EXCEPTION TO SF 30. APPROVED BY NARS S/79
-WA-N' I X7RD FORM 30, JULY 1966 1
- GCNERAI @ZRVICES ADMINI
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FEW PROC. MG. (4) CF1) I -
1		
1. AMENDMENT/MODIFICATION NO.	2. EFFECTIVE DATE	3. *E-OUISITION/PURCHASIE MQUEST NO.	A. 1010JECI "0. (am/
appli-
P00002	30SEP81	1208/5702/81 1	
5. ISSUED BY CODE HIASA7 6. ADMINISTERIED BY al 0AW AWO bAwk 5) CODE S0507A
Virginia Contracting Activity DCASMA San Francisco
ATTN: RS-Q2 1250 Bayhill Drive
Washington, DC 20301 San Bruno., CA 91@6
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NAME AND ADDRESS AAMR4DMEW OF
F souaTATCH NO
SRI International
333 Ravenswood Avenue 9)
(street, eft -
Menlo Park
CA 94025
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and ZIP "OF.O. MDA903-81-C-0292
COWRACf/00100
Code)
L DATED 06APR81 -(seebiek,i)
9. THIS "LOCK APPLIES ONLY TO AMENDMENTS OF SOLICITATIONS
0 The above numbered solicitation is amended as set forth in block 12. The hour and date specified for memo of Wisrs D is exietwied, 13 is not extended.
Offerors must ackno-ledge receipt of this onwndm*nt prior to" hour and date specified in the sokbolion.lorosetweaded, byette efdow liollowim teethods:
(a) By signing and returning-copies of this amendment; (b) by acknowledging receipt of this - to x1mes itto Goa OW of "M offor I W, ;or(c)sy separate letter or selegrom
which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWIEDGMBff TO K K<zr*w AT THE ISSUWG OFFICE PRIOR TO THE HOUR AND
DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. ff, by virtu* of this amendment you desire to dtange no offew aboody sebasittled, auch change way be mode by telegram
or letter, provW*d smh telegram or letter makes reference to the solicitation and this amendment, and is "s prior to do opet"I; how ond cla* specified,
10. ACCOUNTING AND APPROPRIATION DATA (If required)
ACRN: AB 2112020 25-2037 P381321.03250-2572 S18128 2P29 $189,892.00
11. THIS BLOCK APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS
11
This Change Order is issued pursuant to
(a)
The Changes set forth in black 12 are made to the above numbered contract/order.
(b) El The above numbe controct/order is modified to reflect the administrative changes (such as chanow in Ito of It p Wk dolo, ek.) to fortit in block 12.
'
'
(11)
(c@ S This Supplemental Agreement is entered into pursuant to authority of 10 U.S.C. 2304(a
)
It modifies the above numbered contract at set forth in block 12.
12. DESCRIPTION OF AMENDMENT/MODIFICATION I
A. Delete any and all references to Contract No. NDA903-81-C-0292 and substitute therefor
Contract No. MDA908-81-C-0004.
B. Add the following as task number 2.1.10 to the Statement of Work (Classified) dated
19MAR 81:
M 2.1.10 Continue development and evaluation of CRV training program.
C. Add task numbers 2.1 and 2.2 of the Contractor's technical proposal number ESU 81-60
(Classified), dated 23MAR81, to the Statement of Work (Classified) dated 19MAR81.
These tasks shall be remi)-mbered 2.3 and 2.4 respectively.
D. Add an additional paragraph or section to the quarterly and final reports specified
in paragraph C.2 of the contract to cover the tasks added by this modification.
E. Add the following as paragraph H.9 of the contract:
(continued)
Except as prow herein, all twrns and conditions of the document referenced in black 8, as heretofore chattgod. remaim stachoaged oad in ivill farce @pvd effect.'
0 CONYRACTOR/OFFEROlt 15 NOT RKWIRED CONTRACTOR/OFFEROIt IS REGUIRED TO SIGN THIS DOCUAIIEW Ate nETuRm 2 COPIES TO ISSUWG OFFICE
TO SIGN THIS DOCUMENT M

14. NAME OF CON	17. UNI TATIES OF AMERICA-
By_	/1 AAL@-
(549.awe of p.- .0n..d to VVT-	Pis --a-" Z)
Q)
15 NAME OF T171MU NER
rO 4- K C 41 (' 1*0 b re or pring)	
I . DATE SIGNED	- -
IS. IJAAILF - ;;;
1-313-	
19. DATE SIGNED
R-letior	a s e'?@WN9 10	CaARFtVU6jW7,ff ROO 1500110014-0	81SEP29-
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3D-101-20
Approved For Release 2003/09/09 : CIA-RDP96-00788ROopO0110014-0
Contract MDA903-81-C-0292
Modification P00002
(New Contract MDA908-81C-ooo4)
Page 2 of 5
11-9 USE OF MAN SUBJECTS (1978 -Aujt).
(a) -The following definitions are used in this clause:
(1) At risk means that the human subject my be exposed to the
Possibility of lia hys1cal, b1olog1cal9 psychological# sociological, or
other - an a consequence of an act or omission thargoes beyond the applica-
tion of those established and accepted methods or procedures which are In his
best interests. or that Increases ordinary risks of daily life, Including the
recognized risks Inherent In his chosen occupation or field of service.
(2) Human subject mans any human being who* knowingly or unkowingly,
is subjected to an act or'omisslon* whether at rtak or not, the object of which
is to contribute to knowledge to be gained as a part of work to be performed under
the scope of this contract*
(b) The Contractor,, before undertaking to perform any study involving
human subjectes whether at risk or not, shall Insure that the following minimum
conditions are complied with: I
(1) The proposed study has been reviewed and approved by a committee
meeting the requirements set forth in Chapter 46 of Title 45 of the Code.of
-,-Federal Regulationse
(2) The nuv;ber of human subjects used will be kept to the minimum
number that will reasonably achieve the required results.
(3) The study must be such as to contribute significantly to scientific
knowledge and have reasonable prospects of yielding important results essential to
on Army research program*
(4) Th e study will be conducted only by persons possessing the requisite
scientific qualifications. The highest degree of skill and care will be required
during all stages of study of persons who conduct or assist in the study-
(5) The human subject will be informed that at any time during the
course of his participation he has the right to revoke his consent and withdraw
from participation without prejudice to himselfo
(6) Participation by subjects will be Ismdiately terminated if it sub-
sequently appears that the risk to the subjects is significantly greater than
anticipated at the time review and approval was granted.
(7) There shall be no greater Intrusion into the Privacy Of the human
subject than is absolutely necessary for the conduct of the study involved. Ex-
cept for the submission of reports and other data required by this contract, any
Information obtained about human subjects as a result of their participation shall
be held as confidential as the law allows.
(8) The study will be conducted so an to ovoid all unnecessary physical
or mental suffering or Injury.
Approved For Release 2003109109: CIA-RDP96-0078BROO1500110014-0
(continueu)
Approved For Re ileaise 2003/09/09 : CIA-RDP96-00788ROO'1900110014-0
Contract NDA903-81-C-0292
Modification P00002
(New Contract IGA908-81-c-ooo4)
Page 3 Of 5
(9) NO study will be conducted if there Is any Inherent reason to believe
that death or disabling Injury Is likely to occurs Sufficient animal or laboratory
experiments, or other evaluation&-, must have been completed to give assurance of
acceptable tisks prior to the use of human subjects.
(10) The degree of risk to be taken will never exceed that which is
Justified by the benefit to the subject and/or the humanitarian Importance of
the knowledge to be gained.
(11) A physician will be responsible for the medical care of subjects.
Even if not the project leader, the physician ;0111 have authority to terminate
the study at any tine that he believes death, injury or harm is likely to results
(12) Proper preparations will be made, and adequate facilities provided,
to protect the subject against all foreseeable possibilities of Injury, disability,
or death. This Includes but is not limited to hospitalization and medical treatmen
as may be required. In addition, all apparatus and Instruments necessary to deal
with likely emergency situations will be available.
(13) Human subjects will have no physical or mental conditions which will
sake participation sore hazardous for them than It would be for normal healthy
persons, unless such condition Is a necessary prerequisite for the particular
study involved. In any such case, the use of human subjects with such pre-axisting
conditions must have been specifically described and justified in the scope of the
work to be performed under this contracts
(14) The scientifically qualified person conducting the study, and each
amber of his research team, will be prepared to terminate the subject's partici-
pation at any stage If he has reason to believe, In the exercise of the good faith,
superior skill, and careful judgment required of him, that continuation Is likely
to result In Injury, disability, or death to the human subject.
(c) The Contractor, before permitting any person to participate as a human
subject, whether at risk or not, *hall Insure that the following minimum conditions
are complied with:
(1) Legally effective Informed consent will be obtained by adequate
and appropriate methods In accordance with the provisions of this clause.
(2) All consent suet be voluntary. It must be the knowing consent of
the Individual or his legally authorized representative, so situated as to be able
to exercise free power of choice without there having been any use of force, fraud,
deceit. duress, constraint, coercion, or lawful or Improper Inducement. The ele-
ments of information necessary to such consent Include:
I (I) A fair explanation of the procedures to be followedo and their
purposes, Including identification of any procedures which are experimental.
(ii) A description of any attendant discomforts or risks reasonably
to be anticipated.
(continued) 6-00788ROO1500110014-0
Approved For Release 2003/09/09: CIA-RDP9
Approved For Release 2003/09/09 : CIA-RDP96-00788RO0,1500110014-0
Contract MDA903-81-C-0292
Modification P00002
(New Contract No. MDA908-81-C-0004)
Page 4 of 5
(111) A description of any benefits reasonably to be anticipated.
(IV) A disclosure of any appropriate alternative procedure4; that
might be advantageous to the subject.
W An offer to answer any questions concerning the procedure.
(vi) An instruction that the subject in free to revoke his consent
and to discontinue participation at any time without prejudice to himself.
(d) Exculpatory language through which the subject is made to wive,, or
appear to waive, any of his legal rights, Including any release from liability
for negligence, Is prohibited.
(e) Prior consent by a subject or his legally authorized representative
shall be obtained In all cases. Such consent shall be In writing whenever it
Is reasonably possible to do so. The consent form my be read to the subject
or his legally authorized representative, but In any event he or his legally
authorized representative must be given adequate opportunity to read It and to
ask questions they night have. This consent form should then be signed by the
subject or his legally authorized representative and by a witness not directly
Involved In the study. Oral consent way be used only when It has been specifi-
cally described and justified In the scope of the work to be performed under
this contract or approved In writing by the contracting officer. Wen so author-
Ized and used, oral consent'la subject to all the "me standards as apply to
written consent, except that the signature of the subject or his legally author-
Ized representative Is not required.
M Prior to conduct of the study, the contractor shall submit for approval
to the contracting officer a detailed description of the mean@ by which Informed
consent will be obtained, to Include any forms to be used. Upon completion of the
Study, the contractor will submit to the contracting officer detailed report demon-
stratIng compliance with paragraph (c), to Include copies of the written consent If
such was obtained.
(g) The Contractor shall not undertake to conduct either the clinical
pharmacology or clinical trails of an Investigational drug unless this contract
contains the clause entitled "Clinical Study of Investigational Drugs."
W Prisoners of war will not be used under any circumstances.
F. Add the following as paragraph H.10 of the contract:
H.10 All persons participating as human subjects, as defined by paragraph
H.9(a)(2) hereof, shall be known to possess the abilities and qualities
which will be observed and analyzed.during the conduct of this contract.
Approved For Release 2003/09/09 : CIA-RDP96-00788 ROO 1500110014-0
Approved For Release 2003/09/09 : CIA-RDP96-00788 ROO 1 $00110014-0
Contract No. MDA903-81-C-0292
Modification P00002
(New Contract No. MDAgo8-81-c-ooo4)
Page 5 of 5
G. Military security requirements in the performance of contract MDA9o8-81-c-ooo4
as modified shall be maintained in accordance with the revised DD Form 254
attached hereto. The highest classification involved in the performance
of this contrant A..,, mndifi-3 iq TOP (4TPr.PPT
SGFOIA2
Approved For Release 2003/09/09 : CIA-RDP96-00788ROO1500110014-0