Approved For Release 2003/09/09
: CIA-RDP96-00789R002100180001-9 $ 6 JUN
iggQ
PROCEDURES FOR USE
OF HUMANS AS RESEARCH SUBJECTS
IN THE EXTRAMURAL RESEARCH PROGRAM
I.
purpose:
This
is
to establish uniform procedures
and
respon-
sibility for
review of
the
use
of
humans
as
research
subjects,
negotiation of
provisions,
and administration
of
research projects
in
the extramural
program.
Wherever
the
term
"contractor" appears
it shall also mean grantee
and other Government agency.
II.
References
1.
45 CFR
HHS Regulation
on Protection
of
Human Subjects;
2.
U.S.C.
Section
Experimental
Subjects;
980
Limitations
on
Use
of
Humans
as
3.
21 CFR
312
Investigational
Drugs
and Vaccines;
4.
CFR
812
Investigational
Medical
Devices;
5.
CFR
56.111(a)(3)
Advertisement
Guidelines
for
the
Recruiting of Research Subjects;
6.
DOD
Directive
6465.2
Organs and Tissues Obtained
from
Autopsy;
7.
DOD Directive
3216.2
Protection
of
Human
Subjects
in
DOD-Supported Research;
8.
Federal
Acquisition
Regulation
(FAR)
52.228-7
Insurance
Liability
to Third Persons and
FAR
31.109 Advance Agreements;
9.
USAMRDC
Regulation
70-25
Use
of
Human
Subjects
in
Research,
Development,
Testing and
Evaluation;
10.
USAMRDC
Broad Agency Announcement
(BAA);
11.
Army Regulation 340-21
The Army Privacy Program;
and
12.
Federal Acquisition
Regulations
(FAR)
Part
24 Protection
of
Privacy
and
Freedom
of
Information,
52.224-1
Privacy
Act
Notification,
and 52.224-2 Privacy Act.
III.
Objectives
:
1.
Safeguarding
the
rights
and welfare of human subjects
participating
in
research and
development supported
by contracts,
grants and orders awarded by U.S.
Army Medical Research and
SOP
Approved For Release 2003/09/09
: CIA-RDP96-00789R002100180001-9
Approved For Release 2003/09/09
: CIA-RDP96-00789R0021 001 80001 -9
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Development Command
(USAMRDC)
is
of utmost
concern
to the Command,
and
is primarily the responsibility of
the contractor
or recipient
who receives
or
is accountable
to USAMRDC
for
the
funds awarded
for
the support of
the
project.
However,
the
sensitivity
of such
research
necessitates
that
the
Command exercise prudence
in
its
oversight
responsibilities.
The
procedures
employed
shall
be
flexible and
tailored
to
the requirements
of
the specific acquisi-
tion.
2.
It
is
the policy of USAMRDC that
the
Department of Health
and
Human
Services
( HHS )
Regulation on Protection of Human Sub-
jects,
Food
and
Drug Administration Regulations
on
Investigational
Drugs
and
Vaccines
and
Investigational
Medical
Devices,
and
Advertisement Guidelines
for
the
Recruiting
of
Research Subjects
shall
be adhered
to by USAMRDC contractors and recipients,
with
the
addition of
the
following specific DOD/USAMRDC requirements.
a.
Informed consent must
be obtained
in advance
from
the
subject,
or
in
the
case
of
research
intended
to
be beneficial
to
the subject,
the
informed
consent
of
the
subject
or
a
legal
representative of
the subject must
be obtained
in
advance.
b.
Contractors
and recipients
shall provide all neces-
sary medical care
to research subjects
for
injury
or disease which
is
the proximate
result
of participation
in
the
research.
c.
Anatomical
Substances
(organs,
tissues,
or tissue
fluids)
obtained
from autopsy
shall
not
be used
for research or
investigational purposes
without
the expressed consent
of
the next
of
kin.
It should
be noted
that
a general autopsy consent may not,
in
itself,
be sufficient.
If
autopsy tissue
is
to
be used,
the
protocol should
include
a copy of
the consent
form used
to obtain
the
tissue.
d.
Anatomical
Substances
(organs,
tissues,
or
tissue'
fluids)
obtained
from
a
surgical procedure
shall
not
be used
for
research or
investigational purposes without
the expressed consent
of
the
patient or
patient's
legal
representative.
It should
be
noted
that
a
consent
to
perform surgery may
not,
in
itself,
be
sufficient.
If excised tissue
is
to
be
used,
the
protocol
should
include
a copy of
the consent
form used
to obtain
the
tissue.
e.
Anatomical
substances
linked
by
identifiers
to
a
particular person
and used
for research
shall
be
donated
for
the
purpose
of
research,
and
shall
be
lawfully acquired.
The donor
shall
be
the person
from whom the substance
is
removed
or,
in the
event
of
death
or
legal
disability of
the person from whom the
substance
is
removed,
the
next of
kin or
legal representative
of
such person.
Donation
shall
be
made by
written consent and
the
donor shall relinquish all
ownership
and/or
rights
to
the sub-
stance.
If excised
or autopsy tissue
is
to
be
used,
the protocol
should
include
a copy
of
the
consent
form
used
to
obtain
the
tissue.
Approved For Release 2003/09/09
: CIA-RDP96-00789R002100180001-9