ORGANIZATIONAL CHART …………………………………………………… 5
INTRODUCTION ...................................................................................................... 6
I. ANIMAL CARE AND USE PROTOCOL SUBMISSION AND REVIEW ....... 6
A. Protocol Preparation ………………………………….................................. 6
B. Protocol Reviews ............................................................................................. 7
4. Animal Surgery ………………………………………………................ 17
IV. THE LABORATORY ANIMAL PROGRAM ................................................. 20
A. Laboratory Animal Program Facilities and Procedures ………………… 20
Coordinator of Laboratory Animal Care
Joseph M. Scimeca
Director, Laboratory Animal Program
INTRODUCTION The Laboratory Animal Program (LAP) at Southern Illinois University Carbondale (SIUC), with facilities in the Life Sciences II and III buildings, is responsible for all aspects of research and teaching that involve vertebrate animals. Program staff includes a Director/Veterinarian, Coordinator of Laboratory Animal Care, Office Director, four Laboratory Animal Technicians, an Extra-Help Laboratory Animal Caretaker, and a number of Student Caretakers. The LAP is accredited by the Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC) and strives to maintain compliance with the federal Animal Welfare Regulations (CFR 1985) and Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS 1996).
Oversight of all aspects of vertebrate animal care and use, and of the LAP itself, is the responsibility of the Institutional Animal Care and Use Committee (IACUC). Dr. Samuel Goldman, Chancellor of SIUC, delegated, in writing, official institutional responsibilities for animal care and use to Dr. John Koropchak, Vice Chancellor for Research and Graduate Dean, who appoints the members of the IACUC.
I. ANIMAL CARE AND USE PROTOCOL SUBMISSION AND REVIEW Animal Care and Use Protocols (http://iacuc.siu.edu/) must be completed and approved by the IACUC before purchasing animals or beginning any research or teaching activities involving vertebrate animals at SIUC. A. Protocol Preparation Principal Investigators (PIs) must submit an Animal Care and Use Protocol (“protocol”), and receive approval of the IACUC before commencing teaching or research activities involving vertebrate animals. Animal study protocols that do not involve a formal grant proposal are reviewed and approved in the same manner as those involving grants. PIs submit a signed paper and an unsigned electronic copy of the completed protocol to the IACUC Coordinator. The IACUC Coordinator forwards an electronic copy of the protocol to all IACUC members except the non-affiliated member, who is provided a paper copy. The IACUC members review the protocol and return their comments and/or questions electronically to the IACUC Coordinator. The IACUC Coordinator compiles the comments and questions, and takes them to the next IACUC meeting for discussion.
All protocols are discussed at a convened meeting of a quorum of the IACUC and are handled in one of three ways: 1) Approval may be granted by an affirmative vote by a majority of the quorum present. Anyone having a potential conflict of interest does not contribute to the quorum and is required to abstain. 2) Approval may be withheld if the majority of the quorum present feels the requirements of the PHS Policy, Animal Welfare Act, or AAALAC guidelines have not been satisfied. 3) The IACUC may request additional information from the PI in the form of a revised protocol. Depending on the nature of the requested information, revised protocols submitted by the PI may be reviewed by the full IACUC or by designated reviewers. The Chair of the IACUC appoints IACUC members to act as designated reviewers.
PIs submit revised protocols to the IACUC Coordinator in the same manner as original versions. The IACUC Coordinator distributes the revised protocols to either the entire IACUC or the designated reviewers as determined at the previous IACUC meeting. Designated reviewers have one of three options when reviewing revised protocols: 1) Approve the protocol if both designated reviewers agree; 2) Request additional information from the PI to secure approval; or 3) Request a full IACUC review.
B. Protocol Reviews 1. Annual Protocol Review The IACUC Coordinator sends a memo to the investigators at least 2 months in advance reminding them of their annual re-evaluation due date. PIs are asked to indicate on the form if the protocol is to remain active, and to give changes in personnel and methodology. The completed forms are returned to the IACUC Coordinator. If there are no changes, the IACUC Chair signs the form, copies are mailed to the PI, the re-evaluation is entered in the database, and the form is filed appropriately. Re-evaluations with changes are reviewed by the IACUC Chair. If the changes are significant, the protocol re-evaluation is sent to the full IACUC for review. Any change in the health status of PIs or their staff should be checked off. If there is a change, an examination must be performed by a physician and any corrective action taken before the individual can continue to work with animals
2. Triennial Protocol Review PIs are required to submit new protocols for all protocols every 3 years. The IACUC Coordinator sends memos to the investigators at least 3 months in advance of the re-submission due date. The resubmitted protocols, even if they are continuations of the same project, are considered to be new protocols and are reviewed by the entire IACUC as described above.
Electronic Protocol Submission Instructions
Section 1 of the Animal Care and Use Protocol form must be completed for all research or teaching activities involving vertebrate animals. Section 2 must be completed if surgeries are planned, and Section 3 must be completed if the proposal involves animal breeding.
Separate protocols are needed for projects involving:
More than one grant
More than one animal species (one protocol may be used for projects using more than one fish, amphibian, or reptile species, provided all species are involved in similar activities).
Do NOT hit the "Enter/Return" key when entering information.
Use the "Page Up/Page Down" keys to navigate between shaded entry areas or click left mouse button over areas to highlight and permit input.
Click left mouse button to place or remove "Xs" from the boxes.
Click left mouse button to reveal choices at areas marked "Select", then scroll to the appropriate choice and click the left mouse button to make the selection.
Do NOT reference procedures described in other protocols. All procedures should be fully described in each individual protocol.
Use generic drug names whenever possible.
Define all abbreviations and acronyms.
Do not append copies of methods sections from grant applications.
Ensure that all personnel included in Section 1, Part A, # 7 have completed the Occupational Health Program and have been appropriately trained or are qualified to perform the described procedures. Incomplete documentation of qualifications or training, and/or lack of documentation of participation in the Occupational Health Program are the most common reasons for delays in protocol approval. If additional space is needed for to include other personnel, please complete the Additional Personnel form and submit with the Animal Care and Use Protocol.
Protocols funded by external agencies, including Public Health Service, must have an abstract describing research methods and procedures involving animals. This is a compliance requirement for the institution. An External Funding form (available on the IACUC website) should be filled out and submitted with the protocol.
It is recommended that you save an electronic version of the completed protocol for future reference, revision or amendments.
Print a paper copy of the entire Animal Care and Use Protocol form(s).
Read, sign and date the Assurance of Compliance (Section 1, Part 0).
Send the original, signed paper copy of the completed Animal Care and Use Protocol form and any supporting documents (i.e., MUAs, Mouse Antibody Production test results, etc.) for review, consideration, and approval to:
Office of Research Development and Administration
Woody Hall C214
Southern Illinois University Carbondale
Carbondale IL 62901-4709
Send an electronic copy to email@example.com as an email attachment. (If an electronic copy does not accompany the original protocol, the protocol will be returned for resubmission, thus delaying the approval process.)
Revised protocols should have all amended information included in the appropriate areas of the Animal Care and Use Protocol form(s).
The IACUC Chair or the attending veterinarian may address any questions regarding completion of the Animal Care and Use Protocol.
The IACUC website also has forms for technical assistance, and animal transfers from one protocol to another.
D. Changes to Approved Protocols Any change to the approved protocol must be submitted as an amendment to the IACUC and approved prior to instituting the change. This includes, but is not limited to, changes in personnel, methodology, animal numbers, and animal species.
II. ROLES AND RESPONSIBILITIES OF
PRINCIPAL INVESTIGATORS AND RESEARCH STAFF A. Roles The PI, together with his/her research staff, carries out all research associated with the approved protocol, and is responsible for the actions of his/her research staff and for ensuring compliance with all the policies of the IACUC and LAP.
B. Responsibilities The PI’s responsibilities include:
Developing and submitting an IACUC protocol and ensuring that no research is initiated until IACUC approval is obtained
Responding to IACUC comments
Ensuring that all members of the research team are trained – including use of the LAP on-line training models
Ensuring that all members of the research staff have met OHP requirements
Maintaining approval for the duration of the project
Submitting any changes to the protocol for approval, and initiating changes only after IACUC approval
Submitting reports, and allowing inspections, as required by the IACUC
Failure to comply with federal, state, or institutional policies on animal use may result in suspension of the approved protocol and notification sent to regulatory and funding agencies. C. Research Team The research team may be composed of co-investigators, post-doctoral fellows, technicians, and students. All members of the team share responsibility for the humane care and use of animals, and compliance with policies and regulations. Members of the research team must be listed in the protocol, with names updated as needed.
Prior to having contact with animals, each team member must:
1. Occupational Health Program All individuals who will have significant contact with vertebrate animals, as defined above, are required to have a current medical history, physical examination, and appropriate vaccinations/testing prior to any exposure to animals under the SIUC Institutional Animal Care and Use Committee (IACUC) Guidelines.
Step One: Obtain a Medical History Form (MHF): Faculty, staff, students, and visitors having significant contact with live vertebrate animals must obtain a MHF by downloading and printing a copy of the form from the SIUC Institutional Animal Care and Use Committee website: click here.
Take the medical history form to an appointment with a healthcare provider (see part B).
Step Two: Make an appointment for a physical:
All Individuals having significant contact with vertebrate animals must make an appointment with a physician, physican’s assistant, or nurse practitioner for a physical exam and complete the patient section of the medical history form.
Graduate and undergraduate students should make an appointment with Student Health Services for their physical.
Faculty, staff or visitors having significant contact with vertebrate animals may be seen at Student Health Services for this routine physical. A university account number can be used to cover the expense of the physical if provided to Student Health Services at the time of appointment. Alternatively, faculty, staff, or visitors can make an appointment with their primary physician and pay their normal co-pay.
Step Three: The physician/provider will review the individual’s personal health/vaccination history and conduct a physical examination. Based on the animal species to be worked with, as indicated by the individual on the medical history form, appropriate vaccinations and testing will be offered.
Any vaccinations or testing performed will be recorded on the medical history form.
Required vaccinations are listed on the medical history form for various activities and species. These vaccines will be given without charge to the individual. The Principal Investigator is responsible for determining what campus unit will provide funds for any charges accrued.
Step Four: The physician/provider and the individual complete the medical history form together and file it appropriately.
The physician/provider will determine the medical status of the individual, check theappropriate box, make any necessary comments, and sign/date the medical history form.
The individual will read, sign, and date his/her section of the medical history form.
The individual will return a copy of the completed and signed Part A to the Director, Laboratory Animal Program, Room 1062, Life Science III, MC 6506.
Part B of the medical history form will not be copied. It contains confidential information that the IACUC is not privileged to have.
The original medical history form will be kept by the individual.
The medical must be completed every six years, as required by the SIUC Institutional Animal Care and Use Committee.
2. Laboratory Animal Training Program On-line training is provided by the Collaborative Institutional Training Initiative (CitiProgram), and can be accessed at the IACUC web site (http://iacuc.siu.edu/).
III. INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE (IACUC) A. Composition The composition of the IACUC meets the requirements of the U. S. Department of Agriculture and Public Health Service (PHS) regulations. The Committee is composed of at least three members, and shall include at least one individual who has no association with the institution and at least one doctor of veterinary medicine. The Laboratory Animal Program (LAP) is under the direct supervisory authority of Dr. Prudence M. Rice, Associate Vice Chancellor for Research and Director of the Office of Research Development and Administration (ORDA).
The IACUC meets approximately monthly. Current IACUC members are:
Amer AbuGhazaleh, Ph.D. – Assistant Professor, Department of Animal Science, Food and Nutrition
Lydia Arbogast, Ph.D. – Associate Professor, Department of Physiology
Mr. Stephen Banker – Research Project Specialist, Office of Research Development and Administration (ex-officio member)