Frequently Asked Questions


Protocol submission and review

What type of Protocol Review Form do I need to complete?

Complete the Protocol Form for new protocols and resubmissions of expiring protocols.
 
Complete the Bio-Products Protocol Form for work that does not include live animals (tissues, custom antibodies, etc...).
 
Complete the Protocol Amendment Form when making changes to an existing protocol. Changes include:
  • Addition or deletion of personnel (use the Personnel Amendment Form if this is the only change you are making) 
  • Change in animal use location
  • Addition of or change in drugs, anesthesia, analgesia or euthanasia methods
  • Addition of or change in experimental procedures
  • Addition of or change in surgical procedures
  • Additional animal numbers
  • Additional strains or species

What forms need to be completed during the protocol submission process?

In addition to the Protocol Form or the Protocol Amendment Form, you may need to submit additional forms depending on the type of work that is being performed. This may include:
  • Surgical Addendum
  • Rodent Breeding Addendum
  • Good Laboratory Practices (GLP) Studies Addendum
Note that for PHS-funded projects, the animal portion of the grant must be submitted with the Protocol Form. The animal portion of the grant must also be submitted with the Protocol Amendment Form when the amendment is to add new PHS funding.

Who should be listed on my protocol?

Protocols must list all individuals who will come into contact with animals or their tissues/byproducts. Anyone listed on a protocol must have the necessary IACUC training and certification.
 
Personnel no longer associated with the protocol must be removed in a timely manner by submitting a Personnel Amendment Form.

Do undergraduate and graduate students need to be listed on my protocol?

Anyone who works directly with animals or their tissues/byproducts must be listed on your protocol or amendment. This includes any students, whether they receive a stipend or not. Anyone listed on a protocol must have the necessary IACUC training and certification.

When should I start preparing my protocol submission?

Ideally the Protocol Form should be completed when your grant proposal is routed through the University to ensure approval before the grant is awarded. However, for PHS-funded grants, the IACUC accepts just-in-time (JIT) submissions. Please note that if this is your first Protocol Form or if the protocol is particularly complicated, the review period may be longer than usual. In this case, a JIT protocol submission may not be approved in time for the grant award.

How long will it take to review my protocol/amendment?

  • New protocol submissions generally take one to two months from the date of submission to approval
  • Primate protocols average three to four months
  • Amendments will be put on the agenda for the next scheduled review meeting, which occur every month.  

Should I amend my existing protocol or submit a new application?

You should submit a new protocol application if the changes proposed cannot be satisfactorily justified as fitting within the original objectives of the protocol.

How long is my protocol approved for?

Protocols are approved for three years. It is not possible for the IACUC to extend the protocol beyond three years.

Can I get a copy of my protocol? Can I have a list of approved protocols for this staff member/student?

While these types of requests frequently can be filled immediately, there will be occasions when it may take several days before we can get copies of your files to you. It is highly recommended that you keep at least one copy of everything you submit to the IACUC Office in your files. Please note that the individual making the request must be listed on the Protocol as a PI, OSD or protocol contact.

I have another question about my protocol. Who do I contact?

Contact the IACUC Office for answers to any additional questions.
 

Third year protocol renewal

When do I need to submit a renewal

A Protocol Review Form should be completed well in advance of the actual expiration date of your current protocol. On average, a new protocol takes one to two months from the date of submission to approval. If the protocol involves primates, these protocols typically average three to four months from the date of submission until approval.
Please note that a new protocol must be in place before the old one expires, otherwise existing animals will be unavailable for use. Please see the IACUC policy on Protocol Renewals (#107).

What is the renewal process?

Third year renewal of a protocol is performed by the same process as for a new protocol submission, with the exception that the Progress Report for Renewing Protocols section must be completed.

Can the IACUC extend my protocol?

As per OLAW, protocols are approved for a maximum of three years. It is not possible for the IACUC to extend the protocol beyond three years.

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Personnel training and certification

What are the minimum IACUC certification requirements for personnel listed on my protocol?

All personnel listed on the protocol must complete certain training modules, depending on their role and animal activties. In addition, a Risk Assessment Questionnaire (RAQ) must be completed with Occupational Health. For complete information, visit the IACUC Training and Certification Page.

I can't find my IACUC certification number or what training I still need to take. Who should I contact?

You can email either the IACUC Certification Office or the IACUC Office to request your IACUC certification number or check which modules you have completed.
 
If you know your IACUC number, you can check your completed training here.

I have a question about completing the RAQ. Who should I contact?

For questions about the Risk Assessment Questionnaire (RAQ), please contact Occupational Health.
 

Amendments

A protocol can be amended to include changes only if the addition or modification still fits into the scope of the original proposal. Acceptable types of amendments include:

  • Additional animal numbers requested (including Breeding)
  • Additional species requested (including Breeding)
  • Additional strains requested (including Breeding)
  • Addition or modification of drugs, doses and/or routes of administration
  • Addition or change in biological materials of mammalian origin inoculated into rodents
  • Addition or modification of procedures (includes change in time points, test agents, restraint, housing type, type of surgery)
  • Changes to the anesthetic regime
  • Changes in euthanasia methods
  • Change or addition of palliative therapy
  • Change in post-operative care
  • Addition of or change in animal use location
  • Change in protocol title, PI and/or granting agency funding the study
  • Change in personnel

The Protocol Amendment Form can be found here. You must be able to justify how the addition or modification fits into the scope of work as originally approved. Note that amendments adding to or modifying Surgical Procedures or Breeding must be submitted with the appropriate addenda.

What requires submission of a new Protocol Form?

If the changes cannot be satisfactorily justified as fitting within the original scientific objectives of the approved protocol, a new Protocol Form must be submitted.

What are the changes that can be requested by email correspondence instead of a Protocol Amendment Form?

  • Deletion of personnel from a protocol
  • Addition/change/removal of an animal use location

Note that addition of personnel must be requested by filling out the Personnel Amendment Form.

How long will it take to get the Protocol Amendment approved?

Assuming no major administrative issues with the proposed changes, amendments are generally put on the agenda for the next scheduled review meeting, which occur every month. Approval time will depend on the PI's responses to the reviewers' comments.

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Animals and animal facilities

What are the IACUC requirements that must be completed to get keys and access to the University Animal Care animal facility?

  1. You must be listed on an active protocol. Ask your principal investigator to send an email to the IACUC Office requesting that you be added to the protocol.
  2. You must complete the minimum IACUC certification in Laws and Regulations and Intro to Animal Hazards as well as the module for each species you will be working with. A Risk Assessment Questionnaire (RAQ) must be completed with Occupational Health.  
  3. Individuals performing surgery or anesthesia must also take the Surgery & Anesthesia module.
  4. Hands-on training is also required for those individuals who's mice and rats are housed in micro-isolators (MI) or whose mice are housed in individually ventilated cages (IVCs).

I need to breed rodents as part of my protocol. Where can I find information about University Animal Care rodent breeding facilities?

Information about rodent breeding is available here.

I have another question about University Animal Care facilities. Who do I contact?

Contact Information for University Animal Care facilities is available here.
 

Veterinary support

I am writing a protocol/amendment and I have a question about a surgical procedure/drug/anesthesia regimen/euthanasia method. What resources are available?

  • A list of approved anesthesia and analgesia methods are available. Please see IACUC policy #208.
  • A list of approved euthanasia methods is available here
  • A list of signs of pain and distress in lab animals is available here
  • A guidance document on the use of Isoflurane is found here
  • A list of IACUC policies relating to certain procedures such as LD50 studies, footpad injections, ascites production, toe clipping, etc... are listed here
  • For questions about surgical procedures and/or veterinary pre-review of your complete protocol, contact one of the University Animal Care veterinarians

There has been an unexpected animal injury or illness. Who do I contact?

  • For an animal emergency, contact the on-call veterinarian. The phone numbers are posted in each University Animal Care animal facility. If the situation is not an emergency, contact one of the University Animal Care veterinarians.
  • University Animal Care also has an Animal Loss Insurance Program. More information can be found here.

Does University Animal Care provide surgical and/or clinical services?

University Animal Care Biotechnology Support Services (BSS) provides surgical and clinical support to the university research community. BSS can provide an assortment of surgical equipment and supplies along with skilled technical support, including assistance with projects or the performance of surgery on a fee for service basis.

Does University Animal Care provide pathology services?

University Animal Care Pathology Services provides quality assurance testing and diagnostic and comparative pathology support for the research animals and research animal facilities at the University of Arizona. Anatomic and clinical pathology support for research projects, including comprehensive and targeted pathologic phenotyping of genetically altered rodents are available to principal investigators on a fee for service basis.
 

Personnel injury

Someone has been injured while conducting animal research. What do I do?

  1. For life threatening injuries, call 911 or go to the nearest emergency room or trauma center. Tell the medical provider that this is a work-related injury and notify them of the potential for zoonotic transmission of disease.
  2. For non-life threatening injuries, medical treatment for employee injuries is available Monday, Tuesday, Thursday and Friday from 8:00am to 4:30pm and Wednesdays from 9:00am to 4:30pm at the Campus Health Service (1224 E Lowell Street - near Highland & 6th Street) or the employee may use their own primary care provider or any other health facility. Again, notify the medical provider of the potential for zoonotic transmission of disease.
  3. Employees who require medical attention evenings, nights or weekends may seek care from any medical provider. Tell the medical provider that this is a work-related injury and notify them of the potential for zoonotic transmission of disease.
  4. The employee needs to notify their supervisor as soon as possible. The supervisor is responsible for completing the Supervisor's Report of Employee Injury/Illness Form. This form must be submitted to Risk Management within seven calendar days of the injury.
Medical treatment costs associated with on-the-job injury are covered by workers' compensation insurance. Coverage determinations are governed by state law, and are administered by the Arizona State Risk Management Office. If coverage is denied, employees may be responsible for costs incurred after their initial treatment visit.
 
If you have any questions regarding occupational injuries, contact Steve Holland at 621-1556.