FREQUENTLY ASKED QUESTIONS

Transcription

1 FREQUENTLY ASKED QUESTIONS 1. What are all these acronyms & abbreviations? 2. What is the Animal Welfare Assurance Number for Rosalind Franklin University for grant submission? 3. Do I need an Animal Protocol? 4. Who can submit an animal protocol as PI? 5. Who can work with animals? 6. How do I add a new person (technician, student) to an approved protocol? 7. What training is required for individuals listed on an animal protocol? 8. What immunizations do I need to work with animals? 9. A person left my lab. What do I do? 10. How do I order animals from a conventional vendor? 11. What about bringing in animals from a non-standard vendor such as transgenic mice that a colleague has generated at another institution? 12. I have several protocols. Can I use one Animal Order for all? 13. How often do I have to file a new Animal Protocol Application for IACUC review? 14. What if I need to change something in my project? 15. Can the animal use application be submitted online? 16. Can more than one species be listed on a protocol? 17. How do I change title or indicate a funding change for my project? 18. What if I need to order more (or different) animals than what is approved on my protocol? 19. How do I change or add an experimental procedure? 20. How do I change (or add) the location of my study area? 21. My protocol expired. What should I do? 22. I still have animals remaining on my expired protocol - what happens now? 23. I have extra animals and another investigator would like to use those animals for their studies. What do we do? 24. How do I report a concern regarding the use of animals at the University? 25. How do I dress to go into an animal room in the BRF? 26. My student brought the wrong animals to my lab. What do I do? 27. When do I need to wean rodents? 28. I need to separate some of my animals. Where do I get clean cages? 29. What do I do with the dirty cages? 30. How do I transport the animals to my lab? 31. How long may I keep an animal in my laboratory? 32. What are the requirements to perform rodent survival surgery in my laboratory? 33. Where can I perform surgery on non-rodent species? 34. Where do I perform euthanasia of the animals? Updated

2 35. Can I use dry ice as a source of CO2 for euthanasia? 36. Can I use ether as an anesthetic or euthanizing agent? 37. How do I order controlled drugs to use in my animal studies? 38. What do I do with the carcasses? 39. Several of my animals look very unhealthy. What do I do? 40. I was bitten by one of the animals. What do I do? 41. What are the dates of the Full Committee Meeting? Where is the meeting? 42. When are IACUC inspections? 44. What will happen if I do not follow my protocol? 45. What is a good resource for questions about animal research that I provide to my nonscientist friend or neighbor? 1. What are all these acronyms & abbreviations? AAALAC: Association for the Accreditation and Assessment of Laboratory Animal Care International APHIS: Animal and Plant Health Inspection Service - the component of the USDA that administers the Animal Welfare Act. Within APHIS, Animal Care (AC) is the agency that is responsible for ensuring compliance with the Animal Welfare Regulations. AV: Attending Veterinarian AVMA: American Veterinary Medical Association BRF: The Biological Resource Facility is where animals are housed and cared for at the university. IACUC: Institutional Animal Care and Use Committee NIH: National Institutes of Health USDA: United States Department of Agriculture OLAW: Office of Laboratory Animal Welfare the component of the NIH that administers the PHS Policy on Humane Care and Use of Laboratory Animals PHS: Public Health Service a component of the U.S. Department of Health and Human Services (The NIH is part of the PHS). PI: Principal Investigator 2. What is the Animal Welfare Assurance Number for Rosalind Franklin University for grant submission? The number to put on the NIH grant application is: A Do I need an Animal Protocol? An approved animal protocol must be procured by anyone using live vertebrate animals in teaching, research, or testing. This is required regardless of animal use site, funding source, vertebrate species, or animal number. There are a few exceptions (cases in which you don t need an animal protocol): Updated

3 if you are using invertebrates if you are using embryos (e.g. fertilized chicken eggs) but see specific IACUC guidelines on this issue) if you will use obtained from an animal carcass (such as tissue obtained from an abattoir or from another investigator who is providing excess tissue from an animal that has been obtained and euthanized for his IACUC approved research project. Sharing of tissues is desirable in the spirit of reducing animal use. if you will be working at another institution and not utilizing any funds procured (or managed) through RFUMS. if you will be ordering and using custom antibody products from a commercial vendor. However, you always use a vendor that has a PHS assurance number. 4. Who can submit an animal protocol as PI? Only persons with faculty status may submit protocol applications as principal investigator. Students and postdoctoral fellows can participate in protocol preparation but cannot sign the protocol as P.I. 5. Who can work with animals? Individuals who are listed on a roster for a protocol approved by the Institutional Animal Care and Use Committee (IACUC) and who have completed basic training and any specialized training that is required to conduct their duties. The PI must ensure that all necessary training is completed for individuals listed on his/her protocol. 6. How do I add a new person (technician, student) to an approved protocol? The PI submits this information in a letter to the IACUC Chair and the IACUC Coordinator. New people must have completed the web0based basic training prior to being added to a protocol. See web-site for additional information. 7. What training is required for individuals listed on an animal protocol? Information about the training requirements are posted on the IACUC website under Training. All personnel will, at the minimum, need to complete the basic training web modules and receive in-lab training that covers safety and other issues by the PI or designee. More extensive training in specialized procedures (euthanasia, surgery, etc) is often required and this should be carefully documented by the PI. Individual Training Record forms are available on the web site for documentation purposes and should be maintained for all personnel. 8. What immunizations do I need to work with animals? All persons contacting animals need at least a tetanus shot every 10 years. The University will pay for this if requested - Contact Office of Environmental Health and Safety for additional information. Updated

4 9. A person left my lab. What do I do? The PI must inform the IACUC Coordinator of the roster change. 10. How do I order animals from a conventional vendor? The BRF/IACUC coordinator s office maintains a list of assessed vendors and contact information. BRF will order your animals for you only if your protocol has been approved by the IACUC (and has not expired) and if the number requested does not exceed the number of animals approved. Animal orders must be placed no later than Thursday noon for delivery the following week. To complete an animal order you will need to fill out an Animal Order Request Form and put it into the IACUC/BRF drop box. Make sure to fill out the form in its entirety. 11. What about bringing in animals from a non-standard vendor such as transgenic mice that a colleague has generated at another institution? Authorization by the BRF Director must be granted prior to shipping animals to the vivarium. Detailed health records and other information will be requested and only healthy animals will be accepted. If animals screen positive for certain contagious or pathological diseases treatment or re-derivation may be required. The process may require several months and thus PIs are encouraged to start the process early. Please check the web site and contact the BRF Manager for further information. 12. I have several protocols. Can I use one Animal Order for all? No. Please submit an order form for each protocol you are requesting animals for. Be sure the protocol number is on each order form and that you are not requesting more animals than have been approved for that protocol. 13. How often do I have to file a new Animal Protocol Application for IACUC review? Protocols are approved for a period of three years BUT this is contingent upon the PI filing Annual Renewal applications in a timely manner. Two annual renewals are allowed (using the short form). Before the end of the third year, you must submit a new Animal Protocol Application (using new forms if such are available since your last submission) if you wish to continue the project. The IACUC office will send you reminders well in advance of expiration dates. It does not matter if your grant award is for five years- you must still file a new protocol application every 3 years. 14. What if I need to change something in my project? If the changes are minor, submit the request in a letter to the IACUC Chair. If changes are significant, the IACUC requires that you submit the application form called Significant Change to Approved Animal Protocol. Major changes in the application include species change, change in PI, major change in animal number, increase in invasiveness of procedures or other major procedural changes. Contact the IACUC Chair if you are not sure whether your proposed change is minor or significant. Updated

5 15. Can the animal use application be submitted online? Yes. The application should be submitted as an attachment to the IACUC coordinator. However, one printed signed copy of the final application must be submitted before final approval is granted. 16. Can more than one species be listed on a protocol? Yes, there are provisions for describing work with more than one species on the application. However, as best practice, if more than 2 species will be used, the PI should submit a separate protocol for the additional species. 17. How do I change title or indicate a funding change for my project? Title/Funding Changes are appropriate only if the animal related procedures are identical to those in the originally approved application. Submit the Administrative Change form for this purpose from the website. NOTE: No additional animals are approved for Title/Funding changes and the renewal date will remain the same as the original protocol approval date. 18. What if I need to order more (or different) animals than what is approved on my protocol? If the number of animals substantially exceeds the number approved (>20%) or the species changes, you must file a Significant Modification of Approved Protocol application form to the IACUC for review. Once the modification is approved you may order the additional animals. For small overages, a letter requesting a minor modification in animal numbers to the IACUC Chair will usually suffice. Once the minor amendment is approved, you will be able to order the additional animals. A change in species requires a Significant Modification form and approval, a change in sex or strain does not. 19. How do I change or add an experimental procedure? Typically these would all be considered significant changes and thus a Significant Modification of Approved Protocol form should be submitted to the IACUC for review. A veterinary review may be necessary before the modification goes to the committee. Once the modification is approved you may begin the new procedure. 20. How do I change (or add) the location of my study area? A letter detailing this minor modification should be submitted to the IACUC Chair for review. Once the modification is approved you can change your location. Please note that a study area is not the same as a housing area; changing a housing location (to a place outside the BRF) requires inspection and consent by the IACUC and veterinary staff. 21. My protocol expired. What should I do? This is not a good development. Most likely the IACUC office sent you a reminder notice or two informing you of the upcoming expiration date. Had you followed the Updated

6 correct procedure in a timely manner, your protocol will probably have been renewed before the expiration date. However, if the protocol expired, all animal activities must cease until you get IACUC approval for a new protocol. By law, no experimental procedures can be done on animals under an expired protocol. Administrative extensions are not allowed. 22. I still have animals remaining on my expired protocol - what happens now? Your animals will automatically be transferred to BRF s Animal Holding Program (AHP) for up to 60 days. This will allow the PI time to seek approval for a new protocol or transfer the animals to another IACUC approved protocol. During the 60 days, BRF staff will care for the animals; breeding colonies will also be maintained to ensure viability. At the PIs request, the BRF can also euthanize the animals. Any animals remaining on the AHP longer than 60 days will euthanized if no other arrangements are made. 23. I have extra animals and another investigator would like to use those animals for their studies. What do we do? Complete the Animal Transfer form and submit it to the IACUC Chair for review. 24. How do I report a concern regarding the use of animals at the University? Notify either the IACUC Coordinator, the BRF Manager, the Veterinarians, the IACUC Chair, the VP for Research or the Compliance office. Further information is posted in the Reporting Concerns section of the IACUC web site and is posted in the BRF. 25. How do I dress to go into an animal room in the BRF? Generally, personal protective equipment such as lab coats or scrubs, gloves, masks and closed-toed shoes are required. Special entry requirements may be posted on the animal room door and must be followed. Biohazard areas are highly restricted and require special training for permission to enter. 26. My student brought the wrong animals to my lab. What do I do? The first thing to do is notify the BRF Manager! If the animals are still alive, we might be able to return them to the room without any consequence. If the animals are dead and need to be replaced, you will need to send a memo to IACUC explaining what happened. If the animals did not belong to you, you will be required to pay for the cost of the replacement. 27. When do I need to wean rodents? Rodents should be weaned by at least 23 days of age; BRF staff will do this for you if requested. 28. I need to separate some of my animals. Where do I get clean cages? If you need clean cages, ask one of BRF animal care staff to provide you with the cages Updated

7 you need. In case of emergency, you may get them yourself in the "clean side" of the cage-wash. Please pay close attention to the type of cage, stainless steel lid and sipper tubes on the water bottles (there are different sizes). Be certain that lids and doors are latched/locked closed. Make sure that the animals have feed and water. The water bottle should never be filled to the very top; it is necessary to leave an air pocket so the animal can get water from the bottle. Finally, be sure you fill out a cage card with all the relevant information. 29. What do I do with the dirty cages? All dirty cages are brought to the dirty side of the cagewasher. All cages can be left there and the technicians will dump the contents and wash the cages. 30. How do I transport the animals to my lab? Animal cages should be covered with a drape or a lab coat before leaving the BRF. They should be transported this way in the elevators, and all the way to your lab. If the animals are contagious or hazardous additional restrictions will apply. 31. How long may I keep an animal in my laboratory? You can keep an animal in your laboratory up to 12 hours without additional approval from the Institutional Animal Care and Use Committee (IACUC). 32. What are the requirements to perform rodent survival surgery in my laboratory? An area should be dedicated for rodent surgery at the time of use and should be away from any traffic areas in the laboratory. Further guidelines on rodent survival surgery can be found on the IACUC web site. 33. Where can I perform surgery on non-rodent species? For USDA covered species (e.g. vertebrate species of higher order than rodents or birds) a dedicated aseptic surgical facility is required. If you plan to use the animal surgical facilities in the BRF, be sure to call in advance to arrange for use of the facilities. 34. Where do I perform euthanasia of the animals? Euthanasia of the animals has to be done according to the means described in your approved protocol. For rodents and lower species, many investigators set up an area of their laboratories for the procedure. If euthanasia by carbon dioxide is what you need to do, there are tanks available in BRF; in addition the animal care staff in the BRF can also do the procedure. 35. Can I use dry ice as a source of CO2 for euthanasia? No, the American Veterinary Medical Association has recommended that this method not be utilized and thus this method cannot be used at RFUMS. Updated

8 36. Can I use ether as an anesthetic or euthanizing agent? No. There are several anesthetics that can replace ether. Ether is an explosive and irritating to mucous membranes and is not permitted as an anesthetic or euthanizing agent. 37. How do I order controlled drugs to use in my animal studies? A controlled drug must be listed on an approved protocol before it can be purchased. The drug can be ordered by contacting the Purchasing Agent in charge of handling controlled drugs. Currently, the designated DEA person at the University is Rachel Harrington. Controlled drugs cannot be ordered through the BRF. 38. What do I do with the carcasses? Animal carcasses should be placed into plastic bags and taken to the freezer in the BRF. If an animal needs to be examined by the Veterinarian, the BRF staff will assist you in storing it for subsequent necropsy. 39. Several of my animals look very unhealthy. What do I do? Contact the BRF Veterinarian or BRF Supervisor for advice. If these are experimental animals, review the humane endpoints specified in your protocol and consider euthanasia if veterinary treatment is not appropriate. In cases of conflict on whether or not an animal should be euthanized, the Veterinarian, by law, has the final authority over animal welfare. 40. I was bitten by one of the animals. What do I do? Immediately wash the wound with warm soapy water for several minutes. Notify your supervisor/ PI and Security! Obviously, seek additional medical attention if needed. 41. What are the dates of the Full Committee Meeting? Where is the meeting? IACUC Meetings are usually held the third Wednesday of every month at noon. IACUC meeting dates are posted on the web site. 42. When are IACUC inspections? Inspections are held every Spring & Fall (February and August) All live vertebrate animal housing & procedure areas (including BRF and all laboratories in which animals are used in approved protocols) 43. What will the IACUC look for during inspections? Some items the IACUC will look for on inspections include (but are not limited to): Appropriate drug storage, control, and expiration date monitoring Up to date calibration of anesthesia machines No human food and/or drink in any animal room Aseptic technique used in all survival surgeries, appropriate areas designated Updated

9 Staff trained and knowledgeable of protocol and informed of whistle-blower policy General cleanliness of lab areas Logs for temperature/humidity monitoring, room/cage cleaning, etc (for animal housing areas). 44. What will happen if I do not follow my protocol? If a protocol is not followed, an IACUC investigation can follow. The PI may be asked to take corrective action. The PI may be suspended from using animals for a period of time. These incidents will be reported to the Institutional Official, and possibly the USDA, OLAW, and the PI s funding source. 45. What is a good resource for questions about animal research that I provide to my nonscientist friend or neighbor? This site is of interest in discussing issues with laypersons: Updated