Preparing and Submitting a Protocol
Protocol Preparation. The protocol is the complete description of the
research or training plan that is outlined in the protocol that involves
the care and use of animals. In order to facilitate review, the request
that protocols be prepared carefully and completely in accordance with
IACUC Guidelines. All protocols must be typed. The protocols become part
of the permanent records maintained by the Committee and therefore, are
subject to inspection and review by various granting, accrediting and governmental
agencies.
Departmental Signatures. After preparation of the protocol, the
principle investigator must then submit it to his/her department chairperson
for approval and signature. If the principle investigator is the department
chairperson, the Dean's signature is required. For projects involving personnel
from more than one department, investigators must submit the protocol to
the chairperson of each department for signature.
IACUC Policy on who may be a Principal Investigator on a Protocol.
Review by the Attending Veterinarian (AV). The AV or a designee, a ULAR veterinarian, must review all Category C protocols (those involving unrelieved pain or distress), all Category B protocols involving USDA covered species, and all protocols that employ neuromuscular blocking agents. The Principal Investigator should discuss the protocol with a ULAR veterinarian during the protocol development. However, IACUC staff will send protocols meeting these criteria directly to a ULAR veterinarian.
Submitting a protocol:
- The original and one copy of the completed protocol with the appropriate signatures should be submitted.
All submissions must be e-mailed to IACUC@pobox.upenn.edu and the signed protocol and copy should be mailed to ORA:
The protocol may or may not need to be submitted to the ORA office before
or no later than the time the grant is given to the Office of Research
Services for processing depends on the funding agencies instructions. If
the grant is a federal grant it falls under Just-In-Time and a protocol
does NOT need to submitted at the same time as the grant is submitted.
If the PI receives a good score following grant review by the federal funding
agency, please submit your protocol at that time in order to avoid a time
constraint. Do Not wait until the funding agency tells you that you will
be funded. Investigators should check well in advance of a deadline to
assure timely review. IACUC
meeting schedule and submission deadlines.
Agencies, which fund research, require certification by an authorized official
of the institution that research, involving the care and use of vertebrate
animals as described in the application, and in the case of NIH, the grant
application itself has been approved by an IACUC.
The University of Pennsylvania requires the same review process for all
protocols regardless of the source of funding (federal, private or department).
Protocols received by ORA will be date stamped and assigned a protocol
number. A file will be opened and the original will become the file
copy. The Electronic copies of the protocols to be reviewed are available
to all members of the IACUC. The agenda, including protocol titles
and principal investigators will be distributed to all IACUC members
electronically.
Protocol
Review and Protocol Categories
Other
Review Items
|