Questions about college? Contact Us. View Events. Looking for someone? Search Directory. Need Help? The process is the same for all submissions to the committee. A link to IRBNet. The average time from initial submission to approval for new proposals and non-personnel amendment requests is 5 weeks. As per the PHS Policy, the full committee must be allowed the opportunity to review a proposal and are allotted 7 business days to do so. During this time, any member may request full committee review FCR.
If such a request is not made, the Chair will assign two committee members to review the proposal by designated member review DMR. Of foremost concern, will any part of the project cause, or have the potential to cause, harm to the animals involved.
If animals may be harmed, documentation is necessary to show that alternative methods have been considered but are not appropriate, and why, that steps have been taking to minimize the harm, and that the scientific merit of the project outways the harm to the animals. Other elements include, but are not limited to:.
Pharmaceutical-grade chemicals and other substances, when available, must be used. The use of expired materials is not consistent with acceptable veterinary practice, even in terminal procedures. If your project involves collecting animals in the field, you must furnish a copy of your scientific collector permit issued by the state in which collecting will take place, if one is required.
Threatened or endangered species or species of concern are not covered under a scientific collector permit. For more information on permits, visit the Michigan Department of Natural Resources website, or the DNR website for the state in which the research will be conducted. If you are collaborating with a researcher at another institution that has an Animal Care and Use Committee, you will be required to furnish a copy of the project approval letter from that institution.
If you will be utilizing hazardous materials, you are responsible for obtaining approval, if required, from other campus divisions such as the Institutional Biosafety Committee, Office of Laboratory and Field Safety Committee or Risk Management, Environmental Health and Safety.
Failure to provide any additional materials required by the committee could delay the IACUC review process or receipt of the written IACUC approval necessary to begin work on your project.
If you are performing any animal use activities involving a threatened or endangered species or specimen collection, you will be required to submit a copy of any required permits with your AUA. If you are working in cooperation with another institution that has an Animal Care and Use Committee, you will be required to furnish a copy of the project approval letter from that institution.
If you will be utilizing hazardous materials, you will need to determine if approval is required from another campus compliance committee. The IACUC is required to ensure that all animal use is the best use of animals to achieve the expected result. The IACUC is charged with making certain all research utilizing animals complies with the 3 R's reduction, replacement, and refinement. Each protocol submitted is regarded as a stand alone document.
Referencing procedures from other protocols, or from publications, makes the assumption that they are so generally used that everyone will know what you will be doing.
References can not take the place of procedure descriptions. SOP's should be reviewed by the author at least every three years. Alternatives are taken to mean not just replacement of animals with non-animal methods, such as computer simulations, but also reduction of animal numbers to the minimum necessary to satisfy experimental objectives, and refinement of methods to minimize pain and distress.
Current regulatory expectations are that, in most cases, the PI perform a literature search for alternatives. Unfortunately, when done properly, this can be a time-consuming process. See the Alternatives section of this website for additional discussion and resources.
One of the hardest jobs for both research staff and the IACUC is discussion and evaluation of methods to minimize pain and distress. This involves an inevitable balancing act, or cost-benefit analysis, between the experimental objectives and animal welfare. When there is potential for pain or distress, researchers are expected to carefully monitor animals and relieve the pain or distress whenever possible. One method to accomplish this is by administration of anesthetics or analgesics.
By regulation, a specific scientific justification must be provided whenever anesthetics or analgesics are withheld in painful conditions; this might be necessary when the drugs would interfere with the interpretation of experimental data.
Pain and distress also can be reduced by euthanizing the animal, and defining so-called humane endpoints e. The AWARs require that research facilities file an annual report that accounts for numbers of animals used, by species and category of pain or distress see sidebar. Some institutions use a different system for categorizing pain and distress.
This determination is not always straightforward, as illustrated below in the Study Questions. Among other things, the Report must:. Difficult Issues in Protocol Review — Justification for using animals, species, and numbers used. Regulations require that the PI provide a justification for using animals, and for the specific species and numbers of animals to be used.
These are sometimes difficult issues to address, but involve basic questions that should be considered in the planning of any experiment using animals. Implicit in these questions is the notion that animals should not be wasted. It may sometimes seem obvious why animals are needed for a particular experiment, and in some cases, this may be so.
However, the prevailing view is that animals should not be used in research, teaching or testing unless there is no other way to accomplish the objectives of the activity. The need to use animals should be articulated in the protocol form. The species of animal to be used is relevant to protocol review because the characteristics of a particular species anatomy, physiology, behavior might be absolutely necessary for the success of a study. Conversely, use of the wrong species could prevent a successful outcome.
Appropriate numbers of animals are also an important consideration in avoiding unnecessary or wasteful use of animals. There is a common misconception that this means that animal numbers must, as a priority, be minimized. In fact, properly understood, the requirement to justify animal numbers means that there has been due consideration of the experimental design of an experiment, including determination of the optimal number of animals per treatment and appropriate use of controls. Use of too few animals in an experiment may fail to yield interpretable results and is therefore also potentially wasteful.
Proper experimental design includes statistical considerations, and some IACUCs may have expectations for consultation with a statistician. Some committees have statisticians as members, in order to provide advice in this area. The Animal Welfare Information Center has useful information and web links to assist with statistical considerations and animal numbers. Of course, not all use of animals e. IACUCs are still expected to determine that the numbers of animals requested are appropriate for the intended purpose.
Even other scientists may have difficulty in understanding a description of animal use if written in highly technical language specific to a particular area. One suggestion is for the PI to enlist support staff to help with this description. Difficult Issues in Protocol Review — Personnel qualifications and training more below. The IACUC must determine that personnel working with animals are adequately qualified to perform the procedures described in the protocol; this includes everything from basic animal handling to anesthesia support and surgery to euthanasia.
Thorough training of personnel is one of the most important refinements that can be made in studies using animals. Some institutions, especially in industry, rely on detailed training records to document individual qualifications. However, the IACUC remains in the sometimes awkward position of having to ensure that personnel are qualified, and detailed information may be required in the protocol form.
Difficult Issues in Protocol Review — Expired protocols. Unfortunately, there is no provision in the regulations for extensions of approval or grace periods, and use of animals without an approved protocol, including one that has expired, is considered an area of serious noncompliance. Among other things, serious noncompliance must be reported to OLAW.
OLAW encourages institutions to use or modify the document to suit the institution's needs. The last page of the checklist provides a summary page for noting and tracking deficiencies. After review and inspection, a written report including any minority views is compiled and provided to the IO about the status of the program including any recommendations.
The report will include a description of the nature and extent of the Institution's adherence to the Guide , any departures from the Guide, identified specifically with reasons for each departure stated.
The report will note any program or facility deficiencies, distinguish significant deficiencies from minor deficiencies, and include plans and schedules for correcting each deficiency. A significant deficiency is defined as one that is or may be a threat to animal health or safety. The IACUC oversees the specific use of animals by formally reviewing animal use protocols and granting approval prior to the work commencing. FCR may only be conducted at a convened meeting with a quorum simple majority of members present.
A majority vote of the quorum present is needed to approve, require modifications in to secure approval , or withhold approval of a protocol.
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