PREPARING AND SUBMITTING A PROTOCOL (Updated 9/21/16)
The protocol is the complete description of the research or training plan that involves the care and use of animals. In order to facilitate review, the Office of Animal Welfare requests that protocols be prepared carefully and completely in accordance with IACUC guidelines. 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.
Types of Protocol Submissions. The types of protocols that can be submitted at Penn are:
Form A - The standard protocol form for research or teaching involving animals at Penn
Privately owned animal protocol (POAP) - For studies using client-owned animals rather than those procured and bred specifically for research (used primarily by faculty at the Veterinary School)
Offsite Application (formerly Form D) - For animal work that will be supported by funds awarded to Penn but that will take place at an offsite location (requires a copy of the protocol and associated approval letters from the offsite institution)
More detailed information on the various protocol forms and how to submit them can be found on the Forms page.
Note that award sponsors require IACUC approval prior to releasing funds for use. The protocol may or may not need to be submitted to the IACUC office before or at the time of protocol submission. Foundations may require protocol approval prior to grant application. If the grant is a federal grant it falls under Just-In-Time and a protocol does NOT need to be 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. The University of Pennsylvania requires the same review process for all protocols regardless of the source of funding (federal, private, or institutional).
An extensive pre-review is conducted upon the initial submission of a Form A, POAP, Offsite Application, or during a 3-Year Renewal. Amendments, Housing Applications, Continuing Reviews, Exemption Requests, and Salary Support Applications do not undergo pre-review. All submissions other than amendments with administrative-only changes (see “Administrative Amendment Review” below) are assigned to DESIGNATED MEMBER REVIEW (DMR) and the review process starts and proceeds on a "rolling" basis, regardless of the scheduled meeting. There is no monthly deadline for submissions. However, any member of the IACUC may request FULL COMMITTEE REVIEW (FCR) of any submissions at any time. Definitions for these review types follow.
Designated Member Review. In this method, prior to review, all IACUC members are provided with the necessary information concerning the proposed research projects. All members are then given the opportunity to request FCR. Polling is an acceptable mechanism for providing all IACUC members with the prior opportunity to call for FCR. It should be noted that the polling of IACUC members in this instance is not an approval vote on the proposed research. Records of such polling, however, are useful to document that the opportunity for members to call for FCR has been provided. Should the protocol not have to be reviewed by the Full Board it can then be reviewed by one IACUC member (designated reviewer). The designated reviewer has the authority to approve, require modifications to (to secure approval), or request FCR of assigned protocols.
Full Committee Review. Protocols called for FCR are assigned at least two IACUC members as “primary” reviewers and presented to the IACUC at the next convened monthly IACUC meeting with a quorum of members. IACUC meeting dates can be found on the Committee Meetings page. Applications must be submitted at least 7 days before the next scheduled meeting to be reviewed at that meeting if called for FCR. The reviewer has the opportunity to request input from other Committee members and give other committee members the opportunity to comment on the protocol. The Minutes will reflect the discussion of the major issues presented by the reviewer and committee members. A vote will be taken by the IACUC to determine one of the four protocol designations:
Withheld approval pending modifications (subsequently reviewed by FCR at the next meeting or by DMR)
Dissaprove (no protocol can be disapproved without consideration by the full IACUC)
Pain Categories. The pain category of a protocol depends upon the highest pain category of the procedures within the protocol. Pain categories at Penn are "A" (no pain or distress beyond that involved in a simple injection), “B” (pain/distress is relieved by either physical or chemical means), or “C” (pain/distress that is not relieved). These correspond, respectively, to USDA pain categories "C", "D", and "E".
Veterinary Review. For all protocols except those designated as pain category A that do not involve a USDA covered species the pre-review process includes review of the protocol by a veterinarian. A ULAR veterinarian will review all protocols involving USDA covered species that include 1) the use of anesthesia, analgesia, or sedation; 2) pain category B and C procedures; and/or 3) neuromuscular blocking agents. The Principal Investigator should discuss the proposed experiments with a ULAR veterinarian during the development of such protocols. OAW veterinarians review all protocols with 1) procedures (excluding pain category A protocols) that involve non-USDA covered species and 2) pain category A procedures for USDA covered species that do not involve anesthesia, analgesia, or sedation.
Administrative Amendment Review. Amendments that include ONLY one or more of the following changes can be processed upon submission through administrative review without review by the IACUC:
Changing the protocol title
Removing personnel, other than the PI or someone listed as a surgeon or anesthetist on a procedure
Changing the role or category of existing personnel other than the PI
Updating the qualifications for existing personnel
Changing the BA
Adding, removing, or changing funding
Decreasing animal numbers
Adding or removing personnel from procedures, other than someone listed as a surgeon or anesthetist
Correcting typographical or grammatical errors
Protocol Renewal. All renewals must be approved prior to the protocol expiration date. It is recommended that, at a minimum, 3-Year Renewals be submitted 12 weeks prior to the triennial expiration date and Continuing Reviews for protocols with USDA covered species or Department of Defense or Veterans Affairs funding be submitted 3 weeks prior to the annual expiration date. Federal regulations and policies DO NOT permit "grace periods", "extensions," or "expedited reviews" for IACUC renewals. No animal use may be performed on an expired protocol.
Please see the IACUC policy on “Protocol Review” on the Guidelines and Policies page of the website for more detailed information concerning the review of protocol submissions.
Electronic Submissions: ARIES
As of April 1, 2011, ARIES is required for all submissions other than Salary Support (Form F) or those related to current paper Form Ds.
The Animal Research Information & Electronic Submissions (ARIES) is now available to researchers at Penn. ARIES is a secure, web-based protocol and submission application.
ARIES allows the creation, submission, electronic routing, tracking, and managing of IACUC protocol submissions (Form A, POAP, Offsite Application). Additionally, users have the ability to submit Amendments, 3-Year Renewals, Continuing Reviews, Exemption Requests, and Housing Applications associated with IACUC protocols that have been created within the ARIES system. NOTE: Existing paper-based applications cannot be viewed, edited, or submitted via ARIES.
If you have any additional questions or comments, please send an e-mail to
PRINTING A PROTOCOL OR MAKING A PDF
In ARIES you have the option of printing your protocol or creating a PDF of it. Though please note that to create a PDF you need to have software installed on your computer that can do this (e.g., Adobe Acrobat Pro or CutePDF, which can be downloaded for free). The steps for printing a protocol or creating a PDF are as follows:
Find the protocol in ARIES under ‘My submissions’. Go to ‘Submissions history’ for approved or submitted protocols, or ‘Manage drafts’ or ‘Manage revisions’ for those currently being created or requiring revisions, respectively.
Click the ‘View’ (eyeglasses) icon for the submission for which you wish to print or create a PDF.
On the ‘Submission activity’ screen that opens, there will be a ‘Printer friendly’ button on the top right of the screen. Click that and the printer friendly version will open.
Now there will be a ‘Print’ button on the top left of the screen. Click that and a dialog box should open for you to print.
Select a printer and print/save.
Print to paper: Choose your normal printer from the drop-down menu of available printers and click 'Print' or 'OK'.
Create a PDF: If you have the proper software installed then one of the choices in the drop-down menu of available printers should be a PDF option. Choose that and click 'Print' or ‘OK’. ARIES will prepare the file and then ask you for a location to save it. Choose a location and click ‘Save’.
Any Form D for offsite animal work that is still on paper will continue to be on paper until its 3-year expiration. Any Amendments or Continuing Reviews that are associated with the approved paper protocol will continue to be submitted via paper. For Continuing Reviews, mail the current annual approval letter for the offsite protocol to firstname.lastname@example.org. Paper Amendment forms can be found here.
Once a paper Form D reaches its 3-year expiration date, the 3-Year Renewal must be submitted via the ARIES application as a new Offsite Application, which will receive a new protocol number (the old protocol number will be terminated upon renewal).
Form F is meant to be used to connect a salary support grant to a protocol because the grant recipient will be working on an animal protocol that may be approved under a different grant or investigator. These must be completed as a paper submission and emailed to email@example.com. The form can be found here.