Application and Approval Process

Application and Approval Process

There are several steps to be considered before putting an application to the ACEC. Following these steps will assist in ensuring that the teaching or research activity will:

  • Be well thought out
  • Run efficiently if approved
  • Meet the letter and intent of relevant legislation
  • Accord with the principles of the 3Rs
  • Be justifiable
  • Maximise positive animal welfare and minimise negative animal welfare
  • Avoid delay by minimising requests for follow up information.

N.B. The 3Rs are basic and integral to the entire life of any project involving animal use. This includes the planning, application, submission, implementation, body and completion of the project.

Consideration while developing the application

Careful consideration and planning can help maximise the success of an application. The material below provides some guidance in planning the applications. The PREPARE guidelines may also assist in this regard.

  • Step 1 - Examine the hypothesis or teaching activity outcomes

    Step 1: Examine the hypothesis or teaching activity outcomes.

    Have you applied the following questions to the process?

    Research

    Is the outcome(s) clearly formulated and expressed?

    Will the proposed experimental design test the hypothesis?

    Is the question asked one that is valid? Will the answer add to the body of knowledge?

    Have others tested this hypothesis before?

    Have you undertaken a literature review?

    Will the knowledge gained by testing the hypothesis be worthwhile?

    Who will it benefit and how?

    Teaching

    Are the learning outcomes well formulated and expressed?

    Will the proposed teaching activity meet the learning outcomes?

    Have people raised conscientious objections to this activity in the past?

    Have you considered using alternatives for the activity provided for conscientious objections?

  • Step 2 - Test the experiment or teaching activity design

    Step 2. - Test the experiment or teaching activity design.

    Have you applied the following questions to the process?

    Research

    Do you have to use animals for this experiment?

    Can you test the hypothesis in a way that does not need animals?

    If you have to use animals, which species is the most appropriate?

    How did you decide that the species chosen was the most appropriate one?

    Can you substitute a species that evidence suggests is less capable of pain perception?

    How many animals do you need to adequately test the hypothesis?

    Is a pilot study required?

    Have you consulted with a biometrician/statistician if necessary?

    Have you considered statistical power?

    What experimental design will best test the hypothesis (consider significance levels, the experimental unit, randomisation, observer bias, inclusion/exclusion criteria etc.)?

    N.B. It is important that you do not use too few animals. Insufficient data can lead to a flawed statistical analysis. This can then compromise the experimental outcomes. This is a poor use of animals and does not accord with the principle of ‘reduction’.

    Teaching

    Have you tested the integrity of the teaching activity? Can you meet the reliability, authenticity etc by other means?

    Can you meet the learning outcomes without using animals?

    Have you investigated alternatives to live animals?

    Have you provided other learning opportunities before using live animals? Such opportunities should aim to increase the skills and knowledge of the students.

  • Step 3 - Have you considered all organisational elements?

    Step 3. – have you considered all organisational elements? - have you applied the following questions to the process?

    General

    Have you confirmed the necessary facilities will be available for the project?

    Have you confirmed the necessary resources will be available for the project? Resources include animals.

    Have you confirmed the support staff members are available? Have you confirmed that they have the necessary competencies for the project?

    Have you reviewed any relevant guidelines, Standard Operating Procedures or standards?

    Have you applied for relevant licenses or approvals from external bodies (e.g. NPWS)?

    Have you submitted applications to other University committees e.g. Radiation Safety Committee?

    Have you organised a collaborative agreement if necessary? See below for more detail.

    Collaborative research and teaching

    You must acknowledge the involvement of other accredited establishments. You must ensure a collaborative agreement exists between all parties.

    The agreement should be either finalised or under way before submitting the application.

    Collaborative research and teaching includes, but is not limited to, the following:

    A research or teaching project carried out at more than one Establishment;

    A research or teaching project involving investigators from more than one Establishment;

    A research or teaching project in which animals are moved from one Establishment to another during the project;

    A research or teaching project where animals are cared for by animal care or research staff of more than one Establishment, either simultaneously or at different times during the project.

    A research or teaching project where the investigators from one Establishment are conducting research or teaching at another Establishment.

    Animal Research Review Panel Guideline 3 - Collaborative Research between Accredited Animal Research Establishments

    Research

    Have you organised relevant paperwork with the research office?

    Have you organised relevant commercial agreements?

    Is there any other relevant paperwork that could hinder the approval of the application?

The Application

Have you got the correct application form?

Is this a new project or are you submitting a progress report or an end of project report?

Have you ensured enough time to prepare and submit the application form? The ACEC meets eleven times a year and the agenda closes two weeks before each meeting. You should submit the completed form to the Governance Officer for the ACEC.

  • Using plain English

    Using plain English

    The Code (S2.4.12) states that ‘Investigators must use plain English in the application to the AEC to ensure that all AEC members are provided with sufficient information to participate effectively in the assessment of the application’.

    Simplifying complex concepts can be challenging and may take considerable practice. Scientific disciplines often have their own vocabulary. This can make it more difficult to use plain English. There is a tendency to use jargon and acronyms. Novel words or common words given a novel meaning are sometimes used. Examples include ‘up-regulation’, ‘knock-out mouse’.

    It is important to use effective communication in applications. Use everyday language that an interested, intelligent person can understand. You should assume that the reader does not have a scientific or medical background. You should also assume that the reader does not have knowledge of your area of research. Avoid using scientific jargon or unexplained abbreviations. You should only use acronyms after first stating what they mean in full.

    You should explain difficult or unusual concepts in the first instance.

    You should avoid discipline specific words/phrases if possible. Try to substitute more common use words/phrases.

    Avoid obscure words/phrases e.g. ‘floccinaucinihilipilification’

    It is worthwhile asking someone outside your discipline area to read your summary. For example, another researcher or teacher, a family member or friend. They are most likely to identify questions that the Committee might ask. They may also identify areas that are unclear or confusing. This will help you to edit the summary if needed.

    If you cannot avoid using scientific terms you should consider defining them. You could also include a glossary for scientific terms. You should not use the glossary as a substitute for lay language.

  • The ethical argument

    The ethical argument

    The ACEC safeguards the welfare of animals if we use them for scientific purposes.

    The ACEC considers broad issues e.g. the scientific or educational merit of the activity. The ACEC also considers more specific, narrow issues e.g. husbandry, analgesia.

    Some of the information requested by the Committee can appear confusing and irrelevant. Usually this information is requested to help justify the use of animals. It is also to ensure that there are no factors that could invalidate the activity. If the activity is invalid then there is no useful outcome, leading to a waste of animals. This is contrary to the principles of the Code and the intent of the 3Rs.

    It is important that any use of animals is appropriate and justified.

    Elements to consider include, but are not limited to:

    • The cost to the animals weighed against benefits gained
    • The aims of the activity
    • A rigorous application of the 3Rs
    • The application of the principles of the Code and,
    • Particular justification for activities that severely compromise animal wellbeing

    When completing the application ensure:

    • That you make clear statements about why the activity is being undertaken. For example, what is being taught or examined, what are the possible benefits?
    • That you make clear statements about the reasons for using animals. For example, what is the justification for using animals? What are some of the expected welfare costs to the animals?
    • That you describe how you will minimise or avoid welfare impacts.

    That you make clear statements about the reasons for using specific animals. For example, justification for gender, number, species or strain of animal.

  • 3 R's

    The 3Rs.

    You must apply the principles of the 3Rs to the use of animals for scientific purposes. There are many resources available to support the implementation of the 3Rs.

    When you apply the 3Rs there are some questions you should consider. These include:

    Replacement

    • Is it necessary to use live animals at all?
    • Have you explored the use of non-animal alternatives?
      • Alternatives might include:
        • epidemiological data,
        • physical and chemical analysis,
        • computer, mathematical and inanimate synthetic models,
        • simulations,
        • in vitro systems,
        • non-sentient organisms,
        • cadavers, and
        • clinical cases.
    • Is there another suitable species that scientific evidence suggests is less able to feel pain?

    Reduction

    • Are you using enough animals to support the activity but not more than necessary?
    • Have you applied statistical modelling to support the number of animals needed?
    • Will the number of animals allow valid statistical conclusions? Using too few animals can cause ethical and welfare problems.
    • Are there enough animals to secure a reasonable student to animal ratio? The ratio should both support the learning experience and also animal welfare. In some cases using more animals might be appropriate. More animals will allow less students and/or activities per animal. This can improve the learner experience and lessen welfare impact on individual animals.
    • Have you considered re-using animals to decrease the total number of animals used? You will have to weigh the increased impact on individuals against the reduced total. You must consider adverse effects on the wellbeing of individuals. This must include the lifetime experience of the individual animal.
    • If animals are to be re-used this must not result in greater harm to the animals used. This includes pain and distress.

    Refinement

    • Have you made efforts to improve the welfare of the animals if practicable? It is important to aspire to positive welfare, rather than just avoiding poor welfare.
    • Have you identified all potential impacts on the animals’ welfare? Some examples include, but are not limited to:
      • sensory impacts (olfactory, visual, auditory, taste in some activities, tactile),
      • constraints on mobility,
      • social impacts (e.g. isolation of social species, mixing of unfamiliar animals),
      • ability to express a range of normal behaviours,
      • human-animal interactions,
      • pain,
      • suffering and,
      • disease and injury.
    • Have you made efforts to avoid or minimise the impacts identified?
    • Pain and suffering can alter an animal’s behaviour, physiology and immunology. These changes can lead to variations in experimental results. Variations can impair the reliability and repeatability of studies.
    • If the impacts are unavoidable, have you made efforts to mitigate their effects? For example, using behavioural modification techniques such as counter-conditioning and habituation? These methods may allow the use of less restraint or less forceful restraint. They may also make situations less aversive for the animals.
    • If analgesia or anaesthesia is necessary, have you consulted with an anaesthetist?
    • Have you considered recent advances in analgesia/anaesthesia?
  • Anticipated questions

    Anticipating questions

    Using animals for scientific purposes requires oversight and accountability. The University’s Animal Care and Ethics Committee (ACEC) provides such oversight and accountability.

    The ACEC must examine applications as part of this process. This examination will often raise questions.

    It can be difficult to predict what questions might arise, but it is worthwhile trying to do so. Identifying questions ahead of time will allow you to edit the application. Questions can lead to delay in approving applications.

    The most common questions tend to be centred on the following:

    • Clarity of descriptions- see section on using plain English
    • The sequence of events- there is a guide to completing the application
    • Whether you have applied the 3Rs with enough rigour
    • Simple mistakes or omissions in completing the application. Examples include:
      • leaving names out, including names of personnel no longer with the Institution,
      • failing to include licences/agreements/etc,
      • not clearly stating who is responsible for the different aspects of the activity
  • General issues

    General issues when completing application forms

    • Not completing all relevant sections
    • Incorrect start and finish dates
    • Completing the euthanasia section even if euthanasia is not expected
    • Nominating Standard Operating Procedures for the project. It is the applicant’s responsibility to develop new SOPs if the current ones do not cover project activities.
    • Ensuring all consent forms are signed and included.
  • Submitting the form

    Submitting the form

    If you are confident that the form is complete and accurate then you are ready to submit it. Send the complete application form to animalethics@csu.edu.au