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Animal Protocol Fact Sheets

• What is an animal protocol?
• In Advance of Protocol Submission
  • In Advance of Protocol Submission
  • Animal Housing
  • Required Personnel Certifications
  • Office of Biological Safety (OBS) / Occupational Health & Safety (OHS) Issues
  • Deadlines for Protocol Submission
  • Training Opportunities
• About ACUCs
  • About ACUCs
  • Definition
  • Structure of UW Campus ACUCs
  • Function of ACUCs
  • The Review Process
• How to Apply for a Protocol
  • How to Apply for a Protocol
  • Filling Out the Form
  • Submitting the Form
  • Getting Help
  • Deadlines for Submission (according to school or college)
• How to Change an Existing Protocol (Amendment)
  • How to Change an Existing Protocol (Amendment)
  • General Introduction
  • Scientific Changes
  • Administrative Changes
• Protocol Maintenance
  • Protocol Maintenance
  • Annual Protocol Update Requirement
  • Renewals
  • Termination
  • Annual Report on Number of Animals Used
• Protocol Violations and How to Avoid Them
  • Protocol Violations and How to Avoid Them
  • Examples of Protocol Violations
  • When a Violation Occurs
• How Animal Protocols Relate to Grants
  • How Animal Protocols Relate to Grants
  • Matters of Fact
  • When to Add or Remove a Grant from a Protocol
  • How to Add or Remove a Grant from a Protocol
  • When to Amend a Protocol in Response to a Grant Change

Animal Care And Use Protocol Fact Sheets

What is an Animal Protocol?

The animal protocol is a concise description of an animal research project.  Importantly, it is also contractual agreement.  This contractual agreement is between the Principal Investigator and the Animal Care and Use Committee, an agent of the University of Wisconsin-Madison that ensures that animals receive the highest standard of care within both the contexts of experiments and daily care.  Use of animals in research is a privilege, not a right.  Abuse of this privilege and violations of the contractual nature of the protocol will be investigated.  The Animal Care and Use Committees have the right and obligation to impose disciplinary action when appropriate.
Go To Protocol Forms

In Advance of Protocol Submission

Animal Housing

There are a number of university facilities located both on and off campus where animals can be housed.  If you need assistance identifying the most appropriate housing facility for the animals you plan to use, contact the laboratory animal veterinarian for your school or college or the staff at RARC. Contacts

Required Personnel Certifications

1. Animal User Training:  All persons (including the Investigator, animal care staff, research staff, and visiting guests) who handle live research animals under an approved animal protocol must have successfully completed the free RARC “Animal User Orientation Certification” course.  This is the minimum requirement.  Other strongly recommended training is listed below under Training Opportunities.
   The required “Animal User Orientation Certification” course is available on-line 24 hours per day, 7 days per week.  To access the on-line course, click on "On-Line Animal User Orientation Certification" and follow the directions.  Register for Orientation
2. Occupational Health Training:  This is mandatory for all personnel who have animal contact.  Occupational Health training is offered in a classroom setting at various locations throughout campus every other week.  Personnel should attend this training either before they begin animal contact, or during the first month after beginning contact.  Additional certifications may be needed to use biohazardous materials.  A link to the Occupational Health And Safety Registration can be accessed at the RARC website here.  You will need to log in with your NetID and Password.

Office of Biological Safety (OBS) / Occupational Health & Safety (OHS) Issues

Many animal studies involve the use of biohazardous, radioactive, and/or chemical materials.  Separate protocol applications are required to obtain permission to use these materials, and additional training may also be required. Visit their website for information on biological safety, general safety, occupational safety, chemical and environmental safety, lake safety and radiation safety, including instructions and forms for submitting safety protocol applications.  Note: this link will take you out of RARC’s website.

Deadlines for Protocol Submission

The submission deadlines for animal protocols are based on each school's or college's Animal Care and Use Committee meeting schedule. Click here for the deadlines.

Training Opportunities

There are many training opportunities for both new and experienced animal users at UW-Madison.  Most of these training opportunities are offered through RARC, and the Safety Department offers additional training.  Individual animal care units and facilities may offer occasional training opportunities.  To get started, view the courses offered by RARC.  You can contact one of the RARC trainers by email or by calling 265-2694.  They can arrange one-on-one or small group training sessions with your lab.  They can also connect you with other animal users on campus who may help meet your training needs.

Check out the following websites for other training information (these links will take you out of RARC’s website):

Occupational Health Program

Office of Biological Safety (OBS)

Radiation Safety for Radiation Workers & Working Safely with Chemicals

About ACUCs

Definition

The acronym “ACUC” stands for Animal Care and Use Committee.  In animal welfare regulations the acronym “IACUC” – Institutional Animal Care and Use Committee – is used.

Structure of UW Campus ACUCs

There are six ACUCs on campus.  These include one for each of the five schools and colleges where animals are used, and the institutional, or All-Campus, ACUC.  The All-Campus ACUC is comprised of the chairs of the five school/college committees.

Function of ACUCs

The federal Animal Welfare Act and Public Health Service Policy on Humane Care and Use of Laboratory Animals mandate the existence, composition, and responsibilities of the ACUCs at research institutions.  In short, the ACUCs are the oversight bodies for all aspects of proposed and ongoing research, teaching, and outreach activities in which live vertebrate animals are used.  The ACUCs conduct inspections of facilities, review veterinary care standards, formally evaluate the program of animal care and use semiannually, and assess proposed animal use at UW-Madison facilities.  This is facilitated by the animal care and use protocol, which is initially completed by an Investigator as an application and submitted to the ACUCs for review.  The Research Animal Resources Center (RARC) provides administrative support to the ACUCs all of these processes.

The Review Process

The review and approval process of an animal care and use protocol application (“protocol”) follows the general pattern below:

1. Protocol application is prepared by the Investigator and submitted to RARC.
2. RARC assigns the protocol to the appropriate ACUC(s) for review based on where the animals are housed.
3. The ACUC reviews the protocol.  The committee can approve the protocol outright, approve it pending with review questions to be addressed, or defer it to a future meeting after substantial revision is made by the Investigator.
4. RARC staff communicates the ACUC’s decision to the Investigator, along with instructions on how to respond (if a response is needed) or with verification of approval.
5. Once the protocol is approved, work with animals may begin.
6. Investigators must amend the protocol prior to changing any procedures, drugs, or other aspect of the work being performed.  Amendments are submitted via RARC to the ACUC for review as described above.

In addition, there is a required annual review.  Once every year RARC provides a  response form to Investigators that must be completed and returned in order to maintain the active status of their protocol.

Every 3-years protocols must be renewed by the Investigator.  See the “Protocol Maintenance” section for more information about these processes.

Go to Protocol Forms

How to Apply for a Protocol

Filling Out the Form

1. Go to our website: http://www.rarc.wisc.edu/
2. Select Protocol/Other Forms
3. Select Protocol form (under Protocol Forms) in the format you choose
4. Complete all appropriate sections

Go to Protocol Forms

Submitting the Form

Please email your protocol to one of the addresses below and send a signed protocol signature page via campus mail or FAX to 265-9040.

E-mail addresses:

L&S & Med School protocols to Debbie  Questions?  Call Deb at 262-7109.

CALS, SVM, & Grad School protocols to Helen Questions? Call Helen at 265-2696.

Getting Help

1. Ask the RARC staff: Contacts
2. See also the Protocol Guide

Deadlines for Submission (according to school or college)

College of Agricultural and Life Sciences (CALS): 4:00 pm on the 1st of the month

Graduate School:  no deadline, rolling

College of Letters and Science (L&S): no deadline, rolling

Medical School: 4:00 pm on the 15th of the month

School of Veterinary Medicine (SVM): no deadline, rolling

How to Change an Existing Protocol (Amendment)

General Introduction

There are two types of changes, or amendments, to protocols: scientific changes and administrative changes.  The two types, and the procedure to follow for each, are described below.

Scientific Changes

During the 3-year life of an approved animal care and use protocol, situations may arise that requirement an amendment to the original protocol.  Examples include changing or adding experimental procedures, changing drugs or dosages, increasing the number of animals, adding a new species of animal, etc. If the change follows the same science that has been presented and justified in the original protocol, the amendment procedure is as follows:

1. Retrieve the original protocol, and leave all existing information intact.
2. Add new information under the appropriate questions.  Distinguish this new text by using bold print, italics and/or underlining (no color, please).  Include any necessary or requested justifications.
3. Indicate in question 3 that this is an amendment.

Submitting Scientific Changes:

Please email your protocol to one of the addresses below and send a signed protocol signature page via campus mail or FAX to 265-9040.

E-mail addresses:

• L&S & Med School protocols to Debbie  Questions?  Call Deb at 262-7109.
• CALS, SVM, & Grad School protocols to Helen.  Questions? Call Helen at 265-2696.

Getting Help:

1. Ask the RARC staff: Contacts
2. See also the Protocol Guide

Click here for the submission deadlines.

Administrative Changes

Some changes are administrative in nature.  These only involve personnel or funding sources.  In such cases it is only necessary to fill out an administrative amendment form.  Or, send an email to Debbie or Helen indicating the personnel and/or funding change.  Be sure to include the protocol number.

1. Personnel:  Indicate the number of years of experience each individual has working with the species listed on the protocol.  If the individual has less than one year of experience, indicate who will provide training and supervision.  If the individual will be performing surgery, describe the individual’s surgical experience with the species they will perform surgery on.
2. Funding:  Ensure that the science described in the protocol and the science described in the funding or grant application are the same.  This is the Investigator’s responsibility.

Please note that the administrative amendment form or memo should only be used for personnel or funding source changes.  All other changes require showing the change on the actual protocol as described above under Scientific Changes.  As always, if you have questions, please contact RARC. Note: A change in the Principal Investigator is NOT considered an administrative change, and must be submitted as a full amendment and reviewed by the Animal Care and Use Committee.

Protocol Maintenance

By law, approved animal protocols must be maintained in a current active status by the Investigator. RARC assists in protocol maintenance by alerting Investigators of upcoming annual reviews and 3-year full renewals. Below is a brief description of each requirement and examples of the reminders to Investigators that RARC administers to help ensure regulatory compliance.

Annual Protocol Update Requirement

Each year from the date of ACUC approval, Investigators are required to submit an Annual Continuing Review Form provided by RARC in order to keep the protocol active. Failure to complete and return the form can result in the ACUC suspending the protocol for noncompliance. Click here to view a sample form.

1. FIRST REMINDER: The first annual update letter, including a reply by date, is sent via campus mail to the Investigator 90 – 120 days prior to the annual update date of the protocol. The Annual Continuing Review Form is attached to this letter.  A reply by date to return the form appears at the end of the letter.  Click here to view a sample of the first letter.
2. SECOND REMINDER: The second annual update letter is sent via campus mail to the Investigator 60 – 90 days prior to the annual update date of the protocol if no response to first letter is received by RARC by the reply by date. A reply by date for response is included in the second letter.  The Investigator’s department chairperson is copied on this second letter. A duplicate Annual Continuing Review Form is attached to the second letter. Click here to view a sample of the second letter.
3. FINAL RARC ACTION: If no response is received by RARC by the reply by date in the second letter, the noncompliance is reported to the ACUC for further action.

Renewals

Protocols are approved for 3-years (or shorter periods) by the ACUCs.  By law, no extension past the 3-year duration of the protocol may be granted by the ACUCs.

1. FIRST REMINDER: As the expiration date of a protocol approaches, RARC sends a reminder letter to the Investigator that a resubmission is required. A Renewal Return Form, which must be completed and returned to RARC, is attached to the reminder letter. Click here to view the Renewal Return Form. The first reminder letter, including a reply by date, is sent via campus mail to the Investigator 90 – 120 days prior to the renewal (expiration) date of the protocol. Click here to view a sample of the first letter.
2. SECOND REMINDER: The second renewal letter is sent via campus mail to the Investigator 60 – 90 days prior to the renewal (expiration) date of the protocol if no response to the first letter is received by RARC by the reply by date. The Investigator’s department chairperson is copied on this second letter. A duplicate Renewal Return Form is attached to the second letter. Click here to view a sample of the second letter.
3. FINAL NOTICE: A third and final renewal notice is sent to the Investigator via email if no response has been received by RARC to the first two letters.  This email states the expiration date of the protocol.  By law, no extensions beyond this date can be granted.  Click here to view a sample of the final notice email.

Termination

Investigators may terminate their protocol at any time if work with live vertebrate animals has ended and they have no more animals.  The protocol is terminated by emailing RARC with that request. Protocols will terminate upon their renewal (expiration) date if no renewal application has been received by RARC. In either case, a notice of protocol termination is sent via email to the Investigator, department chairperson, attending veterinarian of the relevant ACUC, and the manager of the animal facility listed on the protocol. Click here to view a sample of this notice.

Annual Report on Number of Animals Used

UW-Madison is required by law as a USDA-registered research institution to submit an annual report of animal usage. Only certain species and types of usage must be included in the annual report. RARC coordinates collection of data to prepare the report. Those Investigators whose animal use fits the criteria for the annual USDA report are contacted by RARC with instructions and a worksheet that must be completed and returned to RARC.

Protocol Violations and How to Avoid Them

• Remember, the protocol is a contractual agreement between the Investigator and the Animal Care and Use Committee
  • If you deviate in any way from what is described in the protocol (experimental procedures, monitoring of animal health, etc.), you have violated your protocol.
  • Performing animal research without an approved protocol is a violation of campus policy and Federal law.
  • There are serious consequences for you, your department, your school or college, and the University overall. You could lose your funding, the University could even lose its USDA registration, which would render ALL UW-Madison Investigators unable to work with animals in any capacity.
  • See Statement on Protocol Violations

Examples of Protocol Violations

• Repairing a headcap (or doing any repair surgery) without describing the repair procedures in the approved protocol.
• Replacing mini-pumps or cannulas without describing these procedures in the protocol.
• Conducting a pilot study without approval on the protocol.
• Altering an animal’s diet for experimental purposes if not approved in the protocol.
• Administering test or analgesic drugs/compounds to animals other than those described in the protocol.
• Using a method of euthanasia other than that described in the protocol.
  • See Statement on Protocol Violations for more examples

When a Violation Occurs

1. The Committee investigates the alleged violation.
2. If the Committee determines a violation has occurred, a letter is sent to the Investigator regarding the violation; a written response is required. The response is reviewed, and will be discussed with the All Campus Animal Care and Use Committee.
3. If the Investigator’s response is deemed inadequate, the Committee may require extra training for research staff, changes to procedures, or even suspend the protocol or revoke animal user privileges.
4. If the protocol is suspended, the Investigator is informed of the suspension and is barred from ordering animals or performing experiments.
5. USDA, NIH, granting agencies, accrediting organizations and the Investigator’s department chair can be informed of all protocol violations and suspensions.  In many situations this notification is a regulatory or policy obligation.

See also All Campus ACUC Policy 1999-008 on Noncompliance.

How Animal Protocols Relate to Grants

Question 13 on the University of Wisconsin-Madison Animal Care and Use Protocol Review Form reads, “Indicate any current or pending funding for this project.”

The purpose of associating grants with animal protocols is to assure funding agencies that all funded experimental procedures involving animals comply with the Animal Welfare Act.  A letter stating that the ACUC has approved an animal use protocol satisfies this compliance assurance.

Matters of Fact

1. It is the position of the University and the ACUCs that it is the Investigator’s responsibility to match the grant with the protocol, that is, that the science and animal procedures described in a grant are covered by an approved animal use protocol.
2. It is the Investigator’s responsibility to inform RARC of grants associated with the animal protocol and of changes in grants.
3. RARC issues an “approval letter,” signed by the chair of the ACUC, for each grant on an animal protocol.  Click here to view a sample letter. The letter is valid until the protocol expires (3-years after approval).
4. There is no limit to the number of grants that can be listed on a protocol.
5. The begin/end dates of protocols are independent of the begin/end dates of grants.
6. A grant can be added to a protocol before the funding is approved.

When to Add or Remove a Grant from a Protocol

1. There are no restrictions
2. A letter for a new grant that is being added as part of an amendment cannot be released until the amendment is approved.

How to Add or Remove a Grant from a Protocol

1. Include all applicable grants on new and renewal protocol applications.
2. Grants can be added/updated/removed when a protocol is amended.
3. The Annual Continuing Review Form has space for updating grants. Click here to review a sample form.
4. Grants can be added/changed/removed at any time by simply sending a request in writing to RARC. Click here for information on how to amend an existing protocol.

When to Amend a Protocol in Response to a Grant Change

1. When the experimental procedures to be performed on live vertebrate animals change as a result of a new or modified grant.
2. When the number of overall animals needed for a study changes.
3. Click here for information on how to amend an existing protocol.