What Investigators Need to Know About the Use of Animals (updated April 2016)
This (pdf) publication provides an overview of investigator responsibilities when
conducting research with animals. You will learn about the PHS Policy requirements,
what you need to describe in your grant application and your IACUC animal study protocol,
and guidance for conducting your research to avoid noncompliance.
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What are USDA Pain Categories?
Pain categories are derived from column headings on the USDA Annual Report:
- Column C (animals used in research; no pain involved; no pain drugs administered)
- Column D (animals used in research; pain involved; pain drugs administered)
- Column E (animals used in research; pain involved; no pain drugs administered)
I have a new Grant. Do I need a new Animal Use Protocol?
NO! In most cases additional groups of animals, with their own defined use, can be
added to your existing protocol via amendment. Don't forget to add new Funding Sources
and Fund Project Titles to the protocol to match new grant awards.
How do I see my currently approved protocols in eSirius.
The Mailbox on the left side of the screen controls what is displayed in the Protocol
listings on the right side of the screen. To see approved protocols, click on "Protocols - CREATE, AMEND, VIEW" in the Mailbox to see your currently approved protocol(s) on the right. If you have
multiple roles in eSirius 3G, you may need to adjust the role at the top right of
the screen to (PI) Research Staff Member before making any changes to a protocol.
How do I know who is listed on my protocol(s)?
- Login to eSirius.
- In the Mailbox on the left, click the arrow next to Protocol Management to open the fly-out menu.
- Select Report "Contact Listing by Protocol ".
- Choose a Filter "Protocol Status" "Equals" "Approved"
- Choose a Filter "Current Protocol" and check the box.
- Click "Run Report" to display results or "Export" to save and download a CSV file
that can be opened with Excel.
The report will show all of your personnel by the protocol(s) they are listed on.
What paperwork do I need to submit to obtain approval to use research animals? Where
do I submit it?
The Institutional Animal Care and Use committee (IACUC) reviews all Animal Use Protocols
(AUPs) before research may begin. The AUP form must first be submitted to the IACUC
via eSirius.
How do I submit an amendment to an existing protocol?
- Login to eSirius.
- In the Mailbox on the left, click "Protocols - CREATE, AMEND, VIEW" to display your approved protocols on the right.
- Select the protocol you wish to amend by clicking on its title (the row will turn
yellow).
- Click the "Start Amendment" button above the protocol list.
- Enter a simple short reason for the change, e.g., Add personnel, Add procedure, Add
drug.
- Choose and amend all protocol sections that apply (for example, when adding a drug,
you need to edit the drug page as well as the experimental design, surgery, or euthanasia
section where it will be used.)
- The PI must submit the amendment to the IACUC. Amendments will be listed under "Amendments – Unfinished" until submitted.
- From the Table of Contents, choose the "[S U B M I T]" page.
- Enter your (the PI) password.
- Click the "Submit Document" button. Do NOT press Enter, as that will clear your password and abort the submission.
- In the Mailbox on the left, click "Amendments - unfinished" and verify that nothing is listed in the "Draft Amendments" section on the right. Amendments listed there have not yet been submitted.
What is our Office of Laboratory Animal Welfare (OLAW) assurance number?
See the IACUC Home page.
What was our most recent Association for Assessment and Accreditation of Laboratory Animal Care International
(AAALAC) accreditation date?
See the IACUC Home page.
How do I add a title or funding agency to an already approved AUP?
- Login to eSirius.
- In the Mailbox on the left, click "Protocols - CREATE, AMEND, VIEW" to display your
approved protocols on the right.
- Select the protocol you wish to amend by clicking on its title (the row will turn
yellow).
- Click the "Start Amendment" button above the protocol list.
- Enter "Add Fund Project Title" as the reason for the change.
- From the Table of Contents, choose the "Funding Sources and Titles" page.
- Add the new Title:
- To add a Title for an existing Fund Source:
- Select an existing Fund Source by clicking on its name (the row will turn yellow).
- Click the "Edit Agency Fund" button above the Protocol Funding List.
- Add the exact new title to the "Fund Project Title" field. End each title with a
period and [Enter]. Delete any titles not currently funded.
- Add names to "PI on Grant (if different than PI on Protocol)" as needed. Separate
multiple names with a semicolon.
- Save the entry.
- To add a Title for a new Fund Source:
- Click the "Add Agency Fund: button above the Protocol Funding List.
- Select Fund Type.
- Enter Fund Name, e.g., National Cancer Institute; National Heart, Lung, and Blood
Institute; Department of Defense; Intramural Grants Program.
- Enter the exact new title to the "Fund Project Title" field.
- Add names to the "PI on Grant (if different than PI on Protocol)" as needed. Separate
multiple names with a semicolon.
- The PI must submit the amendment to the IACUC. Amendments will be listed under "Amendments
– Unfinished" until submitted.
- From the Table of Contents, choose the "[S U B M I T]" page.
- Enter your (the PI) password.
- Click the "Submit Document" button. Do NOT press Enter, as that will clear your password and abort the submission.
- In the Mailbox on the left, click "Amendments - unfinished" and verify that nothing
is listed in the "Draft Amendments" section on the right. Amendments listed there
have not yet been submitted.
How do I access animal and/ or occupational health and safety training online?
Follow the steps outlined on the appropriate page under "Access & Clearance" on the
IACUC page navigation menu.
How do I report an animal care concern or complaint?
See the Animal Welfare Incident Reporting page.
How long is an AUP approval valid?
An AUP is approved for three years, but must be reviewed by the IACUC on an annual
basis to keep it active.
How often does the IACUC meet?
The IACUC meets on the 4th Thursday of most months. Meeting dates and submission deadlines
can be found on the Submission Deadlines & Full Committee Meeting Dates page.
How do I access the animal facility?
Follow the steps outlined on the appropriate page under "Access & Clearance" on the
IACUC page navigation menu.
How do I get animals shipped to Augusta University from an outside institution?
If originating from an approved vendor i.e. Harlan, Charles River or Jackson Labs,
contact Laboratory Animal Services at (706) 721-3421.
Where will my animals be housed?
Laboratory Animal Services assigns space after consultation with the investigator
to determine specific animal needs such as nonstandard husbandry, special diet, bedding,
or caging. Direct any questions to (706) 721-3421.
How do I find out about animal costs, including billing and per diem charges?
See Per Diem Rates on the Division of Laboratory Animal Services Animal Facility Per Diem and Service
Rates page.
Why can't we just submit a word document for each animal use protocol?
Some drawbacks to a flat protocol form:
- As years have passed, the number of research protocols has continually increased and
regulatory bodies have increased reporting requirements for animal research, contributing
to the need to store the animal use protocol in a database that is easily managed,
searched and reported from. Over the same period, AU’s IACUC office staff has remained
much the same (peaking at 2 people).
- A flat protocol form cannot limit input to the most recently updated accepted values
(personnel, procedures, surgeries, drugs, euthanasia, etc.) Pick lists in the database
greatly increase accuracy and consistency of the data in the animal use protocol.
- A flat protocol cannot maintain a real-time interface with veterinary, data, husbandry
data, occupational health data, individual training data, and billing for LAS resources.
All of those functions are part of a larger system based on information from the animal
use protocol database.
- Flat protocol forms are not easily verified, stored, nor backed up; the protocol database
is secured by user login (making the content and all changes verifiable), stored on
secure network servers, and regularly backed up.
- A flat protocol form does not allow the IACUC to easily define, correct, and update
a single authorized version of the animal use protocol. Even with limited staff, our
office is constantly updating the animal use protocol to satisfy regulatory requirements
in the simplest, most straightforward way possible for investigators and other staff.
- Unlike a database, a flat protocol form is not able to securely track changes, using
role based security to determine who can finalize the changes.
- A flat protocol form cannot be routed for review to multiple persons at once and automatically
combine all of their comments into a single record.
- A flat protocol form is not easily, nor quickly shared or routed. The official version
of your animal use protocol is often accessed by an IACUC Member, IACUC Office Staff,
LAS Veterinarians, LAS Animal Facility Supervisors, LAS Census Personnel, Environmental
Health and Safety Staff, and LAS Business Office Staff on the SAME day, often at the same time.
- Keeping up with past and current versions of a flat protocol form and all of its amendments
is cumbersome, time consuming, insecure and inefficient.
- Easily identifying, reading, and understanding reviewer comments can also be difficult
with a flat protocol form.
- Lastly, a flat protocol form encourages copying and pasting large amounts of text
directly from a grant application, that often fails to provide the actual (usually
much simpler) information required on an animal use protocol. Remember, a grant application
is destined solely for per review, while an animal care and use protocol should be
written in language understandable by the lay public as well.
