EXCEPTION TO SF 30, APPROVED 13Y NARS 5/79
STANI.ARD F04tm 30, 'U
GENERAL SERVICES ADMI11MAIr. V	0
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FED. PR @ REG (4) CFR) 1-16A01		
AwP;-aNDME?4T/MODIFICAT)ON No. V. EFFECTIVE DATE	3. RfQUISITION/PU1RCHAS1 RIECIMST NO.
P00002 30SEP81	12o8/5702/81
5@ ISSUED by CODE HIASA7	6. ADMMTERED BY (11 stAdw abm 6hwh 5) COM- S0507A
Virginia Contracting Activity	DCASMA San Francisco
ATTN: RS-Q2	1250 Bayhill Drive
Washington, DC 20301	San Bruno, CA 94066
7. CONTRACTOR CODE FACILITY CODE	
NAME AND ADMSS	Ei AAWNDAMM Of
	SOUCRATION "0
SRI International	
333 Ravenswood Avenue	mock 9)
(Sw"4 Menlo Park
CA 94025
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L	I>ATED 06APR81 _fs" "Oek I,)
9. THIS BLOCK APPLIES ONLY TO AMENDMENTS OF SOLICITATIONS
0 the *bow numbered solicitation is amended as set forth in bloc* 12- This hour and date spacified lot reanio of Man 1:1 it saw-tbod, El is no ex%ftded.
006fors must acknowledge receipt of this ow4mclImsint prior to the hour and date specified in the w4kisatim, ar w ewwmdiid@ by one of 96 fowmiftg metivocls;
(a) By signing and rehming-copift of this affioaciment; (b) by acknowledging receipt of this amendismW on esa opipy of dw 916w vAxmkftd; or (c) by separate letter or ft6gram
which kw"s a reforence to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWIEDCA*W TO BE RICEIVED AT THE MW04G OFFICE PRIOR TO THE HOUR AND
DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. ff. by virtuis of this amendmw you 4mike so dininge up offw obeed, milmniood, roch change " be in&& by wlegram
or la"*r, provided suc.1% telegram or letter makes reference to the solicitation and this orint"chrient. cad is receimd prior to die j ami kwur and dale spocified.
10. ACCOUNTING AND APPROPRIATION DATA (if required)
ACRN: AB 2112020 25-2037 P381321-03250-2572 S18128 Mq@ $189,892.00
11. THIS BLOCK APPLIES ONLY TO MODIFICATIONS OF ComTRACTS/ORDERS
(a) 0 This Changii Order is issued pursucint to
The Chongin wt forth in black 12 am nicsde to the above numb*r*d contract/ordef.
(b) n The above wmber*d contract/ordw is modified to reflect 16e admini5ftativit changes (s"h as 4111Fproptiati- 4aft, ek.) ni Ilon% in b6ciLt 12.
(c) In This Suppienwntal Agreement n entered into pursuant to authority of U.S.C. 230 (a)
It modifies the above numbered contract as set forth in block 12.
12 DESCRIPTION Of AA4ENDMfNT/MODlFICATHZtN
A. Delete any and all references to Contract No. MDA903-81-C-0292 and substitute therefor
Contract No. MDA908-81-c-ooo4.
B. Add the following as ta@k number 2.1.10 to the Statement of' Work (Classified) dated
19mAR 81:
(U) 2.1.10 Continue development and evaluation of CRV training progran.
C. Add task numbers 2.1 and 2.2 of the Contractor's technical proposal number Esu 81-6o
(Classified), dated 23MAR81, to the Statement of Work (Classified) dated 19MAR81.
These tasks shall be remumbered 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)
E"W on povklod harein, &N terms and conditions of the d"vinom referstKed in block 1, as heroofoint clictoged. reamin owdimmiged o"d is SIM lierce find allied.
CONTRAC1IOR/0FFfROR 15 NOT REQUIRED CONTRACTOR/OFFEKX IS REOUIRED TO SIGN THIIS VOCUMEW AND WTU&4 2 cows to tssjjw@ OFFICE
TO SIGN THIS DOCUMENT 0
I?. IL"TED TATES Of AAWW,#-
14@ NAME OF CONof:TOR/OFFEROR
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BY By
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;N@AM OF YITL SIGNER try or print) 16. D TE WNED 4. NAME OF OFFICER (T'ype or i-9 DATE SIGNED
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VVCt4, . CIA k-RDP96-00792ROO01 00140015-6
XrProved For Release 00
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Wr aa &I BARRY L. MCVAY 81SEP29
D; t epA 0 e-j
lon
30-101-20
Approved For Release 2003/09/10 : CIA-RDP96-00792ROO0100140015-6
Contract MDA903-81-C-0292
Modification P00002
(New Contract MDA908-81c-ooo4)
Page 2 of 5
11-9 RSE OF MIAN SUBJECTS (1978 -Aua)
-The following definit'
Ions are used In this clause:
(1) At risk means that the human subject may be exposed to the
Possibility of 'a-m- Physical, biological* Psychological, Sociological, or
other - as a consequence of an act or calsolon that goes beyond the applica-
tion of those established and accepted methods or procedures which are in his
beat Interests, or that increases ordinary risks Of daily life, Including the
rocognized risks Inherent in his Chosen Occupation or field of service.
(2) Human Sublect means any human being who, knowingly or unkowingly,
is subjected to an act Or omission, whether at risk 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 perf 'orm any study involving
human subjects, whether at risk or not, shall Insure that the following minimum
conditions are complied with:
(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 Regulations.
(2) The nua;ber of human subjects used will be kept to the ainimum
number that will reasonably achicve 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
an Army research program.
(4) The 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 himself.
(6) Participation by subjects will be Immediately 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 date required by this contract, any
information obtained about human subjects as a result of their participation shall
be held as confidential an the law allows.
(8) The study will be conducted so as to avoid all unnecessary physical
or mental suffering or Injury.
Approved For Release 2003/0 /10 : CIA-RDP96-00792ROO01 00140015-6
lcontinueu)
Approved For Release 2003/09/10 : CIA-RDP96-00792ROO0100140015-6
Contract MDA903-81-C-0292
Modification P00002
(New Contract MDA908-81-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 occur. Sufficient animal or laboratory
experiments, or other evaluations-, must have been completed to give assurance of
acceptable kisks 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 iwill have authority to terminate
the study at any time that he believes death. Injury or harm is likely to result.
(12) Proper preparation$ 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 additions 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
make participation more 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-*xioting
conditions must have been specifically described and Justified in the scope of the
work to be performed under this contract.
(14) The scientifically qualified person conducting the study, and each
amnaber of his research team, will be prepared to terminate the subject's particl-
potion at any stage if he has reason to believe, In the exerc 'lea of the good faith,
superior skill, and careful judgment required of his, that continuation Is likely
to result In injury, disabilitys or death to the human subject*
(c) The Contractor, before permitting any person to participate an a human
subject, %&ether at risk or not, shall 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 must be voluntary. It must be the bmoving consent of
the individual or hie legally authorized representatives so situated as to be able
to exerclose free power of choice without there having been any use of force, fraud,
deceit, duress, constraint, coercions or lawful or improper.-Inducement. The ele-
ments of information necessary to such consent include:
. (1) A fair explanation of the procedures to be followed, and their
purposes, Including Identification of any procedures which are experimental.
(it) A description of any attendant discomforts or risks reasonably
to be anticipated.
Approved For Release 2003/qW&ZLMAd3DP96-00792ROO0100140015-6
Approved For Release 2003/09/10 : CIA-RDP96-00792ROO0100140015-6
Contract MDA903-81-C-0292
Modification P00002
(New Contract No. MDA908-81-C-00CA)
Page @' of 5
(III) A description of any benefits reasonably to be anticipated.
(Iv) A disclosure of any appropriate alternative procedures that
might )w advantageous to the subject.
(v) An offer to answer any questions concerning the procedure.
(vl) An Instruction that the subject to 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 tojusive, or
appear to waive, any of his legal rightes including any release from liability
for negligence, Is prohibited.
(e) Prior consent by a subject or his legally authorized representative
shall te 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 &ny,ev "ent he or his legally
authorized representative must be given adequate opportunity to read it and to
ask quotations they might have. This consent form should then be signed by the
subject. or his legally authorized representative and by a witness not directly
Involvotd in the study. Oral consent my be used only when It has been specifi-
cally described and justified in th 'a scope of the work to be performed under
this contract or approved In writing by the contracting officers When so author-
Lzed and used, Oral consent is subject to all the same standards as apply to
Writtela consent* except that the signature of the subject or his legally author-
Lztd representative is not required.
(f) Prior to conduct of the study, the contractor shall submit for approval
to the contracting officer a detailed description of the means by which informed
consent will be obtained* to include any forms to be used. Upon completion of the
studys 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
pharmalcology or clinical trails of an investigational drug unless this contract
contains the clause entitled "Clinical Study of Investigational Drugs."
J:h) Prisoners of war will not be used under any circumstances.
F. Add the following as paragraph H.10 of the contract:
H.10 A-11 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.
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Approved For Release 2003/09/10 : CIA-RDP96-00792ROO0100140015-6
Contract No. MDA903-8i-C-0292
Modification P00002
(New Contract No. MDA908-81-C-0004)
Page 5 of 5
G. Military security requirements in the performance of contract MDA908-81-C-0004
as modified shall be maintained in accordance with the revised DD Form 254
attached hereto. The highest classification involved in the performance
of this contract as modified is TOP SECRET.
SGFOIA2
Approved For Release 2003/09/10 : CIA-RDP96-00792ROO0100140015-6