How long will it take for my animal study proposal to be approved? Animal study proposals are generally approved in weeks. However, because certain projects can require more than one review or require review at a convened IACUC meeting, it is recommended that proposals are submitted 45 days prior to the anticipated start date of the project.
I am not doing laboratory research, but am only studying animals in their natural habitats. You must contact the IACUC before intiating any research, teaching, or testing involving animals at or through the Institution. I have completed my research project. I still have questions. Who should I contact? There usually are institution-specific instructions available for completion of the protocol-review process, and consultation is typically available from an IACUC office as well as IACUC members.
Veterinary staff are also available for consultation, and should be contacted if projects involve potential for a pain or distress more below. Research staff also should be aware that, in addition to issues directly related to the protocol review process, there may be institutional requirements for training, facility orientation and security measures, and enrollment in an occupational health and safety program more below.
Any significant change in an approved animal use activity must be reviewed and approved by the IACUC. This typically is handled through an amendment or addendum process with institution-specific paperwork. As with initial review, there must be opportunity for every member to request discussion at a convened committee meeting. The AWARs require annual review; lack of details in the regulations means that there may be significant differences among institutions in how this is handled.
The IACUC will need to know what the potential is for pain or distress associated with experimental manipulations, including clinical and behavioral abnormalities associated with spontaneous or induced animal models e.
By regulation, veterinary staff must be consulted in the planning of studies involving potential pain or distress; planning may involve both the preparation of the protocol for IACUC submission and training in the experimental methods. Veterinary consultation is valuable for understanding:. Regulations also require that the PI consider alternatives to potentially painful or distressful procedures.
The IACUC, through the protocol review process, must determine that this has been done appropriately. 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. While it is important that institutions have mechanisms to remind PIs of upcoming expirations, the PI also must recognize the importance of filing appropriate paperwork in time for adequate IACUC review and approval.
IACUCs as well as PIs are interested in ways to reduce the burden of protocol preparation and review, and there is legitimate interest in facilitating the process. Facility reviews are a physical inspection of all buildings, rooms, areas, enclosures and vehicles including satellite facilities in which animals are housed for more than 24 hours that are used for animal confinement, transport, maintenance, breeding, or experiments inclusive of surgical manipulation.
No member wishing to participate in an evaluation may be excluded from participating. The Animal Welfare Act and Regulations AWAR require animal study areas where regulated species are maintained for more than 12 hours to be included in the semiannual facility inspections.
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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