Instructions for Making Amendments to a Protocol

Minor Amendments

Requests for minor amendments to your protocol should now be submitted to the IACUC by using the new Minor Amendment Form. Protocol changes that are considered MINOR include changes to the title of a protocol or a funding source, adding a new strain or genetic background of animal, an addition of animals to your protocol that does not exceed 10% of the originally approved number of animals for that species, a change in animal care facility, housing unit or field site, a change in administration of experiment/treatment as it relates to the timing, dose, route of administration and/or specific chemical composition, and the addition or removal of personnel to a protocol.

For the changes noted above, the minor amendment form should be completed by the principle investigator and submitted to the Institutional Animal Care and Use Committee (iacuc@illinois.edu). The e-mail or cover letter should reference by number and/or title of the protocol to be amended, and provide a summary and justification for all requested changes. As with all submissions to the IACUC, if the amendment request is being made by anyone other than the principle investigator listed on the protocol, the PI must be carbon copied on the email request.

Significant Amendments

Amendments that do not fall into the categories listed above as "minor" must be submitted in writing (preferably by e-mail) by the principal investigator to the Institutional Animal Care and Use Committee (iacuc@illinois.edu). The e-mail or cover letter should reference by number and/or title of the protocol to be amended, and provide a summary and justification for all requested changes.

Submissions must include sufficient information for the IACUC to evaluate changes using the same criteria as in the initial review. Attached to the e-mail or cover letter must a be a revision of the previously submitted and approved IACUC-1 form. The submitted protocol should incorporate all minor amendments approved since the initial protocol approval (or since the last significant amendment approval). If you cannot find an electronic copy of your protocol, please contact the IACUC office and we will gladly help you locate this form.

The complete details of the proposed amendment must be incorporated into the revised IACUC-1 form. Revised text should be clearly indicated in bold, underlined, or italicized fonts. For instance, if a surgical procedure is to be added, the request must describe pre- and post-operative care of the animal; preparation of the surgeon, instruments, and the animal; anesthetics and post-operative analgesics, their dosages and route of administration, etc. If an increase in animal numbers is requested, the PI must provide the reasons for the need of additional animals and justification for the number requested. Reviews of significant amendments by the IACUC do not differ from reviews of full protocols. As with all submissions to the IACUC, if the amendment request is being made by anyone other than the principle investigator listed on the protocol, the PI must be carbon copied on the email request.

IACUC
Room 114 Observatory (MC-193)
901 S. Mathews Avenue
Urbana, IL 61801
iacuc@illinois.edu