- Any member of the kingdom animal with a spinal cord.
- This can include fish, amphibians, reptiles, birds, mammals
- If you are at all unsure if your research involves vertebrates, please send us an email (IACUC@AppState.edu) detailing what your research is and what organism you are using.
Any live, non-human vertebrate being that is used or intended for use in research, teaching or demonstration. Animals covered by this policy are either:
- owned by the University,
- housed by the University,
- are wild animals being studied, captured or otherwise manipulated by an agent of the University, or
- are privately owned animals used by an agent of the University for purposes of University research, teaching or demonstration.
- IACUC: Institutional Animal Care and Use Committee
- PI: Principal Investigator
PIs are responsible for the scientific and administrative aspects of research experiments. PIs also submit proposals for research experiments.
- CDC: Center for Disease Control and Prevention
The federal organization to protect public health and safety
- OLAW: Office of Laboratory Animal Welfare
OLAW provides guidance in regards to the regulations set forth by the Public Health Service policy on Humane Care and Use of Laboratory Animals.
- NIH: National Institute of Health
The NIH strives to apply the information gained in research experiments to enhance health, lengthen life and reduce illness and disabilities.
- CITI: Collaborative Institutional Training Initiative
CITI training is necessary for anyone conducting research involving IACUC covered species.
- RCR: Responsible Conduct of Research
The RCR encompasses principals of honesty, accuracy, efficiency and objectivity that guide research.
- If you have any animal concern, please contact either IACUC@AppState.edu or contact us anonymously with our report a concern button on the top of the page.
- We take animal welfare very seriously and promise to look into any concerns we are made aware of while keeping the source of those concerns anonymous, if desired.
- Only a faculty member can be a PI.
- If a student wishes to partake in vertebrate research, their faculty advisor must complete the application as the PI with the student listed as personnel.
- For new applications, we operate on rolling admissions. However, if the protocol will be reviewed by the full committee, please see our deadlines on the IACUC Home page.
- For annual reviews, we recommend you submit them at least two weeks before the deadline to ensure we have time to process them before the due date. If your protocol will need to be reviewed by the full committee, you may want to submit it over a month in advance. We will gladly accept any annual reviews two months before the due date. Please be aware there are consequences for not turning an annual review in.
- For health forms, we operate on rolling admissions. However, please note we will not approve protocols until personnel has been cleared to work with animals. The faculty/staff process, needed for the PI, can take weeks before clearance comes through.
One or more species listed in the application are covered by the USDA, per the definition of “animal” in the Animal Welfare Act.
- The PI has listed the USDA Pain Class as category E.
- Multiple survival surgeries performed on same animal.
- The procedures in the application are not listed as category E, but indicate a greater risk of pain, distress or unrelieved comfort to the animals than the listed Pain Class indicates.
- An IACUC member has requested it while completing an initial review.
- The IACUC is comprised of at least 5 faculty, staff, veterinarians and community members with appropriate experience and expertise, in accordance with the Animal Welfare Act Regulations and Standards (AWARS), and the Institute of Laboratory Animal Resources’ (ILAR) Guide For the Care and Use of Laboratory Animals, the Federation of Animal Science Societies’ (FASS) Guide for the Care and Use of Agricultural Animals in Research and Teaching, and other regulatory bodies as identified.
- Required categories of membership include: Attending Veterinarian, Chairperson, Nonaffiliated Member, Scientist, and Nonscientist. But there may be multiples of any category except the chairperson.
- We will let you know when we receive and process any forms or new information you send us.
- We will prompt you for the annual review about two months, 4 weeks and 7 days before the due date.
- We will remind you of your protocols expiration date about two months, 4 weeks and 7 days before the due date.
- At minimum, it takes over a week. Generally, first time applications take longer because we need to process the health forms and training records for all personnel (including the PI).
- Applications can take well over a month to approve. This is especially true if the application is to be reviewed by the full committee or several revisions are requested by the IACUC. As the IACUC is a group and not a person, no one can promise how long the approval process will take.
- Any person who will be providing daily care for the animals
- Any person who will be assisting or completing the protocol with the animals
- Any Teaching Assistant or additional faculty who are part of a course protocol
- NOT students who are part of a course that uses a course protocol
- If you have any additional specific questions, please email IACUC@AppState.edu
- All protocol applications received undergo an initial administration review for completeness and personnel verification.
- The administrator will assigned a protocol number that will be sent to you for your records.
- Note: if the initial review requires modification, we will not continue with the review process until the changes are made.
- The IACUC will review the protocol, either with a designated reviewer or as a full committee. This review can result in the following.
- Once approved you may begin your work as describe in the protocol. The IACUC will look forward to hearing about your progress during your annual review.
- If you need to make any new changes or add personnel, please complete an amendment.
- Request for Modification to Secure Approval
- The IACUC may ask for additional information or changes to your suggested protocol.
- Once all the IACUC’s concerns are appropriately addressed, the IACUC will approval your protocol.
- The IACUC will not approve the submitted application for reasons explained in a disapproval letter.
- If you wish to continue with a similar project that would not include any listed IACUC issue, please submit a new protocol.
IACUC approval must be obtained, if it is a vertebrate that is either:
- Owned by the University
- Housed by the University
- wild animal being studied, captured or otherwise manipulated by an agent of the University
- a privately owned vertebrate used by an agent of the University for purposes of University research, teaching or demonstration
Any additional questions or clarifications should be sent to IACUC@AppState.edu
After your application is approved.
Yes. If the course uses vertebrates a Faculty leader of the course will need to submit an IACUC application before the course begins.
FAQs for Post-Approval Monitoring
- Post-approval Monitoring (PAM) is an observation of the research and verification of study documents. Conducting post approval monitoring is common in animal care and use programs and will help to ensure the safety of the research animals, appropriate applications and supporting documents are executed as approved, and any changes or adverse events are reported.
- PAM is not meant to be a “gotcha” moment nor are you being punished. You may actually see a benefit.
Sure! Benefits that may be gained from a review include:
- Increased awareness of the policies and regulations that guide research at Appalachian State University;
- Increased communication between the IACUC and researchers;
- Being potentially identified as having a “best practice”;
- Having an opportunity to ask the IACUC any questions you have.
- The majority of protocols are selected randomly. Studies may be randomly selected from all approved and active protocols, without cause, no more than once per year. A study may be selected more than once in a given year if a “for cause” review is deemed necessary (i.e. At the IACUC’s request from a review, part of an investigation for non-compliance, upon PI’s request).
- Protocols that are pain class E, have USDA covered species, are funded, or considered higher risk to the animals, are more likely to be selected. Should a PI have multiple protocols, it is possible that each protocol may be selected once per year individually or all protocols may be reviewed at once.
Our goal is to make this as unobtrusive as possible. You will be asked to pull records/lab notebooks that demonstrate the protocol was followed as approved. You will be asked questions about how the research project is going in relation to problems or adverse events. The scope of review varies greatly depending on the research, but it will include:
- Reviewing all records with the PI associated with animal care logs, animal health logs and drugs given to the animals;
- Reviewing all animal housing, protocol facilities and animals on the protocol;
- Reviewing the names of all personnel working with the animals;
- Completion of the PAM Review Checklist.
- Viewing a procedure at a future date (by appointment)
Results from a PAM review include:
- A highlighted best practice: The practice will be shared with the IACUC and may be incorporated into guidelines;
- Compliant with the protocol: No further information or follow up is needed;
- Minor deficiencies are noted: The investigator provides a written plan in the resolution column to address the issues found within 30 calendar days, and e-mails the document back to the Post-Approval Monitor;
- Significant deficiencies are noted: The IACUC chair and the committee are notified of significant deficiencies. The investigator provides a written plan to address the issues found within 15 calendar days, and e-mails the document back to the Post-Approval Monitor; the protocol may be subject to a more in-depth review and monitoring to ensure all issues regarding compliance are met.
If there are no findings or once the investigator satisfactorily responds to requests for clarification or revisions, a written report will be provided to the investigator within approximately a week from the review date. The IACUC will review a summary of PAM visits at each convened meeting.
Training & Health Questions
Please see our Training page for more specific information.
- CITI training
- Investigators, staff and students
- Species-specific modules (Mice, Rats, Zebrafish, Amphibians, Gerbils, Guinea Pigs, Hamsters, Rabbits)
- AsULearn Species-specific modules if species is not listed for CITI
- Protocol specific training may be needed depending on the protocol
- The PHS Policy requires a “health program for personnel who work in laboratory animal facilities or have frequent contact with animals” (IV.A.1.f.). The Guide states that, “Each institution must establish and maintain an occupational health and safety program as an essential part of the overall Program of animal care and use…The nature of the OHSP will depend on the facility, research activities, hazards, and animal species involved.” (Guide pages 17-23)
- “A comprehensive OHSP should include a hierarchy of control and prevention strategies that begins with the identification of hazards and the assessment of risk associated with those hazards.” (Guide page 18)
- New protocols: All new protocol applications sent to the IACUC require training for everyone listed on the protocol. Also, students who have paid their student fees must complete the Health Risk Assessment form and send to IACUC@appstate.edu.
- Personnel changes: All students who are added to existing and who have paid their student fees, must complete the training and Health Risk Assessment form and send to IACUC@appstate.edu. All new faculty/staff added to existing protocols will need to complete the required training.
No, the Health Risk Assessment does not ask for your health history or personal medical information. It is assessing potential risks based on the species, environment, and possible exposures with which you will be working, and compares them to any self-identified conditions you may have. This does not serve as/replace a physical exam or other medical evaluation. It is designed to flag possible health concerns.
Yes, you can use your primary care physician so long as you
- Incur the costs yourself
- Provide the completed and signed last page of the form to the Environmental Health, Safety & Emergency Management office.
You will not be cleared to work with animals on an IACUC protocol until your training is complete and your Health Risk Assessment is cleared and on file at EHS & EM.
No, as long as you cover all species you work with in your training and Health Risk Assessment, the process only needs to be completed once. If you change species or your health condition changes, you will be required to complete the appropriate species specific training, and update your Health Risk Assessment as appropriate.
Your students are responsible for meeting the requirements. The IACUC administration will notify you whether a student is cleared at the time of protocol approval or when they are cleared. You are also free to inquire about the status of a student's clearance by emailing IACUC@AppState.edu
There is no cost for health assessments. If a follow up requires a vaccination or other recommendation that could incur a cost, the decision about how to cover the cost will be determined on a case by case basis between the individual, the department, and EHS & EM.
Protocols are review once a year at minimum. It is possible they may be reviewed more frequently at the IACUC’s discretion.
- The PI must email IACUC@AppState.edu with the names of whomever they wish to add to the protocol.
- The personnel must submit a completed health form and complete all required training before they can be added to a protocol.
If you would like assistance or have a question about the protocol application, or completing an amendment, please email IACUC@AppState.edu. We are willing to help you as much as we can, as quickly as our schedules allow us.
- A new application is a new number, new protocol. This is preferred if there are many significant changes or if the changes are so drastic it would be a more efficient use of time to submit a new protocol than modify the old one. In such a case, the old protocol would be ended when the new one took effect.
- A modification, called an amendment, is a change to an existing protocol; it may include a significant change. Overall a modification is preferred if it is only one or a few changes made to a protocol.
- What do you plan tdo? If it isn’t on your current approved application, you would either need a new protocol or an amendment tyour current application.
- It depends on what you wish tadditionally do. If you need tsignificantly change the protocol or a major shift in species or add different research questions, it may be a more efficient use of your time thave another protocol.
- Please see our amendment application (blue link) or our new protocol application (blue link) for more information.
- If you are working with adult mice running a maze and now you wish tadd work with adult zebrafish swimming a maze, you should complete a second protocol. This would involve a second species and new protocol on how tmove the animals tthe maze, inspire them tcomplete it, and duplication search.
- If you are counting the number of one species of salamander and wish talscount the species of a second species of salamander using the same technique, you can amend your previous protocol tcover the additional species
- If you are working with mice running a maze and now you want mice trun on a treadmill, you would need tcomplete a second protocol. This would involve a new protocol, research question and duplication search.
- If you are breeding zebrafish and now you wish tdetermine what type of animal enrichment would improve fry survivability, this would need a new protocol.
No. Approval only covers what is listed in the approved application.
Our policies must reflect the current state and national regulations. When those changes, so must our policies. Additionally, when new situations arise, the institution must adapt to handle them.
Please turn one in as soon as possible. After your annual review is past due, you protocol will be suspended. When this happens you will not be allow to work with the animals.
- If you are the PI, send an email to IACUC@AppState.edu that details which approved protocol you wish to close and that you wish to close it. We will close it for you as long as we have written documentation from the PI asking for a specific protocol to be closed.
- If you are NOT the PI, you cannot close someone else’s protocol.
- For radioactive waste, please see the Research Protections Radiation Safety page or contact Compliance@AppState.edu
- For all others please see Appalachian’s Office of Environmental Health, Safety, and Emergency Management.