use" procedures for Project CENTER LANE, which is related to the GRILL FLAME program. The purpose of these procedures is to protect subjects from any adverse effects they may experience while participating in scientific experiments. The regulations are based on Public Law 93-348 and apply to agencies or contractors receiving funding from the Department of Health and Human Services (DHHS) or its subordinate agencies. The memorandum states that Project CENTER LANE and its predecessor were determined to involve "human experimentation" and have been conducted under the "Human Use" regulations since 1981. The Secretary of the Army authorized the project to continue under these regulations in September 1983. The document emphasizes the importance of obtaining informed consent from participants with regards to the research activities and experimental procedures involved. It also mentions the establishment of a review board to ensure compliance with the guidelines. For the DIA-centered GRILL FLAME program, the document suggests obtaining a determination from the DoD General Counsel on whether it falls under the regulations and obtaining official approval if necessary.

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Body:  Approved For Release 2005103iO9   U    P 6-00788R001500050001-1
 IAGPA-F-SD                                                13 December 1983
 MEMORANDUM FOR RECORD
 SUBJECT:  CENTER LANE "HUMAN USE" Procedures (U)
 1.   (U)  References.
 a.   Procedure 13,  DoD Directive 5240.1R (U),  dtd Dec 1982
 (Incl 1)
 b.   DAMI-ISH Memorandum, dtd 12 Aug 1983,  Subject:   CENTER
 LANE (U)--ACTION MEMORANDUM (S) (Incl 2)
 c.   45 CFR 46,  "Protection of Human Subjects,"  (U)  dtd 8
 March 1983 (Incl 3)
 d.   (U) USAINSCOM Regulation 15-3,  "Boards,  Commissions and
 Committees:   HIGH PERFORMANCE REVIEW PROCEDURES".
 e.   (3) (U) AR 381-10, paragraph 2-18
 f.   CENTER LANE Participant Consent Form (S)  (Incl 4)
 2.   (U)  The "Human Use" regulations are intended to safeguard
 subjects from unwittingly risking or  incurring adverse effects
 from scientific  experiments  in which they are     participating.
 These regulations are based on Public Law 93-348, as interpreted
 in ref. c. above by the Department of Health and Human Services
 (DHHS),   the proponent agency.   By definition,  both the Public
 Law and   ref c. apply only to    those agencies  or  contractors
 receiving grants or other funding from DHHS or      its subordinate
 agencies.
 CLASSIFIED BY:   CG,  INSCOM
 DECL:   OADR
 ARMY review(s) completed.
 Approved For Release 2005/03/09 : CIA-RDP96-00788 R001500050001-1
 Approved For Release OO   3/.89, Cif, RD ,,96-00788ROO1500050001-1
 IAGPA-F-SD                                                 13 December 1983
 SUBJECT:      CENTER LANE "HUMAN USE" Procedures (U)
 3.   (S/CL-1/NOFORN)   In a memorandum dated 28 October 1981, the
 technology utilized by USAINSCOM's Project CENTER LANE and  its
 predecessor, the Army version of GRILL FLAME, was determined to
 constitute "human experimentation" by the Army General Counsel,
 and has  since been  conducted  under  the  requirements  of  the
 "Human   Use"   regulations  governing   programs   involving
 experimentation on human  subjects  (references              a, b, and c).
 With the original GRILL FLAME "Human Use" approval of 1 February
 1982  as precedent,  the Secretary of  the   Army most  recently
 authorized the Project to continue under the provisions of said
 regulations on 1 Sep 1983.   Guidelines referenced  in paragraph
 1.  above are made to apply to the CENTER LANE Project  through
 the auspices of ref a., which stipulates     that "Experimentation
 on human  subjects...may be  undertaken      only with the  informed
 consent  of   the  subject, in  accordance  with"  the      DHHS
 guidelines.   CENTER   LANE  activities generally  involve  well
 established and thoroughly scientifically validated operational
 procedures.   However,  since the Project's mission     included the
 additional requirement to research "emerging technologies," some
 aspects might by definition have constituted "experimentation on
 ,human subjects," and therefore fall under the various guidelines.
 4.   (S/CL-1/NOFORN)    Applying  DHHS  guidelines  to  CENTER  LANE
 primarily  involved  the  adoption  of procedures  insuring     that
 "Informed  Consent"  was  properly  obtained  from each      program
 participant.   Section  46.116,   ref c., lists    the  eight  basic
 elements  of "Informed  Consent."   Of  particular importance     is
 subparagraph  (a)(1) of Section 46.116,  ref c.,   which requires:
 "A statement that the study involves research, an explanation of
 the purposes of the research and the expected duration of the
 subject's participation, a description of the procedures  to be
 followed,  and  identification  of  any  procedures  which are
 experimental."   All personnel directly  involved  in CENTER LANE
 operations  were  required to   complete a  "Human  Use"  consent
 statement (ref f.).
 5.               (U) Further provisions of the  human use regulations,
 referenced  above,  require  an agency-internal   review  board  to
 insure  compliance  with  Human  Use            guidelines. Operating
 originally as an ACSI-directed   project  under  the  GRILL FLAME
 Protocol  of  1 June  1981,  Center Lane  had  heretofore  been
 reviewed by the Department of the Army's     general     "Human Use"
 review board.   However,  on 11 January,  1984  the  INSCOM Human
 Technology  Review  Board was  formed,   with  the   intent  of
 fulfilling review functions IAW references b and d.      If the DIA
 program is adjudged human use, some provision for a review board
 will be required.
 Approved For Release 2005/03/09 : CIA-RDP96-00788 R001500050001-1
 Approved For Release 20p5/03/09 : CIA-RDP96-00788 R001500050001-1
 6.   (S/CL-2/NOFORN)   Actions  that  will  need  to  be  taken  on
 behalf   of   the developing   DIA-centered   GRILL       FLAME
 psychoenergetics  effort  to  insure against  serious     human  use
 reprecussions are as follows:
 a.       (S/CL-l/NOFORN)   Obtain a determination     from  the  DoD
 General  Counsel  as  to  whether or  not  GRILL FLAME     will  be
 interpreted as a human use activity and hence be subject to the
 pertinent controls and regulations.
 b.       (U)   If the DIA GRILL FLAME program is indeed determined
 to constitute human use,   official   approval from Secretary or
 Undersecretary level must be obtained to allow legal  operation
 of the project.   Further, if they are not already,  the requisite
 procedures, as outlined in this paper and references a, b, and
 c, must be implemented.
 4'~ '/~
 ("'-B
 RIAN BUZBY
 as                                            LTC, MI
 Project Manager
 Approved For Release 2005/03/09 : CIA-RDP96-00788 R001500050001-1