Who must submit an IACUC Protocol?
You must have a protocol approved by the URI Institutional Animal Care and Use Committee (IACUC) before you may obtain animals or conduct any project involving research, teaching, or testing using live, vertebrate animals. The use of animals in research, teaching and testing is a privilege, not a right, and it may be withheld or revoked by the IACUC.
Who qualifies to be listed as a Principal Investigator on an IACUC Protocol?
Only URI faculty/staff may be listed as Principal Investigator on an IACUC Protocol.
You are eligible to submit an IACUC application as a Principal Investigator if you have one of the following URI appointments:
- Tenure-track (Professor, Associate Prof., Assistant Prof.) and emeritus faculty
- Research Associate
- Senior staff
*Adjunct (part-time) faculty may be listed as Co-I with faculty or research assoc.
Who should be listed on a protocol?
All faculty, staff, students and visiting scholars using animals must be listed on a protocol. New personnel must be added to a protocol prior to their use of laboratory animals. All personnel must have the required training – CITI “Working with the IACUC” course, applicable species-specific modules, and hands-on training. See web-site at: http://web.uri.edu/researchecondev/about/IACUC/training/
How do new personnel get added to an animal use protocol?
The PI listed on the protocol must submit a modification to the relevant protocol and make the necessary changes to the application. Be sure to complete administrative and/or functional roles for all personnel added to the animal protocol.
New personnel on an animal study must complete all of the required training (i.e., on-line CITI modules, species-specific training, related facility orientation/training) and be added to a protocol and approved before beginning any live animal work.
May the investigator begin animal work before receiving IACUC approval?
For what kinds of species do I need to have an approved IACUC protocol?
All warm and cold-blooded vertebrates, both in the field and the laboratory, e.g., amphibians, fish, birds, rodents require IACUC protocol review.
Must I complete a protocol form if I use only lobsters, oysters, insects, or microorganisms in my research/teaching activities?
No. You only need to complete the protocol form if you are working with vertebrate animals.
PHS Policy defines an animal as “any live, vertebrate animal used or intended for use in research, research training, experimentation, or biological testing, or for related purposes”. The Animal Welfare Act Regulations (AWAR) define an animal as “any live or dead dog, cat, nonhuman primate, guinea pig, hamster, rabbit, or any other warm-blooded animal, which is being used or is intended for use for research, teaching, testing, experimentation, or exhibition purposes, or as a pet. This term excludes birds, and rats and mice bred for use in research.”
The IACUC ensures the campus is in compliance with all regulations by applying both the AWAR and PHS regulations to all vertebrate animal use on campus for teaching and research.
If I am only using chicken eggs (embryos), that will not be allowed to hatch, do I need to submit an IACUC protocol?
No. “The PHS Policy is applicable to proposed activities that involve live vertebrate animals. ‘live vertebrate animal’ is interpreted to apply to avians (e.g. chick embryos) only after hatching.”
Do I have to complete an IACUC protocol if I am only using “animal parts”?
If a live animal was not purchased by the investigator to obtain animal tissue, a protocol is not necessary. For example, if tissue is obtained from an abattoir or from another investigator who is providing tissue on an animal that has been obtained and euthanized for his approved research project, then a protocol does not have to be submitted.
Is IACUC approval required for the use of animals in breeding programs, as blood donors, as sentinels in disease surveillance programs, or for other non-research purposes?
Yes. Although animals used as sentinels, breeding stock, blood and blood product donors, or for other similar purposes may not be part of specific research protocols, their use is part of the institutional research program and directly supports research activities.
I’m a new investigator. How do I start an IACUC application?
Visit the URI Animal Care and Use web page, at http://web.uri.edu/researchecondev/about/IACUC/ , and click the link for IACUC Forms. You may download the form to your desktop to complete it, and then e-mail as an attachment to the IACUC office at email@example.com . Contact the Compliance Office at firstname.lastname@example.org with any questions.
To expedite the review process, the principal investigator should contact the Attending Veterinarian (874-5380) regarding issues related to surgery and pain/distress. No animals may be ordered or received and no animals may be used until the protocol has been approved. (Student projects involving the use of animals must comply with the above regulations, whether or not the projects are in partial fulfillment of degree requirements.)
Who can I contact for advice about preparing an IACUC protocol?
For help in preparing a protocol form, general assistance on policy/procedures, or for advice about the laws, regulations and policies that may affect your proposed use of animals, contact the Research Compliance office at email@example.com. For assistance in planning specific animal care or use procedures (e.g., special animal care requirements, transportation, etc.), contact the animal technician staff at 874-2833. For veterinary assistance, e.g., anesthesia, surgical procedures, analgesia, euthanasia, contact URI’s Attending Veterinarian at 874-5380.
Is it acceptable to have different individuals named as PI on the grant application and the IACUC protocol?
May I let someone else fill out my Animal Use Protocols?
The URI IACUC encourages Principal Investigators to write and submit each IACUC protocol form; however, a staff member may fill out a protocol form with the permission of the Principal Investigator. The individual listed as PI must sign the assurance form, indicating full responsibility for the protocol.
What are the meeting dates and submission deadlines for the IACUC?
View the current IACUC meeting schedule at: http://web.uri.edu/researchecondev/about/IACUC/meetings/
Generally, the IACUC meets twice monthly on the first and third Monday (but only once monthly in the summer). The deadline for each meeting is two weeks prior to the meeting date.
How do I transfer animals to my protocol?
Complete and submit an Animal Request Form, available from this site: http://web.uri.edu/researchecondev/about/IACUC/forms/
How do I arrange to acquire animals?
Live vertebrate animals cannot be purchased or otherwise acquired without an approved IACUC protocol. All arrangements for the acquisition and transportation of live vertebrates from any source must be made through the Central Laboratory Animal Facility (CLAF). Call 874-2833 with questions.
This includes the acquisition of animals from another investigator or institution, and transportation of animals between campus facilities. Plans to acquire, transport, and house animals in the field will be reviewed and approved by the IACUC as part of the regular review process. If wild animals are to be used, arrangements for any necessary quarantine must be made through the CLAF before animals are obtained.
The investigator also is responsible for determining if permits (such as U.S. Fish and Wildlife or California Fish and Game) are required, and all applicable permits must be obtained before animals are acquired.
How is animal housing space assigned?
Animals cannot be housed without an approved IACUC protocol. However, approval of a protocol does not guarantee that animal housing space will be available for the proposed project. The animal care staff is responsible for the management of animal housing space on campus, and assigns space when it is available.
What is an IACUC?
The Institutional Animal Care and Use Committee oversees the University’s animal care and use programs, facilities and procedures. It also ensures the appropriate care, use and humane treatment of animals being used for research, testing and education. The IACUC is responsible for reviewing all animal use protocols, ensuring compliance with federal regulations, inspecting animal facilities and laboratories and overseeing training and educational programs.
The IACUC serves as a resource to faculty, investigators, technicians, students, and staff, providing guidance in planning and conducting all animal use procedures in accordance with the highest scientific, humane, and ethical principles. The members of this Committee are appointed by the Institutional Official (Vice President for Research).
Comprised of faculty members, an Attending Veterinarian, and at least one representative of the public (not affiliated with URI), the IACUC oversees all URI research and instruction that involves vertebrate animals, in order to ensure that the highest ethical and animal welfare standards are met.
The IACUC reviews all animal projects for compliance with the requirements of the Animal Welfare Act and Regulations, the NIH Guide for the Care and Use of Laboratory Animals, the Public Health Service Policy on the Humane Care and Use of Laboratory Animals, and URI Policies and Guidelines. The IACUC may suspend any activity involving animals which violates approved animal welfare regulations, policies, and procedures.
Twice a year, the IACUC conducts inspections of all URI animal facilities, evaluates all aspects of URI’s animal care and use program, and submits reports and recommendations to the Vice President for Research.
The IACUC will consider the three “Rs” when reviewing protocols – Refinements to research, Reduction of animal numbers, and Replacement with non-animal models.
The federal mandate in U.S. Government Principle IV to avoid or minimize discomfort, distress, and pain in experimental animals consistent with sound scientific practices, is synonymous with a requirement to implement refinements (e.g., less invasive procedures or use of analgesia).
Similarly, the mandate in U.S. Government Principle III to use the minimum number of animals necessary to obtain valid results is synonymous with a requirement to reduce animal numbers.
U.S. Government Principle III further states that mathematical models, computer simulation, and in vitro biological systems should be considered, and is synonymous with a requirement to replace non-animal models wherever possible.
Thus, consideration of the three “Rs” should be incorporated into the animal use protocol, as well as other aspects of animal use (e.g., investigator training).
Is the IACUC required to review the grant application?
PHS Policy and the NIH Grants Policy Statement (Part II, Terms and Conditions) require the institution to verify, before award, that the IACUC has reviewed and approved those components of grant applications and contract proposals related to the care and use of animals. This is not an explicit requirement for the IACUC to do a side-by-side comparison of an application/proposal and the IACUC protocol. However, institutions are responsible for ensuring that the information the IACUC reviews and approves is congruent with what is in the application/proposal.
Is the IACUC responsible for judging the scientific merit of proposals?
The IACUC is expected to include consideration of the U.S. Government Principles in its review of protocols. Principle II calls for an evaluation of the relevance of a procedure to human or animal health, the advancement of knowledge, or the good of society.
Other PHS Policy review criteria refer to sound research design, rationale for involving animals, and scientifically valuable research. Presumably a study that could not meet these basic criteria is inherently unnecessary and wasteful and, therefore, not justifiable. It is not entirely possibly to separate scientific value from animal welfare – some overlap is inevitable. The IACUC may question the scientific rationale or necessity for a procedure.
How long is IACUC approval of a protocol in effect?
Three years. You should write the animal use application to include all work and all animals requested for three years. You will be required to rewrite the protocol application every third year. The IACUC also requires you to update the information on your protocol annually by using a short (“Information Update”) form.