THE UNIVERSITY OF MELBOURNE ANIMAL ETHICS COMMITTEE APPLICATION FOR APPROVAL TO USE ANIMALS FOR SCIENTIFIC PURPOSES RESEARCH OR TEACHING ACTIVITY Before completing an application, applicants should familiarise themselves with all relevant guidelines and legislation, including the NHMRC Australian code for the care and use of animals for scientific purposes (2013). Applicants should visit the OREI website and download the Application Form each time a new application is prepared, in order to ensure the most up-to-date version of the form is used. Applicants should also read the separate Additional Information sheet for specific guidelines on how to complete the application. To ensure that all AEC members are provided with sufficient information to participate effectively in the assessment of the application, all responses should be clear, concise and written in plain English. *Please save your application as a Word file (not a PDF) and use the Ethics ID number as the file name* 1. ADMINISTRATIVE DETAILS Project ID and Title: ID No: Example2 Title: Demonstration of Ultrasound Technology for the detection of pregnancy in bovines to dairy industry advisers Contacts: Name Department Project Supervisor Investigator 1 Veterinary and Agricultural Sciences Primary Contact Investigator 1 Veterinary And Agricultural Sciences 2. PROJECT BACKGROUND & AIMS 2.1 Provide a plain English summary of the background to the proposed work It is well documented that global dairy herd fertility has been declining over the last few decades with the reproductive performance of the Australian dairy herd following a similar deterioration. In response to this well recorded decline, the Australian dairy industry conducted a large-scale fertility study about 15 years ago to describe herd reproductive performance and identify risk factors. The study became known as the Incalf project and it proved to be a valuable resource, providing six key management areas for farmers to address in order to help improve herd reproductive performance. Since the completion of the project, many dairy farmers have been following the advice set out by the Incalf project; however, declining fertility still remains one of the biggest problems facing the Australian dairy industry. In response to the deterioration, the current needs and priorities around dairy herd reproductive performance were re-evaluated through industry-wide reviews conducted by Dairy Australia in its "Foundation for an industry plan" in 2010 and a review of factors critical to performance by the Geoffrey Gardiner Foundation in 2011. In light of these reviews, the Dairy Australia Animal Performance (fertility) Program has been put in place to deliver research and extension programs to improve dairy herd fertility. Part of the re-evaluation has concentrated on training advisers to be able to investigate and understand the reproductive performance of client herds so that they have the capability and confidence to take the next steps. A working group of key stakeholders was created to design and implement a training course called "Repro Right" for industry advisers (veterinarians and other professionals) to become highly skilled in reproductive management in a supported and sustainable manner. Office for Research Ethics and Integrity | Animal Ethics New Project Application form | Version 1.1 | July 2015 Page 1 of 5 2.2 Outline the overall aim and individual aims of the proposed work We will hold a half-day workshop, part of a series of training modules undertaken over a six month period, which aims to provide participants with an introduction in the use of manual and automated technology to detect pregnancy, sexing of a foetus and visualisation of reproductive tract disorders in bovines. 2.3 If applicable, provide details of the relationship of the proposed work to other work, e.g. AEC approved research or teaching, and clinical or agricultural activities. Include, as relevant, application ID numbers. Eight early pregnant (less than 16 weeks) teaching herd cows (previously diagnosed in the pregnancy testing cattle class for DVM 3 - Ethics ID 1234567.1) will be selected for the demonstration based on their state of pregnancy and the fact that they have not been used in a teaching class for at least seven days (as per the protocol requirements relating to cows used for rectal procedures ID 1234567.1). 3. EXPERIMENTAL OR COURSE DESIGN Provide the details of your proposed research or teaching activity. It should be clear and concise, but must contain enough detail that a proper assessment of the impacts of the protocols/procedures on each animal (or group of animals) can be made. You should make reference to: the number and types of animals, relative to specific procedures; the details of each protocol/procedure; the details of pain or distress experienced by the animals; the details of monitoring; and the fate of the animals. Overview: The major instructional component of the course will be delivered as an interactive workshop in a seminar room, followed by a 90 minute practical session using the teaching cows to demonstrate the effectiveness of ultra sound technology. Bluetooth enabled monitors will be linked to the scanning equipment to enable the participants to see the images being generated by the technician as he places the probe in the rectum of a cow. Procedure: The cows will initially be brought to the holding yard at the entrance to the cattle facility by the farm staff prior to the commencement of the workshop. At the start of the session four cows will be placed in each of the four crushes and fed an appropriate amount of pellets to relax them before being scanned. The experienced instructor will then demonstrate the technology by introducing a well-lubricated 5mHz sector probe within a rectal introducer (a stainless steel, thin arm containing the scanning device at the end of the probe) into the rectum of the cow. Depending on the stage of pregnancy the arm is moved in or out and with sideways sweeping motions to locate the uterus and the developing foetus. The instructor will be wearing the imaging equipment in a portable backpack to which the probe is connected. He will also have goggles that are connected to the backpack to display images of the internal organs as he sweeps the probe inside the rectum of the cow. Images that are transmitted to the headset of the operator are also transmitted using bluetooth technology, to three monitors placed conveniently in the shed to allow the 15 participants sufficient space around a monitor to observe the images. The instructor will then point out structures of interest and any abnormalities detected as well as the stage of pregnancy and possibly the sex of the foetus, depending on the quality of the image. The procedure should take no more than 5 minutes per cow but may be extended for about 5 minutes if abnormalities are detected or the discussion results in further interest in the findings. At the completion of the scan, the probe is withdrawn and the cow released from the crush and allowed to return to the holding yards to wait to be walked back to the paddock. Pain & Distress: The cows used in this project will only be required for the limited time required to scan their reproductive tracts and display the images on monitors placed in the cattle facility. The cows are domestic animals and are accustomed to close handling and, in our experience, tolerate involvement in practical classes very well. The diameter and size of the rectal introducer is such that an experienced user does not upset the cow, allowing her to stand quietly in the crush while the procedure is undertaken. The scanning procedure will create minimal pain and distress for the cows and is actually less invasive than the manual use of an arm for a rectal examination. The procedure is promoted by manufacturers as "gentler" on cows compared to manual pregnancy testing and, as a result, many farmers now choose to have their herds examined by ultrasound. Office for Research Ethics and Integrity | Animal Ethics New Project Application form | Version 1.1 | July 2015 Page 2 of 5 Monitoring: Animals will be continually observed for excessive vocalisation and aggressive resistance to the procedure during the workshop. If animals resist or display aversion behaviours during the session (such as sinking to the ground, kicking or excessive straining when the probe is inserted) they will be removed from the crush and returned to the holding yards to settle down before being walked back to the paddock. They will be observed on a daily basis for signs of lameness, any signs of swelling or discharge, appetite and demeanour. Fate of Animals: At the end of the workshop the animals will be returned to the teaching herd. Animals would not normally be killed as part of this workshop. If euthanasia is necessary due to medical events, this will be performed by the cattle teaching staff using an overdose of about 200mL of intravenous barbiturate, administered into the jugular vein by means of a 16G intravenous catheter. 4. INVESTIGATORS & COMPETENCY In the table below, identify individual investigators against the protocols/procedures that they will be performing. For each protocol/procedure, indicate whether the investigator is ‘C’ (competent) or ‘T’ (training). Where an investigator is not performing a particular protocol/procedure, the associated cell should be left blank. All Animal Facility Managers need to be named here if animals are to be located in University animal facility premises. In addition, animal facility staff must be included if they will be involved in performing procedures. C Ultra sound techniques Monitoring health Investigator 1 Investigator 2 General husbandry INVESTIGATOR Clinical Examination PROTOCOL/PROCEDURE C C C *Add more rows as necessary 5. HOUSING OF ANIMALS 5.1 For each species/strain requested, complete a row in the table. Species / Strain Cattle - Jersey Location Vet Science Werribee cattle facilities Housing {select one} Standard Grouping {select one} Grouped *Add more rows as necessary 5.2 If relevant, provide further details of housing, including, as relevant, details of outdoor housing, any special housing requirements, details of enrichment, etc. Where housing is not applicable, please explain why. Cattle are kept in paddocks on-site at Werribee. The amount of shelter is equivalent to that given to cattle in commercial herds. The cattle are not housed. Office for Research Ethics and Integrity | Animal Ethics New Project Application form | Version 1.1 | July 2015 Page 3 of 5 6. REPLACEMENT Replacement refers to methods that avoid or replace the use of animals. 6.1 Explain why it is necessary to use animals for the proposed work. The scanning demonstrations are necessary to display real time images to enable the workshop participants to see and understand the bovine reproductive tract. These images can only be reproduced using live, pregnant, female cows or heifers. 6.2 Provide evidence for the consideration of alternatives to animal use. As an alternative to animal use, the majority of the workshop will involve the use of lecture material, video footage and post-mortem samples to demonstrate size, structure and function of the bovine reproductive tract. 6.3 Provide justification for the choice of animal/s (species, strain, genetic modifications, sex and age) The workshop specifically concentrates on bovine reproduction and therefore requires female, pregnant bovines to demonstrate pregnancy by ultrasound technology. 7. REDUCTION Reduction refers to methods that minimise the number of animals required to achieve the aims of the work. 7.1 Provide statistical or other justification for the number of animals requested. Break down the total number by procedures, treatments, repeats, groups, etc. Eight animals were chosen based on the variability of when cows would cycle and then conceive during the mating period. The eight cows will represent a sufficient range of stages of pregnancy from 4 - 16 weeks (each seven days the image of the developing foetus and uterus changes dramatically) for demonstration purposes. 7.2 Have the animals been used in another project? If so, outline the cumulative burden and provide justification for re-use. The cows have been used for teaching the husbandry and medicine of cattle to enrolled veterinary students. These classes are repeated each year in order to provide the stated course curriculum that is approved by various national and international accreditation bodies. The eight early pregnant (less than 16 weeks) cows will be selected from the teaching herd cows (previously diagnosed in the pregnancy testing cattle class for DVM 3 - Ethics ID 1312933.1) for the demonstration based on their state of pregnancy and the fact that they have not been used in a teaching class for at least seven days (as per the protocol requirements relating to cows used for rectal procedures ID 1312933.1). 8. REFINEMENT How have techniques been refined to minimise impacts on animal welfare? The scanning procedure is actually less invasive than the manual use of an arm for a rectal examination, and is promoted by manufacturers as "gentler" on cows compared to manual pregnancy testing. 9. OVERALL JUSTIFICATION Explain how the potential impacts on the wellbeing of animals in this project are justified by the potential benefits of the proposed work. The workshops that form a significant proportion of the Repro Right course, such as the ultrasound demonstrations, are designed to expose participants to advanced theoretical and technical skills that will enable them, as advisers, to reach evidence-based decisions when dealing with reproductive performance analyses. Although the training will not ensure professional competence in all aspects of the technological methodology they are exposed to, it will ensure some familiarity with procedures and establish pathways to seek further advanced training should they wish to expand their professional competence. The impact on the animals is minimal and, due to the nature of the demonstration, unlikely to have an effect on the wellbeing of the animals involved. Office for Research Ethics and Integrity | Animal Ethics New Project Application form | Version 1.1 | July 2015 Page 4 of 5 10. GLOSSARY Provide descriptions/definitions of abbreviations and scientific terms in language that can easily be understood by the lay reader. Scientific Term Lay Description *Add more rows as necessary Office for Research Ethics and Integrity | Animal Ethics New Project Application form | Version 1.1 | July 2015 Page 5 of 5