HUMAN USE GUIDELINES

CIA-STARGATE

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The document provides guidelines for the use of human subjects in research conducted by the CIA. The definitions section clarifies that human subjects are individuals with whom the researchers interact physically or manipulate their environment. Non-U.S. citizens are foreign nationals, excluding personnel on active duty. The document emphasizes compliance with applicable laws, regulations, and instructions, such as the Protection of Human Subjects regulation and the Limitations on Use of Humans as Experimental Subjects law. The contractor is responsible for safeguarding the rights and welfare of subjects and must seek approval from a Contractor Human Use Review Board. The contractor must also provide written assurance of compliance with the Protection of Human Subjects regulation and ensure the protection of subjects' identities. The document stresses the need for consent from each subject, provision of necessary medical care for any injuries or diseases resulting from research participation, compliance with laws and practices in foreign countries where studies are conducted, and reporting and documentation requirements. The contractor must retain relevant documents for at least three years, allow access for inspection by authorized representatives, and only disclose subject-related information with consent or as necessary for the legal responsibilities of the Defense Intelligence Agency (DIA). Additionally, the contractor must provide a list of unused test materials upon contract termination and promptly notify the DIA Contracting Officer of any inquiries from external sources regarding the use of human subjects.

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Body:  Approved For Release 2003/04/18 : CIA-RDP96-00789R003000420010-2 ,
 HUMAN USE GUIDELINES
 A.   DEFINITIONS
 1.   Human Subject:   An individual about whom an investigator
 conducting research obtains data through interaction with the
 individual,  including both physical procedures and manipulations
 of the subject or the subject's environment.   The term does not
 include military or civilian personnel who are qualified to test
 by assignment to duties that call specifically for such
 qualifications such as test pilots and test engineers.
 2.  Non-U.S. Citizens:   Foreign nationals, excluding,
 personnel on active duty.
 3.  Research:   The term does not include individual or group
 training of military personnel such as combat readiness,
 effectiveness, proficiency, or fitness exercises.
 B.   GENERAL GUIDANCE
 1.  The contractor shall conduct research using human
 subjects at all times so as to be in full compliance with all
 applicable laws, federal regulations and DOD instructions.  Among
 them are:
 a.   45 CFR 46 Health and Human Services (HHS)
 Regulation,  "Protection of Human Subjects";
 b.   10 U.S.C. Section 980,  "Limitations on Use of
 Humans as Experimental Subjects";
 c.   DOD Directive 3216.2  (January 7,  1983)  "Protection
 of Human Subjects in DOD-supported Research";
 2.  Safeguarding the rights and welfare of subjects at risk
 in activities supported by this contract is the responsibility of
 the Contractor.  Compliance with this contract will in no way
 render inapplicable pertinent federal, state, or local laws or
 regulations.   In order to provide for the adequate discharge of
 this institutional responsibility, no activity involving human
 subjects under this contract shall be undertaken unless a
 Contractor Human Use Review Board (CRB) has reviewed and approved
 such activity.
 3.   The contractor must provide the Contracting officer with
 a written assurance that it is in compliance with all provisions
 of 45 CFR 46 HHS Regulation,  "Protection of Human Subjects," as
 Approved For Release 2003/04/18 : CIA-RDP96 L-tB      0004 0I11013)sure 1
 Approved For Release 2003/04/18 : CIA-RDP96-00789R003000420010-2
 4.   The Contractor will assure the Contracting Officer that
 the identities of all subjects will be protected.
 5.   Informal consent must be obtained in writing from each
 human subject before research is undertaken..
 6.   The contractor shall provide all necessary medical care
 to research subjects for injury or disease which is the proximate
 result of participation in the research.
 7.   Studies conducted outside the United States,  its
 territories or possessions, shall be conducted in compliance with
 all laws, customs, and practices of the country in which the
 study is to be conducted.
 C.   REQUIREMENTS FOR REPORTING AND DOCUMENTATION
 1.   Copies of all documents presented or required for
 initial and continuing review of the CRB, e.g., Board minutes
 pertaining only to the contract, record of subjects consent,
 transmittal on actions, instructions and conditions resulting
 from Board deliberations addressed to the activity director, are
 to be retained by the Contractor for at least three (3) years
 after completion of the research.  All documents shall be
 accessible for inspection during normal working hours by the DIA
 COTR or authorized representative.
 2.   Except as otherwise provided by law, information in the
 records or possession of the Contractor which refers to or can be
 identified with a particular subject may not be disclosed except:
 a.  With the consent of the subject or his legally
 authorized representative, or
 b.  As may be necessary for the DIA to carry out its
 legal responsibilities.
 3.  Upon expiration or termination of this contract, a list
 of all unused test material shall be provided to the DIA
 Contracting Officer.
 4.  The Contractor shall immediately notify the DIA
 Contracting Officer, by telephone, of inquiries from sources
 outside the Department of Defense concerning the use of human
 subjects under this contract.
 Approved For Release 2003/04/18 : CIA-RDP96-00789R003000420010-2