Animal Care and Use Protocols

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An Animal Care and Use Protocol is a request made to the Institutional Animal Care and Use Committee (IACUC) to conduct a scientific experiment on live, vertebrate animals.

Animals cannot be ordered or used at Davidson College until a protocol is approved by the Davidson College IACUC.

Each protocol submitted must include a detailed description of the research being conducted, minimize the number of animals being used in the study, minimize pain and distress to animals in the study, prove there is not a replacement or alternative model to the use of a living animal, prove the research is not a replication of previous work, and submit justification that the research being conducted is beneficial to the advancement of scientific knowledge.

Submitting to IACUC

Protocol Form

This has been designed to help guide the investigator by requiring the specific information needed in order to comply with federal regulations. Please remember that submitting a protocol to Davidson College is a request for permission to conduct research using live vertebrate animals at Davidson College facilities. Under no circumstance should you attempt to purchase your own animals to begin your research until your request has been approved by the Davidson College Animal Care and Use Committee (IACUC).

Protocol Amendment Form

An Amendment is required when a PI would like to make a change to an approved protocol.  Amendments to protocols require the IACUC review and approval prior to initiation.  Proposed modifications to an approved protocol include; Additional procedures or modifications of procedures (including frequency, duration, or number), changes in analgesics or anesthetics, species or number of animals, housing, etc.  The IACUC reserves the right to determine whether proposed changes require more information, full committee review, or submission of a new protocol.

Personnel Amendment Form

Any person that is to work with animals must be listed on an approved protocol and complete the IACUC requirements before beginning.  Proposed additions to personnel are submitted by the Principle Investigator. It is considered an issue of non-compliance if a person works with animals and is not listed on the relevant IACUC protocol or has not completed the personnel requirements. It is recommended that new personnel work on their requirements before submission. To remove inactive personnel from a protocol, send an email with the name(s) of people to be removed.

Protocol Annual Renewal Form

Annual Renewal forms are used only for the first TWO years of a protocol. After that a new Protocol Form must be submitted. Principle Investigators will receive email notification regarding annual renewals as well as prior to their protocol expiration date, upon which a new protocol must be submitted.  If personnel are to be added to the protocol, you must fill out the Personnel Amendment Form.

Upon receipt of your New Protocol, the IACUC will assign your study a protocol number and you will be given a date the committee plans to meet to review your request. Once reviewed, the committee will cast a vote and you will be notified via your email to three possible scenarios:

Your Protocol #... has been approved. This will mean that you can contact the animal facility and order your animals. The experiment you proposed can begin. You will be required to resubmit your protocol yearly to the IACUC for updates and assurance of compliance.

Your Protocol #... Modifications are needed to secure approval. This will mean that you must make proposed corrections to your initial request, before your research can begin. If your choose to make the committee recommended changes to your protocol, you will resubmit your protocol including those changes and the committee will respond with an "approved" vote. You may then order your animals through the facility and begin your research. If you disagree with the committee's recommended changes, you may either propose a meeting with the committee to discuss the procedures in question or you may submit a letter to the committee justifying your initial request. The committee will then consider your justification and issue another vote.

Your Protocol #... has not been approved. This will mean that the committee has found your proposal unacceptable and you will not be allowed to order animals or conduct experiments outlined in this submitted protocol at Davidson College.

Renewals, Reviews and Amendments

For already approved protocols, there will be additional requirements including annual renewals, reviews for some protocols, and any subsequent amendments to the protocol. 

For an Already Approved Animal Care and Use Protocol

Every year following your protocol's initial approval, you will be required to submit a Annual Protocol Form. This will be an opportunity for the committee to notify you of any changes in Institutional policy concerning your research. It will also give you an opportunity to propose changes to your study that may be necessary from your experience the past year. At this time, the institution will confirm that you are to complying with approved procedures.

For an Approved Animal Care and Use Protocol

Triennial Review (3rd-Year De Novo Review)

Federal regulations (PHS Policy and AWA) mandate a comprehensive, "De Novo" review of every protocol every three years. Renewed protocols retain their original protocol number with a version identifier, i.e. v2 or v3 and are assigned a new approval period not to exceed three years. 

                          This is  NOT an annual renewal and follows a different process:

  • Timeline: The PI must provide a full, current application at least 8 weeks before the 3yr anniversary of the original approval date.  No administrative extensions are permitted beyond the 3-year mark.
  • Submission Requirement: The PI must provide a full, current application including:
    • A progress report summarizing findings to date.
    • Updated animal numbers for the next three-year cycle.
    • A newly conducted and documented literature search for alternatives to painful procedures.
  • Review process:  The new application undergoes the same rigorous review as a brand-new submission.  This requires either Designated Member Review (DMR) or Full Committee Review (FCR).  An administrative review (as used for annual renewals) is insufficient and not permitted by federal policy.
  • Approval: Final approval requires a formal vote from the reviewers (DMR) or the convened IACUC (FCR).

 

For an Already Approved Protocol

If you wish to increase the number of animals you need or there is a minor change in the procedures of your already approved protocol, then you must complete a Protocol Amendment and submit it to the committee requesting this change. If you are planning to make a major change in your protocol (i.e. a change in drugs used, different surgical site, etc.), then you must submit a new Protocol Form and will not be able to submit an amendment.

An Amendment is submitted on-line in Kuali Build and it will be automatically sent to the IACUC Administer to review and forward to the IACUC.

Diamond Arrow

Types of Protocol Review

There are two methods for reviewing protocols at this institution, Designated Member Review or Full Committee Review.

  1. Designated Member Review (DMR): A subcommittee of the IACUC is designated to review proposed research. DMRs have the authority to approve, require modifications to secure approval, or request Full Committee Review. If a DMRs calls for a FCR, then the proposal is reviewed at a convened meeting of the IACUC.  The Designated Member Reviewer(s) decision must be unanimous; any decision other than unanimous results in the protocol receiving an FCR. 
     
  2. Full Committee Review (FCR): All proposals conducting activities that will involve animal pain and stress and for which the use of appropriate anesthetic, analgesic or tranquilizing drugs will/will not be used requires a convened committee meeting, discussion, and a vote of the IACUC. Animal use protocols require a majority committee vote to be considered "approved". This majority must minimally include all Public Health Service (PHS) required committee members giving an "approval" vote. Any committee member, presenting a conflict of interest, is not considered as part of the vote to approve his or her own protocols.