Instructions to complete IACUC form A:

“Application to use vertebrate animals in research, testing or instruction”

Page 1

  • The project title must match the funding grant title
  • Check off what other sections pertain to your study (Sections A-F) – be sure to include these sections with submission of the protocol.
  • Complete all contact information for all investigators

Page 3

  • Please include all funding information
  • Animal numbers:
  • Include species (common name or Latin name) as well as strain, if applicable.
  • This table includes the number of all new animals as well as all animals that are to be transferred from another protocol.
  • Please pay attention to the USDA definitions of the different categories and list ALL animals that will be in EACH of the different categories.

Page 4

  • Include contact information for those OTHER than the PI who is responsible for the animal welfare and should be contacted in the case of an emergency.

Specific Questions:

  • Question 1 – this must be in LAYMANS terms. How would you explain your research to your grandmother?
  • Question 2 – Are there alternatives to use of animals? If not – please state that and why. If there are, why can you not use them or why are they not appropriate?
  • Question 3 – Why is the specific species or strain the most appropriate for your study?
  • Question 4 – Check all that apply. In cases where an additional section should be completed – please complete and submit with the protocol (Sections A-F).
  • Question 5 – What are the specific aims of your study? What is the experimental design for each aim? This question should have all your experimental groups, number of animals and the timeline which they will be used. What is being done to the animals in each group (in basic terms – please save specifics for your SOPs and surgical sections)? If the provided table is not helpful to explain this information – please delete and explain in a manner that is easy to follow.
  • All referenced SOPs must be included with the protocol. SOPs must be provided for all procedures.
  • Question 6 – Please do not list all your experimental groups again here. Please provide justification (preferably statistical justification or drawing from previous or comparable studies) for the number of animals requested.
  • Question 7 – What are the adverse events that could reasonably be predicted or possible with any of the procedures or manipulations that are planned?
  • Question 8 – Who is observing the animals after any planned procedures or manipulations? Provide a monitoring sheet to record those observations. What specific signs are being monitored? What are the specific criteria for intervention? How frequently will the monitoring be done over the course of the study?
  • Question 9 – What interventions/care will be provided for animals experiencing adverse events, pain or discomfort? (there should be room on the monitoring sheet to make notes of any interventions or care provided).
  • Question 10 – What are the criteria for euthanasia? (These criteria should also be listed on a monitoring sheet).
  • Question 11 – is natural death the endpoint of the study? In most cases this DOES NOT APPLY. If death IS the endpoint – please provide well researched and documented justification as to WHY it is not possible to euthanize an animal before it dies, on its own, as a result of the study.
  • Question 12 – ANY drugs used that are not part of anesthesia/surgery need to be listed here. This includes experimental treatments or possible interventions to an adverse event.
  • Question 13 – if paralytics are used they need to be listed and justified.
  • Question 14 – ANY samples taken from LIVE animals needs to be listed here. This includes blood, ascitic fluid, or other tissues.
  • Question 15 – what are the possible options for the final outcome of the animal?
  • Question 16 – How will you be euthanizing the animal? Please note: if a controlled substance is to be used, it needs to be listed in Section C.
  • Question 17 – Review the AVMA guidelines on euthanasia – if your method is currently not recommended by the AVMA , please provide justification for its use.
  • Question 18 – What secondary method will be used to ensure the animal is dead? Physical methods are preferable.
  • Question 19 – for animals listed in USDA pain category D or E this table MUST be completed. It is not necessary for other categories, but it is always a good idea to look for refinements or alternatives to animal use and procedures.
  • We are asking that you look for alternatives to the possibly painful procedures, but also refinements.
  • Refinements include any modification of any procedure or method from the time an animal is born until its death that minimizes the pain, stress or distress experienced by that animal and enhances its overall wellbeing.
  • This can include simple things like changes to bedding, feed or other environmental approaches; but also changes to a pain management protocol or changes to tissue handling to minimize trauma, etc…
  • Links to good resources for conducting these types of searches are included.
  • Question 20 – Please provide a summary of what you learned from your alternative/refinement search. If you feel you must include your search results – please provide separately).
  • Question 21 – Where will the animals be housed?
  • Question 22 – Will you be maintaining your animals outside of approved housing for >12hrs? Where is this? Why?
  • Question 23 – Review pertinent guidelines for the use of animals in research…will you be doing anything that deviates from these guidelines? Please justify.
  • Question 24 – What enrichment will be provided?
  • Question 25 – Are cell lines to be used?

Page 15

  • Personnel forms – A separate form must be completed for EVERYONE who will be handling, treating, making observations, doing procedures, etc... Please fill this form out completely. All persons must have completed all ARF training prior to their participation in this animal research. Please complete the DATE that training was completed (“pending” is not a date). What experience does each person have with each of the procedures to be performed? If they have none, or minimal – how will they be trained?

Additional information that must be submitted with an animal protocol:

SOPs

  • Include SOPs that detail the specifics of all procedures and manipulations. All referenced SOPs should be listed in question 5.

Monitoring Sheets

Section A – Surgical Section

  • Complete for any minor, major or non-survival procedure. This will be where you can include details about the surgical procedure as well as anesthesia and post-operative pain management.

Section B – Breeding Section

  • Must be completed if doing any breeding. Complete separate forms if doing multiple breeding schemes.

Section C – Biosafety Section

  • If using the following – this section must be completed:
  • Biological material/Animal productions to be used in animals
  • Recombinant DNA or transgenic rodents
  • Controlled substances
  • Toxic hazards
  • Biological hazards
  • Radioactive hazards
  • Gas Anesthetics

Section D – Antibody Production Section

  • If you will be producing antibodies (e.g.: Ascitic fluid), this section must be submitted.

Section E – Prolonged Restraint Section

  • Submit with any protocol that requests restraint greater than 15min.

Section F – Food/Water Restriction Section

  • Submit with any protocol that requests non-surgical food or water restrictions.