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.
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
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 Protocol Form. Highlight any changes made to your protocol since it's last approval.
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.
Types of Protocol Review
There are two methods for reviewing protocols at this institution, Designated Member Review or Full Committee Review.
- 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.
- 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.