CENTER LANE 'HUMAN USE' PROCEDURES

• Document Type: CREST
• Collection: STARGATE
• Document Number (FOIA) /ESDN (CREST): CIA-RDP96-00788R001500050001-1
• Release Decision: RIFPUB
• Original Classification: S
• Document Page Count: 3
• Document Creation Date: November 4, 2016
• Document Release Date: January 24, 2005
• Sequence Number: 1
• Publication Date: December 13, 1983
• Content Type: MFR

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.
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 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.
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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
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