Approved For Release 2000/08/09
: CIA-RDP96-00792R0006001 70002-2
Policy on Research Involving Human Subjects
1.
Introduction.
Group activities may from time to time include research involving human
subjects.
This memorandum
sets
forth Defense Technology Group policy for these
activities.
2.
General.
It is the policy of the Group to conduct research activities involving human
subjects so as in everyday to be in compliance with United States Government federal
policy for the protection of human subjects, as set forth in the Federal Register. Volume
56, No. 117, June 18, 1991. This policy applies to all Group research activities involving
human subjects, regardless of the sponsoring organization.
3.
Definitions
a.
Research: A systematic investigation, including Research development, testing,
and evaluation, designed to develop or contribute to generalizable knowledge.
b.
Human
Subject:
A
living individual about whom an investigator conducting
research obtains data through intervention or interactions with the individual, or
identifiable private information.
c.
IRB:
An
Institutional Review Board established
in accord with and
for the
purposes expressed in this policy.
d.
Minimal Risk: The probability and magnitude of harm or discomfort anticipated
in
the
research
are
not
greater
in
and
of themselves
than
those
ordinarily
encountered
in
daily
life
or during
the performance of routine
physical
or
psychological examinations or tests.
e.
Principal Investigator:
The scientist responsible for the planning, execution and
reporting of the research.
f.
Informed Consent: Written consent to participate in the research provided by each
research
subject
after receiving extensive information outlined
in the Federal
Register (cited above).
4.
Specific.
When Group activity
is proposed which includes research involving human
subjects, the following actions will be accomplished:
a.
The principal investigator will prepare a research protocol which at a minimum
will
set
forth
research
objectives, experimental
design, methodology
for data
collection and analysis, scientific background pertinent to the research, description
of the research subjects including number, age, gender, recruitment source and
recruitment procedure, and such other information as may be needed to make a
Approved For Release 2000/08/09
: CIA-RDP96-00792R0006001 70002-2
Approved For Release 2000/08/09
: CIA-RDP96-00792R0006001 70002-2
judgement of degree of risk to the research subjects and of the benefits to be
derived from the research.
b.
A IRB
will be established in accord with federal policy
that
is competent to
review the research to be conducted:
(1)
The IRB will be composed of at least 5 members; membership will include
both men and women, and at least one person who is not an employee of the
Company; no member may be associated in any way with the proposed research,
nor may be a subordinate of the principal investigator; the majority of members
must
reside
in
the
state,
or
states
adjacent
to, where
the
research
will
be
conducted, and to reflect local community attitudes.
(2)
The IRB will receive research protocols in advance of each meeting and
will review them based on the following criteria:
risks are minimized; risks are
reasonable in relation to anticipated benefits; selection of subjects
is equitable;
informed consent will be obtained and documented; the experimental design is
sound for the research questions being posed; and the research plan provides for
the safety and confidentiality of the subjects.
(3)
The IRB may approve or disapprove
research
protocols;
it may
also
withhold approval pending additional information being provided or changes being
made in protocol, thus serving as a quality control on compliance with this policy.
(4)
The IRB
will meet at least annually and will receive at least an annual
report of progress on each approved protocol, thus serving as a quality control on
compliance with this policy.
(5)
The IRB will receive for review and approval notification of any change
to the approved protocol before the change is implemented.
(6)
The IRB
has
authority
to
suspend
or
terminate
research
not
being
conducted in accord with the approved protocol.
(7)
The IRB will have staff support to maintain records of its proceedings.
c.
No Research involving human subjects will be undertaken without IRB approval.
d.
Any unanticipated problems involving risks to subjects or others will be reported
promptly to the IRB.
e.
The Group Manager will designate a Company representative for each IRB who
will receive the results of IRB deliberations and will transmit those results to the
principal investigator.
Group Manager
Approved For Release 2000/08/09
: CIA-RDP96-00792R0006001 70002-2