SENT BY:SAIC/Los Altos ; 7- 9-91 ; 3.30 41596059674 4 58564 1
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  USE OF HUMAN SUBJECTS
  A. Def Initlon
  Human Su~lect 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 torm does not include personnel of any type who are qualiftd to test by
  assignment to duties that call specifically for such qualifications (e.g., test engineers).
  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 and federal regulations. Among them are:
  * 45 CFR 46 Health and Human SeMces (HHS) Xegulations "Protection of Human Subjects."
  * 10 U. S. C. Section 980, "Limitations on Use of Humans as Experimental Subjects."
       2. Safeguarding the rights and welfare of subjects at risk In activities supported by this contract is the
  responsibility of ft 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 responsilbility, no activity involving human subjects under thi's contract shall be
  undertaken unless a Contractor Human Use Review Board (CRB) has reviewed and approved such
  activity.
           3. nB contractor must provqde the Contracting Officer with a written assurance that it is 'in com-
  pliance with all provisions of 45 CFR 46 HHS Regulafioi:4 "Protection of Human Subjects," as
  amended.
           4. The Contractor will assurB the Contracftg Officer that the identities of all subjects VAII, be pro-
  tected.
       S. Informal consent must be obtained in writing from each human subject beforBresearch is undertak.
  en,
       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.
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   Approved For Release 2000108108 : CIA-RDP96-00789ROO3000420008-5
   C.RequIrements for Reporting and Documentation
        1. Copies of all documents presented or required for initial and, continuing review of the CRB (e.&.,
   Board minutes pertaining only to the contract, record of subjects consent, transmittal on actions,
   instructions, and conditions resulting from Board deliberatioris addressed to the activity director)
   are to be retainad 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 sponsor's COTR or
   authorized representative.
        2. Except as otherwise provided by law, information in the xecords of 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 maybe necessary for the sponsor to carry out its legal responsibilities.
        3. Upon eViration or texmination of the contract, a list of all unused test material shall beprovidod to
   the sponsoes Contracting Officer.
        4. The Contractor shall immediately notify the sponsor's Contracting Officer, by telepbone, of inqui-
   ties from sourcas outside the government concerning the use of human subjects under this contract.
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