ࡱ> g :bjbjVV 7pr<r<G2@ @ 8zDKO^Lhhh> NNNNNNN$QTbNNhh4O333hhN3N33FIhcO;G"NO0KOGTTDII0TJLF63|,NNKOT@ `:  founded 1782 300 Washington Avenue, Chestertown, Maryland 21620-1197 INSTRUCTIONS FOR COMPLETING APPLICATION FOR ANIMAL SUBJECTS REVIEW CERTIFICATION FOR TEACHING AND RESEARCH Revised: 8/2013 The Institutional Animal Care and Use Committee (IACUC) at Ҵý is comprised of faculty, staff, students, a consulting veterinarian, and a representative of the local community. The IACUC is charged with reviewing all proposals to insure that the use of animals by faculty, staff members or students in teaching and research will comply with public laws, policies, and guidelines. The following information is required for compliance with the Animal Welfare Act (PL. 89-544, PL 91-579 and PL 94-279), PHS Guidelines on the Humane Care and Use of Laboratory Animals, and the ILAR Guide for the Care and Use of Laboratory Animals (2012). This information must be provided prior to submission of grants, or ordering or use of animals for teaching or research. Please send proposals by e-mail (wc_iacuc@washcoll.edu) for review and submit a signed hard copy to the Chair of the IACUC. The Chair of the IACUC welcomes and is available for consultation prior to submitting the protocol for review. The current Chair can be contacted at the IACUC e-mail address (wc_iacuc@washcoll.edu). Submission and Review Guidelines: Submitted protocols will be circulated to committee members for review within two weeks of submission. However, if the members of the committee deem it is necessary they may defer their final decision until the next scheduled meeting of the full committee. The primary investigator will receive written notification of the outcome of the review within two (2) working days of the Board's decision. In some cases the Board may determine that more extensive discussion of a proposal is required, that the PI must provide additional information regarding their proposal, or that the proposal must be revised and resubmitted for review. For these reasons, investigators are strongly encouraged to submit their proposals at least three (3) to six (6) weeks prior to the intended start date for the project. Students should work closely with their research advisors to develop their protocol proposals before submitting them to the IACUC. Projects that will be conducted during a period when classes are not normally in session (i.e., during the summer or over the winter break) should be submitted for review during the semester preceding the proposed starting date of the project. Review of proposals submitted within the last week of classes in any semester will normally be deferred until the following semester. Instructions: The protocol form is saved as a Microsoft Word document. Before completing the form: 1) RENAME and save a working version of the form using the SAVE AS option. This preserves a copy of the original form should you need one. 2) The form is protected so that you may only enter text/data in specific fields that are shaded. To move from field to field, use the TAB key. Double click on a shaded check-box and select checked or unchecked to toggle between a checked and unchecked box. Please fill out form as completely as possible in language understandable by a lay person. Enter N/A for those items not applicable. Use the space provided in the form. If you need more space, please attach separate sheets identifying which section of the form the information refers to. The following are guidelines and additional information required to complete the protocol application form. The numbers and letters refer to the appropriate section of the form. Certification Data A. This form is to be used to submit a new protocol or to renew a previously approved protocol. The protocol must be approved before doing research with vertebrate animals. The Modification/Addenda form should be used if significant changes will be made to an approved protocol after research or teaching has begun. A separate form is available on the Research Policy website ( HYPERLINK "https://zmail.washcoll.edu/zimbra/" \l "11" http://www.washcoll.edu/academics/research-policy.php). Examples of significant changes are an increase in the number of animals, addition of a new procedure or personnel, or change in species. Minor changes that do not require an amendment are such things as a change in treats from one brand to another. A Continuing Review form (available on the Research Policy website) must be filled out annually and submitted to the IACUC. Protocols are approved for a maximum of three years contingent on an annual continuing review. After three years, protocols may be submitted for renewal by checking Renewal of Protocol # and fill in previously approved number. Complete the remainder of the form and submit as normal to the Chair of the IACUC. I. Carefully consider which category the proposed research falls into. If multiple procedures will be performed on an animal, the animal is placed in the category appropriate for the most painful/distressful procedure. The USDA classifications of pain or distress are as follows: A - Experiment is completely non-invasive and non-traumatic. Animals will be observed without manipulation of their environment (i.e., field studies). B - Experiment is expected to produce little or no discomfort. This category includes: occasional simple invasive procedures such as blood sampling or injections; physical behavioral testing without significant restraint or noxious stimuli; research on completely anesthetized animals that do not regain consciousness; and standard methods of euthanasia that induce rapid, painless unconsciousness, such as an anesthetic overdose. Additional examples are: Routine examinations Brief physical restraint (< 1 minute) Ear punching for identification C - Experiment is expected to produce some discomfort. This category includes procedures causing momentary minor discomfort, anxiety, illness, or pain of short duration, such as: behavioral experiments on awake animals involving restraint; food/water deprivation for short periods (<24 hours); limited application of noxious stimuli from which escape is possible or not possible; social isolation/crowding; repetitious minor invasive procedures, such as frequent blood sampling; surgical procedures under anesthesia from which the animal will recover consciousness; exposure of blood vessels and implantation of chronic catheters; and gonadectomy. Additional examples are: Short term restraint of conscious animals (< 30 minutes) Functional deficits including lameness D - Experiment is expected to involve significant but unavoidable distress or pain. This category includes: induction of behavioral stress to test its effect; major surgical procedures under anesthesia that will result in significant post-operative discomfort or functional deficit; repeated application of noxious stimuli from which escape is not possible; and prolonged periods (several hours or more) of physical restraint. Additional examples are: Pain or distress alleviated by anesthesia, analgesia, or sedation. Exsanguination under heavy anesthesia Polyclonal antibody production Chronic maintenance of animals with a disease or moderate functional deficit E - Experiment is expected to inflict severe pain on unanesthetized conscious animals.* Such experiments include: use of muscle relaxants or paralytic drugs for surgical restraint without the concomitant use of anesthetics in sufficient dosage to produce loss of consciousness; severe trauma inflicted on unanesthetized conscious animals; recovery of consciousness after severe physical trauma has been inflicted under anesthesia; and any other traumatic procedures performed without the use of anesthetics, analgesics, and/or tranquilizers, including toxicity testing and exposure to radiation. Additional examples are: Pain, discomfort or distress that cannot be alleviated because no known treatments exist Pain, discomfort or distress than will not be alleviated because the treatment would interfere unacceptably with the goals of the study Functional deficits including induced blindness or paraplegia Testing to endpoints of moribund or death *Any protocols in this category will require a thorough explanation as to why relief cannot or will not be provided and alternative procedures cannot be used. Description of Animal Use A. Order forms for animals are available on the IACUC website. Please forward to the Vivarium Manager after protocol is approved. Lead time for ordering and receiving animals is 1 to 2 weeks depending on the supplier. Animals must be quarantined upon arrival for 1 week before being used in the protocol. Please plan accordingly. C2. Complete a Laboratory Animal Allergy Initial Questionnaire. Please have each person that will be working with animals fill out the questionnaire and forward to the Director of Health Services. The purpose of the questionnaire is to help assess the risk of developing allergies to laboratory animals. A follow-up questionnaire (available on the Research Policy website) will need to be submitted to the Director of Health Services annually. All personnel working with laboratory animals must complete the following training before handling animals: Laboratory Animal Allergens powerpoint - available on Canvas and Research Policy website All personnel using needles or performing surgery during the course of their research or teaching must complete the following training: OSHA Bloodborne Pathogens - available on Canvas All personnel working with mice must complete the following training: Training in Basic Biomethodology for Laboratory Mice - NIH CD available in Vivarium office All personnel doing surgery must complete the following training: Training in Survival Rodent Surgery - NIH CD available in Vivarium office The Vivarium Manager is available for hands on training in use and handling of laboratory animals. Records of training will be kept in the Vivarium office. E1. Copies of the American Veterinary Medical Association (AVMA) Guidelines for the Euthanasia of Animals: 2013 Edition are available in the Vivarium office N110. F1. Animals euthanized with carbon dioxide and that have metabolized any chemical or drug exposure are eligible for donation to a local raptor rescue organization. Those animals are placed in the green container in the chest freezer. Any animals euthanized with an overdose of barbiturates or have not metabolized chemicals or drugs must be placed in the red container in the chest freezer for incineration. Project A2. Justify the choice of species and numbers requested paying careful attention to the principles of Russell and Burch (1959). Replace the species with less sentient animals or organisms. Consider cell cultures, invertebrates, plants or eggs of birds and reptiles. Reduce the number of animals needed by careful planning of experimental groups to insure statistical power. Refine the procedures planned to limit pain and distress. Use analgesics as appropriate or change techniques to reduce the incidence of stressors. Use the least amount of animals as possible, but make sure that there are enough to provide statistical significance and scientific validity. Take advantage of on-line resources to plan your research. Several links are available:  HYPERLINK "http://statpages.org/" http://statpages.org/ has much useful information on statistical power and tests.  HYPERLINK "https://rgs.usu.edu/iacuc/files/uploads/Policies-Guidelines/animal_numbers.doc" https://rgs.usu.edu/iacuc/files/uploads/Policies-Guidelines/animal_numbers.doc has information on how to determine animal numbers with an extensive bibliography and links to other sites. A3. Standard Operating Protocols (SOPs) have been developed for common procedures. They are posted on the IACUC website. Use of these SOPs is encouraged and simplifies the application and approval process. Training in the SOPs is available from the Vivarium Manager. B1. Describe in detail the procedures planned in which animals will be used. Pay careful attention to such details as: Method of restraint Use and monitoring of analgesics, sedation, or anesthetics Surgical procedures Pre and post operative procedures and monitoring Description of behavioral conditioning and testing Assessment of pain or distress Method of sample collection Assurances A1. The USDA and the PHS require that alternatives to animal research be considered. At least two databases must be consulted using appropriate search terms. There are a number of good sources for help in constructing searches including the Animal Welfare Information Center ( HYPERLINK "http://www.nal.usda.gov/awic/" www.nal.usda.gov/awic/) and AltWeb ( HYPERLINK "http://altweb.jhsph.edu/" http://altweb.jhsph.edu/).     IACUC Form (rev. 8/13) Page  PAGE 2 of  NUMPAGES 5 IACUC Form (rev. 8/13) Page  PAGE 1 of  NUMPAGES 5 $%&4GHu% , . 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