TABLE OF CONTENTS
- Common Acronyms and Abbreviations
- Animal Care and Welfare
- How do I report a concern regarding the use of animals?
- Who do I contact about an animal health problem or emergency?
- Animal Care Protocols – New and Continuation
- What approvals are necessary to work with animals at UNC?
- How is the expiration date of my protocol determined?
- How do I submit an application?
- What are the basic guidelines for navigating the ACAP (Animal Care Application) online system?
- What is the difference between a “New” and a “Continuation” Application?
- Can one application be submitted for several species?
- Do I need an Animal Care Application for the use of chick embryos?
- Annual Renewals and Amendments
- Which protocols require Annual Renewals and how do I submit them?
- What if I need to make changes in procedures, drugs, techniques, etc. to the Animal Care Application?
- What if I need to make a large change to the scope of my original Animal Care Application?
- When is an amendment NOT required?
- What online forms and online training are required before working with animals at UNC?
- What are the requirements for hands-on training prior to IACUC approval of my application?
- What is a Laboratory Animal Coordinator (LAC) and how do they train and certify other laboratory personnel?
- Can LACs certify personnel in all hands-on techniques?
- Can LACs certify personnel in the OACU lectures?
- How do I receive training for techniques and lectures?
- How does the Laboratory Animal Coordinator (LAC) certify training of laboratory personnel?
- Title/Funding Changes
- How do I submit a title/funding change?
- Can my protocol title be altered with a title/funding change?
- Do all funding agencies require a matching title between the protocol and grant?
- I believe I need a title/funding change. When should this be submitted?
- What is grant congruency and why is it done?
- What is the procedure for requesting a congruency review?
- When will the grant congruency review be completed?
- What will be looked for and what if discrepancies are identified during the congruency review?
- What funding agencies require that a congruency review be conducted?
- What if my grant has a foreign collaboration?
- Environment, Health and Safety (EHS) Information
- What is the University’s Occupational Health Program for animal handlers?
- How do I include the use of hazardous materials in my animal care application?
- Where do I find the PI Lab Safety Plan?
- How do I submit Institutional Biosafety Committee (IBC) Registration forms?
- Division of Comparative Medicine (DCM) Information
- How do I submit a DCM Request, such as an animal order, transfer, import, export, or cage card request?
- Where can I find additional information about animal facilities, animal ordering, billing, cage cards, per diem charges, or veterinary care advice?
Common Acronyms and Abbreviations
- AAALAC: Association for the Accreditation and Assessment of Laboratory Animal Care International
- ACAP: Animal Care Application (the UNC-CH online protocol/application system)
- DCM: Division of Comparative Medicine
- DOD: Department of Defense
- EHS: Department of Environment, Health and Safety
- IACUC: Institutional Animal Care and Use Committee
- IBC: Institutional Biosafety Committee
- LAC: Laboratory Animal Coordinator
- NLAC: Network of Laboratory Animal Coordinators
- OACU: Office of Animal Care and Use
- OLAW: Office of Laboratory Animal Welfare
- PI: Principal Investigator
- PHS: Public Health Service
- UEOHC: University Employee Occupational Health Clinic
- USDA: United States Department of Agriculture
- VA: Veteran’s Affairs
Animal Care and Welfare
How do I report a concern regarding the use of animals?
Please see Reporting Animal Welfare Concerns or Animal Protocol Noncompliance.
Who do I contact about an animal health problem or emergency?
During normal working hours, please call the DCM Veterinary staff at 919-966-2906 or page them at 919-216-1235. On weeknights, weekends, and holidays, please page the on-call DCM Veterinary Staff at 919-216-1235 or Animal Husbandry at 919-216-6434.
Animal Care Protocols – New and Continuation
What approvals are necessary to work with animals at UNC?
The PI must submit an Animal Care Application (ACAP) which must be approved by the IACUC prior to conducting any work with vertebrate animals. An application that has been reviewed and approved by the IACUC is valid for up to 35 months. Should you wish to continue the project at the end of the 35-month protocol approval period, you must submit a continuation application. Please note: Applications describing work with USDA-covered species and those using DOD or VA funding must be reviewed by the IACUC annually during the 35-month approval period. Please see the “Training” FAQ section for more information.
How is the expiration date of my protocol determined?
The date that the application is initially reviewed by the IACUC determines the protocol expiration date. To remain compliant with federal regulations governing 3-year de novo reviews, protocols expire on the last day of the 35th month following the initial review by the IACUC. For example, an animal care application reviewed by the IACUC at the August 2017 meeting will expire on July 31, 2020. The application approval date has no bearing on the protocol expiration date.
How do I submit an application?
Please use ACAP to submit your application electronically.
What are the basic guidelines for navigating the ACAP (Animal Care Application) online system?
Please see Tips for Submitting Applications in ACAP. When submitting applications created from templates of previous protocols, please also see Tips for Submitting Continuation Applications in ACAP.
What is the difference between a “New” and a “Continuation” Application?
- New Application: This is an application submitted for a new project.
- Continuation Application: This is an application submitted to continue an ongoing project, typically as the end of the 35-month approval period approaches. A continuation may also be submitted if the scale of the project must be increased beyond what can be approved by an amendment (i.e. significant increase in animal numbers, introduction of survival surgeries, etc.).
Can one application be submitted for several species?
In most cases, a separate application is required for each species. If you have questions, please contact OACU at 919-966-5569 or firstname.lastname@example.org PRIOR to starting your application.
Do I need an Animal Care Application for the use of chick embryos?
If the work involves chick embryos only and no chicks actually hatch, then a protocol is not required. It is the responsibility of all Principal Investigators who use research animals to contact the DCM staff to report any animal health problems, including the unexpected hatching of poultry.
Annual Renewals and Amendments
Which protocols require Annual Renewals and how do I submit them?
Annual Renewals are only required for USDA-covered species protocols or protocols that use DOD or VA funding. Annual Renewals can be submitted through ACAP by selecting the approved protocol from, then clicking “Annual Renewals” in the left-hand column. You will be asked a series of questions to confirm the progress made to date and the current scope of the project. It is strongly recommended that PI’s look over their protocol before the annual renewal is submitted to see if an amendment is needed. Any amendments should be submitted and approved PRIOR to Annual Renewal submission. Please note: Protocols that DO NOT involve USDA-covered species or use DOD or VA funding will automatically be renewed annually throughout the life of the protocol.
What if I need to make changes in procedures, drugs, techniques, etc. to the Animal Care Application?
An amendment must be submitted if changes are needed to protocols that are already approved. Amendments can be submitted through ACAP by selecting the approved protocol, then clicking “Amendments” in the left-hand column. Please see the UNC Standard for Amendments and Other Protocol Changes.
What if I need to make a large change to the scope of my original Animal Care Application?
A continuation application will need to be submitted if a large change in the overall purpose of the study, change in animal species on a single species protocol. When adding surgical procedures to a non-surgical protocol, or when an increase in animal numbers greater than 25% of what was approved in the original application is needed, please email email@example.com to determine if the circumstances require a continuation application, or if an amendment will be sufficient.
When is an amendment NOT required?
Please email firstname.lastname@example.org to make the following changes that do not require an amendment:
- Termination of protocol(s).
- Removal of personnel – include full name, PID number, and relevant protocol number(s).
- Change in animal housing location – between buildings only, not rooms within the same building. Include new housing location, old locations and relevant protocol number(s).
What online forms and online training are required before working with animals at UNC?
Depending on the personnel roles assigned to individuals, the following may be required:
- Research Profile (complete first)
- Lab Worker Form (complete once, update as needed)
- Animal Handler Form (complete annually)
- IACUC Online Orientation (complete once)
- DCM Online Orientation (complete every 3 years)
What are the requirements for hands-on training prior to IACUC approval of my application?
Animal training for individuals using live vertebrate animals is federally mandated. At UNC, this training certification may be acquired by attending a training class offered by DCM (formerly by OACU) or from a certified LAC. Please see the “Laboratory Animal Coordinator (LAC)” FAQ section for more information.
Note: Online sign-up via the UNC Event Registration page does not guarantee registration. If a space is available, you will be notified of enrollment via email. Please call the OACU office at 919-966-5569 if you do not receive confirmation within 48 hours of sign-up. If you need to cancel, please inform the OACU office as soon as possible so we can accommodate people on the waiting list.
What is a Laboratory Animal Coordinator (LAC) and how do they train and certify other laboratory personnel?
Each Investigator must appoint a LAC at the time of application submission. The LAC is a trained and certified member of the research team who is responsible for coordinating animal activities in the laboratory and for training and certifying other members of the laboratory in proper animal handling. The LAC must complete the OACU LAC Lecture and be trained and certified in hands-on techniques by DCM (formerly by OACU). The LAC should be a permanent employee rather than a student and can be the PI.
Can LACs certify personnel in all hands-on techniques?
No. LAC’s can only train others to perform techniques to which they have attained the highest score (1) from DCM. If a LAC has previously scored a (2) or (3) during training for certain techniques and would like to be re-evaluated, they can schedule a one-on-one training to demonstrate their proficiency by calling 919-966-5569.
There are several hands-on techniques to which a LAC cannot train others regardless of their score. Contact the DCM Training Team at 919-966-5569 to arrange training for the following techniques:
- Cervical Dislocation without Anesthesia
- Decapitation without Anesthesia
- Retro-orbital Bleed
- Retro-orbital Injection
Can LACs certify personnel in the OACU lectures?
No. To register for the Laboratory Animal Coordinator Lecture or Mouse Cage Density Policy Lecture, please go the to the UNC Event Registration page.
How do I receive training for techniques and lectures?
If certified, your LAC can train in certain techniques (Certifying Laboratory Personnel). Please also see the LAC certification instructions below. If your LAC is not certified to train, classes, lectures, and one-on-one training (under certain circumstances) are also available. Spaces fill up fast.
- DCM hands-on class (mice & rats) and Isoflurane training – Class Sign-up
- OACU lecture sign-up (mice & rats) – Lecture Sign-up
- DCM one-on-one training – 919-966-5569
- DCM Euthanex Smartbox training – Contact the director of your DCM facility (Facilities Overview section of the DCM website)
- DCM other species training – 919-962-5335
How does the Laboratory Animal Coordinator (LAC) certify training of laboratory personnel?
- Login to the Animal Research Registration system.
- At the top of the page, hover over “Certifications” then click on “Laboratory Coordinator Certification.”
- Search for personnel by clicking on the “Last Name” box and entering the person’s last name into the pop-up window.
- Click on the person’s name to populate their information into the “Certification Administration” page.
- “Select a Species” then click the “Next” button.
- Under the “Techniques” box, select the appropriate techniques by first holding the control key (PC) or command/apple key (Mac) then clicking on each certified technique.
- Click the “Next” button to complete the certification process.
How do I submit a title/funding change?
Title/funding changes can be submitted through ACAP by selecting the approved application, then clicking “Title Funding Changes” in the left-hand column.
Can my protocol title be altered with a title/funding change?
No. The protocol title is finalized when your application is approved. A title/funding change can only associate an additional title with your protocol as is sometimes needed for funding purposes.
Do all funding agencies require a matching title between the protocol and grant?
No. The NIH, NSF, and ACS do not require matching grant and protocol titles. The AHA prefers matching titles. Please refer to your sponsor for specific requirements.
I believe I need a title/funding change. When should this be submitted?
The title/funding change is for guaranteed awards only and is submitted after the sponsor issues the Notice of Award and the award account has been created in RAMSeS.
What is grant congruency and why is it done?
Grant congruency is the process by which Institutions ensure that all animal activity outlined in a grant application has been approved by the IACUC in an approved animal protocol.
The principal funding source for live vertebrate animal research at UNC-Chapel Hill is the U.S. Department of Health and Human Services (HHS), primarily through the Public Health Service (PHS) and its National Institutes of Health (NIH). In order to receive funds for live vertebrate animal research, the University is required to follow PHS and NIH policy. Excerpts from both the HHS and NIH Grants Policy Statements are noted below.
- HHS Grants Policy Statement
- “… If an application is selected for award and the verification of IACUC review has not been submitted, the awarding office will contact the organization with instructions for negotiating an assurance or submitting the IACUC verification.”
- NIH Grants Policy Statement
- … “Verification of the IACUC review may be filed at any time before award unless required earlier by the institutional committee. Therefore, following peer review and notification of priority score/percentile, applicant organizations with approved Assurances should proceed with IACUC review for those applications that have not yet received IACUC approval and that appear to be in a fundable range. Regardless of when the review occurs, the IACUC should ensure that the research described in the application is consistent with any corresponding protocols reviewed and approved by the IACUC. If an application is selected for award and the verification of IACUC review has not been submitted, the awarding office will contact the organization with instructions for negotiating an assurance or submitting the IACUC verification.”
What is the procedure for requesting a congruency review?
- If the funding agency utilizes the Just In Time (JIT) process: OACU staff will be notified via email once the status of a grant application has been updated by the Office of Sponsored Research in RAMSeS to “JIT Request Received.” The PI will be sent an email to inquire about the likelihood of the grant being funded. If it is likely that the grant will be funded, OACU staff will conduct a congruency review of the grant application with the corresponding IACUC protocol(s).
- If there is no JIT notice: OACU will not know about the proposal unless the PI completes the online form: Request a Congruency Review Online.
Requesting the congruency review as soon as it is known that funding is likely is advantageous because it will allow time for any discrepancies between the grant application and the IACUC protocol(s) to be resolved and helps to avoid a delay in submission.
When will the grant congruency review be completed?
Grant applications will be reviewed by OACU staff in the order in which they were received or in order of priority. Grant applications will be reviewed within one week of receiving a request from the PI or email notification from RAMSeS. Grant applications requiring review on an emergency basis (based on OSR/SPO confirmation) will be given priority and reviewed immediately. OACU staff will make every attempt to accommodate funding/award deadlines but PIs should allow sufficient time for OACU staff to review the grant application.
What will be looked for and what if discrepancies are identified during the congruency review?
* If it is in the grant proposal it needs to be approved on an IACUC protocol*
- All procedures (surgical, non-surgical, behavioral, etc.)
- Proposed use of drugs (agents, dosages, and route of administration)
- Method(s) of euthanasia
- Proposed animal work performed off site (including custom generation of antibodies contracted off-site)
- Experimental endpoints
If an OACU staff member identifies discrepancies between the grant application and the IACUC protocol, the PI will be emailed with a detailed description of the discrepancies and suggestions on how the discrepancies can be resolved. Discrepancies between the grant application and the IACUC protocol(s) are usually resolved by providing an explanation or submission of a new amendment or protocol.
What funding agencies require that a congruency review be conducted?
- National Institutes of Health (NIH)
- All NIH subdivisions (e.g. NCI, NHLBI, NIAID, NIDDKD, NIAAA, etc.)
- National Science Foundation (NSF)
- US Department of Health & Human Services (DHHS)
- USDA National Institute of Food and Agriculture
- American Heart Association (AHA)
- American Cancer Society (ACS)
- Department of Veterans Affairs (VA)
- March of Dimes (MOD)
- Cystic Fibrosis Foundation (CFF)
- Susan G. Komen for the Cure
What if my grant has a foreign collaboration?
Please review the “Foreign Collaboration” section of the Grant Congruency page for information.
Environment, Health and Safety (EHS) Information
What is the University’s Occupational Health Program for animal handlers?
The UEOHC is a program is designed to provide individuals, who are exposed to or have contact with animals, access to trained medical personnel. Each person listed on the application that handles animals or comes in contact with animal allergens must submit a UEOHC Research Animal Handlers & Animal Caretakers medical history registration form, or Animal Handler form. The UEOHC staff reviews this form and may schedule further medical screening depending on the degree of your animal contact and associated risk. It is recommended that individuals working with or exposed to animals complete the form annually or if there are any new health risks. Only individuals listed on the application who are exposed to or handle animals should complete the UEOHC animal handler form. To update your Animal Handler form, login to the Animal Research Registration site.
How do I include the use of hazardous materials in my animal care application?
Chemical, biological, and radiological hazards must be described within the Animal Care Application and the appropriate “Use of Hazardous Materials in Laboratory Animals” form(s) will need to be filled out. You can generate and access these forms from within the Chemical, Biological and Radiological Hazards sections of your application after the sections are added from the Addendum Checklist. If you are not sure if an agent is considered hazardous or have any related questions, please contact EHS Chemical Safety, Biological Safety, or Radiation Safety. All hazard forms must be approved by EHS prior to application approval.
Where do I find the PI Lab Safety Plan?
You can access the online Laboratory Safety Plan here on the EHS website. More information about Lab Safety Plans can be found at: http://ehs.unc.edu/lab/lsp/.
How do I submit Institutional Biosafety Committee (IBC) Registration forms?
Information regarding IBC Registration forms can be found here on the EHS website. Information about the IBC can be found here on the EHS website. Please note that Animal Care Applications cannot be approved until all Schedule forms are approved by the IBC. Schedule G forms are reviewed at the monthly IBC meetings, typically held on the first Wednesday of the month, and must be submitted by the 15th of the month prior for review. Please plan accordingly. Contact EHS Biosafety for more information.
Division of Comparative Medicine (DCM) Information
How do I submit a DCM Request, such as an animal order, transfer, import, export, or cage card request?
DCM requests can be submitted by accessing your application through the ACAP home page. OACU is not involved in processing these requests so if you have questions, please contact DCM at the numbers below:
- Animal Ordering, Transfers, and Cage Cards: (919) 843-6571
- Animal Import and Export: (919) 843-5031 or (919) 966-0711
Where can I find additional information about animal facilities, animal ordering, billing, cage cards, per diem charges, or veterinary care advice?
Additional information regarding these topics can be found on the DCM Home Page.