University of Illinois at Urbana-Champaign
DIVISION OF ANIMAL RESOURCES and
AGRICULTURAL ANIMAL CARE AND USE PROGRAM

Protocol Preparation, Submission and the Review/Approval Process

No research, teaching or testing using vertebrate animals in projects affiliated with the University of Illinois may begin without an approved animal use protocol. To prepare and submit a protocol, follow these steps:

* Download the IACUC-1 form from the IACUC website (http://www.iacuc.uiuc.edu/forms.html).

* Answer all questions completely.

* Answers must be typed and included in the body of the protocol form.

* Documents attached or references cited in lieu of answers to specific questions will not be accepted.

* "N/A" should be inserted for items that do not apply to a given protocol.

* Submit the completed form electronically to the IACUC (iacuc@iacuc.uiuc.edu).

* IACUC Specialists and DAR or AACUP veterinarians can assist research personnel who have questions during preparation of a protocol.

Protocol Review and Approval:

* The protocol review and approval process includes an initial "pre-review" by a IACUC an IACUC specialist to insure that the protocol is complete and properly filled out, and is usually completed the same day as the protocol is submitted. If the specialist finds that changes will improve the protocol, she will communicate these to the PI via e-mail. Some changes, such as resubmitting on a current protocol form, may be required, while others may be suggestions aimed at precluding questions from the reviewers. No further action is taken until the PI responds to the suggestions with a revised protocol or gives notice that he or she does not wish to make the changes. Once finalized, the protocol is sent to an IACUC member and a DAR (laboratory animals) or AACUP (agricultural animals) veterinarian for review.

* Reviewers' questions regarding the project are compiled and sent to the PI via e-mail.

* PI's are asked to respond within two weeks. Responses must include the questions and responses in the body of an e-mail, as well as being incorporated into the protocol, and the revised protocol must be attached.

* Failure to respond in a timely manner may result in termination of the review process. Delays by the PI in responding to questions are the biggest impediment in getting a protocol approved in a timely manner.

* Protocols including certain critical procedures, even if scientifically justified, such as unrelieved pain, prolonged restraint, multiple major survival surgeries, or death as an endpoint, are automatically held for full committee review at a convened monthly meeting. Also, any protocol that raises concerns about its use of animals, or doubts about the PIs ability to complete the work, will be held for full committee review. A very small percentage of submitted protocols will require discussion by the full committee.

* Following discussion at the convened meeting, a protocol may then receive approval, or the IACUC may require additional information from the PI before approval can be granted.

* Each week, IACUC members receive summaries of those protocols which do not have pending reviewer questions and do not have critical issues that require full committee discussion.

* IACUC members have 72 hours to ask additional questions, or call for full committee review of a protocol at a convened monthly meeting.

* Protocols for which the IACUC members have not requested additional information or review at a convened meeting are examined by a designated reviewer, usually the IACUC Chair. He will grant the final approval if all issues have been resolved and requirements met. At this point, a signature page is sent to the PI to sign.

* The signature page is a contract. By signing it, the PI pledges to adhere to all aspects of the protocol as approved, keep all project participants fully informed of all procedures and any procedural changes, and inform the IACUC, via submission of an amendment request, before any changes in procedure, personnel, etc. are implemented.

* Once the signature page is returned, an official approval letter is sent via e-mail, and work may begin, providing any stipulations are met. Stipulations may include such things as completion or documentation of training, observation of a specific procedure by a subcommittee or veterinarian, review and approval by an appropriate section of the Division of Research Safety, or other specific protocol modifications.

* Principal Investigators who submit protocols for which approval is denied have the option of appealing the decision to the IACUC. A request to address the IACUC can be directed to any IACUC member.

last updated: October 18, 2005