Applications are submitted through the Animal Ethics Online system.

Introduction

An application to the Animal Care and Ethics Committee (ACEC) to hold or use animals at UNSW is required by the NSW Animal Research Act 1985. Projects must not commence until written approval has been received from the ACEC. The Committee is most willing to assist researchers to meet their obligations under the Act. The Committee offers itself as a resource for resolving any issue relating to the care and welfare of animals used in research and teaching.

The ACEC's primary purpose is to protect the welfare of the animals and ensure that they are used in a way that is scientifically worthwhile. There are two ACECs at UNSW and these ACECs are composed of approximately 16 people. Four members are lay people, three members represent animal welfare organisations, and four members are veterinarians. The remaining members are animal researchers and are drawn from the biological, medical, and behavioural sciences.

The purposes and composition of the ACEC are important for researchers to remember when applying for approval. In particular, the applications must be written in "plain English" suitable for an interested, educated person from the general community, not a specialist. Applications that are written in the language of the specialist - as if they were grant applications - are not helpful to the Committee. Approval of a project requires unanimous approval of the Committee. Accordingly, it is essential that all members of the Committee have a reasonable, but not in-depth grasp of the aims, significance, and procedures of the project as they pertain to animal welfare. Clarifying what is happening to the animals frequently causes delays in gaining approval.

In considering an application, the ACEC is concerned primarily with what is happening to the animals, particularly when they are conscious. Over the years, the majority of the Committees’ deliberations have revolved around four questions:

1. Scientific Merit? Does the research justify the use of animals at all?

The aims and significance of most projects can be explained in approximately a half-page of "plain English". When addressing this issue, think about the style of English you would use if you were explaining your project on an ABC science show.

This question applies to all projects, even when they entail little risk of pain or distress to the animals. The underlying principle here is that poorly-conducted research is unethical even if it involves no harm to the animals. The key issues here concern:

• the general scientific merit of the project

• the experience of the investigators with the animals and procedures

• the experience of the investigators with the proposed procedures

• whether the number of animals yields adequate statistical power and/or replication.

Many applicants have trouble expressing the aims and purposes of their project. Some researchers give a brief abstract that would be suitable for a journal but is mystifying to the ACEC, including scientific members from other areas. Other researchers go to the other extreme and give an extensive background found in a grant application, which also mystifies the ACEC.


2. Impact on the Animals? What are the risks to the animals' welfare from their perspective?

Most of the Committee's concerns relate to this question. For all projects, the housing and husbandry of the animals must be adequate. For projects involving surgery, the potential for pain during and after the surgery must be assessed by the applicant. For any other interventions in the animal's activities, the potential for pain or distress must be assessed by the applicant.

3. Adequacy of Monitoring? Are procedures in place for ensuring the animals' welfare? Will the procedures be detecting and recording any threats to the animals' welfare?

This question covers:

• routine husbandry (e.g., are the animals' receiving adequate water?)

• early detection of identified threats to animals' welfare (e.g., possible morbidity from a tumor?)

• unexpected threats to animals' welfare (e.g., infection in the animal colony?)

While the Committee needs an outline of the biological measurements and analyses to assess the scientific worth of the project, the procedures to ensure the animals' welfare are more important to the Committee's decision. Unfortunately, some applications skim over the issues of monitoring in a few words and then spend a page on the fine details of assay on tissue taken from the animal.


4. Adequacy of Safeguards? Are precautions taken to minimise threats to the animals' welfare?

This is the area where practices are changing most rapidly, and researchers may find what was acceptable even three years ago is no longer acceptable. These changes are related to improvements in veterinary practice as well ethical judgments.

Among other things, this question covers:

• Use of appropriate anaesthetic in surgery? (e.g., ether is largely unacceptable now; there are less irritating anaesthetics.)

• Use of appropriate analgesia? (There have been substantial improvements in the type and availability of appropriate agents, e.g., buprenorphine.)

• Plans for veterinary emergencies? (e g does the researcher have access to a veterinarian in the case of illness beyond the researcher's competence to treat)

• Appropriate euthanasia? (e.g., cervical dislocation without anaesthesia or analgesia is acceptable under restricted circumstances)

• Pain testing? (Some worthwhile projects investigate the processes by which organisms protect themselves against pain, distress, and injury. These projects necessarily receive close scrutiny by the Committee. Over the past few years, the Committee and researchers have evolved procedures for minimizing the use and magnitude of pain tests in a manner that minimizes discomfort to the animal and achieves the worthy scientific objectives of the project.)

The Committee recognises that writing an ethics application is a balancing act between brevity and completeness. Since its inception, the Committee has assigned a spokesperson to each application to work with the applicants to fill in any gaps before the application is considered by the Committee. This procedure is intended to allow the Committee to consider approval of the project without delay and with all needed information.

Applications are to be submitted for projects rather than for each experiment or separate procedure. Projects are normally approved for a maximum period of three years provided no significant modifications are made to the approved protocol. However, State legislation requires that all projects be reviewed by the ACEC on an annual basis. Researchers will be required to provide a brief, annual progress report for their projects. A complete application for renewal of a project must be submitted at the end of three years if it is to be continued.

After approval for the project is granted, the applicant must apply by letter to the Presiding Member for approval regarding any substantive changes in the project. For example, substantive changes include a new species, different housing, different anaesthetic, a new drug, or a different behavioural test, particularly for pain.

Please answer all questions, even if only to indicate they are not applicable. As noted on the application form itself, incomplete applications will be returned without consideration by the Committee.

Applicants are required to be familiar with the following documents. They can also be of help in filling out the application. In addition, they must be readily available in your laboratory. Both ACEC and State inspectors can and will require you to present them.

• Australian code of practice for the care and use of animals for scientific purposes 7th edition 2004

• NSW Animal Research Act 1985

• The University's Rules on the Use of Animals in Research/Teaching

• UNSW Guide to Housing and Care of Laboratory Animals 1994

In filling out the application, please feel free to add remarks or additional sheets. The Committee recognises that there will be occasions when the application form does not fit the particular features of a project.

At the end of the application, you will find an extensive list of items that should be considered in filling in your application. This list is not a formal part of the application.

A1: Title of Project. Where possible use "plain English". However, a more technically-phrased title that matches that of a grant application is also suitable.

A2: Name and Designation of Chief Investigator. The Chief Investigator must be an employee of UNSW and preferably a person with an academic appointment. Under NSW law, a Chief Investigator is the person who must take prime responsibility for the ethical conduct of the project. In brief, a Chief Investigator must adopt a "buck stops here" attitude. Ordinarily, the Chief Investigator is closely involved with a project, and there is no doubt about that person's responsibility. On some occasions, Chief Investigators have been only remotely involved with a project, but the ACEC discourages this practice.

Where students are using animals in a teaching and/or research program, then the Chief Investigator has responsibility to ensure that students carry out procedures and conduct themselves in an ethical manner. Acceptance of this responsibility is implicit when the application is signed and submitted.

A3: Conjoint appointments and collaborators. When submitting an application, the Chief Investigator has a duty to identify all interactions with other institutions relevant to that proposal. This question is aimed at ensuring appropriate oversight of the animals' welfare when a single project is being conducted across more than one institution, especially if the animals are moved from one institution to the other.

A5 and A6: Proposed date of commencement and proposed date of completion.

Please make sure you submit your application so that it can be considered at a meeting at least one month before your starting date.

There has been an ongoing problem in coordinating the ACEC approval dates with the span of grant funding. Many researchers want approval to conduct initial studies to take to NHMRC interviews that occur in the year before a grant commences. Accordingly, it would be convenient if the ACEC could grant approval for four years rather than three years. Under law, however, approval is formally allowed for only one year, but the State Government allows the ACECs to give approval for three years subject to annual review. Approvals beyond three years without a full renewal application are not permitted. At present, there is no way out of this dilemma.

A7: External Funding
If you have applied for external funding or already have external funding for your project, two copies of the grant application (excluding budget pages) must be attached to your ethics application. These copies are requested so that the spokesperson can cross check the ACEC application and the grant application. Such submissions will be held by the Committee in strict confidence. All procedures described in your ethics application should accurately reflect the procedures used in your laboratory. The Committee recognises that, for previously funded projects, some procedures may have changed. If so, describe how they differ from those described in the grant application.

The other Committee members do not see the grant application. Accordingly, the grant application cannot be a substitute for an appropriate description of the project in the ACEC application.The Committee will not accept extracts from grant applications as part of the protocol. The details of the protocol must "stand alone" and not refer to other documents. Details must be written in such a fashion that they can be understood by all members of the Committee.

B1: Aims of the Project
This section is crucial in assessing the scientific merit and the necessity of animal use. The level of details should fall between broad generalities, e.g. "this project will delineate the mechanisms of neural conduction as they pertain to Alzheimer's disease" and an exposition of the intricacies of the project's empirical and theoretical background.

B4: Sequence of Events
The Committee often has considerable difficulty in discerning the sequence of events that occurs to the animals, particularly when there are different groups of animals receiving different treatments. Accordingly, please list the procedures in sequence. Flow charts and other diagrams are very helpful to the Committee. If there are several groups of animals that receive different combinations of treatments, please list them in tabular form and include the number of animals in each group.

C4: Number of Animals
The number of animals should be adequate to achieve reliable results, either in terms of sufficient statistical power or in terms of replication across experiments.
The ACEC recognises that some projects require hundreds and even thousands of animals. Where a large number of animals are required, the applicant should take special care in C5 in showing how the number of animals relates to the number of experimental and control conditions.

C7: Animal Supplier
Animals may only be obtained from the Biological Resources Centre (BRC) with an ACEC approval number. Animals must not be obtained from an external source unless the Supplier is a Registered Animal Supplier. If a registered supplier is not available, the ACEC Executive Member must be advised, and suitable arrangements will be made.

C8: Free-Living Animals
If a project involves the use of "Free-Living Animals" as defined by the Animal Research Act 1985, please complete form FLA1, available from the Research Services webpage.

J2. Re-use of Animals
There is no direct prohibition against using animals that have been used in previous research. However, the NSW Animal Research Act and its Regulation require that proposals for re-use of animals be closely scrutinized. Re-use will be authorised when it reduces the number of animals bred for research and when the previous research was relatively innocuous, e.g. reward training, behavioural observation, and drawing of blood samples.

Section N: Signatures
Please make sure all required signatures, including all the investigators and Head of School, are obtained. If the Head of School is an investigator in the project, a counter signature is required by a senior academic not involved in the project.