Research at The University of Toledo : IACUC Protocol Procedure Summary

This is a guide that will take you through all of the steps an Institutional Animal Care and Use Committee (IACUC) protocol takes from submission to approval to termination.

NOTE: ALL communications regarding IACUC protocols are directly with the responsible Primary Investigator (PI).  Techs, Secretaries, Students, and Post Docs are not be copied on any communications.  The PI may set up an Outlook inbox rule to automatically forward communications to the proper people in their lab; however, all return communications must come directly from the PI in order to be considered valid by the committee.  To facilitate easy management of Outlook Rules, all communications from the IACUC office have the following format:

IACUC Protocol# 111111 – PI Name – Protocol Issue

Ex: IACUC Protocol# 123456 – Beavis – Revisions

1. Submit protocol by the last Wednesday of the month.  Protocols are submitted to IACUC Administrator, Matthew DeVries (Matthew.DeVries@utoledo.edu).
   1. DLAR encourages all PI’s to consult them during the planning phases of all animal use protocols.  DLAR consultation is REQUIRED before protocols involving USDA-regulated animals will be accepted for review.
   2. Protocol PI’s must be UT Faculty members (not students, post docs, volunteers, adjunct appointees, etc.)
   3. Form can be downloaded at: [Insert Link to Forms page, IACUC Anchor]  Protocol form requires Adobe Acrobat Reader Version 9 or later, or Adobe Acrobat Professional Version 8 or later.
   4. Email one saved Adobe form to:
      1. Must be mailed from PI’s UT-issued email address
      2. It is advised that you use Outlook’s “Read Receipt requested” feature to serve as proof that the protocol was received on time
   5. Send one hard copy signed in ink to IACUC Administrator in Research and Sponsored Programs (RSP). 
   6. Emailed protocols received after the deadline will be reviewed the following month.
      
2. The IACUC meets to review protocols on the second Wednesday of the month
   1.  Protocol is reviewed - One of the following outcomes is applied to the protocol at the meeting:
      NOTE: To avoid unnecessary approval delays, if the PI is uncertain about acceptable procedures, or does not fully comprehend the context of a question on the form, they should contact the IACUC office, an IACUC committee member, or the Attending Veterinarian’s office for clarifications or assistance.
      1. Approved
         1. Protocol is signed by Attending Veterinarian (AV) and Committee chair, work can begin immediately
      2. Modifications are required to secure approval
         1. Memo is emailed to the PI indicating that the protocol requires substantive modifications before it can be approved.
         2. Depending on the extent and subject matter of the requested modifications, the revised protocol will be re-reviewed via:
            1. Full Committee Review
               1. After submission the revised protocol will be reviewed by the committee at the next regular IACUC meeting
               2. Minimum time before protocol approval – 1 month
            2. Designated Member Review
               1. AV, Committee Chair, Chair-appointed reviewers work with the PI to address the requested modifications.
                  NOTE:  Any protocols not revised within 3 months will be administratively withdrawn from committee
               2. Protocol will be approved after all reviewers are satisfied with the modifications
         3. IACUC administrator will send a final electronic copy to the PI to be printed, signed, and returned to the IACUC office via campus mail or personal drop off. (revision process does not require ink-signed paper copies, this can all be done via email, only the final version needs to be signed)
         4. AV and Committee chair sign the approved protocol, original is returned to the PI, work can begin
      3. Deferred or tabled review
         1. In effect no review has taken place as the committee feels that substantial information is lacking or unclear making a complete review impossible.
            1. Common examples include:
               1. Missing procedural description, such as surgery
               2. Search for alternative methods incomplete
               3. Lack of a statistical basis/rationale behind animals numbers
         2. Memo is emailed to the PI describing the issues that need to be changed or clarified.
            NOTE:  Any protocols not revised within 3 months will be administratively withdrawn from committee.
            a. Be advised that following review of the re-submitted protocol, the committee is likely to require modifications that were not part of the initial review attempt.
         3. PI can request to attend the follow-up IACUC meeting on the second Wednesday of the following month to directly address the committee and answer and questions the committee may have, however they will not be able to remain in the room when the committee is deciding/voting.
      4. Approval Withheld
         1. Protocol is rejected outright and will not be considered by the committee.  This would be due to gross violation of animal welfare regulations or failure to demonstrate that proposed work can be done at UT while maintaining animal welfare.
            NOTE:  Animal Welfare regulations expressly forbid higher institutional authority from overruling an IACUC decision to withhold approval
3. Approved protocols
   1. Protocol is approved for 1 year from the date the IACUC Committee reviewed the protocol (not from the approval date)
   2. Annual renewal paperwork is required for protocol to be re-approved, these forms will be sent via campus mail 3 months prior to the protocol expiration date.
      1. Completed paperwork must be received by the first day of the month in which the protocol expires in order to ensure the protocol is re-approved for the subsequent year of the protocol.
      2. If for some reason, the PI has not received the annual renewal paperwork 2 months prior to expiration of the protocol, it is the PI’s responsibility to contact the IACUC office to request the forms.
      3. To avoid problems, it is recommended that upon receipt of an approved protocol the PI sets up these dates using the calendar reminder feature in Outlook to remind them these dates are approaching
   3. Every 3 years, resubmission and de novo re-review of the complete protocol is required.  Resubmissions must be done on the latest version of the IACUC forms.
4. Expiring protocols
   1. The IACUC office will send out a notice via campus mail 3 months prior to expiration date advising you of the expiration date, and the deadline for resubmission of new protocols.
   2. Ending protocols
      1. It is the PI’s responsibility to ensure that there are no animals on the protocol when it expires.
   3. Renewing protocols
      1. All protocols must be submitted for a complete de novo review of the whole protocol every 3 years.
      2. Renewal protocol must be received by the IACUC office for review 8 weeks prior to the protocol expiration date.  Protocols received after the submission deadline (8 weeks prior to protocol expiration) will not be reviewed by the IACUC in time to avoid a gap in approval.  If a protocol is not renewed in time, it is the PI’s responsibility to ensure that there are no animals on the protocol when it expires.  Department chairs will be alerted at the deadline as after the protocol expires, all animal-related charges incurred will be applied to departmental accounts.
   4. If a protocol expires with animals remaining on the protocol, none of the following can be avoided:
      1. As this is considered a major protocol violation, per UT Assurance with the Office of Laboratory Animal Welfare (OLAW) an IACUC subcommittee will be formed to investigate the matter.  Furthermore, NIH policy requires the Institution to report the matter to OLAW when the work is NIH-Funded.
      2. Granting Agency that funds the animal work will be alerted.
      3. Department Chair will be alerted that the protocol expired.
      4.  As most funding agencies specifically forbid animal-related charges without an approved IACUC protocol, all animal related charges will be applied to departmental accounts.
      5. DLAR will take possession of all remaining animals; all scientific manipulations will be suspended.  The ultimate dispensation of the animals will be at the discretion of the AV.