Approved For Release 2000/08/08
: CIA-RDP96-00789R003000420009-4
HUMAN USE GUIDELINES
A.
DEFINITIONS
1 .
unman 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 2000/08/08
: CIA-RDP96-00789RiPiPgyft(H|f|^PiP09-4o Enclosure
Approved For Release 2000/08/08
: CIA-RDP96-00789R003000420009-4
amended
.
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 2000/08/08
: CIA-RDP96-00789R003000420009-4