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 in 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 a 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.
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.” (§126.96.36.199, 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 # 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.
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 it’s 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.