Requesting changes to approved protocols
Stipulations from the committee
Transfers, Timelines and Reactivation
I'm requesting a change in protocol for a procedure that I've done previously on a prior protocol. Can I just reference that protocol in my request?
Each protocol must contain details of each procedure performed and references to other protocols are not accepted. P lease also note that regulations continue to evolve, so procedures approved in the past may require additional information before committee approval.
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How do I add a title to my existing IACUC protocol?
The IACUC can add additional titles if the study personnel, animal numbers and animal work remain identical to what has already been approved by the IACUC under an approved protocol and that the addition of this title does not involve any change to the protocol. Submit a letter (signed by the principal investigator) confirming the addition of titles meets this requirement.
If the protocol is receiving additional external funding for the additional title, please complete and submit Appendix O for each additional title.
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Do I need to complete appendices for alternatives to stress levels B or C, breeding, outside housing, surgery, blood draw, etc. when making a change in protocol request.
Yes. The necessary appendices are available on the IACUC web site and are required by IACUC.
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How can I make a change in the principal investigator for a study?
Send a letter of request to IACUC summarizing the change, explaining the reason for the change. It must contain original inked signatures from the former and future principal investigators.
Changes in study leadership may constitute significant changes in expertise therefore, the IACUC requires change in PIs to be reviewed at an IACUC meeting, so please check the submission deadlines as posted.
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Is there anything that can help my review when I request additional animals?
Complete the table found on the IACUC application entitled, "Animal Request Table" located in section 1.
This table details the species, pain class, source of animals, housing and location of procedures information that are often stipulated by IACUC. See Animal Request Table Explained: Purchasing, Breeding, & Transferring for help with this table.
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How should I prepare my response to stipulations set by IACUC?
Your response should be written on letterhead with an original inked signature from the principal investigator. Unless directed to do so, you do not need to submit a revised application form, but rather summarize the amendments in the letter and attach any necessary appendices.
Typically, a response to stipulation letter does not need to be reviewed by the entire committee. Individual members of IACUC review these letters to ensure rapid turnaround time.
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Is a response to "deferral" the same as "stipulations"?
You may follow the same format for re-review, but if you are submitting a response to deferral, your response requires review by the full committee at the next IACUC meeting. These submissions must meet the deadlines as posted on the web site.
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Why do I still have a stipulation for animal certification even after study staff have already completed IACUC's training?
The most common problem with verification of training is that names have been misspelled or the name was difficult to decipher on a continuing review form.
Sometimes study personnel have completed an RAR training session, ie. radiation training session, etc. and have that training confused with the IACUC training.
Occasionally a staff person is listed on an application who has a role on the project which will NOT involve animal use. In that case, submit correspondence detailing the role and the protocol can approved noting that person is not certified to work with animals.
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I have responded to the committee’s stipulations, but I have been waiting for approval for more than a week. What could be holding up my protocol?
The IACUC sends e-mail to the principal investigator(s) when IACUC has reviewed response to stipulation letters, but there may be outstanding stipulations remaining. There may be animal training certification requirements that need to be satisfied or there may be review processes outside the IACUC that are pending and delay the review.
Examples of outside reviewing include "Controlled Substances Review", "Environmental Health and Safety Review" and "Food Chain Review". To check on the status of these reviews, call the number listed on your stipulation letter to determine the nature of the delay.
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What if I have a disagreement with a committee
decisions?
Please review this link
and then call (612) 626-5654.
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How do I transfer animals to my protocol?
- Animals should be listed on the IACUC Animal Usage Form (in the Animal Request Table - Section 1) to be transferred once the protocol is approved. Animals can be transferred from:
- an existing approved protocol, or
- a breeding protocol.
- Once the protocol is approved, animals must be transferred through Research Animal Resources (RAR). The transfer cannot occur until the Protocol Transfer Request Form
 has been completed and submitted to RAR.
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How soon can I expect to hear results from the IACUC meeting?
The IACUC posts the results of the meeting within 24 hours of a meeting on the web site and then produces its correspondence from the meetings. The goal for completion of all meeting correspondence is 10 business days.
Correspondence pertaining to protocols that are "approved as submitted" are completed first and can be faxed upon request. All letters detailing reasons for deferral or stipulations are sent via e-mail to the principal investigator as soon as possible.
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I have submitted my continuing review form. When will I receive the notification of its renewal?
Continuing review forms are reviewed by IACUC at a meeting preceding the expiration date of previous IACUC approval. Prompt response to deadlines listed on the form is essential to ensure adequate time to resolve questions before protocol expiration.
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My protocol was inactivated by the IACUC expiration, can I reactivate it?
Failure to respond to deferral, to stipulations or continuing review by the stated deadline can result in inactivation of the request. Extensions prior to deadlines can be granted by the IACUC.
Reactivation requires an explanation for failure to meet the deadline and documentation of fulfillment of the outstanding requirement.
Please note that files inactivated are eventually filed off-site and requests to reactivate files with a delinquent response may be subject to a $50 off-site retrieval fee.
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