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.

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.

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.

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.

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.

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.

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.

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).

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.

There is not a submission deadline for protocols now that we have moved to the IRAP system. Protocols received are sent to IACUC members in a pre-review status within 48 hours of being received by the IACUC office. The pre-review status is changed to either designated member review or full committee review once all the primary IACUC members have an opportunity to review the submissions received for any given week, and the IACUC chair approves the reviewer assignments. Protocols called for review at the committee meeting at the end of the month, should be submitted no later than 20 days prior to the meeting. For more details and a list of criteria for protocols typically requested for committee review please see the Submission Review Deadlines and Dates page.

There are a few checks you can perform before you submit your protocol to prevent delays.

• Be sure the title on your form matches the grant title. When submitting to multiple administration offices (OSP, OH&S, etc.) be sure that information like the project title and PI name match on all forms. Many times our offices need to communicate about projects and if this information doesn't match it can cause delays.
• Check that all personnel have completed or begun the required training and health enrollment. See Training page for more details.
• Make sure you have responded to all required questions within the form.
• When renewing/updating, check your renewal reminder notice to ensure you are submitting the correct form.

Yes, competing continuations require an AUR form and full review. Since the Office of Sponsored Projects (OSP) assigns a new link number and Grants Accounting will assign a new account number(s), the competing continuation is considered a separate grant and must be reviewed as such for tracking purposes. The IACUC is required to perform a grant-to-protocol comparison and review all procedures related to this grant segment.

Protocol review is conducted in many stages and by several reviewers with a variety of expertise. Most review teams consist of a volunteer scientific reviewer, a veterinarian, an OH&S representative, a grant reviewer and an office staff member for administrative items.

Each review of your protocol may be conducted by different reviewers. Different review teams may focus on different aspects of the protocol or may have varied undertsanding of the research being conducted. If you ever have difficulty with questions or feel a question has been asked inappropriately, please contact the IACUC office. With the implementation of the new electronic form (eForm), the IACUC hopes to increase consistency and greatly reduce the number of review questions by: refining existing questions, adding required questions that may not have been previously included, and providing more guidance to both the PI and reviewer about the expectations of each question.

The length of the review process is based on 2 main factors: how quickly the reviewers complete the review and how quickly the investigator responds to questions. Other issues such as use of hazardous agents, complexity of the protocol, special requests (outside housing, exemptions, etc.) and incomplete or incorrect forms can also affect review length. To help speed up the process you can:

• Check all forms for congruency and completeness prior to submission.
• Respond to all reviewer questions as completely and quickly as possible.
• Complete training and enrollment as soon as possible.

For reviews on paper forms: When responding to reviewer questions there are 2 items to complete: a response memo and a revised form. Response memos should contain the reviewers' questions and your response to them. The forms should contain any needed revisions from the reviewers' questions preferably highlighted or in a different color font. While these 2 items may seem redundant, they can speed up the review process by allowing the reviewers to focus only on your revisions. There have been problems in the past where only a revised form was submitted and after spending a great deal of time reviewing the entire revised document, the reviewers found that not all requested changes were included in the form.

For reviews on electronic forms (eForms): Make the requested changes to the eForm, and upload any supporting documents as needed. Then simply submit. The reviewers will be able to compare the form verisons to see the changes that were made in the response submission.

Yes. Training and enrollment must be completed before approval is granted, but you should respond to reviewer questions as soon as possible even if training and enrollment are still pending. In the eForm, you will be able to check a person's training certifications as they are added to the form so that you can inform them of any required training prior to submission.

If you will be administering hazardous substances to animals, you will also need to submit paperwork to Occupational Health and Safety (OH&S) for review before you can begin your experiments. You will need to complete and submit the Project Registration Form to OH&S. If they determine that the material you are using requires special handling of the exposed animals, they will create the Animal Use and Safety Information (AUSI) form at the conclusion of their review. You will be contacted by the ARP Health and Safety Specialist to conduct a safety briefing which covers any specific handling rules or precautions and at that time you will receive the final AUSI. Once the briefing has been conducted, the IACUC will notify you that you are allowed to begin your animal work.

Both the Animal Welfare Act and Regulations (AWAR) and the PHS Policy require inspection of animal housing facilities and activity areas at least every 6 months. The UAB IACUC reviews all facilities and laboratories where live animals are taken on a rolling schedule every 6 months and reports these findings in the Semiannual Report of the Animal Care and Use Program. The IACUC may also visit your lab if you have been unresponsive to reminders to update your AUR eForm. This helps to ensure that any changes made related to your animal work are properly documented and approved to prevent noncompliance.

The IACUC inspects the ARP animal facilities on a rolling schedule every 6 months. When deficiencies are identified the responsible party is notified of the issue and given a timeline for correction. If you receive an inspection sheet for your space in the ARP facility, locate the deficiency on the sheet noted in the PI column. You are only responsible for deficiencies marked in the PI column. Determine if you are responsible for the deficiency and then respond back to the IACUC with how you have corrected the problem or will correct the problem. Note that recurring deficiencies of the same nature in the same area can be considered noncompliance so it is important to take steps to prevent recurrence.

There are no special steps to take prior to a lab audit, but here are some tips for having a successful audit:

• Make sure the lab space is clean and organized.
• Don't try to answer questions about lab procedures with which you are unfamiliar. It is ok to say I don't know or I don't do that work and direct the auditor toward the correct person.
• Answer questions honestly. We can't help you fix a problem if we do not know about it. It is much easier for us to work with you directly to correct an issue than to find out about it indirectly as noncompliance.

It is most important to have personnel present that are actually responsible for working with the animals and conducting procedures. Anyone is welcome to attend, but it is best to have the personnel actually doing the animal work answering questions about it.

Besides the semiannual lab and facility inspections conducted by the IACUC, there are external groups that may visit various sites within the UAB animal program. The USDA inspects facilities and reviews IACUC records once a year on an unannounced visit. AAALAC inspects the enitre animal program every 3 years. The VA, OLAW, NIH, EPA, DEA and other various sponsors and agencies also inspect/audit various aspects of the animal program on a regular basis.

A deficiency or noncompliance is any deviation from an approved IACUC protocol, UAB policy or the regulations and standards dictated by oversight agencies (e.g. OLAW, USDA, or AAALAC) and regulatory documents (e.g. the Guide, PHS Policy, or Animal Welfare Act) for the care and use of research animals. Depending on the type of deviation and its impact on animal welfare, various corrective actions are applied to both correct the deficiency and prevent future recurrence. The institution is required to report some deficiencies to external oversight groups and/or to the applicable funding agency.

The most common types of noncompliance are deviations from approved IACUC protocols. Even small deviations can be considered noncompliance so if you are unsure whether you are allowed to perform a procedure it is best to check with the IACUC office first. Other types of noncompliance inlcude but are not limited to:

• Overcrowding of cages
• Improper transportation of animals
• Ineffective euthanasia
• Using expired drugs
• Performing experiments without an approved protocol

In general a noncompliance event is observed by or reported to the IACUC office, office staff speak with the involved persons, and report their observations and findings to the Compliance Subcommittee. The Compliance Subcommittee is a group of IACUC members that use the regulations and requirements of animal care and use oversight agencies to apply the appropriate corrective actions and initiate reporting requirements where applicable. The Subcommittee presents its recommended actions and reports to the full IACUC committee for approval or modification. After approval from the full committee, the IACUC office staff or designated persons communciate the committee's decision to the noncompliant party and follow-up on implementation of corrections and reports to internal and external entities as needed.

As soon as a cage is tagged as overcorwded it is already out of compliance. Breeding colonies should be maintained in a manner to avoid having cages tagged and not depend on notices for colony maintenance. ARP copies IACUC on the email notices that are sent to PIs and research staff. The IACUC logs and tracks the number notices received for each PI, the number of cages tagged, number of cages on census, and the APN involved. Once a particular PI has reached the limit of 4 separate instances per month, the IACUC will contact the PI to determine why there is an overcorwding issue and how the problem may be corrected. This limit is flexible to take into consideration the % of overcrowded cages or housing in multiple rooms. If overcrowding continues to be a problem after the initial contact by IACUC additional corrective actions may include mandatory retraining of personnel or meeting with the Compliance Subcommittee.

If you have any suspicion that animals are being used or cared for inappropriately it is very important that you report it immediately to the IACUC so that we may intervene and suspend any noncompliant actions or behavior. There are many methods of reporting concerns about animal welfare including an anonymous hotline. Please see the IACUC's Reporting Deficiencies Policy for further information.

Approved protocols must be renewed/updated every year and will lapse after 365 days or 3 years for eForms. If your protocol expires you will receive an automatic email notice informing you of the lapse. If you have animals on census, the Compliance Coordinator will send an email notifying you that any animals under this protocol have been temporarily moved to the ARP Holding Protocol. Until your protocol is approved, you may not conduct any experimental procedures on animals under that protocol. You are allowed to perform normal colony maintenance (breeding, weaning, genotyping, etc.) or treatments related to the health of the animals (e.g. providing insulin for diabetic animals). Once your protocol has been renewed, the animals will be released from the holding protocol and you may resume experimental activities. To prevent lapses, pay attention to the renewal/update reminder notices you receive for your protocols. They are sent 6 weeks prior to protocol expiration, and will tell you which form or type of review is due.

In order to work with animals you must complete the following training requirements: Using Animals for Research, Teaching, and Testing (all) Species training (species dependent) Rodent Surgery (only for those performing surgery in mice or rats) Enrollment in the Employee Health Program (all, non-employees must receive permission through their general physician) All IACUC online training is available through the Learning System and enrollment information can be found on the OH&S Employee Health website.

The ARP Facility Manager grants access to individuals who have completed the required training, enrolled in the Employee Health Program, and have been added to an approved IACUC protocol. To apply for access, please complete the Building Access Form and follow the instructions for submission.

If you have any suspicion that animals are being used or cared for inappropriately it is very important that you report it immediately to the IACUC so that we may intervene and suspend any noncompliant actions or behavior. There are many methods of reporting concerns about animal welfare including an anonymous hotline. Please see the IACUC's Reporting Deficiencies Policy for further information.

The IACUC is responsible for overseeing the use of animals for research, teaching and testing at UAB. This includes all vertebrate animals and some invertebrate animals housed within the ARP facilities or that have contact with vertebrate species. The IACUC may also be responsible for overseeing animal work performed at other institutions if it is being directed by UAB personnel or funded by a grant awarded to UAB. If you are unsure if your work requires IACUC approval please contact the IACUC office.

Graduate students seeking admission to candidacy are required to have an IACUC official sign off on their forms if their work includes animals. Any IACUC office staff may provide this approval during the normal office business hours. Please come prepared with your completed form and the correct Animal Project Number (APN).

The best thing to do is call the IACUC office. There are several variables (e.g. length of visit, contact with animals, level of involvement) that will impact what training and safety requirements will be required, and there are rules regarding visitors that you will need to be aware of relevant to animal facility access, risks and liability. These individuals may also need to be given a temporary Human Resources employment status.

If you are using hazardous agents you should have received an Animal Use and Safety Information (AUSI) sheet from the ARP Health and Safety Specialist. This sheet must be displayed on the animal housing room door ONLY if you are currently using the indicated hazardous agent. If you are not using the agent or if it is inactive, turn the AUSI face down on the door. The posting or reversing of the AUSI alerts personnel entering the room of any hazards present and what preventive actions must be taken when handling the animals or materials. Please be aware that if an AUSI is posted, there should be cages tagged with a corresponding APN and hazard sticker. If you have questions about the AUSI or handling of animals or materials related to approved hazardous agents, please contact the ARP Health and Safety Specialist, 934-3538.

An investigator who for any reason needs to transfer an active IACUC approved protocol to another PI can do so by following these steps:

• Submit a letter/memo to This email address is being protected from spambots. You need JavaScript enabled to view it. summarizing the reasons for the transfer, indicating who will be taking over the protocol project and some basic information about the qualifications the receiving PI and staff have for performing this type of research project. Note: depending on the situation and funding source, documentation informing the funding agency may be required before the transfer can be approved by the IACUC.
• For paper submissions, the investigator taking over the project should submit the most recently approved Animal Use Request form changing the information in section I (General Information) questions 1-4 with current updated information and submit it toThis email address is being protected from spambots. You need JavaScript enabled to view it. for review and approval. For eForms, the existing PI must submit a Continuation/Modification indicating the change in PI.