Skip to Main Content

Do I need to submit an IACUC protocol?

Will your research or teaching study involve living or dead (tissues, body parts, etc.) vertebrate animals?

Living

Will the study manipulate, change or alter the animal’s behavior in any way? (ex. laboratory experiments, teaching activities, creating enrichment activities, trapping, flashing lights, etc.)

If yes, complete a research protocol submission for IACUC review in Cayuse. See directions below.

If no, complete an Exempt - Observation Only IACUC Protocol Waiver for IACUC review in Cayuse. 

Dead

Submit a Tissue or Carcass Application in Cayuse. No trainings are required for tissue/carcass applications unless authorized by the Environmental Health Safety Office or IACUC.

IACUC Protocol Submissions in Cayuse - Launching July 15, 2026

Researchers working with animals are required to submit their studies for review and approval by the Institutional Animal Care and Use Committee (IACUC). To streamline this process, our institution utilizes the Cayuse electronic system for protocol development, submission, and management. Creating and maintaining IACUC protocols within Cayuse ensures accurate, organized, and accessible documentation throughout the life of your study. Researchers can prepare submissions, track revisions, respond to reviewer comments, and access previously approved materials in one location. If you need assistance, contact Julie Robinson (robinss48@miamioh.edu or animalcare@miamioh.edu). 


Literature Searches

Principal Investigators using USDA regulated species in their research are required to submit a literature review.  Generally, mammals and birds not bred for research purposes are considered USDA regulated. Consult King Library (or copy/paste: https://libguides.lib.miamioh.edu/iacuc) for guidance on the search process. At least two databases must be searched.
Laboratory Mice (Mus) and Rats (Rattus) are not USDA regulated and do not require a literature review.

Controlled Substances, Dangerous Drugs or Other Substances (ex. Experimental Agents)

If you are using controlled substances, dangerous drugs (ex. requiring DEA registration or OBP license) or any other substances (ex. for experimental agents-not requiring a license), you must complete a form prior to submission. Locate Research Protocol Drug-Substance Form.pdf in the Access Additional Forms folder, complete the form, and send the completed form to cncs@miamioh.edu. This ensures your substances are uploaded to Cayuse.
Controlled Substances/Dangerous Drugs logs are available for download here
If you want to apply for an OBP/DEA registration, contact Vice President of Research and Innovation (VPRI) for assistance first ( copy cncs@miamioh.edu).

Resources and Training Materials

How-to documents and videos are available to get researchers started in Cayuse. Please visit the following resources:

 

Research Protocol Drug-Substance Form.pdf must be directed to Julie Robinson (robins48@miamioh.edu c.c. animalcare@miamioh.edu) prior to protocol submission. This ensures that the substances are available in Cayuse for protocol creation. 

Go to Cayuse--Start Your Protocol!

A few hints to get you started: 
  • Remember to select Animal Oversight from the Products drop-down menu in Cayuse. Researchers must select Researcher Staff Member from the Role drop-down menu to get started.
  • Just want to update personnel? Submit an amendment to add people to your protocol or contact Julie Robinson (robins48). 
  • Need help? Contact Julie Robinson (robins48@miamioh.edu c.c. animalcare@miamioh.edu) or see the Researcher How-to Guidance Documents/Videos.

Visit Cayuse

 

Additional Forms

Researchers and personnel can download any of the additional forms below to supplement protocols.

  • Procedures and Housing Application
    • For areas outside the Lab Animal Facility or ERC
  • Occupational Health and Safety Screening
    • Steps for Health Screening
    • Animal Exposure and Health History Form (OCC Health & Safety Form C)
  • Personnel Commitment Agreement
    • By electronically signing this document, each person agrees to uphold the best practices set forth for responsible conduct of research. 
  • Adverse Events Form
    • This form is used for reporting adverse events associated with protocols approved by the Miami IACUC. 
  • Research Protocol Drug-Substance List
    • Submit this form prior to protocol submission to document drugs or substances used in the protocol.
  • General Application
  • IACUC Waiver - Observation Only
  • Tissue and Carcass Application
  • Amendment Application

Access Additional Forms.



Researchers should reach out to animalcare@MiamiOH.edu with questions or concerns.

 


Principal Investigator (PI) Eligibility:

Individuals serving as PI on an IACUC protocol must have sufficient authority, accountability, and experience for the purpose of accepting primary responsibility for the appropriate care and use of live vertebrate animals in testing, research, and training, as well as the ability to oversee protocol staff education, training, safety, and compliance. The role of Principal Investigator is exclusively reserved for the Lab Head, Instructor of Record or Facility Director.
  • Any change of PI is a significant protocol modification which requires IACUC review and approval.
  • If an individual’s title or employment status changes, the IACUC may review their eligibility to serve as PI.
  • The PI must complete all training requirements and participate in the Occupational Health and Safety program.

 

IACUC Review Process

IACUC Review Process - Full Committee Review

  1. PI submits the completed application and additional materials to members via Cayuse.
  2. During the first 5 days, the committee will choose from two methods to review the protocol called the Full Committee Review (FCR) or Designated Member Review (DMR).
  3. During FCR, members meet and an outcome of at least three possible scenarios may occur: a. Committee may approve, require modifications the PI addresses, or withhold approval of protocol.
    b. Note a FCR can be called at anytime during the review process, not just the first 5 days.

IACUC Review Process & Designated Member Review (DMR)

  1. After the initial 5-day waiting period, if FCR is not called, the Designated Member Review (DMR) process begins. 
  2. The IACUC Chair appoints a member of the committee to serve as the DMR. The committee reviews the protocol over the next two weeks. 
  3. The IACUC Chair complies all comments/questions in Cayuse within each section and returns the protocol to the PI to provide responses via Cayuse.
  4. The PI responds to comments via Cayuse.  Changes are automatically tracked into the application. A final approval may be provided by the DMR on behalf of the committee or additional modifications are requested to which the PI will respond. This continues until a determination is rendered.
  5. Designated Member (DM) approval is required for all responses.
  6. Submission of an application does not guarantee approval. Researchers must receive an approval from the IACUC Chair before any animal research commences via Cayuse. 
    a. If your protocol application requires a literature search (using USDA regulated species), please refer to IACUC Literature Searches through King Library for guidance.
    b. Wildlife permits, verification of drug license submissions and/or the Research Protocol Drug-Substance Form need to be provided with initial submission.
    c. Note, the entire process can take as much as 4-6 weeks. Please plan accordingly.

Basis for Oversight

For Investigators/Instructors using vertebrate animals, review of the protocol for this use is required by two federal agencies:

  • The United States Department of Agriculture (USDA)
  • The U.S. Public Health Service (PHS)

The USDA and PHS requirements are similar and the systems of oversight are interconnected and complementary. PHS provides for planning, documentation, and reporting and USDA operates by conducting facilities inspections and review of approved protocols. Most federal funding agencies require compliance with PHS policy and rules, as do many private foundations. Miami maintains a statement of assurance, the Animal Welfare Assurance (AWA), approved by the PHS. The AWA details how Miami University will comply with the PHS policy and rules (as well as those of the USDA). Miami University’s Assurance and USDA Site Certification numbers are listed on the IACUC home page.

The PHS Policy requires that institutions base their animal care and use programs on the Guide (PHS Policy IV.A.1) Download a pdf of the Guide for the Care and Use of Laboratory Animals: Eighth Edition from the Office of Laboratory Animal Welfare.


Miami Institutional Official (IO)

The person at the institution with operational and legal responsibility for providing a system that meets regulatory and contractual requirements. At Miami, this is the Vice President for Research and Innovation. Direct responsibility reverts to the institutional CEO if the IO is not able or available to respond to program requirements.


Miami Institutional Animal Care and Use Committee (IACUC)

Federal guidelines state that the University CEO (President), or his/her designee, shall appoint an IACUC consisting of not less than 5 members and including at least:

  • A doctor of veterinary medicine
  • A practicing scientist experienced in research involving animals
  • A member whose primary concerns are in a nonscientific area (e.g., ethicist, lawyer, clergy)
  • An individual who is not affiliated with the institution in any way other than as a member of the IACUC and is not a member of the family of a person who is affiliated with the institution

Functions of the IACUC

  • Review at least once every 6 months the institution's program for humane care and use of animals
  • Inspect at least once every 6 months all of the institution's animal facilities
  • Prepare reports of the IACUC activities above
  • Review concerns involving care and use of animals
  • Make recommendations to the Institutional Official about any aspect of the animal program, facilities, or personnel training
  • Review and approve, require modifications to, or withhold approval of activities related to the care and use of animals
  • Review and approve, require modifications to, or withhold approval of proposed significant changes in use of animals in ongoing activities
  • Be authorized by the institution to suspend an activity involving regulated animals

Contact Us

To report an adverse event or non-compliance with protocols, contact
 
animalcare@miamioh.edu 
as soon as possible. 

Ethics Point

Miami has contracted with EthicsPoint to provide an anonymous and confidential reporting tool. EthicsPoint allows one to report illegal, unethical, or other conduct that violates Miami's policies.