Preparing
and Submitting a Protocol
Form A- IACUC
FORM A
Note: The 2005
Forms will no longer be accepted.
Protocol Review Form. Form A
must be prepared carefully and completely in accordance
with
the requested
information on the forms and within these Guidelines. If possible,
the study title should not exceed two lines of 50 characters
each.
Projects involving live vertebrate animals shall be submitted
to the IACUC for approval. The completed form is forwarded to
the Office of Regulatory Affairs as part of the pre-submission
campus review process. An IACUC number will be issued for each
protocol and will be used for review, procurement and animal
housing.
The Protocol Review Form will be used as an official University
record and must receive full IACUC approval before initiating
any activity involving all vertebrate animals at this institution.
Common
Problems and Omissions in Preparing Protocol A
Form
B - Continuing Review Form (USDA
species only) Updated Dec 2005
Continuation of Applications to PHS using USDA covered
species. Non-competing continuation applications to PHS are no
longer afforded a 60-day grace period for submitting IACUC certification
of approval to the sponsor. These protocols must have a current
status prior to processing through Research Services. All IACUC
protocols must reflect the exact experimental work proposed in
any submission to a sponsoring agency and presented in a timely
manner for Committee review.
Form
C - Animal By-products Protocol Form 2
pages
Updated March 2005
The Animal By-Products protocol form (Form C). Form
C should be used by principal investigators who use animal by-products
(fresh or frozen) in their research. If embryonic eggs are to
be used and they are used 72 hours prior to the expected hatching
date, Form C can be used in lieu of the longer protocol. It is
not necessary to fill out the long protocol for these type experiments
if live animals will not be used. The original form must be forwarded
to the Director of Regulatory Affairs. Other investigators may
use tissues or individual organs of euthanized animals, which
were not exposed to infectious agents or chemical contaminants.
Form C is used for this propose. No activity may commence until
approval has been given by the IACUC.
Form
D - For Testing Vertebrate Animals at Non-University of
Pennsylvania Sites Updated March
2005
Collaborating Institution Form D. Form D must be used
by investigators doing work at a collaborating institution (off-campus
facility), but with funds administered by the University. An approval
letter from the collaborating institutions IACUC and a copy of
the animal protocol/assurance from the collaborating institution
is required for submission with Form D. Note, if the collaborating
institution does not have a PHS approved Assurance of Compliance
for animal welfare on file with OLAW the investigator must contact
the Director, ORA.
Form
E - Animal Users Risk Assessment Questionnaire · Mac
version -
Form E New Bolton Version
Risk Assessment. Each principle investigator must complete
an IACUC Form E, "Animal Users Risk Assessment Questionnaire"
and submit it with the protocol to Regulatory Affairs. The responses
are evaluated and the protocol assigned a risk factor. For most
protocols, the research staff is required to read a description
of zoonotic and other concerns
involved with the species they are using. Each individual
working with animals or animal tissues on the protocol must sign
a statement saying that they have read and understand both the
protocol and the zoonotic information. For those protocols involving
increased risk (i.e. working with macaques or certain biohazards)
the research staff must participate in physical exams, TB testing,
vaccinations etc as appropriate.
Form
F - Salary Support Protocol Updated July 2004
Many grants are only for salary support in which the
investigator will be working on an animal protocol that may be
approved under a different grant or investigator. The salary
support grant does not require a separate protocol with a new
protocol number but needs to be linked to an approved animal
protocol. This SOP will describe the procedures necessary to
link a proposal to a protocol
Form
G - Program, Center, and Training Grant Form
To be used by investigators submitting these types of grant
applications that use vertebrate animals under approved protocols.
They may be reviewed by designated review. Animals can only
be ordered under the individually approved protocols and not
under the IACUC number assigned to this overall application.
The ORA requires a complete copy of the grant proposal for
review.
Amendments - Significant
Any modifications to a protocol (ie. any changes in surgical or non-surgical methods; changes in method of euthanasia; modifications in time points; or revisions to the purpose or aim of the study) require approval by the IACUC prior to implementation. A principle investigator may request these changes by completing and submitting the IACUC amendment form.
Extensive modifications (ie. production of monoclonal antibody production in mice; changes in the pain/distress category from A to B, or B to C; or any changes which deviate considerably from the original procedures described by the investigator) may be referred to the full IACUC for review, and may require submission of a new or revised protocol (Form A).
Amendments - Administrative Modifications
Any administrative changes to a protocol (ie. change of funding source or grant title; addition of personnel or change of location for procedures and/or satellite housing) may be completed by submitting the administrative modification form. Please note that although these modifications do not have to go through the complete review process, all documentation and training must be completed and submitted before approval will be granted
EHRS Animal Protocol Review Process
Investigators intending to administer or treat live
animals with hazardous materials must submit a copy of their
Institutional
Animal Care and Use Committee (IACUC) animal protocol review
form (Form A) to the Office of Environmental Health and Radiation
Safety (EHRS) for review and approval before the IACUC will give
its full approval to the protocol. For details, see the EHRS
Web site.
If you need to amend the material submitted to EHRS, please
use the Potentially
Hazardous Substance Form.
Updated July 2005
Privately-Owned-Animal
Protocol Review Form Updated February 2007
Protocols using privately-owned animals must be reviewed and approved
by the Hospital Protocol Review Committees (VHUP or NBC) before
approval by the IACUC.
General Owner
Informed Consent Form Updated July 2004
Venipuncture Owner
Informed Consent Form for VHUP Updated
July 2004
Record
Keeping for Progeny Bred In-House (Annex 24)
Immediate Postoperative Care Record
-- used to record observations from the time an animal is extubated
until returned to colony housing.
Post
Operative Care During Periods of Analgesic Administration
(contained within Annex 12)-- used to
record observations and medication administration after the animal
is returned to colony housing.
Final
Disposition Form (Surgical procedures) -
complete this form in the event of an
animal death related to surgery.
Request
for Housing of Animals Within a Study Area Updated
January 2006
Exemption Form
To be used if, due to specifications/ requirements of the research protocol, an exemption from the standards, federal regulations, and/or U Penn policies are required. (i.e. space requirement [including innovative enclosures and metabolic cages], use of an animal in more than one major survival surgery, etc.)
Privately-Owned-Animal Protocol Review Form**OLD** (Do Not Use)
