ࡱ> UWT_ Wbjbj 0h9b9bO,ACCCCCC$pgg|aaaAaAaaa_?Qa-0a`a`a`aagga`B ^: GUIDELINES FOR COMPLETING AN APPLICATION FOR USE OF ANIMALS IN RESEARCH March 2019 v.1 Below is a list of guidelines to help applicants complete the Animal Ethics Committee (AEC) application form for the use of animals in research. These guidelines are provided to ensure the applicant provides the requested information in the required detail, as failure to do so may lead to further information being solicited from the Animal Ethics Committee and this will result in a delay in the application being evaluated. If you have any questions, or are unsure how to answer a question, please contact the AEC for further guidance and help. Section 1, title: Give the title of your project here. The title should reflect the work you propose; although this may seem obvious, the AEC has received a few proposals in the past where we had trouble seeing any connection between the project title and what the applicant proposed to do! Section 2, applicant details: Provide the requested contact details here. Please ensure you provide an email address that you check regularly, as most communication between you and the AEC will be via email. If you are a student, you must also provide the contact details of your supervisor. Section 3, plain language summary: In this section the AEC is requesting you provide a PLAIN LANGUAGE summary of your work. This section ensures those members of the AEC that are not experts in your particular field will still understand your proposal. If a member of the AEC is unable to understand the basics of your project from the summary, you will be requested to re-write this section. The plain language summary should be written so that anyone outside your field will be able to clearly understand your proposed project. In other words, describe your project as you would to any member of the public, such as a newspaper reporter. You should not use excessive jargon or specialised terminology, and if it is necessary to include such terms, please define them in a glossary. Please keep this section concise and within the 250 word limit (you will be asked to shorten excessively long summaries). The summary should clearly state: (1) the objectives of the proposed project, (2) the key methods that you plan to use, and (3) the contribution this research will make to our understanding. Section 4, time period of study: List the start and end dates of the study. Applications cannot be approved for a period exceeding 3 years. Studies that carry on beyond 3 years need to reapply to continue the project. If you need to extend your study (and it still falls under the 3 years in total), you must submit an application to the AEC to amend your approval. To minimise the need to ask for an extension, think carefully about the time required and err on the generous side. For example, lets say you ask for a period of 3 months for your project (and this is granted), but in practise and due to unforeseen circumstances, your animals do not arrive until 6 weeks after the start date. As a result you need to apply for an extension, which may further delay your project. To avoid this problem, better to ask for 6 months or a year initially. You are not compelled to use the full time allocated, and if all goes to plan, you complete the project in 3 months. Section 5, purpose of research: In this section you are asked to explain the purpose of your proposed research. There are 5 parts to this section. Section 5a: In this section provide a brief background to your proposed project. In other words, describe the scientific reason(s) for your work. You can think of this section as a brief literature review, in which you set the context for your project based on our prior understanding. You can use more technical language here and make references to earlier work (if you cite references, please list these at the end of the application). However, again please keep the language simple and non-technical as possible. You should be able to explain the background to your project within 1-2 paragraphs. Section 5b: In this section, clearly state the objective(s) of the proposed project. In many cases, you will have a specific hypothesis (or set of hypotheses) you are intending to test. List these here. Details on how you will address the objectives are given in section 9. Section 5c: Describe the benefits that you anticipate will be obtained from your proposed research. In other words, what will we learn from your research, as this benefit needs to be weighed against the cost in harm/stress to the animals in order to justify approval of the project. Note that a benefit is not the work will allow me to complete my MSc, but instead, for example, this work will allow me to determine the effect of hormone disrupting pollutants on whitebait reproductive behaviour. Section 5d: You might think science progresses on being able to replicate previous work and so being asked to justify any study that involves repetition of an earlier study should not be questioned. However, the AEC is still interested in this aspect to your study, as the benefits gained from the repetition of studies needs to be evaluated in terms of the likely costs in the potential suffering to animals as a result. The AEC acknowledges the value of being able to replicate earlier work, but like any research on animals, you will have to justify the value of the study. Section 5e: State here how the results of this project will be used for the purposes of a thesis, publications, conference presentation, etc. It is expected that the results of research projects will be disseminated to the rest of the scientific community. If you do not tell others about the results of your research, then the study will likely need to be repeated by someone else (who hopefully does publish the results). This means the animals used in your project will have been subjected to stress or more invasive procedures (i.e., experienced a high cost), yet with no benefit as a result (since no one else will know what you discovered). Section 6, total number of animals to be used: Fill in the provided table with the number of individuals you plan to use of each species. Use a separate line for each species (add lines if needed). The scientific name of species is useful to give, although it is not required for common lab animals such as rats and pigeons, etc. Please double-check the numbers here with that described elsewhere in the application. Mismatches between numbers in different sections of the application is one of the most common problems identified by the AEC when reviewing proposals. Section 7, justification of numbers of animals requested: This section asks you to justify the number of animals you have indicated in section 6. This includes describing the experimental design, such as the number of treatment and control groups and how many individuals are in each group. It may be helpful in studies with complex experimental designs to include a table with each of the groups/treatments listed. Justifying the number of animals to be used is critical to your application. Tell the AEC why you need to use the number of animals requested. How did you arrive at this number? The committee is looking for some evidence that this number has a basis in statistical methods, or is justified on previous research which identified the minimum number needed for a similar study to the one you propose. Remember that the use of too few animals, which can limit any statistical power, may be just as problematic as overkill with excessively large sample sizes. The committee also realises that in some cases there is little prior experience or evidence to help guide such a justification. If this is your situation, then tell the committee this. One solution may be to conduct a pilot study to obtain some estimate of variance in the results that can then be used to justify a final sample size. Note that if you do not know the number of animals to be used, you must still provide your best estimate (do not leave this table blank or put in a question mark) as the AEC cannot approve applications that are open-ended. If it proves necessary to increase the number of animals used in a study after approval has been granted, you are requested to contact the AEC and to submit an amendment to alter the conditions of your approval. Section 8, the three Rs: The three Rs (replace, reduce and refine) are fundamental principles of conducting research on animals. Explain to the AEC how you have considered each of these principles in the design of your study. Are the proposed sample sizes the minimum needed but which still ensure sufficient statistical power? If you cannot change an aspect of your study tell us so and why. For example, is it possible to replace your study animal with either a non-sentient species or a computer model/simulation? If not, why not? Are the techniques you are proposing to use the least stressful or invasive way of obtaining the information needed? Are there less invasive methods available that would provide the same answers? Section 9, the approvals you are requesting: In this section you need to detail each of the procedures you plan to use. If more than one procedure is to be undertaken, describe each one in turn (add and number more subsections as needed). Provide enough detail so the committee members can fully understand what the animal will encounter in the course of your study. The level of detail should be sufficient so someone else can replicate your set-up or at least visualise what you plan to do. This includes descriptions of the treatments to which the animals will be subject, time periods involved in each treatment, post-treatment care, etc. Note that if you are capturing animals from the wild, the capture and transport of these animals needs to be listed as a procedure, even if it is not a part of the actual experiment. For some procedures, there are Standard Operating Procedures (SOP) available; these are documents approved by the AEC that detail particular procedures that are commonly used. Thus, you can cite these as the basis for the methods you will use, although please still provide a brief overview in the application. Check with your animal facilities manager for SOPs that available in your department. Section 10, grading of procedures: In the table, list each of the experimental procedures described in section 9. Name the procedure, number of animals to be used with each procedure, and assign a grading according to the criteria listed in the Appendix (NAEAC impact grades). Even if your proposed procedures are not specifically listed, the examples in the appendix will provide you with some guidelines to assign a grade. In the gradings, consider both the impact to the animal in terms of level of stress or pain experienced, and the timeframe of this impact. Keep in mind that timeframes vary across species, so an experiment lasting 1 week to a fish species that lives only 1 year has more of an impact that a 1 week experiment on a fish that lives 50 years on average. Although the grading criteria may seem somewhat subjective, as a rule of thumb, any work involving invasive surgical procedures with a period of post-operative care, rates at least a C ranking. Please also note that catching a wild animal is also classified as a C ranking. Under the table, please provide an explanation for the rankings you have selected. Note that the committee may suggest other rankings but a researcher will often have first-hand experience with the study animals that the committee would like to hear. Ranking the severity of procedures is a useful way of focusing the researchers attention on the level of pain or stress likely to be felt by the animal: you should always be asking yourself if there are alternative ways to obtain the information you require with procedures that have a lesser impact and timeframe. Section 11, cumulative grading of procedures: Using the gradings in the table in section 10, in this table we would like you to now consider the cumulative grading for any combination of procedures experienced by an animal. This takes into consideration multiple occurrences of stress/pain experienced by an animal over the course of your study. In some cases, the overall ranking will be same as the highest single ranking (e.g. B + A still equals B), but in other cases a higher overall ranking is warranted (e.g. B + B = C). As in section 10, please provide a brief explanation for the cumulative rankings you have assigned. Section 12, alternative methods: Researchers should always consider whether alternative methods are available that are less stressful or invasive for the animal but which still provide you with the necessary information required for your study. In this section, describe why alternative procedures are not suitable for the procedures you listed in section 9. The AEC realises that not all alternative methods may be suitable for the purposes of your study, but you need to tell us why this is the case in this section. Section 13, endpoints: An endpoint is the point in your study in which the experiment will be considered completed and the procedure is stopped. All procedures must have an endpoint and cannot carry on indefinitely until you get the result you want. Note by endpoint we do not mean the date at which you intend to finish the study (section 4) but the point at which you will discontinue subjecting an animal to a treatment. In this section, please also describe the conditions at which an experiment will end prior to such a predetermined endpoint. For example, if an experiment involves exposure of a fish to low oxygen for 45 minutes, then your endpoints might be something like the following: The endpoint will be 45 minutes of exposure to low oxygen. However, experimentation will stop with any fish that spends more than 1 minute at the surface of the water gasping for air. If more than 2 of the first 10 tested fish meet this criterion within 45 minutes, then the 45-minute end-point will be revised after consultation with the AEC. Thus, in this section the AEC wants to see an indication of the protocols you expect to define the end an experiment, and how to deal with situations that do not go according to plan. In other words, we want to know what you will do if all goes according to plan but also what you will do in the worst case scenario. If you need to change end-points and experimental design, remember that this can only be done upon approval by the AEC of an amendment application. Section 14, anaesthesia: In some studies, you may need to anaesthetise your animals (e.g. surgical procedures, sedating wild animals). Administering an anaesthetic can be risky (too little and the animal goes into shock during surgery, too much and the animal dies of an overdose). Thus, we are looking for detailed information here on how you will carry out anaesthesia, including justification for the type of drug selected, dose rates and how this was determined, methods of administration, monitoring, etc. This section will be closely examined by the University Vet and thus needs to be detailed enough to allow the Vet to assess the appropriateness of what you propose. SOPs for anaesthesia of some animals (e.g. rats) may be available to guide you. Note that most anaesthetic drugs are strictly controlled and approval will only be given by the AEC when accompanied by an IDAO approved by the University Vet. Section 15, post-operative care: In this section, provide us with detailed information on how you will look after the animals after they have been subjected to surgery. As above, this section will be closed examined by a Vet, and must contain sufficient detail to allow assessment of the appropriateness of care: what sort of analgesics will you use, at what dose, how will they be administered, etc.? It is also important to describe the schedule for monitoring animals after surgery and the criteria you will be using to assess the condition of the animals (e.g., frequency of checks, what will be monitored on each check, procedures if animals do not recover, etc.). Again, SOPs may be available from your animal facility manager to guide you in this area. Section 16, euthanizing animals: In some situations, an animal may not recover from a procedure as expected, whether it is from surgery or an accidental injury incurred in an experiment. If it seems unlikely that the animal will recover, euthanasia may be warranted. List the conditions that will lead you to decide that an animal will not recover and thus needs to be euthanized (e.g., rat does not become BAR within 12 hours of surgery, fish surveyed after electrofishing do not recover within 15 minutes in a recovery bucket of water, etc.). Describe the method of euthanasia, the dose to be used if a drug, and how death will be confirmed. Euthanasia must follow accepted methods, but as this varies across species, please check with your animal facility manager for advice or contact the University Vet. Section 17: List the locations of your study. The AEC needs to know the exact location of your study and where the animals are held, as we are required to inspect sites at regular intervals. Section 18, participants in project: In this section the committee wants to know who will actually be conducting the research on animals. In most cases this will be the named applicant(s) but often other personnel may be directly involved with the project, such as technicians or field assistants. Please tick the boxes that are relevant to your proposal (you can tick more than one box). In some cases the names of these people may not yet be known (e.g. field assistants to be hired in the second or third year of the study) but you should still indicate their involvement with the project. Note that all applicants and their supervisors must have appropriate training in the procedures proposed, and to have also passed the animal ethics exam. Field or lab assistants are not required to complete the AEC exam, but they must be supervised by the applicants when conducting this project. Confirmation of training (or confirmation that training will be provided) is requested in section 19. Section 19, qualifications: In this section describe the previous experience of the applicants and other personnel (see section 18) and their ability to carry out the proposed work. If any of the personnel do not have the training or skills required to carry out the work, describe how this training will be obtained prior to the start of the study. It is not the responsibility of the AEC to train researchers in their fields, but to ensure that they have the training required before being allowed to proceed with the research. Section 20, surgical experience: If you will be using anaesthetics and/or undertaking surgical procedures, describe your experience and qualifications to carry out such procedures in this section. The University Vet is required to monitor procedures involving surgery and will likely request to be present when you carry out a surgical procedure. The Vet may also be willing to provide training in surgical procedures, but this is something that must be arranged before you start your project (the Vet will then report to the AEC that the researcher has the experience to carry on with the rest of the project independently). As surgery is generally the most invasive procedures likely to be carried out in animal research, the AEC expects researchers using surgery to work to the highest standard. Section 21: Tell us what will happen to your animals after the study. If the animals are to be euthanised, explain why this needs to be done. Please be aware of regulations that involve releasing wild animals back in the environment after they have spent a period of time in captivity (e.g., it is not legal to release amphibians in NZ, even into the same pond they were collected from because of the risk of spreading fungal diseases). Section 22, declaration and signatures: please ensure you sign and date the application, and if you are a student, that your supervisor also signs. For all applicants, the application must be first approved by your head of department and this must be indicated by her/his signature. 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