IACUC Regulations, Guidance, FAQs

The �� Office of Research Compliance, and �� IACUC, have provided resources and answers to Frequently-Asked Questions below, to make the application and compliance process for animal-involved research as simple as possible. If you need resources that cannot be found on this site, feel free to contact the ORC at (330) 672-2704 or researchcompliance@kent.edu.

Investigator Resources

	The NIH adopted the 8th Edition of the Guide in January 2012. The mission of the Guide is to assist institutions in caring for and using animals in ways judged to be scientifically, technically, and humanely appropriate. It is also intended to assist investigators in fulfilling their obligation to plan and conduct animal experiments in accordance with the highest scientific, humane, and ethical principles (p. xiii).
	The Animal Welfare Act includes the minimum acceptable standards for animal care, and is enforced by the USDA. The AWA was signed into law in 1966. The most recent amendment was passed in 2008.
	OLAW provides guidance and interpretation of the Public Health Service Policy on Humane Care and Use of Laboratory Animals, supports education, and monitors compliance with the Policy.
�� Policy Register 10-02.2	The Policy Register is a compilation of the official University, administrative, and operation procedures of ��.
�� Policy and Procedure Manual	The IACUC has developed the policy and procedure manual to ensure animal research is conducted in accord with the federal and local laws and regulations that govern animal research, and to provide the research community with an understanding of the IACUC's expectations.
	The Public Health Service Policy requires that an IACUC determine that requested methods of euthanasia will be consistent with the recommendations of the American Veterinary Medical Association Guidelines, unless a deviation is justified for scientific reasons in writing by the investigator.
Anesthesia and Analgesia Guidelines	This document provides a list of commonly used agents and information on dosages, routes of administration and typical drug combinations.
Small Animal Survival Surgery SOP	This document provides aseptic technique guidelines.

Reporting Concerns

To ensure that �� researchers are emboldened to hold each other to the highest standards of safe and ethical research, ��'s Office of Research Compliance and the �� IACUC provides a platform by which investigators, students, or others involved with the research process can related to the care and use of animals, without the fear of reprisal. Upon receipt of this survey, the ORC or the IACUC Chair will initiate an investigation.

IACUC FAQs

General Items

I received DoD funding, where can I learn more about IACUC review and requirements?
- Information can be found at:
- Additionally, DoD requires Principal Investigators to report to ACURO immediately when:
  - The IACUC protocol is modified in any way, including adding personnel. ACURO, as well as KSU must approve any new or revised procedures before they are conducted on animals; the IACUC protocol is renewed (including annual renewal), and/or when a noncompliance/adverse event letter related to DOD funded study has been issued.
How long does it take to obtain IACUC approval, and how can I expedite the process?
- Do not wait until the last minute to submit your application. Approval typically takes two (2) to six (6) weeks, but may take longer for complex applications. In general, the more complete an application is, the sooner it will be approved. Please be sure to observe the form instructions/mark-ups when completing your application. Failure to properly complete forms will most likely result in approval delays.
What is the AAALAC, and why is it important?
- The — is an accrediting organization that promotes the humane treatment of animals in science, through voluntary accreditation and assessment. As an AAALAC accredited institution, �� (AAALAC 000665) has demonstrated that it meets all legal requirements, and supports the humane use of animals in research.
What training must research personnel complete?
- Information can be found on the IACUC training page. All personnel must complete the Occupational Health and Safety program and . In addition, all personnel who working in a lab must complete the appropriate safety courses offered by the Office of Research Safety and Compliance. Protocol-specific training is overseen by a project's PI, and should include training on specific procedures, lab SOPs, safety, etc.

Principal Investigator Responsibility

What is required of me during semi-annual inspections?
- Either you, or an experienced lab member who is aware of all animal care and use activities occurring in the lab, must be present for the inspection. The IACUC can not and will not conduct an inspection if the PI/experienced lab member is not present. An alternate time must be scheduled, by contacting the ORC.
I expect to receive extramural funding; what do I do?
- In accordance with , the institution must ensure that the procedures in a funded project are accounted for through approved IACUC protocols. The Office of Sponsored Programs or the PI will notify the OCR, and the congruency review process will be initiated.
What are my responsibilities as PI?
- The PI has the overall responsibility for the study, which includes — but is not limited to — ensuring personnel are properly trained, compliance paperwork (i.e. amendments and annual reviews) is appropriately filed and approved, ensuring animals are humanely and ethically treated, and ensuring the study adheres to the IACUC-approved parameters.

FAQs Regarding Forms

When does my project expire? Do I need to submit an annual review?
- The ORC may send an "Annual Review/Closeout/New Protocol Due" reminder to you by email as a courtesy. However, it is the responsibility of the PI to be aware of the study expiration dates, and to submit the appropriate forms in a timely manner. Operating outside of approval dates is considered a form of non-compliance. Please remember that after three years (the original protocol, followed by two annual reviews), a new protocol or closeout form is required. Please submit annual review forms at least four (4) weeks prior to the expiration date. For projects continuing beyond three years, please submit the necessary forms no later than six (6) weeks prior to expiration. Please remember to observe meeting dates, should your project require full board review.
How do I modify my approved protocol?
- You must complete, submit, and receive the approval of a Modification Request Form or Minor Modification Request (details on IACUC Forms page).
How do I add personnel to my approved IACUC Protocol?
- To add personnel to an already-approved study, you must submit and complete an (details on "IACUC Forms" page). When completing the form, please complete it according to the form mark-ups on the right-hand side, and be sure to include dates of relevant training — at a minimum Occupational Health and Safety training and CITI training.

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