If your proposed studies consist of simple non-invasive observation of wild animals in their natural habitat, or of zoo animals, an animal care and use protocol is not required.
Submit new and renewal protocols in ARROW according to the following schedule.
CALS and LSVC
CALS: CALS: 4:00 p.m., 1st of the month. Submit for RARC veterinarian pre-review by the 15th of the preceding month. NOTE: Veterinary pre-review must be completed BEFORE submission for the 1st of the month deadline.
LSVC: No deadline, rolling reviews. Questions? Contact Diane: 608-265-3989, firstname.lastname@example.org
SVM: No deadline, rolling reviews. Questions? Contact Debbie: 608-890-4563, email@example.com
Deadlines: 4:00 p.m., 15th of the month. Submit to an RARC veterinarian for prereview by the 10th of the month.* Questions? Contact Debbie: 608-262-7109, firstname.lastname@example.org
There are two types of changes (amendments) to protocols: significant changes and administrative changes.
During the 3-year life of an approved animal care and use protocol, situations may arise that require 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, adding personnel*, etc. If the change follows the same science that has been presented and justified in the original protocol, the amendment procedure is as follows:
To submit an amendment for protocols not in ARROW, complete the following steps:
Retrieve the original protocol and leave all existing information intact.
Add new information under the appropriate questions. Distinguish this new text by using bold and underlined print. The text may also be highlighted with color.
Indicate in question 3 that this is an amendment.
Include with the email, or in a separate letter, a brief explanation of what the changes are and where the changes are located in the protocol (refer to specific question numbers in the protocol).
Email the protocol with significant changes to one of the following protocol staff. Then send a signed protocol signature page via campus mail or FAX to 265-9040.
Please note: No new information can be added to a protocol currently in the review process unless directed by the IACUC or unless the version in review is withdrawn. The only new information that will be accepted is information provided in response to any IACUC review questions.
To submit an amendment for ARROW protocols, complete the following steps:
Locate the protocol you wish to amend under the Active tab.
Click on the “Create an amendment” activity button.
Complete the summary page (two questions) and click “Finish.”
Click on “My Home” and locate the protocol (number with extension Axx) in your inbox.
Click on the title of the protocol to go to the amendment workspace and using the “edit” activity button, make the appropriate changes in the protocol.
When done, exit the protocol and submit for review.
Send funding changes via email to the appropriate protocol manager. As of July 1, 2013, all grants that are funded by the Public Health Service (PHS, NIH, etc.) will be required to undergo a congruence review by RARC staff to verify that the science described in the protocol and in the grant are the same.
*Personnel changes should be made within the actual protocol (Q15, Q24), bolded and underlined, and sent to the appropriate protocol manager.
*For both funding and personnel changes, use the non-review change activity in the protocol workspace, complete the changes and submit the non-review change.
By law, investigators must maintain approved animal protocols in a current active status. RARC assists in protocol maintenance by alerting investigators of upcoming annual reviews and 3-year full renewals.
NOTE: Approval of amendments does not change the protocol approval date
Annual protocol update requirement on paper
Prior to the first and second anniversaries of protocol approval, investigators will receive and are required to return a brief Annual Continuing Review Form in order to keep the protocol active. The IACUC can suspend a protocol if the investigator fails to complete and return the form. View a sample form.
First Reminder: The first annual update letter is sent via ARROW to the investigator 90–120 days prior to the update date. A reply-by date* is at the end of the letter.
Second Reminder: If RARC does not receive a response to the first letter by the reply-by date, a second annual update letter is sent to the investigator 60–90 days prior to the annual update date. The investigator’s department chairperson is copied on this second letter.
Final Action: RARC reports noncompliance to the IACUC if a response is not received by the second reply-by date.
*NOTE: Reply-by dates are not the same as the update requirement deadline, which is the approval anniversary date.
Annual protocol update requirement and renewals -- ARROW protocols
The ARROW system will notify PIs and protocol writers by email when annual updates and renewals are due, following the same schedule noted above.
IACUCs approve protocols for three years or less. By law, IACUCs cannot grant protocol extensions past three years.
First Reminder: The first reminder is sent to the investigator 90–120 days prior to the protocol's expiration date.
Second Reminder: RARC sends a second reminder to the investigator 60–90 days prior to the expiration date of the protocol if the investigator does not respond to the first reminder by the reply-by date. The investigator’s department chairperson is copied on this second letter.
Final Notice: A third and final renewal notice is sent to the investigator 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.
Investigators may request termination of a protocol before or on its expiration date if work with live vertebrate animals under the protocol has ended or will end and no animals are/will be assigned to the protocol. To terminate a paper protocol, the PI should email the request with an end date to the RARC IACUC office. To terminate an ARROW protocol, log into ARROW, navigate to the protocol workspace and click on the "terminate" activity button.
If the protocol is not terminated before the expiration date, and if no renewal application has been received by RARC, a protocol will end on its expiration date.
Whether a protocol ends early or on its expiration date, RARC sends a notice of its termination to the investigator, department chairperson, attending veterinarian of the relevant IACUC, and the manager of the animal facilities listed on the protocol.
PHS Policy and the NIH Grants Policy Statement ((Part II, Terms and Conditions, 184.108.40.206)) requires institutions to ensure that each NIH and NSF-funded grant that contains research with live vertebrate animals is congruent with one or more ACUC-approved animal use protocols. A congruence assessment is therefore required before Research and Sponsored Programs (RSP) at UW will release money to the investigator.
This process applies only to grants funded by NSF, and any of the agencies within the Public Health Service (primarily NIH, CDC, and FDA).
Grants can be associated with more than one protocol (same or different PI) and protocols can have many grants listed. Grant-protocol congruence will be assessed at the time of award, and upon award of competitive renewal.
What we look for in a grant-protocol congruence review:
The protocol should contain the animal species listed in the grant, and have at least the number of animals as described in the grant, although it can have more
The protocol should contain a description of each procedure performed on live vertebrate animals that is listed in the grant
The protocol should contain every agent, drug, or class of drugs used on live vertebrate animals described in the grant
For example, the drug class “small molecule inhibitors” may be described instead of listing each drug.
What PIs and/or research administrators should do:
If you receive a fundable score on your grant application, now is the time to make sure that all the procedures and agents that will be administered to live animals are listed in your protocol. If they are not, submit amendment(s) to the ACUC.
When you get notice from a grants management officer at NIH (not the automated message) that your project will likely be funded, download the congruence request form. Send the completed form, along with a copy of the grant (or the Vertebrate Animal Section and Research Plan/Strategy sections) to email@example.com.
Please ensure attachments are not larger than 5MB
Add your grant to your protocol. (See instructions below.) This can be done as an administrative amendment at any time. This will make the process quicker on our end if the grant is already listed on a protocol.
Please do not:
Send us a grant-protocol congruence request immediately after you submit your grant. We will likely not conduct the congruence review until the grant is funded.
Wait until the last minute and send a request that must be reviewed in less than 48 hours. In general, we will need at least five to seven business days for a grant-protocol congruence request to be processed. This time will be increased if a protocol amendment is necessary to make the protocol congruent with the grant. Please plan ahead!
When congruence has been verified, RARC will label the grant as “congruent” in our database. This database updates nightly to the PLuS look-up tool, by which RSP and grants administrators can verify the congruence status. We are no longer routinely issuing congruence letters. However, letters are readily available upon request.
How and when to amend a protocol in response to a grant change
Grants can be added/changed/removed at any time:
After you log into ARROW, select the applicable protocol
In the left column under “My Activities” select the Non-Reviewed Changes button
In the pop-up window, click on the Funding tab at the top
In #1 “RSP-Managed Funding” click “select”, then search (Filter) by MSN number, the title of the grant, or PI last name. Then select the correct grant from the drop-down menu. Please choose the grant that lists the full funding period, such as the 5-year listing for an R01
Click “Submit Changes” at the bottom of the form
Include all applicable grants on new and renewal protocol applications.
Grants can be added/updated/removed when a protocol is amended.
When there are changes in the experimental procedures on live vertebrate animals, or changes in the total number of animals proposed for use as a result of a new or modified grant, the protocol must be amended.
A letter for a new grant that is being added as part of an amendment cannot be released until the amendment is approved.
Tips on writing the vertebrate animal section (VAS)
The first section of the grant that RARC personnel read when performing a grant-protocol congruence check is the VAS. It will help facilitate the process if all the procedures and agents to be used on animals are clearly outlined in this section. Identify the species, strains, ages, sex and numbers of animals, and concisely describe the proposed procedures the animals will undergo. Include all experimental and control groups. A brief timeline of the experimental procedures for each group, as well as the total number of animals to be used, is helpful.
The following information can be used in your VAS when describing the veterinary care at UW-Madison:
UW-Madison employs 14 veterinarians with experience and training in research animal care. The veterinarians and veterinary technicians provide care during regular business hours, after business hours via a 24-hour on-call service, and on weekends and holidays. All veterinary staff have workplace cell phones and email access. Additional veterinary support is contracted with area clinics primarily to serve outlying agricultural facilities. Veterinary staff are actively involved in preventative medicine, disease surveillance programs, clinical care, participation in animal surgery programs, training staff, and consulting with investigators.
All animal use protocols are reviewed and approved by one of the UW-Madison Animal Care and Use Committees, which oversee the research animal program according to PHS Policy, the Guide for the Care and Use of Laboratory Animals, and the Animal Welfare Act and Regulations. The animal programs for the School of Medicine and Public Health, the School of Veterinary Medicine, the Vice Chancellor and Graduate Research Education Centers, and the College of Agricultural and Life Sciences are all accredited by AAALAC International.\