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Instructions for UCSD Animal Use Protocol Application
Before you begin... What to expect... Finding a protocol... It’s easy to get a list of your current protocols. From the menu choose "List the existing protocols for PI ID #", leave the field empty and hit the SUBMIT button. You will receive a list of your current protocols, the status of the protocol and buttons to edit or print those protocols. If you have permission granted to access another PI’s protocols, you may enter the ID# in the field and hit the SUBMIT button. People... General Tips and Recommendations… Use only one species per protocol. If you do the same experiments on another species, simply choose the "clone" menu choice to produce a copy and then edit for the second species.
The IACUC recommends that you combine all experiments for each particular species into one protocol application. Frequently Asked Questions… Computer Access How do I get a password? What if I forgot my password? Click here to request a login and you will receive an email response within 24 business hours. Only UCSD employees and students may obtain access to this system. Where do I get help for computer problems? The IACUC web site is best viewed with IE 5.0/higher or Netscape 6.0/higher, resolution 800x600 and COOKIES TURNED ON. If cookies are not turned on, you will not be able to submit an online protocol. Do not use your browser BACK button when in the online form. For technical assistance, please call your departmental computer support first, then call 858-534-1086.
Questions about Forms Where do I get help with online forms? First, click on the red question mark or the hyperlinks that you see on the form for further explanation about each question on the form. If you still need help, call 858-534-6069. Who must apply to the UCSD IACUC? You must have a Protocol for Animal Use approved by the UCSD Institutional Animal Care and Use Committee (IACUC) before you can conduct any project involving research, teaching, or testing using live, vertebrate animals at UCSD. The protocol must be approved by the IACUC before you can begin the proposed activity. Only UCSD faculty and individuals otherwise eligible to apply for research grants through UCSD may be the Principal Investigator on an Animal Use Protocol. The use of animals in research, teaching and testing is a privilege of faculty at UCSD, not a right, and it may be withheld or revoked by the IACUC. Can I save my work and come back later? Yes. Scroll to the bottom of the form and hit the button “Save as a Draft”. You may come back at anytime and continue to fill out the form. Can I put more than one species on my protocol? No. Each protocol should include all of the experiments and procedures that you will perform on one species. What should I do if I am working on more than one species? Use the menu choice “Clone a Protocol” to create a copy of any protocol; the clone will appear with a new Protocol Number. You may then edit any aspect of the protocol and submit. Can I let someone else fill out my Animal Use Protocols? The UCSD IACUC encourages Principal Investigators to write and submit each Animal Use Protocol. The online form makes it easy to give complete and correct answers. However, a staff member may fill out an online protocol with the permission of the Principal Investigator. Can I let someone else fill out my Personnel Qualifications Form? No. The IACUC has determined that each person who uses animals must fill out his/her own Personnel Qualifications (PQ) Form. You may not fill out this form for another person. How long does it take to review my Personal Qualifications Form before I receive approval? Your Personal Qualifications Form will be reviewed within one week and you will be notified of any classes required or other requirements. Can I attend training classes prior to filling out and submitting a Personnel Qualifications Form? Yes, although it is recommended that you fill out the Personnel Qualifications Form as early as possible to avoid any possible delays. Will training taken at other universities count in lieu of the UCSD training program? Anyone performing animal research at UCSD must take, at a minimum ,Orientation to Research at UCSD. Additional training may be required depending on background experience, procedures, and/or species. Do I need to fill out all sections of the Animal Use Protocol? Yes. You need to answer each question in order to submit the Animal Use Protocol. If you do not answer every question you not be allowed to submit the Protocol. If an answer is incomplete, your Animal Use Protocol may be delayed and you will receive an email from the IACUC asking for more information. Why is there data missing in my Animal Use Protocol? The UCSD IACUC has recently launched a new Online Protocol System. There are many features which will make it much easier to complete your forms, keep track of your approvals, “clone” old forms to create new applications, view your current forms and change information online. The old system did not capture data from all sections of an application, so the data we have imported is limited. Also, since the old system was not in the best shape, there may be discrepancies between what we have and what you know is correct. Please do not be alarmed by this. Feel free to correct these errors when you come across them. What if I can’t answer a question on the form? First, check out the hyperlink help for the question. If you still need help, please call the IACUC office (Animal Welfare Program) at 858-534-6069. An IACUC administrator may help you or refer you to an analyst for more help. Can I see a list of my Animal Use Protocols? Yes. After you log in you will have a menu of options. Choose List the existing protocols for PI ID #. If you leave the field blank it will default to a list of the protocols from the logged-in user. You may also enter another ID number in this field. How can I decide which Pain and Distress Category my experiments are in? The USDA regulations require UCSD to report each year on the number of animals used and the pain category of each animal. We must therefore ask you to report both prospectively and retrospectively on your animal use and category. A good explanation is available in Pain and Distress Categories C, D & E. No. You only need to complete the animal use application if you are working on a vertebrate animal. PHS Policy defines an animal as “any live, vertebrate animal used or intended for use in research, research training, experimentation, or biological testing, or for related purposes”. The Animal Welfare Act Regulations (AWAR) define an animal as “any live or dead dog, cat, nonhuman primate, guinea pig, hamster, rabbit, or any other warm-blooded animal, which is being used or is intended for use for research, teaching, testing, experimentation, or exhibition purposes, or as a pet. This term excludes birds, and rats and mice bred for use in research.” The IACUC ensures the campus is in compliance with all regulations by applying the AWAR and PHS regulations to all vertebrate animal use on campus for teaching and research. Who should be listed on a protocol? Everyone with direct animal contact should be listed. New personnel should be added to a protocol prior to their use of laboratory animals. Each person must also complete and submit a Personnel Qualifications Form. Can I get help with writing my animal use protocol? Yes. For questions on federal assurances, funding or experimental design, email iacuc@ucsd.edu or call 858-534-6069. For consultation on animal procedures or veterinary care issues email kjenne@ucsd.edu or call 858-822-5687. For consultation on anesthesia, analgesia or surgical issues email jfujimoto@ucsd.edu or call 858-534-8612. What if all I need is some blood or tissue, or I want to buy some antibodies? You must have a Tissue Transfer Approval before you can import animal tissue (fixed or unfixed) from another investigator within UCSD or from an outside source. Generally, the tissue source must have an NIH Animal Welfare Assurance.
How do I? How do I get animal facility access? 1. Log in from the IACUC Home Page 2. Fill out a Personnel Qualifications (PQ) form and submit 3. Ask your P.I. to add you to each protocol that you will work on or to send an email to iacuc@ucsd.edu. 4. You will receive an email confirmation of your PQ with a list of the mandatory classes you must attend. 5. Attend Orientation to Animal Research at UCSD after you register online. 6. Go to the Animal Care Program office to get your photograph taken and hand scanned for access. This service is available each Tuesday and Thursday 1:30 to 4:00 p.m. Note: your ID badge and facility access will not be issued until you have completed the above steps. Who do I call if I have a question about animal anesthetics, analgesia, surgery, monitoring, or training in procedures? The Animal Care Program has many services, equipment and training available to you. For a consultation on anesthetics or analgesia call 858-534-8612. For other services see the Animal Care Program Index of Services web page. Who can I call with a question that is not on these FAQs? Please call the Animal Welfare Program at 534-6069. We will be glad to answer your question or direct you to the help you need. Who should I contact if my project involves hazardous biological agents or radioactive material? UCSD Environmental Health and Safety has a website with detailed information about obtaining a BUA or RUA and also contains valuable information on the employee occupational health program, ergonomics, chemical safety, and hazardous waste. Do I need to participate in the Occupational Health Program and medical surveillance? You will need to take the risk assessment screening questionnaire located online at the EH&S web site to determine if you are required to enroll in the program or if it is recommended that you enroll in the program.
When? How long does it take to review my Animal Use Protocol before I get approval? You must allow 6 – 8 weeks for the approval process after you submit your application. Your Animal Use Protocol application goes through a very thorough review process where it is reviewed by veterinary staff, Environmental Health and Safety, administrative professional staff, and the entire Institutional Animal Care and Use Committee at a monthly meeting. What happens to the protocol after it is submitted? All protocols receive veterinary review, administrative review by Animal Welfare Program staff to assure that all animal care and use conforms to PHS, USDA, and UCSD requirements, and (as necessary) Environmental Health and Safety (EH&S) review and Conflict of Interest (COI) review. Depending on these reviews, the Principal Investigator may be asked for additional information or clarifications by telephone, email, or letter. These responses may then receive additional veterinary and administrative review. When complete, the protocol is reviewed by the UCSD IACUC. One member may be appointed "Primary Reviewer" for a particular protocol. If the Primary Reviewer has questions not previously addressed in veterinary or administrative review, he or she may contact the PI directly. At the monthly meeting of the IACUC, the Primary Reviewer presents the protocol, and his/her recommendations, for discussion. The IACUC will vote to either:
Will I be notified of the expiration and renewal dates of my Animal Use Protocol? It the responsibility of each Principal Investigator to track the expiration dates of each protocol. You will receive a courtesy notice from the IACUC (Animal Welfare Program) allowing you enough time to complete your renewal. If you do not respond by the deadline for renewal, your protocol will expire and you cannot purchase or use animals on this campus. What are the meeting dates and submission deadlines for the IACUC? The IACUC meets monthly on the third Wednesday of each month. The deadline for each meeting is the third Friday of the previous month. A yearly calendar of these dates is published. How long is a protocol approval good for?Three years. You should write the animal use application to include all work and all animal requested for three years. You will be required to rewrite the protocol application every third year. However, federal regulations also require you to update the information on your protocol annually. How do I renew my protocol?From the IACUC website choose log in. After you log in you will have a menu of options. Choose Annual Renewal. When should I report changes or modifications to my protocol? Every change or modification to your protocol must be approved by the IACUC before you begin. From the IACUC website, choose log in. After you log in you will have a menu of options. Choose Amend Protocol. If I received word that my protocol was approved, when can I start my work? If your approval letter states full approval you may begin work immediately. If your approval letter lists conditions then you must fulfill the conditions before beginning the work. If your approval letter states “Modifications Required…” you must answer the questions asked of you and wait to receive approval to begin your work. Can I order animals before I have an approved Animal Use Protocol? No.
What do all these terms and acronyms mean? What is the UCSD Animal Care and Use Program? Federal Regulations require that each institution have an Animal Care and Use Program to assure that all Animal Welfare laws, regulations and policies are implemented and consistently followed at the institution. At UCSD the Animal Care and Use Program consists of three components which work together – the IACUC, the Animal Welfare Program and the Animal Care Program What is the IACUC? The Institutional Animal Care and Use Committee oversees the University's animal care and use programs, facilities and procedures and ensures the appropriate care, use and humane treatment of animals being used for research, testing and education. The IACUC is also responsible for reviewing all animal use protocols, ensuring compliance with federal regulations, inspecting animal facilities and laboratories and overseeing training and educational programs. The IACUC serves as a resource to faculty, investigators, technicians, students, and staff, providing guidance in planning and conducting all animal use procedures in accordance with the highest scientific, humane, and ethical principles. The faculty members of this Committee are appointed by the Institutional Official (Vice Chancellor for Research) from each school and functional unit of the University. What is the Animal Welfare Program? The Animal Welfare Program is the administrative, regulatory and compliance arm of the Animal Care and Use Program. You should contact the Animal Welfare Program to get an Animal Use Protocol approved, renewed or amended. You should contact the AWP to report animal concerns. What is the Animal Care Program? The Animal Care Program is the veterinary care, housing, and husbandry arm of the Animal Care and Use Program. You should contact the Animal Care and Use program to arrange for purchasing animals, housing animals or to report animal health concerns. You should contact the ACP with facility or caging concerns. What is the meaning of this term/abbreviation/acronym? Please check our glossary. What is our PHS Assurance Number?
If you wish to propose a study that uses a species not on this pull down list, please email vetservices@acp.ucsd.edu. ACP veterinary staff will respond to you within 24 hours to discuss the species, housing requirements, and location. If approved, you will be notified that the new species has been added to the pull down list. Goals of the research must be clearly written to explain the purpose, scope, and significance of the research being proposed. It should be written in language that can be understood by a college graduate with no medical background. Scientific jargon should be held at a minimum. Abstracts that are submitted to scientific meetings and abstracts which are parts of a grant proposal generally have too much scientific jargon and assume considerable knowledge of the subject being discussed. Not all scientific disciplines are represented on the Committee and the non-faculty members of the Committee should be able to clearly understand the intent and significance of the study. Explain your rationale for using animals in your studies. The rationale should include reasons why non-animal models cannot be used. Consider in vitro testing, computer modeling, cell lines, organisms lower on the phylogenetic scale, bacteria, fungi, plants, drosophila, non-vertebrates. Check these sites for help: http://www.vetmed.ucdavis.edu/Animal_Alternatives/main.htm
United States Department of Agriculture (USDA) defines animal as any live or dead dog, cat, nonhuman primate, guinea pig, hamster, rabbit, or any other warm-blooded animal, which is being used, or is intended for use for research, teaching, testing, experimentation, or exhibition purposes, or as a pet. This term excludes: birds, rats of the genus Rattus and mice of the genus Mus bred for use in research, and horses not used for research purposes and other farm animals, such as, but not limited to livestock or poultry, used or intended for use as food or fiber, or livestock or poultry used or intended for use for improving animal nutrition, breeding, management, or production efficiency, or for improving the quality of food or fiber. With respect to a dog, the term means all dogs, including those used for hunting, security, or breeding purposes. Procedures classified as category D or category E Category D: Potential pain or distress
relieved with anesthetics, analgesics and/or tranquilizer drugs or other
methods for relieving pain or distress.
Animals to be used in Category D or E procedures should be of an appropriate species and quality and the minimum number required to obtain valid results. Methods such as mathematical models, computer simulations, and in vitro biological systems should be considered whenever possible. Proper use of animals including avoidance or minimization of discomfort, distress and pain consistent with sound scientific practices is imperative. Faculty, students, and staff should consult Essentials for Animal Research, a useful resource for investigators. How to satisfy regulatory requirements for alternativesPrincipal Investigators often ask about the requirement to search for alternative procedures to those involving alleviated or unalleviated pain or distress. The AWA requires the Principal Investigator to consider alternatives to procedures that may cause pain or distress to animals and to provide a written narrative in their protocol of the methods used and sources consulted to determine the availability of alternatives. Alternatives should be considered during planning of the animal use proposal and should form part of the routine scientific literature search and not be separate from it. If a bona fide alternative method is identified, the written narrative should justify why this alternative was not used.Alternatives should aim at avoiding or minimizing discomfort, distress or pain without compromising research goals using the so-called “3 Rs”. The 3 Rs include: replacement with no-animal systems when possible, reduction in the number of animals required to obtain scientifically valid data through better experimental design and refinement techniques that decrease or eliminate pain or distress. All three approaches should be considered. The federal requirements can be met by any of the following:
Animal Welfare Information Center (AWIC), an information service of the National Agricultural Library, was created specifically by Congress to provide information on ways to minimize pain and distress. AWIC can formulate search strategy, select key words and databases, access unique databases, train in conducting effective alternatives searches, and perform no-cost or low-cost electronic database searches. AWIC has developed an anesthesia and analgesia database that is now available on ALTWEB. Other sources for alternatives searches are:
The IACUC recognizes that, for certain situations, a computerized literature search may not be an appropriate means of identifying alternatives. In such cases, the investigator should record the source of expert information, qualifications and the date of consultation. The PI must also supply a narrative that includes all findings from the search for alternative methods. Question 11. Strains/Breeds All strains, breeds or genotypes used in these studies must be listed in this section. Although you only see one line on the form, more lines will be created each time you hit the SAVE STRAIN button. It is essential that the IACUC reviews potential health issues due to phenotypes expressed in genetically altered animals. You may describe these phenotypes briefly in this section and later in the Pain and Distress section you will indicate how you will minimize and recognize pain and distress in these animals. The Lab ID section is for your optional use if you have a shortened strain designation ("nickname") that you would like to enter. This is the ANIMAL NUMBERS SECTION. Here you request the total number of animals you will need for studies during the THREE YEAR course of this protocol. Although in years past you were asked to request numbers for one year, this is no longer true. You are asked to plan and justify the animal numbers for THREE YEARS. Step One: Plan out your experimental groups. The IACUC has determined that each experimental group must be listed and described. Step Two: Determine the pain/distress classification for each experimental group of animals by referring to the IACUC Policy on Pain and Distress. Breeding colony groups are always Pain/Distress category C. Step Three: Fill out the table; to add new groups simply press the SAVE GROUP button. If you have indicated that you will run your own breeding colony (i.e. you checked the box for breed animals in the Procedures to be Performed Section) then two groups will automatically appear in this table - Colony Maintenance and Transferred. You cannot delete these groups but you can place a 0 for number of animals if you do not transfer animals out of the protocol.
Step Four: Press the REFRESH button to automatically total for you the numbers of animals requested. Step Five: For each group/experiment that you have listed a text field will be created. Enter the brief description of the studies that will be performed on the group. This should be an overview that enables the IACUC reviewer to understand your experimental design and be able to understand what procedures (including treatments, data collection, endpoints) will be done on each animal through the course of the study. Provide a brief explanation of numbers requested.
Question 13. Justification of the number of animals requested. How were the sample size, number of groups, and number of repetitions determined? A key principle in the ethical use of animals in research, testing and teaching is that the number of animals used in each project is the minimum necessary to obtain valid and meaningful results. By law the IACUC must review the number of animals requested in each protocol and agree that the number is appropriately justified in terms of the stated goals of the project.
The number of animals should be based on the experiments designed to test the hypothesis or otherwise achieve the goals of the project. That is, the number of animals must be justified by the scientific objectives. A brief description or outline of the proposed experiments should be provided to the IACUC that includes: · The purpose of each experiment or set of related experiments, · The number and species/strain of animals per group/subgroup, · The number of groups/subgroups, and · The number of control and experimental animals
If the project involves euthanizing animals for tissue, the protocol should explain how the number of animals requested relates to the amount of tissue/cells needed for particular in vitro experiments. Animal numbers cannot be justified on the basis of how many experiments the lab personnel can perform in a week, month, etc; nor can the cost of the animal be the primary justification.
Research and testing studies should be designed to test statistical significance of the result(s) with a minimum number of animals.The number of animals requested can be based on previous experience or published information using similar procedures, and whenever possible, justified statistically. Statistical techniques should be used to maximize the analysis of the data generated from each animal, thus reducing the total number of animals necessary for a particular set of data.The number of animals must be sufficient to obtain meaningful data. Replication within experiments can lead to a seemingly large number of animals being used; however this may be well-justified and necessary. Biological variation in the test system can obscure the effects of a given intervention if the sample size is insufficient to obtain a statistically significant result (e.g., n=1 is generally not acceptable). It is useful to consult with a statistician or utilize a statistical software package during the design. Pilot StudiesDepending on the nature of the pilot study, the number of animals can be justified in terms of:· Determining the feasibility of a procedure or technique, · Assessing the effect of a procedure on the animal, or · Generating sufficient data to allow the investigator to project the approximate number of animals that will be needed to reach statistical significance (such as power analysis).
All animals involved in the project must be included in the protocol and justified. This includes not only experimental animals, but also donor animals, breeding pairs, pregnant mothers, and offspring that cannot be utilized because of genotype, sex, etc. Any need for additional animals due to anticipated losses due to morbidity, mortality or other known difficulties with the experimental procedures should be explained and justified. Repetition of ExperimentsRepetition of experiments is important in certain cases. For example, changes in technology that greatly enhance the data resolution may justify a series of experiments being repeated. Also, comparisons between species are important if certain specific phenomena are to be shown to be more generally applicable. Repetition that is a direct repeat of a previous study is less readily justified and investigators are discouraged from such studies. The Animal Welfare Act requires that investigators state that a proposed activity is not "unnecessarily duplicative" of previous studies.
More help is available in Animal Experimental Design and Online Statistics Textbook Section 16. In Vivo Blood/Tissue Collection If you agree to follow the guidelines as stated in the IACUC Policy, you can simply check the box. If you are asking for a variation from the policy you must describe your procedure in the text field and provide justification.Too much blood collected at any one time may cause hypovolemic shock, physiological stress and even death. If smaller volumes are collected too frequently, anemia may result.
As a general rule, 20% of the total blood volume can be collected at one time every 2-4 weeks, or 1% at more frequent intervals of 24 hours or more. The total blood volume can be calculated as approximately 6% of body weight. The estimated volume at exsanguination is approximately half of the total blood volume.
Mice
To improve vasodilation effects in rodents, it is helpful to warm the entire patient. This can be accomplished in 10-15 min at 40o C with a special commercially available warming chamber. Care should be taken to prevent overheating. The choice of anesthetics is an important consideration when collecting blood from rodents due to physiologic effects of the anesthetic. Consult with an ACP veterinarian. If you are not experienced in blood collection techniques, training is recommended. If you have questions or comments about any of the above techniques, contact an ACP veterinary technician at vetservices@acp.ucsd.edu.
Total blood volume = 6% of lean body weight.Maximum blood collection = 10% of total blood volume every two (2) weeks. Example: 30 gm mouse = 0.03 kg x 0.06 = 1.8 ml x 0.10 = 0.18 ml
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