Animal Care and Use Protocols
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.
Submission of New Protocol
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 or begin your research until your request has been approved by the Davidson College Animal Care and Use Committee (IACUC).
Upon receipt of your 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 #... has been approved, pending the below list of committee recommended changes. 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.
Submission of a One-Year Renewal
For an Already Approved Animal Care and Use Protocol
Every year following your protocol's initial approval, you will be required to submit a One-Year Renewal. 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 complying with approved procedures.
Please resubmit the Animal Care and Use Protocol form used in your initial request. Highlight any changes made to your protocol. If you are requesting additional animals, please also submit a letter justifying your increased need. If you are changing the procedures of your protocol, you must submit the protocol as a new protocol. Email your document in Word format to email@example.com.
Upon receipt of your protocol, the IACUC will assign your study a new 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:
- Approved, pending corrections
- Not approved
See the above descriptions of scenarios for clarification.
Submission of a Third-Year Review
For an Approved Animal Care and Use Protocol
Every third year, approved protocols involving pain or stress, whether with or without drugs, will need to be completely reviewed.
A complete review will entail the following:
- There will be a tour of the investigator's lab to affirm compliance with approved procedures.
- All documentation will need to be available to the committee. This will include: drug use logs, procedure records, colony room logs, census activity sheets, behavior\observation records (if applicable), weight logs, etc.
- Protocol census will be confirmed as accurate. The number of animals ordered, used and disposed of for the experiment under review will be confirmed. Additional animal requests will be evaluated for appropriateness.
- The investigator will be asked to submit a status report outlining the progress of the study under review. The PI may be asked to explain reasons for continuation of the study, justify reasons for additional animals or time to complete the study or clarify delays in progression. This submission must be in writing and, in addition, the PI may be invited to attend the review meeting to discuss the projects status and answer committee member's questions.
Please resubmit the Animal Care and Use Protocol form used in your last yearly renewal. Highlight any changes made to your protocol since it's last approval. Include a cover letter outlining the progress of the study (See #4 above for details) and, if your are requesting additional animals, please also submit a letter justifying your increased need. If you are changing the procedures of your protocol, you must submit the protocol as a New Protocol. Press the "Submit" button at the bottom of the document or email your document in Word format to firstname.lastname@example.org.
Upon receipt of your Protocol, the IACUC will assign your study a new 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: 1) approved, 2) approved, pending corrections, or 3) not approved. See the above descriptions of scenarios for clarification.
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 Animal Care and Use Protocol, you may send an amendment 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 in letter format and on Davidson College stationary. Please include in your letter:
- Your name and the date of amendment submission
- Your approved protocol number
- Clearly state the change that you wish be made to your protocol
- Justification or reason the change is being requested
Email your document in Word format to email@example.com.
Upon receipt of your Amendment, the IACUC will assign you a date when the committee plans to meet and review your request. Once reviewed, the committee will cast a vote and you will be notified via your email to three possible scenarios:
- Approved, pending corrections
- Not approved
See the above descriptions of scenarios for clarification. For additional questions concerning protocol submission or status of an already submitted protocol, please contact firstname.lastname@example.org.
Types of Protocol Review
There are two methods for reviewing protocols at this institution, Expedited Committee Review or Full Committee Review.
- Expedited Committee Review: Proposals that qualify are those that involve only animals being bred, conditioned or held for research use and those proposals that do not involve pain, stress, or the use of pain-relieving drugs, can qualify to be approved via the Expedited Committee. This Institution's Expedited Committee is selected by the chair and includes the chair, the veterinarian and the non-affiliated member. All reviewers on the Expedited Committee are sent the same information and act as one unanimous entity. If a protocol is approved, then the outcome is sent via email to the submitting investigator. If any expedited IACUC reviewer feels the protocol requires modification, a full-committee discussion, and/or does not approve of the proposal, then the Expedited Committee calls a Full Committee meeting to review and vote on the protocol. The investigator will receive notification via email of the Expedited Committee's decision to move to Full Committee review process.
- Full Committee Review: 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.