Approved For Release 2003/09/10 : CIA-RDP96-00792R600100140058-9 Contract MDA903-81-C-0292 Modification Fooo0o2 (New Contract MDA908-81C-0004 ) Page 2 of 5 Hg USE OF HUMAN SUBJECTS (1978 Aug) (a) .The following definitions are used in this clause: (1) At risk means that the huma n subject may be ex sed t Other = ae a conn gehyeseal, biological, psychological, sociological. or ot an act or omission that. oes beyond th tion of those established and acce . a vhich ace data Ppted methods or procedures which best interests, or that increases ordinary risks of daily life ineladion i 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 ~¥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 scientific knowledge and have reasonable Prospects of yielding important results essential to. an Arny 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 fs 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 es to avoid all unnecessary physical or mental suffering or injury. : Approved For Release 2bo8rd9meex01A-RDP96-00792R000100140058-9 : cee ast bee EERIE So hue, SA ne TT ENON CBRE ee ABM Tp ETO ee RRR, RE RL NORTE RM TRG ORE nt ce gg coe ev eR eR YRS TIRE Se re
Contract MDA903-81-C-0292 Modification Pooooe Approved For Release 2003/09/10 : CIA-RDFGEBOFOZRODGH OOASB9-C-0001 ) age 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 juetified 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 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 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. s (14) The scientifically qualified person conducting the study, and each meaber 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, 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. (if) A description of any attendant discomforts or risks reasonably to be anticipated. . ( continued ) ee Kpproved For Release 2003/09/70 7 CIA-RDP96-00792RO00100140058-9 °°
Approved For Release 2003/09/10 : CIA-RDP96-00792RP00100140058-9 Contract MDA903-81-C-0292 Modification POOo02 (New Contract No. MDA908-81-C-000} ) Page * of 5 (111) A description of any benefits reasonably to be anticipated. (iv) A disclosure of any appropriate alternative d wight be advantageous to the subject. 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 time without prejudice to hinself. (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 ie reasonably possible to do so. The consent form may 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 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 so 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 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 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 euch was obtained. (g) The Contractor shall not underteke to conduct either the clinical pharmacology or clinical trails of an investigational drug unless thie contract contains the clause entitled “Clinical Study of Investigational Drugs.” (h) 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-RDP96-00792R000100140058-9
Approved For Release 2003/09/10 : CIA-RDP96-00792R)00100140058-9 Contract No. MDA903-81-C-0292 Modification Pooo02 (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-RDP96-00792R000100140058-9
‘ . \ A Approved For Release 200 HOMO cSlARAR 296 P07 AZR000100140058-9 PCO; DA, Defense Supply Seryice-Washington, Room 1D245, The Pentagon, Washington, DC 20310 Agent /Specialist Sidney M. Koss ‘ Date 9 2 JUN 1931 Telephone; Area Code 202 694-4577 PLIN: MDA903-81-C-0292 Modification Number a ee - TO OPY ADDRESS NO. 01 SENT COPTE:! SRI International 1. Contractor 333 Ravensworth Avenue 1 Menlo Park, CA. 94025 DCASMA San Francisco 2. Admin Contracting Officer X | 1250 Bayhill Drive 5 San Bruno, CA. 94066 DCASR Los Angeles 3, Payment Office P.O. Box 45011 1 | Los Angeles, CA. 90045 { 4 Pre-Certification Office (pte ren re Defense Contract Audit Agency 5. Auditor -| X |298 So. Sunnyvalle Avenue, Suite 103 1 Sunnyvalle, CA. 94086 Pi COTR except DARPA Bureau 1001 1 e i Erma Ona 333 Ravensworth Ave. 94025 Menlo Park, CA, 17. Consignee berense Intelligence Agency 1 Washington, D.C. 20301 (8. Other - DAR 20-401 ‘9. Supply Coordinators A. All Bureaus Except DARPA B. Bureau 1001 = DARPA COMPLETE A or B gm 1400 Wilson 3B 10. Station Code (Cite "S" Code 503744 1 DSS-W, Policy & Procedures Branch Room 1€243 11. Reporting P&P The Pentagon, Washington, DC 20310 1 12. Reporting: DD 1057 Room 1E230, The Pentagon, Washington, DC 20310 DSS-W, Financial Mgmt, Room 1E231, The Pentagon 13. Bureaus: 8000 thru 8999 Washington, DC .20310. Information Mgmt & Financial Operations Office Blocks "X" are Mandatory Distribut Revised Jan 81 Approved For Release 2003/09/10 a GLA RDF 96-00792R000100140058-9 ry
* Approved For Release 2003/09/10 : CIA-RDP96-00792R000100140058-9 eA SED SSID SEE EOE A OS AIT 1. THE REQUIREMENTS OF THE DOD IH DUSTRIAL SECURITY MANUAL APPLY TO ALL SECURITY ASPECTS OF THIS EFFORT. THE FACILITY CLEARANCE REQUIRED 1s, FOp_Secret DEPARTMENT OF DEFENSE mS CONTRACT SECURITY CLASSIFICATION SPECIFICATION 5. THIS SPECIFICATION 15: (See “NOTE” below. If item b or c le ‘'x'a®, also enter date for item a) 3. CONTRACT NUMBER OR OTHER IDENTIFICATION NUMBER (Prime contracts must be shown for al! aubconiracte) @ PRIME CONTRACT NUMBER DATE TO BE COMPLETED (Estimated) THIS SPECIFICATION ts FOR: PRIME CONTRACT MDA903-81-C-0292 b, FIRST TIER SUBCONTRACT NO. a ORIGINAL (Oomplete date in all ceace) ib, REVISED REVISION (superecdos NO, DATE all pig vio e epect fcatlona) ce FINAL 82 Apr 05 b. SUBCONTRACT (Use item 15 for subcontracting beyond second tier) C. REQUEST FOR BID, REQUEST FOR PROPOSAL OR REQ FOR QUOTATION 6. Is this a follow-on contract? (KX) yes | []No. If YES, complete the following: ¢c. DUE DATE c. IDENTIFICATION NUMBER a. DNAOO] -78-C-0274 b. c. Accountability for classified material on preceding contract NM eee eee PRECEDING CONTRACT HUMBER DATE COMPLETED . {J 1s [CT] te not, transferred to this follow-on contract. c. Neme, Address & Zip Code of Cognizant Security Office DCASR Los Angeles, ATIN: Directorate of Industrial Security, 11099 S. La Cienga Blvd., Los Angeles, CA. 90045 c. Neme, Address & Zip Code of Cognizant Security Office Name, Address & Zip Code of Prime Contractor * b. FSC Number SRI International 333 Ravenswood Ave enlo Park, CA 9402 . Name, Address & Zip Code of First Tier Subcontractor * 94025 b. FSC Number b. FSC Number that specified, identify such other location in Item IS. Qa. Name, Address & Zip Code of Second Tier Subcontractor, or c, Name, Address & Zip Code of Cognizant Security Office facility sesuciated with IFB, RFP OR RFQ * * When actual performance is at a locetion other than 10a, General identification of the Procurement for which this specification applies S&T Intelligence Study/Analysis identified in Item 16d. W74V8H Are there additional security requirements established in accordance with paragraph 1-114 or 3-115, ISR? (Ll Yes (K] No. If YES, identify the pertinent contractual documents in Item 15. _} Yes If YES, explain in inspection responsibility of the cognizant security office? LX] No. d. Are any elements of this contract outside the Item 15 and identify specific areas or elements. fr ino | ACCESS REQUIREMENTS (Continued) ves | No | {| j. Access to SENSITIVE COMPARTMENTED INFORMATION. rx {| k. Access to other Special Access Program information (Specify in ttem 15). 1. Access to U, &. classified information outside the vu. 8, Panema Cana! Zone, Puerto Rico, U. 5 Possessions and Trust Territories. a. Access to Classified Information Only at other contractor/Government activities. 1. ACCESS REQUIREMENTS b. Receipt of classified documents of other material for reference only (nu generation). c, Receipt and generation of classified documents x || or other material. - | Xx | RS PT m. Defense Documentation Center or Defense information Analysis Center Services may be requested. d. Fabrication/Modification/Storage of classified hardware. e. Graphic arts services only. {. Access to IPO information. g. Access to RESTRICTED DATA. ; DOD DIR 5200.17 h. Ac 1 ified COMSEC Inf i DOD DIR 5200.1R i. Cryptographic Access Authorization re quired. 12. Refer all questions pertaining to contract security classification epecification to the officiel named below (NORMALLY, thru ACO (item 160); EMERCENCY, direct with written record of inquiry and response to ACO) (thru prime contractor for subcontracte). a. The classification guidance contained in this specification end attachments referenced herein is complete and adequate. 7 J c. Activity name, eddress, Zip Code, telephone number and ofits symbol Defense Intelligence Agency ATTN: DT-1A SG Washington, D.C. 20301 1 Als) 9a NOTE Original Specificati p authority for contrectors to remark of the Industrial Security ManuBl.
a We ae hE ore awe ae ee . . Fie - ) towne - * re es a y -9 13a. Information pertaining to classified contracts or projects. even though such information is considered ynclassified, shall not be released for public dissemination except as provided by the Industrial Security Manual (paragraph So end Appendix 1X). BL. Proposed public releases shall be submitted for approval prior to release {~ ] Direct {(C ] Through (Specify): Public Release of SCI is not Authorized. te the Directorate For Freedom of Information end Security Review, Office of the Asciatant Secretary of Defense (Public Alleire) * for review in accordance with paregraph So of the Industria! Security Manual. . © In the case of non-DoD User Agencies, see footnote paragraph 5o. Industrial Securit Manual, 21a. Security Classification Specifications for this solicitation “contract are identified below cx" applicable boxes) and supply attachments 6§ re quired). Any narrative oF classification guide(s) furnished shall be annotated or have information sppended to clearly and precisely identify each element of information which requires © classification. When o classification guide Is utilized, that portion of the guide(s) pertaining to the specific contractual effort may be extracted and furnlshed the contractor, When & total guide(s) is uthlized, each individual portion of the guide(s) which pertains to the contractual effort ghall be clearly identified in Item i4b, The following information must be provided for each item of classified information identified in an extract oF guide: (ft) Category of classification. dD Date ot event for declassification or review for dectassification, and (ill) The date or event for downgrading (If applicable). . The official named In Item 12b, is te sponsible for furnishing the contractor copies of all guides and changes thereto that sre made s part of this specificetion. Classified Information may be attached of furnished under separate COveT. : Cl a A completed narrative fs qt) CI attached, of (2) ip. @ transmitted under separate cover and made & part of this specification. Cb. The following classification guide(s) is made @ part of this apecification and is (2D) (_) attached, or (2) Cc transmitted under separate cover. (List guides under Item 15 or in an atiachment by Utle, reference number and date). (ic. Service-type contract/subcontract. (Specify instructions in accordance with ISR/ISM, a# appropriate.). Ta. x" only if this is & final specification and Item 6 is @ NO’ answer. In response to the contractor's request dated retention of the identified classified material is authorized for ® period of : CJe. Annual review of this DD Form 254 is required. If ayra’?, provide date such review is due: a 18. Remarks (Whenever possible, Hlustrate proper classification, deciaseification, and if applicable, downgrading instructions) a. this contract requires access to SCI. The Defense intelligence Agency has exclusive security responsibility for such information released to the contractor or developed under this contract. DIAM 50-5 provides the necessary guidenace for physical, personne} and information security measures and is a part of the security specifications for this contract. DCASR is relieved of responsibility for all SCI material or information released to the contractor under this contract. b. Foreign national employees of the contractor or subcontractor(s) are not authorized access to classified information resulting from or use in the performance of this Contract. ° c, The Contractor shall notify the COTR in writing no later than five (5) days after receipt of the contract of the following {nformation regarding the individuals assigned to work on this contract. 1) Name 2) Date and Piace of Birth ; : 3) Social Security Number (SEE CONTINUATION SHEET) 16a. Contract Security Classification Specifications for Bubcontracts {ssuing from thie contract will be approved by the office named in Item 16¢e below, oF by the prime contractor, a8 authorized. This Contract Becurity Classification Specification and attachments raferenced herein are approved by the User Agency Contracting Officer or his Representative named in Item 16b below. med name and title of spproving official REQUIRED DISTRIBUTION: (Ca Prime Contractor (Item 7a) i) Cognizant Security Office (Item 7c) SG1 J {] Adminiatrative Contracting Office (Item 160) (X) Quetity Assurance Representative (CJ Subcontractor (Itwm Ba) Ki Cogntsent EoTaly Office (Item Be) (C1) Program/Project Manger (Item 126) {Cl w. 6. Activity Responsible for Overseas Security Administration d. Approving offig al’s activity address 6 az Defense Intelligence Agenc Washington, D.C. 20301 ‘ame, oidress and Lip Code of Administrative Contracting Office . WN ‘DCASMA San Francisco 1250 Bayhill Drive saRPo620079 fRe00 TUG 7 ADDITIONAL DISTRIBUTION: m nrs-d6 A Bi Ss pproved For Release 2003/09/10 : CIp =) * :
Approved For Release 2003/09/10 : CIA-RDP96-00792R000100140058-9 DD Form 254 (Continued) (4) Certification of clearance investigation and clearance, date clearance granted, and name of agency granting clearance. © c. Final classification of the information generated under this -@ontract is the responsibility of DIA (DT-1A). Information generated under this Gontract is subject to the guidelines contained in DoD Regulation 5200.1R, dated 2 November 1978, which implements EQ 12065 which became effective 1 December 1978. Technical reports classified as high as TOP SECRET SI/SAO will be provided the Contractor by DIA and other DoD activities, and other DoD contractors for use in connection with this Contract. These reports may be retained for the duration of this Contract unless no longer needed. Upon termination of this Gontract, the reports shall be returned to the sender (if required) or destroyed in accordance with current security regulations. If these documents are to be retained beyond the ending date of. this €ontract, written justification must be forwarded to and authorization given by the €ontracting Officer. e. All copies of final documents generated by the €ontractor under this Contract will be transmitted to DIA (DT-1A) for . dissemination to the Grill Flame Committee. No other distribution jis authorized. f. Use of the ARFCOS system is required. . Approved For Release 2003/09/10 : CIA-RDP96-00792R000100140058-9 a