CIA-RDP96-00792R000600160003-2

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USE OF HUMAN SURJECTS:
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 (Jamary 7, 1983) "Protection of Human
Subjects in DoD-Supported Research";
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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 amended.
4.
The Contractor will assure the Contracting Officer that the
identities of all subjects will be protected.
5.
Informed consent must be obtained in writing from each human
subject before research is undertaken.
ARMY review(s) completed.
MDA908-93-C-0004
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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 COIR 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 of 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 inquires from sources outside the Department of
Defense concerning the use of human subjects under this contract.
MDA908-93-C-0004
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Approved For Release 2005/03/09 : CIA-RDP96-00792R000600160003-2