DoyrAa : i EXCEPTION TO SF 30, APPROVED BY NARS 8/79 WA edi AE ANT ARD FORM 30, JULY 1966 . . * GENERAL TERVICES ADMINIS oved*MERe MEN OBSONEITAHOR MOR 2. EFFECTIVE DATE 3. REQUISITION /PURCHASE REQUEST 30SEP81 1208/5702/81 FED" PROC. REG. (41 CFR) 1-16. i 7 AMENOMENT/MODIFICATION NO. 6. ADMINISTERED BY (if ether than block 5) DCASMA San Francisco P0002 5. ISSUED BY 1250 Bayhill Drive AMEND FY 8/ San Bruno, CA 94066 CONWTIZAL 7- 0 AMENDMENT OF SOUCTTATION NO Virginia Contracting Activity ATIN: RS-9Q2 Washington, DC 20301 7. CONTRACTOR CODE NAME AND ADDRESS rm SRI International ,.. 333 Ravenswood Avenue fountyremre, Menlo Park, CA 94025 and ZIP Code) DATED__ See block 9) [il conmeactomer wo_MDAQ03-81-C-0292 pateo_OCAPRE1 (See block 11) + THIS BLOCK APPLIES ONLY TO AMENDMENTS OF SOLICITATIONS : The above numbered solicitation is amended os sat forth in block 12. The hour ond date specified for receipt of Offers C7 is extended, (7 is not extended. Ofterors must acknowledge receipt of this amendment prior to the hour and dote specified in the solicitation, or as amended, by one of the following methads: {o) By signing and returning Copies of this amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; of (c) By separate letter or telegram which includes a reference to the solicitation ond amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO ®E RECEIVED AT THE (ISSUING OFFICE PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. ff, by virtue of this amendment i or letter, provided such telegram or letter mokes reference to the solicitation and this a 10. ACCOUNTING AND APPROPRIATION DATA (If required) ACRN: AB 2112020 25-2037 P381321.03250-2572 818128 2P29 $189,892.00 11. THIS BLOCK APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS {a) Cj This Change Order is issued Pursuant to The Changes set forth in block 12 are made to the above numbered contract/order. (b) O The above numbered controct/arder is Modified to reflect the administrative changes (such as in paying office, appropricticn dota, etc.) set forth in block 12. {c} 4 This Supplemental Agreement is entered into pursuant to authority of 10 U AS) -C. 250K a ) (11 ) tt modifies the obove numbered contract as set forth in block 12. 12. DESCRIPTION OF AMENDMENT/MODIFICATION A. Delete any and all references to Contract No. MDA903-81-C-0292 and Substitute therefor Contract No. MDA908-81-C-o00L., B. Add the following as task number 2.1.10 to the Statement of Work (Classified) dated L9MAR 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 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 ) Except as provided herein, off terms and conditions of the document referenced in block 8, as heretofore changed, remain wachonged ond in to force ond effect. 1 [1] SONTRACTOR/OFFEROR 15 NOT REQUIRED [4] CONTRACTOR/OFFEROR 15 REQUIRED TO SIGN THES DOCUMENT AND RETURN 2 COPIES TO ISSUING OFFICE TO SIGN THIS DOCUMENT 19. DATE SIGNED 81SEP29 (Signature of person aufhbrired t0 sign, ton 15, NAME OF TITLES Spence, Director, 30—-101~20 ‘ype or print)
Approved For Release 2003/09/09 : CIA-RDP96-00788R001500110014-0 Contract MDA903-81-C-0292 Modification Poo002 (New Contract MDA908-81C-0004 ) Page 2 of 5 A 9 USE OF HUMAN SUBJECTS (1978 ‘Aug) (a) .The following definitions are used in this Clause: (1) At risk means that the human subj ect may be exposed t th other = as a conn, Physical, biological, psychological, sociological. or of an act or omission that. ces beyond th lica- tion of those established and acce : 4 “are ia h pted methods or roced wh best interests, or that increases 4 y life, trenegten tte ordinary risks of daily lif. recognized risks inherent in his chosen occupation or field of serine the (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 ~¥ederal 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 sctentific 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 gtanted,. (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 2003/09/09 : CIA-RDP96-00788R001500110014-0 continue )
lea: ) 800110014-0 Release 2003/09/09 : CIA-RDP96-00788R0015001 Approved For Re Contract, MDA903-81-0-0299 Modification Poo002 (New Contract MDA908-81-C-0001 ) 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 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 will 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 @s may be required. In addition, all apparatus and instruments necessary to deal with likely emergency situations will be avatlable. (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-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 menber 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 cereful judgment required of him, that continuation is likely to result in injury, disability, or death to the hunan 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 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: - (1) A fair explanation of the procedures to be followed, and their purposes, including identification of any procedures which are experimental. (11) A description of any attendant discomforts or risks reasonably to be anticipated. . (continued) Approved For Release 2003/09/09 : CIA-RDP96-00788R001500110014-0
Approved For Release 2003/09/09 : CIA-RDP96-00788R001500110014-0 Gontract MDA9Q3-81-C-0292 Modification PoOOO02 (New Contract No. MDA908-81-C-0004 ) Page * of 5 (111) A description of any benefits reasonably to be anticipated. (iv) A disclosure of any appropriate alternati might be advantageous to the subject. ve procedures that (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 tine without prejudice to hiaself. (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 may be read to the subject er 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 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 under this contract or approved in writing by the contracting officer. When eo author- ized and used, oral consent is subject to all the same standards as apply to written consent, except that the signature of the subject or his legally author- ized representative is not required. (f) Prior to conduct of the study, the contractor shall subeit 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 study, the contractor will submit to the contracting officer detailed report demon- atrating 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.” Ch) 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-RDP96-00788R001500110014-0
; — - 01500110014-0 slease 2003/09/09 : CIA-RDP96-00788R0015 Approved For Releas Contec we sono03-61-0-089¢ Modification POO0o? (New Contract No, MDA908-81-C-000L ) 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 2003/09/09 : CIA-RDP96-00788R001500110014-0