IACUC FAQ

FAQ

New Application
What is a vertebrate?
Do I need both IBC approval and IACUC approval?
How does the university define an animal covered by IACUC?
Does the IACUC review pets and service animals?
Common acronyms & abbreviations
How do I report an animal concerns?
Where are the forms?
Who can be a PI?
When are the form deadlines?
What makes a protocol require full committee review?
Who are the IACUC members?
When are meetings?
How do I submit an application?
What notifications will I receive from the IACUC office?
How long does approval of an application take?
Who should be listed under personnel?
What is the review process?
The animal I use is not covered by AWA, do I need IACUC approval?
Can one application cover several species?
When do I order animals?
Where is the IACUC Administration office located?
Do teaching activities need IACUC approval?
I can’t find my question or an answer, who can I talk to?

Training and Health Questions
What training is needed?
What is the occupational health program?
Who has to fill out the health form?
Is the health form a medical evaluation?
Can I use my own doctor for the health form?
What if I choose not the complete the recommendations of the health form?
Will I have to complete a new health form for every IACUC protocol?
As a Faculty PI how do I know if my students are cleared?
Is there a cost involved with the health form?

After Approval
How often does approved application need review?
How do I add personnel?
When do I need to modify or amend an existing IACUC application?
How do I modify or amend an existing IACUC application?
Can I do an emergency or expedited amendment
Can I get retroactive approval?
Who can I ask for assistance with completing a protocol or amendment?
Modification versus new application
I have an approved IACUC, do I need a second?
Doesn’t IACUC approval cover any use of the species I have listed?
Why do the regulations and policies keep changing?
What should I do if my annual review is past due?
Where are the AWA, and USDA numbers?
How do I close a protocol?
What should I do with hazardous materials I don’t want anymore?

New Application

• What is a vertebrate?
o Any member of the kingdom animal with a spinal cord.
o This can include fish, amphibians, reptiles, birds, mammals
o 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.

• Do I need both IBC approval and IACUC approval?
o If the animals are transgenic, YES.
o If you will be making transgenic animals, YES.
o If you are still unsure, please see the IBC FAQ site or contact either IACUC@AppState.edu or IBC@AppState.edu

• How does the university define an animal covered by IACUC?
o 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:
o owned by the University,
o housed by the University,
o are wild animals being studied, captured or otherwise manipulated by an agent of the University, or
o are privately owned animals used by an agent of the University for purposes of University research, teaching or demonstration.

• Does the IACUC review pets and service animals?
o No. Please see the animal policy (blue link http://policy.appstate.edu/Animals_on_Campus) for compliance information

• Common acronyms & abbreviations

• IACUC
o Institutional Animal Care and Use Committee
PI
o Principal Investigator.
o PIs are responsible for the scientific and administrative aspects of research experiments. PIs also submit proposals for research experiments.
• CDC
o Center for Disease Control and Prevention
o The federal organization to protect public health and safety.
• OLAW
o Office of Laboratory Animal Welfare
o 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
o National Institute of Health
o The NIH strives to apply the information gained in research experiments to enhance health, lengthen life and reduce illness and disabilities.
• CITI
o Collaborative Institutional Training Initiative
o CITI training is necessary for anyone conducting research involving IACUC covered species.
• RCR
o Responsible Conduct of Research
o The RCR encompasses principals of honesty, accuracy, efficiency and objectivity that guide research.

• How do I report an animal concerns?
o 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.
o 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.

• Where are the forms?
o On our FORMS (blue link it) page.
o If you can’t find what you are looking for, please email IACUC@AppState.edu

• Who can be a PI?
o Only a faculty member can be a PI.
o 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.

• When are the form deadlines?
o 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.
o 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 (blue link to review SOP?) for not turning an annual review in.
o 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.

• What makes a protocol require full committee review?
o One or more species listed in the application are covered by the USDA, per the definition of “animal” in the Animal Welfare Act.
o The PI has listed the USDA Pain Class as category E.
o Multiple survival surgeries performed on same animal.
o 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.
o An IACUC member has requested it while completing an initial review.

• Who are the IACUC members?
o 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.
o Required categories of membership include: Attending Veterinarian, Chairperson, Nonaffiliated Member, Scientist, and Nonscientist. But there may be multiples of any category except the chairperson.

• When are meetings?
o Meetings are scheduled on an as-needed basis, when a protocol is received that requires Full Committee Review. Generally, they are once a month during the academic year.

• How do I submit an application?
o Download our initial application and fill it out completely.
o Send the completed application to IACUC@AppState.edu

• What notifications will I receive from the IACUC office?
o We will let you know when we receive and process any forms or new information you send us.
o We will prompt you for the annual review about two months, 4 weeks and 7 days before the due date.
o We will remind you of your protocols expiration date about two months, 4 weeks and 7 days before the due date.

• How long does approval of an application take?
o 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).
o 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.

• Who should be listed under personnel?
o Any person who will be providing daily care for the animals
o Any person who will be assisting or completing the protocol with the animals
o Any Teaching Assistant or additional faculty who are part of a course protocol
o NOT students who are part of a course that uses a course protocol
o If you have any additional specific questions, please email IACUC@AppState.edu

• What is the review process?
o All protocol applications received undergo an initial administration review for completeness and personnel verification.
o The administrator will assigned a protocol number that will be sent to you for your records.
o Note: if the initial review requires modification, we will not continue with the review process until the changes are made.
o The IACUC will review the protocol, either with a designated reviewer or as a full committee. This review can result in the following.
o Approval.

• 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.
o Request for Modification to Secure Approval
o The IACUC may ask for additional information or changes to your suggested protocol.
o Once all the IACUC’s concerns are appropriately addressed, the IACUC will approval your protocol.
o Disapproval
o The IACUC will not approve the submitted application for reasons explained in a disapproval letter.
o If you wish to continue with a similar project that would not include any listed IACUC issue, please submit a new protocol.

• The animal I use is not covered by AWA, do I need IACUC approval?
o IACUC approval must be obtained, if it is a vertebrate that is either:
o Owned by the University
o Housed by the University
o wild animal being studied, captured or otherwise manipulated by an agent of the University
o a privately owned vertebrate used by an agent of the University for purposes of University research, teaching or demonstration
o Any additional questions or clarifications should be sent to IACUC@AppState.edu

• Can one application cover several species?
o This is a case by case situation and specifics of your situation should be sent to IACUC@AppState.edu

• When do I order animals?
o After your application is approved.

• Where is the IACUC Administration office located?
o In the Office of Research on the 3rd floor of the John E. Thomas (JET) building. Please email us at IACUC@AppState.edu for more specific instructions to determine which office number you will need.

• Do teaching activities need IACUC approval?
o Yes. If the course uses vertebrates a Faculty leader of the course will need to submit an IACUC application before the course begins.

• I can’t find my question or an answer, who can I talk to?
o If you email your question to IACUC@AppState.edu, we will answer it as soon as we are able to.

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Training and Health Questions


• What training is needed?
o Please see our Training (blue link it) page for more specific information
o CITI training
• Investigators, staff and students
• Species-specific modules (Mice, Rats, Zebrafish, Amphibians, Gerbils, Guinea Pigs, Hamsters, Rabbits)
o AsULearn Species-specific modules if species is not listed for CITI
o Protocol specific training may be needed depend on the protocol

• What is the occupational health program?
o 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)
o “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)

• Who has to fill out the health form?
o 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.
o 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.

• Is the health form a medical evaluation?
o 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.

• Can I use my own doctor for the health form?
o Yes, you can use your primary care physician so long as you
o Incur the costs yourself
o Provide the completed and signed last page of the form to the Environmental Health, Safety & Emergency Management office.

• What if I choose not the complete the recommendations of the health form?
o 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.

• Will I have to complete a new health form for every IACUC protocol?
o 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.

• As a Faculty PI how do I know if my students are cleared?
o 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

• Is there a cost involved with the health form?
o 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.

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After Approval

• How often does approved application need review?
o Protocols are review once a year at minimum. It is possible they may be reviewed more frequently at the IACUC’s discretion.

• How do I add personnel?
o The PI must email IACUC@AppState.edu with the names of whomever they wish to add to the protocol.
o The personnel must submit a completed health form and complete all required training before they can be added to a protocol.

• When do I need to modify or amend an existing IACUC application?
o If you want to change any aspect of the approved protocol, please email IACUC@AppState.edu BEFORE you initiate the change. We will advise what steps to take on a case by case basis.

• How do I modify or amend an existing IACUC application?
o Submit a protocol modification form to IACUC@AppState.edu
o Depending on the modification, an update to the original application may be needed. For more information, please email IACUC@AppState.edu

• Can I do an emergency or expedited amendment?
o Please contact us, at IACUC@AppState.edu, to determine if it is possible in your circumstance.

• Can I get retroactive approval?
o No.

• Who can I ask for assistance with completing a protocol or amendment?
o 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.

• Modification versus new application
o 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.
o 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.

• I have an approved IACUC, do I need a second?
o What do you plan to do? If it isn’t on your current approved application, you would either need a new protocol or an amendment to your current application.
o It depends on what you wish to additionally do. If you need to significantly change the protocol or a major shift in species or add different research questions, it may be a more efficient use of your time to have another protocol.
o Please see our amendment application (blue link) or our new protocol application (blue link) for more information.
o Examples:
o If you are working with adult mice running a maze and now you wish to add work with adult zebrafish swimming a maze, you should complete a second protocol. This would involve a second species and new protocol on how to move the animals to the maze, inspire them to complete it, and duplication search.
o If you are counting the number of one species of salamander and wish to also count the species of a second species of salamander using the same technique, you can amend your previous protocol to cover the additional species
o If you are working with mice running a maze and now you want mice to run on a treadmill, you would need to complete a second protocol. This would involve a new protocol, research question and duplication search.
o If you are breeding zebrafish and now you wish to determine what type of animal enrichment would improve fry survivability, this would need a new protocol.

• Doesn’t IACUC approval cover any use of the species I have listed?
o No. Approval only covers what is listed in the approved application.

• Why do the regulations and policies keep changing?
o 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.

• What should I do if my annual review is past due?
o 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.

• What is the contact information for the IACUC?
o IACUC@AppState.edu

• Where are the AWA, and USDA numbers?
o On the IACUC Homepage, at the bottom

• How do I close a protocol?
o 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.
o If you are NOT the PI, you cannot close someone else’s protocol.

• What should I do with hazardous materials I don’t want anymore?
o For radioactive waste, please see the office of research radioactive page (blue link it) or contact Compliance@AppState.edu
o For all others please see Appalachian’s Office of Environmental Health, Safety, and Emergency Management (blue link http://safety.appstate.edu/)

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Contact

Director of Research Protections
Robin Tyndall
828-262-2692
tyndallrs@appstate.edu

Assistant Director of Research Protections
Monica Molina
828-262-4060
molinamm@appstate.edu

Assistant Director of IACUC and IBC Programs
Shante' Mathes
828-262-2901
mathessc@appstate.edu

Compliance Coordinator
Dennis Gabriels
828-262-2721
gabrielsdl@appstate.edu

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