Protocol Forms

Protocol Forms

What forms do I submit for a new protocol?
If you will be working with vertebrate or invertebrate animals you will need to complete and submit the Animal Use Request/Registration (AUR) electronic form (eForm). Invertebrates must be registered with the IACUC if they will be housed in the ARP facilities or will contact vertebrate animals e.g., as a disease vector,etc.

Who can be the PI on an IACUC protocol?
In order to be the PI listed on the IACUC protocol you must have Instructor status or higher. Graduate students and Postdocs should list their mentor as the PI. If you are a student and the PI on the corresponding grant, list your name in parentheses after the title on the protocol. If a faculty appointment is contingment upon the grant award that you are submitting to IACUC, then you may list yourself as the PI.

How do I know when my protocol  is due for renewal?
All protocols must be renewed or updated annually. Protocols that are still on the paper forms will expire at 365 days, but protocols submitted on the eForm will expire at 3 years. Renewal/Update reminders are sent electronically 6 weeks prior to protocol expiration. These reminders will tell you the expiration date of your protocol and which form to use for the renewal. You must plan your renewal submission in order to avoid a lapse in protocol before the renewal is approved.

Which form do I submit for my renewal?
The attachment in the renewal reminder will state which form to use for your renewal. Until January 1, 2017, the Renewal of Approved Protocols form can be used for most renewals, however each protocol is required to undergo complete or "de novo" review every 3 years which requires submission of the AUR eForm.

How do I reference the use of a UAB Core Facility?
Some laboratories have protocols to specifically cover certain procedures that are offered to other investigators typically for a fee. There are specific questions regarding use of Cores in the AUR and modification forms, and use of Cores can be noted as a modification in the renewal form. To reference a Core first check with the facility to ensure the procedure being performed is covered under the Core's protocol. Second, include the Core name and APN on your form and state which procedures they will perform. You do not need to include the details of the procedures just the procedure names and frequency for each animal.

How do I perform a database search?
There are 2 types of database searches inlcuded in the IACUC protocol forms: an alternatives search and a duplication search. The alternatives search is a way to determine if there is a less painful or distressful alternative for a procedure or experimental state. There are suggested databases offered, but you may also use other scientific databases. Keywords should include terms like alternatives, animal model, pain, in vitro, etc. The duplication search is to ensure that this work has not already been performed. Any scientific database may be used and keywords should inlcude terms relevant to your study. All searches should include a relevant range of years and should be performed within 3-6 months of protocol submission. Reviewers do periodically check the database searches. For more help on database searches visit the UTSA Libraries for a tutorial on creating, running and evaluating searches.

Is my surgery major or minor?
The 8th edition of the Guide for the Care and Use of Laboratory Animals defines major surgery as any surgery for which a body cavity is exposed, there is substantial physical or physiological impairment, or substantial dissection of tissues. Examples include organ transplants, cecal ligation and limb amputation. Minor surgery is defined as any surgery that does not expose a body cavity or cause substantial physical or physiological impairment. Examples include subcutaneous implants, intracranial injections, and skin biopsies. See the Surgery procedure for more information.

In which pain category should I place my animals?
The UAB IACUC has 3 categories for pain classification for experimental procedures and conditions: C, D, and E. These categories are defined as follows:

  • Category C (formerly A)- mild or momentary pain/distress (e.g. ear punches, injections, noninvasive imaging)
  • Category D (formerly B)- substantial pain/distress that is alleviated (e.g. surgery with anesthesia and analgesia, retro-orbital bleeds under anesthesia, prolonged restraint with conditioning or anesthesia).
  • Category E (formerly C)- substantial pain/distress that cannot be alleviated for scientific reasons (e.g. disease states, sepsis, inflammation).

How do I write an animal numbers justification?
Writing numbers justifcations for complex protocols or complicated breeding schemes can be challenging. Below is a list of common points you should consider when writing your number justification. Please also see the Animal Numbers Justification Guidelines for more information.

  • Describe how you determined group or experimental size through either statistics, literature references, or past experience.
  • Justify numbers based on scientific objectives not how much time or staff are available to complete the study (e.g. do not state you need 52 rats because you can only process 1 rat per week).
  • When you need to describe breeding first establish how many experimental animals you need and then work backwards to determine how many breeders, excess animals, strains/crosses, etc. you will need to produce those animals. For additional guidance on calculating breeding numbers you can use the Excel Breeding Calculator or the CAMP Genotype Predictor. (These calculators may not work for all breeding schemes).
  • When possible show your work. Tables or equations (e.g. 5 per group x 3 groups x 2 time points x 2 strains= 60 animals) can help the reviewers understand your justification.