Format: Use
the following editable documents to propose an amendment or revision
to an existing IACUC-approved protocol. Forms are provided in Adobe
Acrobat 
and Microsoft
Word 
formats.
The applicant is responsible for ensuring that no change occurs
in the formatting or pagination of their proposal. The IACUC will
not accept or review applications that do not appear as represented
in the Adobe Acrobat version of each form.
Submitting
to the IACUC: Amendments or revisions to an IACUC-approved
protocol must first be proposed to, and 
approved
by the IACUC by submitting them to Research Compliance at MDC
35, fax 974-7091.
Changes
to a Protocol: Any changes to an IACUC-approved protocol
must be minor, within the scope of the original hypothesis and
proposed work, and described on either a Request to Amend
an Animal Use Protocol or a Request for a Procedural
Change to an Animal Use Protocol.
Acceptable
Amendments: Amendments to existing protocols (i.e.,
a change in the certified research personnel other than PI, title,
funding source other than federal or major agency sources, addition
of another strain of the same species if justified in writing,
or the use of conventional therapeutics, drugs, analgesics, or
anesthetics) are reviewed by the IACUC Chairperson within 7 days
of receipt, and approval communicated to the full IACUC membership
at its next regular monthly meeting. Requests to amend federal
or major funding agency sources of support to an existing IACUC
protocol other than a mouse colony protocol must be accompanied
by the grant proposal, and are subject to full IACUC review at
the next scheduled regular monthly meeting.
- Request
to Amend an Animal Use Protocol or REVISED
- Form Effective October 2007
Acceptable
Procedural Changes: Minor procedural changes, including
requests for additional animals to be made available to the protocol,
can be proposed to the IACUC but must be justified in writing,
within the scope of the original research hypothesis, and involve
the original species. The IACUC Chair and two assigned IACUC
members review requests for procedural changes within 7 days
of receipt, and when unanimously agreed upon, approves the change,
and this approval is communicated to the full IACUC membership
at it's next regular monthly meeting. Requested changes not unanimously
approved by the reviewers are submitted to the full IACUC committee
to be reviewed at the next regular monthly meeting. Amendments
and minor changes to existing protocols may be communicated to
the funding agency at the discretion of the PI.
-
Request
for a Procedural Change to an Animal Use Protocol or REVISED
- Form Effective October 2007
Emergent
Mouse Phenotypes: Mouse colony protocols must be amended
using the form linked below whenever aspects of the emergent mouse
phenotype, recurring clinical condition(s), or an unanticipated
outcome are recognized that were not described in the original Application
to Establish/Maintain a Mouse Colony.
-
Declaration
of Emergent Phenotype and Request for a Procedural Change to
a Mouse Protocol or
Major
Changes Requiring a New IACUC Application: Major changes
(e.g., a change in the scope of the original hypothesis, or a
change from the original specific aims of the research, or a
change in procedures which exceeds the limits set by the Request
for a Procedural Change to an Animal Use Protocol, or a
change from the originally proposed species) to research, teaching,
or testing protocols using animals cannot be amended to an existing
IACUC-approved protocol, but must be described on a new Application
for the Use of Animals in Research, an Application for
the Study of Wild Animals In or From Natural Settings, an Application
to Establish/Maintain a Mouse Colony, or an Application
for Antisera Production. The PI must obtain prior approval
from the funding agency for major changes in scope, aims, objectives,
or purpose of the research involving animals. Major changes in
research involving animals and verification of IACUC approval
of the newly established protocol must be reported to the funding
agency.
Please address
questions to CompMed@research.usf.edu,
telephone (813) 974-9796, fax (813) 974-9432; IACUC@research.usf.edu,
telephone (813) 974-7106, fax (813) 974-7091.
