- 1. What is the Institutional Animal Care and Use Committee?
The IACUC is a standing committee and charged under the Animal Welfare Act with representing “....society's concerns regarding the welfare of animal subjects ...” The Committee oversees the University’s animal care and use program and is responsible for reviewing all animal care applications using vertebrate animals, ensuring compliance with federal animal welfare regulations, inspecting animal facilities and investigator laboratories, and investigating animal concerns.
- 2. What is an Animal Care and Use Protocol?
The Animal Care and Use Protocol describes, in detail, how an investigator will utilize animals in their proposed research. This animal care and use protocol is submitted through Research Compliance System (RCS) online system.
- 3. When should an Animal Care and Use protocol be submitted to the IACUC?
An Animal Care and Use protocol should be submitted to the IACUC for all research that involves the use of live vertebrate animals for testing, instructional and research purposes.
- 4. What happens after submission of the Animal Care and Use protocol for IACUC review?
When protocol submission is received, it will undergo pre-review process. If additional details are needed based on pre-review feedback, the Compliance Administrator may contact investigator to request revisions. Once revisions is received and protocol added on the agenda for IACUC review, feedback from the meeting is sent back to the investigator (usually takes 5-7 business days following a meeting). Most protocol revisions would at least require minimal time, however other protocols could require additional time, for IACUC reviewers to verify that responses to the IACUC questions have been adequately clarified. All requested modifications must be addressed before final protocol approval is granted. No animals may be ordered or research procedures conducted prior to the receipt of written IACUC approval.
- 5. What is the deadline for submitting a protocol?
Refer to the “Meeting & Deadline Calendar” for submission deadlines.
- 6. What is the average time before IACUC approval is received?
On average, IACUC approval is received within 3-4 weeks of protocol submission. Approval times vary depending on the completeness of the protocol and the efficiency of the investigator in addressing the committee's questions regarding the submitted protocol. Therefore, it is recommended that investigator plans for 4-6 weeks to obtain IACUC protocol approval.
- 7. What criteria should the IACUC consider when reviewing protocols?
IACUCs must confirm that:
- the protocol is consistent with the Guide unless a scientific justification for a departure is presented and is acceptable to the IACUC;
- the protocol conforms with the institution's Assurance;
- the protocol will be conducted in accordance with the USDA Animal Welfare Regulations if applicable; and
- the protocol meets the requirements of the PHS Policy at IV.C.1.a.-g.
For further guidance, the IACUC should refer to the U.S. Government Principles.
- 8. May the IACUC approve pilot studies?
Yes. Pilot studies may be appropriate to determine the technical feasibility of larger studies or to make initial assessments of the effect of procedures on animals (Guide pages 26, 28). Whether proposed by investigators or required by the IACUC, pilot studies require review and approval by the IACUC in accordance with the PHS Policy.
- 9. May the IACUC administratively extend approval of a project that has expired?
NO. IACUCs do not have authority to administratively extend approval beyond three years. When IACUC approval expires the protocol lacks valid approval. Continuation of animal activities in the absence of valid approval is a serious and reportable violation of PHS Policy (See NOT-OD-05-034) [A11], and may jeopardize both investigator and university funding. All activities involving the use of animals must stop immediately. Animals will go on the ARF Holding Protocol for only routine husbandry (no research manipulations) and federal funds may not be used to pay for housing per diems during this time.
- 10. What other submissions investigators need to know after protocol approval?
- Annual Review: All protocols require an annual report to the committee. This submission includes up-to-date numbers of animals used and a statement of progress/cited publications resulting from the study.
- Triennial (de novo) Review: Protocols are approved for a maximum of 36 months. All protocols expire at the three-year anniversary of the initial IACUC approval. If the research study were to continue beyond its 3-year, investigator must submit a 3-year renewal protocol through RCS online system for IACUC review.
- Modifications: Before beginning any research animal activities, make sure that they are described within the approved protocol. If not, please submit an amendment modification for IACUC review and approval. Do not initiate any research animal activities without IACUC’s approval. The proposed changes could include the following but not limited to: changes and/or addition of personnel, animal manipulation(s), surgical procedure(s), animal number(s), strain(s), substances administered, and others.
- Unexpected Problems: During the life of the protocol, unanticipated problems, protocol deviations, and adverse events should be reported to the IACUC. For further guidance, please refer to RU Guidelines for Reporting of Unanticipated Research Outcomes.
- Protocol Termination: Contact IACUC office for any questions. Submit IACUC Termination Form via the Research Compliance System
- 11. What are useful resources available for investigators and IACUC?
- The U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training,
- The U.S. Public Health Service Policy on Humane Care and Use of Laboratory Animals
- The USDA Animal Welfare Act and Regulations
- The Guide for the Care and Use of Laboratory Animals.
- 12. What is the difference between the IACUC and ARF?
Institutional Animal Care and Use Committee (IACUC): The IACUC is a standing committee of the university whose primary responsibilities include the review of animal research protocols (no animal work may begin until final approval is secured), oversight of the Rice University’s Animal Care and Use Program (primarily through semi-annual program reviews and facility inspections), post-approval monitoring of ongoing research, and investigating animal concerns. The IACUC is not involved in the day-to-day business operations of ARF (e.g., per diem charges/billing, animal procurement, and housing assignments).
Animal Resources Facility (ARF): ARF provides professional veterinary and husbandry services to support animals used in biomedical and behavioral research such as: animal procurement, transportation of animals, and veterinary care. ARF is not involved in the administrative aspects of the IACUC office (e.g. receipt, routing and processing of IACUC protocols).