Instructional Leadership, emphasis: K-12 School Leadership (MEd)
Outdoor meadow with pine trees and mountains. People in casual clothing engaging in pollinator research in the field working with containers and tools.
  1. IN
  2. NAU Research
  3. Research compliance
  4. Animal care
  5. Animal care and use resources
  6. IACUC procedures for submission and review of protocols, modifications, and annual reports

IACUC procedures for submission and review of protocols, modifications, and annual reports

SOP No: AC-22-0033
Revision No: 04
Approval: IACUC
Supersedes: AC-20-0033
Date: 7-29-2022

1. Purpose

This document describes the process for the review of protocols, modifications, and annual reviews by the IACUC members.

2. Scope

NAU Animal Research Program

3. Responsibilities

  • IACUC members
  • Investigators

4. Definitions

AR-Annual Review
DMR–Designated Member Review
DR–Designated Reviewer
FCR–Full Committee Review
IACUC–Institutional Animal Care and Use Committee
IC–IACUC Coordinator
PI–Principal Investigator

5. Applicable regulations

  • Animal Welfare Act (AWA, Public Law 89-544, 7 U.S.C.)
  • Animal Welfare Act Regulations (AWAR, 9 CFR, Chapter 1, Subchapter A)
  • Health Research Extension Act of 1985 and Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals
  • National Research Council Guide for the Care and Use of Laboratory Animals, Eighth Edition. National Academy of Sciences, 2011
  • AVMA Guidelines for the Euthanasia of Animals (most current version)

Submission of protocol or modification

  1.  The investigator completes a protocol or modification form using the current version available on the NAU Animal Care Research webpage https://in.nau.edu/research/research-compliance/animal-care/iacuc-forms/. This completed form is then submitted to IACUC coordinator (IC). All protocol submissions listed as Category D or E will be sent by the IC to the AV for a veterinary pre-review. The veterinarian will review for appropriate animal use procedures, anesthetic, analgesic, and euthanasia methods.
  2. The veterinarian reviewed protocols and modifications are then submitted to the IACUC Coordinator via email with a file name to reflect veterinary review complete and date completed.
  3. The IACUC coordinator will then process submission for either Full Committee Review (FCR) Designated Member Review (DMR), or Administrative Review as described below.

Review process

Full Committee Review

  1. The IACUC will review an initial protocol or modification at a convened meeting of quorum if the proposed activities involve at least one of the following:
    • Major survival surgery
    • Unrelieved pain or distress
    • Death as an endpoint
    • Multiple major survival surgeries
  1. An IACUC member may request a full committee review of any modification or protocol at any time even when scheduled for DMR.
  2. The IC will forward the protocol submission and any associated documents to the committee using an electronic method such as email or Microsoft Teams prior to the scheduled convened meeting.
  3. IACUC members should review all protocol/modification documents in advance of scheduled convened meeting.
  4. At the full committee meeting, the Chair or designee will lead the discussion of the protocol/modification including the justification for FCR. 
    • Any IACUC member that has a conflict of interest (COI) will recuse themselves. No IACUC member may participate in the review, discussion, or approval of a research protocol in which the member is personally involved or has a financial conflict, except to provide information requested by the IACUC. If the AV is listed as a PI, collaborator or participant in an NAU IACUC protocol, an outside veterinarian will be consult for review of the protocol. 
  5. Upon completion of the discussion at the convened meeting of quorum the IACUC will vote for one of three available options:
    • Approve
    • Requires additional information to secure approval
    • Not approved

(The decision must be cast by a majority of voting members present at the meeting.)

  1. If additional information is required to secure approval then the IACUC must indicate whether responses can be reviewed and approved by FCR or DMR. DMR will only be allowed if all voting members at a fully convened meeting of quorum agree. When the DMR option is elected than a committee member is selected by the Chairperson to be the Designated Reviewer. As well, the responses provided by the Investigator are submitted to the entire committee for review as for any DMR process as described.
  2. Requests for additional information will be sent to the PI by the IACUC Coordinator along with any administrative requirements still to be completed before final approval is granted.
  3. If a protocol is not approved, the reason for will be sent to the PI by the IACUC Chair or Coordinator. The PI has the opportunity to respond at the next scheduled full committee meeting in person or in writing. The committee can request the protocol to be reviewed again based on new information from the PI during the appeal process. This will require a new protocol to be submitted.
  4. Once approved via FCR and all administrative requirements have been completed, an approval letter will be sent to the PI by the IC notifying them that the protocol or modification has been approved. Date of approval is based on when FCR or DMR was completed and all administrative requirements, if applicable, were completed, whichever is later.

Designated Member Review (DMR)

  1. The IACUC will review new and renewal protocols and modifications that do not need to be reviewed at a convened meeting through the designated member review process. Annual reviews are also conducted using this process.
  2. The IC will post all information to the committee using Microsoft Teams primarily with email as a secondary method. The committee has 5 business days to review the information and call for FCR. The chairperson will assign a designated reviewer at this time. The assigned member remains the designated reviewer for this protocol until it expires. All committee members can provide comments using Microsoft Teams or email.
  3. An IACUC subcommittee may be formed as needed to facilitate review of specific activities such as satellite housing requests, client owned animal projects, etc. The subcommittee members can provide comments to the assigned designated reviewer.
  4. The DR will review and has the authority to:
    • Approve
    • Requires additional information
    • Refer to Full Committee Review
  5. The DR posts any comments or questions to Microsoft Teams and the IC will submit this to the PI for additional information as needed. The IC will also include any committee comments when requesting additional information from the PI. 
  6. Administrative requirements will be considered complete as determined by IC or designee based on information provided in the protocol form to include Occupational Health form, Respiratory Protection registration, Institutional Biosafety Committee approval, and required CITI training. Protocols cannot be approved if administrative requirements are not met.
  7. Once approved by the IACUC and all administrative requirements are completed, the IC will finalize the approval in Microsoft Teams and send an approval letter and final version of the submission to the PI.

Review of modifications

  1. Modifications are reviewed by either FCR or DMR as described above if considered as a significant change to the protocol.
  2. The following significant changes will be reviewed by full committee:
    • Addition of a major survival surgery activity
    • Addition of unrelieved pain or distress activities
    • Addition of death as an endpoint activities
  3. The following significant changes will be reviewed by the DMR process unless a member calls for the modification to be reviewed by full committee.
    • Change of species
    • Addition of animals greater than 10% of those already approved
    • Housing outside of a designated area for longer than 12 hours
    • Any change in location not previously approved
    • Change of non-survival to survival surgery
    • Increased invasiveness of a procedure
    • Increase in duration of pain, discomfort or distress to an animal (not Cat E)
    • Hazardous agents administered to animal
    • Change in PI
    • Change in study objective
    • Change in humane endpoints
    • Changes that impact personnel safety
  4. Review of modifications by Veterinary Verification and Consultation (VVC):
  1. Examples of significant changes that are covered by IACUC reviewed and approved policies and formularies that may be handled through an administrative process in consultation with any NAU veterinarian.
  2. The veterinarian is acting as a subject matter expert to verify that there is compliance with IACUC reviewed and approved policies that are appropriate for the animals in the specific circumstance.
  3. The consultation with the veterinarian must be documented and the protocol must be updated by the Principal Investigator within 30 days of the consultation. The updated version of the protocol will be reviewed by the NAU veterinarian that was consulted.
  4. The veterinarian may refer any request to the IACUC for review for ANY reason and must refer any request that does not meet the parameters of the IACUC reviewed and approved policies and formularies.
  5. Examples of significant changes that can be handled administratively via VVC include:
    • A change in anesthesia, analgesia, or sedation that is on the NAU Formulary.
    • A change in euthanasia method to anything that is approved in the most current version of the AVMA Guidelines for the Euthanasia of Animals.
    • A change in blood collection method or volume or route of substance administration that is included in the Blood/Fluid collection and Injection Guidelines.
    • Minor changes to the duration, frequency, timing, or number of IACUC approved procedures performed on an animal as long as the change is not reasonably expected to increase the pain, distress, or degree of invasiveness from what was originally approved.

Review of administrative changes to protocol

  1. Modifications are considered minor and routed for administrative review if:
    • There is an increase in animal numbers less than or equal to 10% of currently approved numbers
    • An addition of another stock/strain or the same animal species
    • Change or addition in funding source
    • Change in animal use location to an area already approved by the IACUC
    • Personnel additions
  2. If it is not clear that a change should be considered significant, the determination will be made by the IACUC Chair.
  3. Administrative changes are initiated by the PI using the modification form available on the NAU website.  The modification form is submitted to the IC who will review and determine if the modification meets the criteria for administrative review.  Any further clarity will be provided by the IACUC chair.
  4. Once the modification has been reviewed and processed by the IC, an approval letter will be delivered to the PI via email.
  5. The final administrative modification will be posted to Microsoft Teams.
  6. Modification requests that do not meet requirements for administrative review will follow the path of DMR or FCR as described above.

Annual reviews

  1. An Annual Review (AR) is submitted by the PI to the IC using the Annual Report form available on the NAU Animal Care webpage https://in.nau.edu/research/research-compliance/animal-care/iacuc-forms/.
  2.  ARs are posted to Teams by IC for review by the IACUC. The IC will compile any committee requests for information and submit to the PI prior to review completion.
  3. The annual review is submitted in the 3rd and final year of an approved protocol and is considered the final review. All completed annual reviews are posted to Microsoft Teams by the IC.
  4. IACUC members should review all protocol/modification documents in advance of scheduled convened meeting.

IACUC meeting schedule

  1. The IACUC typically meets during the second week of each month. This schedule is subject to change.

Submission, review, and approval timelines

  1. Veterinary/administrative pre-review shall be completed within 10 business days from receipt for new protocols and modifications. 
  2. The IC will post protocols and modifications to Teams for IACUC review within 3 business days of receipt of a completed document.
  3. The committee has 5 business days from date posted to Teams to review and request FCR.
  4. DR has 5 business days to review and submit request for additional information to IC.
  5. Once the DR review is complete, the IC will submit a request for additional information to the PI within 3 business days.
  6. Responses from PI are due within 5 business days of receipt.
    • Any delays in the PI response will delay the review process.
  7. FCR will be determined by IACUC meeting schedule.
  8. Modifications eligible for administrative review are typically completed within 3 business days from receipt of completed document.
  9. Exceptions to this schedule are to be determined on a case by case basis.
  10. A final approval letter is sent to the PI usually within 5 business days of IACUC approval and completion of administrative requirements.

IACUC submission timeline

IACUC submission timeline illustration showing the numbers of days it take to process a submission.