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Document Creation Date: 
November 4, 2016
Document Release Date: 
October 28, 1998
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PDF icon CIA-RDP96-00792R000100140015-6.pdf355.67 KB
srAra.A FORM . niup~ v GENERAL SERVICES D d v d d EN~t41~TdT UF0~4i17~~ATit~N~Ife1 16 ATK I CTRACT ' '~ of 5 PR RIFG (4) CFR) 1-16A01 D. , AMENDME T!~ /MODIFICATION NO. 1. 9. EFFECTIVE DATE 3. REQUISITION/PURCHASE REQUEST NO. 4. PROJECT MO WAPPIk-OW) P00002 30SEP81 1208/5702/81 5. ISSUED BY CODE HLASA7 6. ADMINISTERED BY (II "Adw Ohm Week 5)5) cam S 0507A Virginia Contracting Activity DCASMA San Francisco ATTN: RS-Q2 1250 Bayhill Drive Washington, DC 20301 San Bruno, CA 9L066 7. CONTRACTOR CODE 5 FACILITY CODE NAME AND ADDRESS -" AME 8.IT Of ^ I SOUCTTATION NO SRI International 333 Ravenswood Avenue a-TEa rsca Nock e) (frast4 Menlo Park CA 94025 t w , co"a y, o e, and ZIP ca- r T/ORIxR wo. MDA903-81-C-02 2 Coda) L J DATED 06APR81 rsca ",,k 11) 9. THIS BLOCK APPLIES ONLY TO AMENDMENTS Of SOLICITATIONS ^ The above numbed solicitation is off-ended as set forth in block 12. The hour and dote specified fw reeeio of Men 1:1 it aatar, provided such telegram or letter makes reference to the solicitation and this omersdnrant, end is received prior to the opmsimg law and dose specified. 10. ACCOUNTING AND APPROPRIATION DATA (if required) ACRN: AB 2112020 25-2037 P381321.03250-2572 518128 2P29' $189,892.00 11. THIS BLOCK APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS (a) ^ The Changes Order is issued pursuant to The Chongm set forth in block 12 are mode to the above numbered contract/ord.. (b) ^ The above numbered contract/order is modified to reflect the administrative changes (such as d~a~e. sue p+ryiwg office, tepproprialiw dohs, etc.) sue forth in block 12. (c) The Supplemental Agreement is entered into pursuant to authority of 10 U . S . C . 2304 (a) (11) ^. ~_ It modifies the above numbered contract as set forth in block 12. 12 DESCRIPTION Of MAENDMENT/MODIFICATION 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: (U) 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 renumbered 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 on provided herein, oR terms and conditions of the document referenced in block B, as heretofore cha ged. remises asckoaged sued is Id low" sod allied. CONTRACTOR/ OFFEROR IS NOT REQUIRED ] CONTRACTOR/OFFEROR IS REQUIRED TO SIGN THIS f HT AND RETURN 2 COMES TO ISSUING OFFICE ^ TO SIGN THIS DOCUMENT U Ia. NAME OF CON :TOR/OFFEROR 17. UNITED TATES Of , BY BY (Sgnoture el persow a need w rpm W 1 S NAME OF TITL 'SIGNER F ype or prim!) r 16. DATE SIGNED 1B. NAME OF C OFFICER (7 I or ) 19. DATE SIGNED 'P hCt4, XrProved For Release . CIA 00 ) -RDP96-00792R000100140015-6 ' r ec`1~f)r-r ~(7 r 4e.X 4dm na 6'0 r1(J J'- N I( BARRY L. MCVAY 81SEP29 30-101-20 Approved For Release 2003/09/10 : CIA-RDP96-00792R000100140015-6 Contract MDA903-81-C-0292 Modification P00002 (New Contract MDA908-81C-0004) Page 2 of 5 H` 9 USE OF T?tAN SUBJECTS (1978 Aug) (a) -The following definitions are used in this clause: (1) At risk means that the human subject may Possibility of harm - physical, biological y c lSoci'olo ito the other - as a consequence of an act oromissionthat oggoes beyond theapplica- 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 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 perform 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 number 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 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 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 as to avoid all unnecessary physical or mental suffering or injury. Approved For Release 2003/0 /10 : CIA-RDP96-00792R000100140015-6 continue(. ) Approved For Release 2003/09/10 : CIA-RDP96-00792R000100140015-6 Contract MDA903-81-C-0292 Modification P00002 (New Contract MDA908-81-C-0004) 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-, oust have been completed to give assurance of acceptable risks 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 sill have authority to terminate the study at any time that he believes death, injury or harm is likely to result. (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 sental 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-existing 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 member 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 his, 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, 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 bowing consent of the individual or hie 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) A fair explanation of the procedures to be followed, and their purposes, including identification of any procedures which are experimental. (ii) A description of any attendant discomforts or risks reasonably to be anticipated. Approved For Release 2003/@WQ:tAd3DP96-00792R000100140015-6 Approved For Release 2003/09/10 : CIA-RDP96-00792R000100140015-6 Contract MDA943-81-C-0292 Modification P00002 (New Contract No. MDA908-81-C-0001+) Page ~ of 5 (iii) A description of any benefits reasonably to be anticipated. (iv) A disclosure of any appropriate alternative procedures that might be advantageous to the subject. (v) An offer to answer any questions concerning the procedure. (vi) An instruction that the subject is 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 waive, 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 road to the subject or his legally authorized representative, but in ony,ev.ent herhhis is legallyto authorized representative must be given adequate opportunity to ask questions they might 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 may be used only when it has been specifi- cally described and justified in the scope of the work to be performed undsuthor- this contract or approved in writing by the contracting officer. When so and used, except a that Is of the s bject standards or a his legally apply the subject signature all written consent, ized 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 Upon completion of the consent will be obtained, to include any forms to be used. 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." (b) 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 2003/09/10 : CIA-RDP96-00792R000100140015-6 Approved For Release 2003/09/10 : CIA-RDP96-00792R000100140015-6 Contract No. MDA903-81-C-0292 Modification P00002 (New Contract No. MDA908-81-C-0001+) Page 5 of 5 G. Military security requirements in the performance of contract MDA908-81-C-OO01+ as modified shall be maintained in accordance with the revised DD Form 251+ 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-RDP96-00792R000100140015-6