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| CONTRACTS AND GRANTS |
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PHS ANIMAL CARE AND
USE POLICIES
(posted to web 10/20/00)
In recent months the Office of Laboratory Animal Welfare (OLAW)
at the NIH has increased its monitoring of certain US Public Health
Service (PHS) regulations related to proposal submissions to PHS
agencies. These regulations require consistency in the animal care
and use components of all contract and grant applications and the
corresponding application submitted to the Institutional Animal Care
and Use Committee (IACUC which is the CAR at UCSF). They also require
that either a CAR approval or an application for the use of animal
subjects must be on file with the CAR at the time of grant proposal
submission. If the CAR application is in process at the time of grant
proposal submission follow-up certification of CAR approval is required
within 60 days of the deadline for which the grant proposal was submitted.
Principal Investigators and fellowship applicants are reminded of
the following points:
- When a grant application is submitted to PHS and CAR approval
of animal subject use is noted on the face page as apending,â it
is understood that the CAR application has been, at minimum,
received in the CAR office and is, therefore, scheduled for
review. Institutional
certification of that review and approval is due to PHS within
60 days of the deadline for which the grant was submitted.
No grant proposal will be submitted to the NIH or any PHS
agency
until either
the CAR application is on file and in process for review
or CAR approval has been given.
- When UCSF Contracts and Grants reviews a grant application
for approval and submission it is expected that the
principal investigator of the grant is also identified in the CAR-approved
protocol. This includes post-doctoral fellows who
cite
their sponsor's/mentor's CAR approval. Grant proposal
submission must be delayed if this is not the case.
When citing a CAR approval or pending application for someone
other than the principal investigator of the grant
application it is imperative that that CAR approval or pending
application
include the same animal care and use components as
in the grant application.
- UCSF is responsible for assuring
that the animal care and use
described in the grant matches the protocol
or protocols approved by the
CAR.
- PHS
grant applications that involve the
use of animal subjects must provide the
following information in the Research Plan
section of the application:
-
- Provide
a detailed description
of the proposed use of animals
in the work outlined in
the Research Design and
Methods section. Identify the
species, strains, ages, sex,
and numbers of animals
to be used in the proposed
work.
- Justify
the use
of animals,
the choice
of species,
and the
numbers
to be
used. If
animals are
in short
supply, costly,
or
to
be
used
in
large
numbers,
provide
an
additional
rationale for
their
selection
and
numbers.
- Provide
information on
the veterinary
care of
the animals
involved.
- Describe
the procedures
for
ensuring that
discomfort,
distress, pain,
and
injury will
be
limited
to
that which
is
unavoidable in
the
conduct of
scientifically
sound research.
Describe
the
use
of analgesic,
anesthetic,
and tranquilizing
drugs
and/or comfortable
restraining
devices, where appropriate,
to
minimize
discomfort,
distress, pain,
and
injury.
- Describe
any
method of
euthanasia
to
be
used
and
the
reasons
for
its
selection.
State
whether
this
method
is
consistent
with
the
recommendations
of
the
Panel on
Euthanasia
of
the
American
Veterinary
Medical
Association.
If
not,
present
a
justification
for
not
following
the recommendations.
As
a result of the above requirements,
the following new procedures have
been put in place for both PHS and
non-PHS grant and fellowship applications
in which animal activities are
involved. More will likely be
put in place in the upcoming months:
- Principal
Investigators (and fellows)
submitting grant applications
using animal subjects must
include as attachments
to the Contracts and Grants
Approval Form a copy of the
CAR Approval Letter(s) or
a copy of the CAR Cover
- Page(s)
showing the date the application was submitted
to the CAR office. The
Approval Letter and/or CAR
application must correspond
with the activities involving animals
as described in the grant
application. PHS proposals
will not be forwarded on
to the funding agency until
verification has been provided that CAR approval
has been given or that an
application has been submitted
to the CAR.
- No
proposal for
a non-competing
continuation application
may be
submitted without
a current
CAR approval,
in accordance
with PHS
policies. Principal
Investigators are
reminded of
the requirement
to renew
animal care
and use
protocols annually
without any
lapse in
approved status.
- If
the name
of the
principal
investigator on
the grant
application does
not match
the name
on the
CAR-approved protocol
or pending
application,
then the
principal investigator
must also
submit a
copy of
the
Personnel Chart
of the
CAR application
indicating his/her
participation in
the
study. For
fellowship proposals,
it should
be noted
that the
CAR
approval which
has been
previously obtained
by the
sponsor/mentor is
not
a valid
approval for
a fellowship
proposal until
the fellow
has
been added
to the
protocol, along
with any
modifications to
the
protocol as
needed for
performance of
the
work
described
in the
fellowship.
- The
PI certification
section of
the CAR
Application has been
revised so
that
the
PI
will now
be
certifying on
the
CAR application
that
the CAR
protocol
matches the
grant. The
funding
source of
the
protocol must
be
properly indicated
on
the
CAR
Cover Page
and
the grant
title
and award
number,
if known,
listed.
It is
recommended that
the
titles of
the
CAR and the
PHS
applications match.
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