Obtaining Approval for Research and Teaching Activities With Animals

1. Complete online trainings for Responsible Conduct of Research and Laboratory Animal Welfare through the Collaborative Institutional Training Initiative (CITI) program (research, teaching or testing only).
2. Download the IACUC Protocol Review Checklist for your use in following all of the correct procedures.
3. Complete an Animal Care & Use Protocol (AUP) Application form and submit it to the Institutional Animal Care and Use Committee (IACUC) through the Research Compliance office via email.
4. Complete the Protocol Risk Assessment Questionnaire.
5. Submit the completed protocol application and the Protocol Risk Assessment form via email to [email protected] or hand deliver to Research Compliance in Velma K. Waters Library 225B.
6. Each participant listed on the protocol must complete the Occupational Health & Safety Program Questionnaire. Important note: the information in the questionnaire is confidential. Each participant must hand deliver their form to the Research Compliance office in Velma K. Waters Library 225B.

Use of animals is defined as any activity involving vertebrate animals in which the natural life style or movements of the animal is materially altered. All research, testing, teaching, or any other use involving animals, animal carcasses, tissues, and fluids must be approved through a protocol by the Institution Animal Care and Use Committee (IACUC).

An individual certifies the following when signing the animal use protocol application:

1. Discomfort and injury to animals will be limited to that which is unavoidable in the conduct of valid scientific research or teaching.
2. A veterinarian will be consulted when potentially painful procedures are to be performed.
3. Licenses and permits for collecting wild animals (if appropriate) will be obtained and are attached to the protocol application.
4. Letter of Assurance, and all applicable state and federal laws governing animal welfare will be followed.
5. All personnel will be appropriately trained, educated about, and provided with appropriate protective equipment when working with animals and any associated hazards.
6. Any work with animals is limited specifically to what is approved in the approved protocol application.
7. Will abide by all Standard Operating Procedures SOPs, rules, regulations and policies for research.

Protocols should be submitted to the IACUC in advance for review. Please refer to our calendar for the IACUC meeting schedule and deadline for protocol submissions.

If you are unsure if your project involves the use of animals, contact the Research Compliance at [email protected].

All protocol application submissions will be reviewed by Research Compliance for completeness. If necessary, the IACUC or veterinarian may request clarification on certain items listed on the application.

An AUP number is assigned to the protocol application. All future communications should reference this number.

After initial review, the application is sent to the Attending Vet and the IACUC Chair for further review.

The animal use protocol (AUP) is distributed to the committee members for their review.

There are two possible review pathways, Designated Member Review (DMR) and Full Committee Review (FCR).

The Chair of the IACUC committee will distribute the protocols to the committee members for their review. The committee is given a designated time period (typically 10 days) to consider the protocol. The Chair of the committee will consider all of the comments or concerns raised by the committee members.

If further clarification is required, the Chair will contact the investigator via email. If at any time during the review period serious concerns arise, a committee member may call for full committee review (FCR) of the protocol application.

If none of the members call for FCR, the Chair will assign this to a primary and secondary reviewer (DMR) whose responsibility is to conduct a thorough review of the protocol, grant, and all committee comments. In addition, the investigator may be contacted and interviewed by at least one of the reviewers. The Designated Reviewers must agree on the course of action. They may approve the protocol, require modifications to secure approval, or refer the protocol to FCR. The Chair of the IACUC committee communicates by letter the results of the DMR to the Principle Investigator and Research Compliance.

Any time during this review period, a committee member may call for a full committee review (FCR) of the AUP. This occurs when there are serious concerns.

The investigator may be contacted by any of the committee members for clarification. The protocol will be brought before the next full meeting of the IACUC for discussion and consideration. There is no requirement for the investigator to attend the meeting, but it is encouraged. If further clarification is needed by the committee, a pending approval memo will be created and sent to the investigator requesting revisions be made and resubmitted within 30 days of receipt of the memo.

The Chair of the committee will consider all of the comments or concerns raised by the committee members. If further clarification is required, the Chair will contact the investigator via email and request specific information.

Upon revision, the protocol may be reviewed under either the DMR or FCR rules. If a majority of the fully convened meeting of the IACUC votes against approval the protocol is disapproved. The Chair of the IACUC committee communicates by letter the results of the meeting to the Principle Investigator and Research Compliance. Research Compliance tracks documents and sends out reminders for annual review follow-ups.

The IACUC meets according to the schedule posted on the main IACUC page. Protocols should be submitted at least 30 days in advance for review. Please click here to see a list of the IACUC members. If you are unsure if your project involves use of animals, contact Research Compliance at [email protected].

Once approved, the IACUC Chair will prepare and send an approval letter to the investigator electronically via email. A copy of the approved animal use protocol will be sent to the investigator.

The approved protocol will remain effective for three (3) years. The IACUC requires that an Annual Report be submitted regarding the status of each non-exempt and exempt teaching and research protocol. To submit the Annual Report, complete the Annual Report: Teaching/Research form and submit it via email to [email protected]. The final year requires the Closure Form to be submitted.

If there are any significant changes to the project (personnel, species usage, animal procedures, anesthesia, post-operative care, or biohazard procedures) you will need to submit the changes on the  a minimum of 30 days prior to initiation of the proposed changes. The proposed changes will be reviewed for approval. The approval for an amended animal protocol does not extend the original expiration date of the originally approved protocol.

Examples of amendments which might be requested include but are not limited to:

• addition of new personnel or departure of personnel from a project;
• changes in animal procedures, such as anesthesia, surgical procedures, feeding, or sampling;
• need for additional animals or new species;
• changes to animal housing sites or procedure areas;
• change in ultimate disposition of animals;
• administrative changes such as a change in principal investigator, funding source, or project title; or
• designate personnel to act on behalf of the principal investigator to submit amendments, annual reviews, and transfers

Complete all sections of the amendment form, describing the exact nature of the changes requested and a justification. Be sure to include any associated information normally requested on the AUP form. For example, if you are requesting an increase in animal numbers, please provide a justification for the increase and a justification for the number of animals requested. If you are adding personnel to a project, please describe their training and experience with the procedures they will perform.

Significant changes in procedures or experimental objectives may result in a request for a new AUP.

If an animal will be transferred from one protocol to another, an animal transfer form must be completed and submitted to [email protected] with both investigators emailing their approval for the transfer from their personal work computer.

The IACUC Project Closure Form must be submitted no later than 30 days after the research is completed.