Q. What is the IACUC?
A. IACUC is the acronym for Institutional Animal Care and Use Committee. The IACUC is a self-regulating entity that, according to U.S. federal law, must be established by institutions using vertebrate animals in research, instructional, training, outreach and display projects. The IACUC is charged with ensuring that animals used in research, teaching, etc. are used and cared for in a humane manner. Members are appointed by the President’s Office. Recommendations for members are sought from outgoing members, the VPR and the IACUC Chair.
Q. What is APHIS?
A. The Animal and Plant Health Inspection Service (APHIS) is an agency of the United States Department of Agriculture (USDA) responsible for protecting animal health, animal welfare, and plant health. APHIS administers the Animal Welfare Act (AWA).
Q. What is AWA?
A. The Animal Welfare Act (AWA) is a Federal law that regulates the sale, use and handling of animals.
Q. Who is the Institutional Official (IO)?
A. The Institutional Official is the individual who has the authority to sign the Institution’s Assurance, making a commitment on behalf of the University that the requirements of the Public Health Service policy will be met.
Q. What is OLAW?
A. Office of Laboratory Animal Welfare (OLAW) is the NIH office responsible for implementing the PHS Policy.
Q. What is the PHS Policy?
A. The PHS Policy is a document that implements the Health Research Extension Act of 1985, and governs activities involving animals conducted or supported by PHS agencies.
Q. My grant is for five years but the protocol says that I can only get approval for three years. How do I get an extension?
A. The three year limit on animal protocols is explicitly stated in the Federal regulations. Extensions cannot be given for any reason. You must submit a new protocol for review and approval.
Q. Do I need an IACUC protocol to use dead animals or animal parts?
A. If you are obtaining animals or tissue that were already dead (rat livers from another laboratory, steaks from the supermarket, etc.), then you do not need an IACUC protocol. However, there may be exceptions to this depending on the study; please contact the IACUC office for guidance.
Q. If I have questions about the IACUC form or other questions about the IACUC process, who do I contact?
Q. I submitted my de novo late and my previous protocol will expire before the de novo is approved. What do I do?
A. Animal research cannot be conducted without an approved protocol. All research activity must cease until the new protocol is approved. Please contact email@example.com immediately for assistance.
Q. Do I need an approved protocol before I can order or house animals in a facility on campus?
A. Yes, only PIs that have an approved IACUC protocol may order and/or house animals on campus.
Q. Do I need an IACUC protocol for field studies or behavioral studies?
A. Yes, if the activity involves live vertebrate animals, IACUC approval is required.
Q. Do I need an IACUC protocol for teaching activities?
A. Yes, if the course uses live vertebrates, you will need to submit an IACUC protocol and get approval before the activity begins.
Q. When can I submit an amendment instead of a new protocol?
A. A protocol can be amended to include changes if the changes are consistent with the original protocol scope and objectives.
Examples of amendment changes include: adding additional animals, changes to drugs or anesthetics, modifications or additional procedures to the animals.
If the proposed changes do not fit with the scope and/or objectives of the original protocol, a new IACUC Protocol should be submitted.
Q. How do I close a protocol?
A. Please email firstname.lastname@example.org indicating that you would like to close your protocol; only the PI can close a protocol.
Q. How long does it take to get IACUC approval?
A. Protocols are reviewed at IACUC meetings via the full committee review (FCR) process or via the designated member review (DMR) process. It may require many weeks from initial protocol submission to final IACUC approval for an amendment or protocol, so please plan accordingly.
Q. What do reviewers look for when they are reviewing my submitted protocol?
A. The reviewers are ensuring that the use of animals is justified, the procedures listed are clear, and that the protocol complies with Federal regulations and institutional policies. Please consult the IACUC web page for resources to help you prepare your protocol.
Q. Am I required to attend an IACUC meeting to answer questions about my protocol?
A. No, you are not required to attend. However, the committee encourages you to attend to discuss questions that may arise in their review of the protocol.
Q. I need to have a protocol reviewed before the next committee meeting. Can review of my protocol be expedited?
A. Depending on when the protocol is submitted, there may be an opportunity to review the protocol prior to a committee meeting. At a minimum, a protocol requires a week for committee review outside of a committee meeting, and in some cases the protocol may require full committee review. Please see the IACUC web page for information about full committee review (FCR), designated member review (DMR), and the committee meeting schedule.
Q. My original protocol was reviewed and returned to me to address committee feedback, and then I was asked to provide additional information about the revised protocol, requiring an additional delay in beginning my work. Why doesn’t the committee provide all of their feedback in one request?
A. Occasionally, responses to the committee’s original review prompts additional questions from the committee. The committee strives to promptly review protocols and resubmissions; please consult the IACUC web page for the committee meeting schedule to plan adequate time for review and revision of your protocol.
Q. How soon after the meeting will I hear back from the IACUC?
A. The IACUC staff will follow-up within 3-7 business days. Please note that no work may begin until you have received approval from the IACUC.
Q. Who is required to participate in the Occupational Health & Safety Program (OHSP)?
A. Any person listed on the IACUC protocol is required to enroll in the Occupational Health & Safety Program (OHSP).
Q. What is the purpose of the IACUC facility inspections?
A. Per regulations, the IACUC is required to inspect at least twice a year any area where live animals are housed or used. This includes all buildings, rooms, enclosures and vehicles.
Q. When are inspections scheduled?
A. Inspections are usually conducted in October and April. ORC and the IACUC will do their best to accommodate PIs and facility manager schedules within this timeframe. The PIs and lab representatives will be notified of the inspection at least a week before the anticipated visit.
Q. How does the inspection process work?
A. Using a checklist, the Committee categorizes items as acceptable, minor deficiency, or a significant deficiency. Significant deficiencies are items that are or may be a threat to the health and safety of animals. The Committee then discusses the inspections reports and provides the investigators with a notification with a schedule for resolving the issues.
Q. Does the Principal Investigator need to be present for the inspection?
A. No, anyone who is knowledgeable of the animal care and use activities occurring in the facility/lab may accompany the inspection team.
Q. Will the IACUC also review documents during the inspection?
A. Yes, the IACUC may review protocols, amendments, health records, training logs, Standard Operating Procedures (SOPs), sanitation logs, controlled substance logs, surgery logs, and/or husbandry logs. The IACUC will check monitoring records for evidence that records are consistent with the plans described in the protocol. In short, the IACUC may ask for any documents related to the use and care of the animals.
Q. What signage should be posted in the lab or Animal Facility?
A. The following signage should be posted in the lab or Animal Facility:
- Emergency contact information.
- The cage card(s) for the approved protocol(s).
- The animal concern poster.
- Signage for any biological, chemical, etc. hazards.
Q. How can I make sure my lab/facility is inspection ready?
A. You can use this inspection checklist as a tool to help you be inspection ready.
Q. What are common deficiencies found during IACUC inspections?
A. Common deficiencies in IACUC inspections include:
- Expired drugs and supplies
- Drugs and supplies not labeled
- Drug logs that are incomplete
- Improperly stored or improperly labeled feed and bedding
- Incomplete records for personnel training (such as surgery, animal handling, drug administration, etc.)
- Incomplete animal care records (missing daily care logs, incomplete surgery logs, etc.)
- Incomplete sanitation records
- IACUC protocols not available or posted for current studies
- Clutter and inadequate housekeeping
- Cage cards not displayed
Q. What are USDA inspections?
A. Inspectors from the USDA visit any lab where USDA species are used. These inspections are unannounced.
Principal Investigator and Study Team Management
Q. Who is eligible to be a PI on an Animal Care and Use Protocol?
A. The principal investigator (PI) must be a University of Maine faculty member or staff member. Students and non-University personnel may be listed as co-PIs.
Q. I will be hiring some additional students to work on my approved IACUC protocol; what do I need to do to add them?
A. The personnel must take the required IACUC training. Once the training is complete, the PI should email email@example.com requesting that the personnel be added to the protocol. The email should include what experience he/she has working with the species and procedures on the protocol as well as the role the person will play on the project.
Q. Who should be listed as personnel on the IACUC protocol?
A. The Principal Investigator, and anyone that comes into direct contact with live animals for all research, testing, training, or teaching purposes should be listed on the protocol.
Q. What training documentation does my lab need to maintain?
A. All procedure specific training must be kept by the laboratory/PI.
Q. I am the PI on a protocol and I am leaving the University of Maine, what do I need to do?
A. Your protocols must be closed or a new PI must be added and approved, and arrangements must be made for the transfer or disposition of animals left on protocols. 60 days prior to your departure, you should begin planning for the disposition of the animals. If you are transferring animals, please contact the Facility Manager where the animals are housed and the Attending Veterinarian to make the appropriate arrangements.
Q. How do I submit a change in PI?
A. The change in PI should be submitted as an amendment. See the form and instructions on the IACUC website.
Q. How do I remove personnel from the IACUC protocol?
A. To remove personnel from a protocol, the Principal Investigator should send an email to firstname.lastname@example.org requesting the person(s) be removed, along with the protocol number and title.
Q. Why is a grant to protocol review needed?
A. PHS and NIH Grants Policy require that the institution verify that the institution’s IACUC has reviewed and approved the animal work outlined in the proposal: “It is an institutional responsibility to ensure that the research described in the application is congruent with any corresponding protocols approved by the IACUC.” (§220.127.116.11, NIH Grants Policy Statement 11/15).
Therefore, a congruency review is required for all funding that uses live vertebrate animals to ensure that the work described in the proposal is congruent with an active, approved protocol.
Q. How do I add a new or updated grant to a protocol?
A. Email email@example.com as soon as possible with a copy of the Vertebrate Animal Section (VAS) or Methods section, the protocol number, and protocol title the grant should be added to and any deadlines. You will then receive further instructions depending on the outcome of the congruency review.
Q. I have a grant application due, when I should submit the IACUC protocol?
A. Most agencies require documentation of IACUC approval before awarding grants. You should check with the sponsor to determine the deadline for documenting IACUC approval. You should work with the Office of Research Compliance to ensure that protocols are submitted with sufficient time for IACUC review and approval.
Materials Used in Animal Studies
Q. Can I use expired pharmaceuticals and materials in animals?
A. The use of expired pharmaceuticals and supplies is not consistent with acceptable veterinary practice. Per Federal regulations euthanasia, anesthesia and analgesia solutions cannot be used beyond their expiration date, even if a procedure is terminal.
Other expired materials should not be used unless the manufacturer can verify efficacy beyond the expiration date, or the investigator is able to document that its use will not negatively impact animal welfare or compromise the validity of the study and the use is approved by the IACUC.
Q. What do I do with hazardous materials I do not want any more?
A. Please contact Safety Management at firstname.lastname@example.org.
Q. May non-pharmaceutical-grade compounds be used in my study with animals?
A. Pharmaceutical-grade chemicals and other substances, when available, must be used.
If you have any further questions, contact the IACUC office.