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THE SECRETARY’S ANIMAL CARE AND ETHICS COMMITTEE (SECRETARY’S ACEC) ANIMAL RESEARCH APPLICATION (General Research) GENERAL INFORMATION It is the responsibility of the investigator to ensure that all facets of animal care and use meet the requirements of the Australian Code for the Care and Use of Animals for Scientific Purposes. This includes a responsibility to protect and promote the welfare of animals used. The Code of Practice embodies the principles of: * Reduction of animal use * Replacement of animal use * Refinement of animal use. It is important to consider these principles when designing and carrying out projects. Under the NSW Animal Research Act, an individual who wishes to carry out a research project involving the use of animals must be issued with an Animal Research Authority by an Accredited Research Establishment or the Secretary of the Department of Regional NSW (DRNSW). Approval by an Animal Ethics Committee (AEC) is also required for the use of any vertebrate animals for research and teaching. In assessing applications for animal research it is often difficult for the AEC to obtain a clear picture of what happens to individual animals from the beginning of a project to the end. The AEC must assess the impact of all procedures on animals and of the project as a whole. Secretary’s ACEC Application Form GENERAL November 2020 INT20/379338

Transcript of  · Web viewDetails should include treatment substances, dose rates, routes of administration;...

THE SECRETARY’S ANIMAL CARE AND ETHICS COMMITTEE

(SECRETARY’S ACEC)

ANIMAL RESEARCH APPLICATION

(General Research)

GENERAL INFORMATION

It is the responsibility of the investigator to ensure that all facets of animal care and use meet the requirements of the Australian Code for the Care and Use of Animals for Scientific Purposes. This includes a responsibility to protect and promote the welfare of animals used.

The Code of Practice embodies the principles of:

* Reduction of animal use

* Replacement of animal use

* Refinement of animal use.

It is important to consider these principles when designing and carrying out projects.

Under the NSW Animal Research Act, an individual who wishes to carry out a research project involving the use of animals must be issued with an Animal Research Authority by an Accredited Research Establishment or the Secretary of the Department of Regional NSW (DRNSW). Approval by an Animal Ethics Committee (AEC) is also required for the use of any vertebrate animals for research and teaching.

In assessing applications for animal research it is often difficult for the AEC to obtain a clear picture of what happens to individual animals from the beginning of a project to the end. The AEC must assess the impact of all procedures on animals and of the project as a whole.

The application should, therefore, focus on what is happening to animals and what is being done to ensure their wellbeing. It is important that this information is presented in a way that shows clearly what is happening to individual animals from the beginning of the project to its completion. The impact of procedures needs to be clearly detailed. The investigator should provide a step-by-step explanation of all treatments (substances, dose rates, routes, volumes, anaesthetics, surgical procedures etc) and the expected effects. Flow charts or sequence of events tables are often of assistance. In addition, factors that will impact animals, such as housing, (type, duration, opportunity for social interaction) should be considered.

The application should also explain clearly why the use of animals is justified, why the species and number of animals have been chosen and that the qualifications of personnel are suitable for the procedures to be performed.

It is important for applicants to be mindful of the composition of the ACEC. Applications must be written to be understood, primarily, by an interested, intelligent person without a scientific background, not for a specialist. The use of specialist language is not helpful to the committee and may delay the processing of an application, while explanations are sought.

Investigators should be familiar with the:

*Australian Code for the Care and Use of Animals for Scientific Purposes (8th edition, 2013), published by the National Health and Medical Research Council (NH&MRC).

*NSW Animal Research Act 1985.

*NSW Animal Research Regulation 1995.

Please return form to:

Email: [email protected] or [email protected]

Mail:

The Secretary’s Animal Care and Ethics Committee

Department of Regional NSW (DRNSW)

Department of Primary Industries (DPI)

Chief Scientist Branch

Locked Bag 21

ORANGE NSW 2800

[email protected]

For inquiries, please phone Colleen Turnbull on (02) 6391 3682 or send an Email: [email protected]

FORMS MUST BE TYPED OR WORD PROCESSED

Secretary’s ACEC Application Form GENERAL

November 2020

INT20/379338

Secretary’s ACEC Application Form GENERAL

November 2020

THE SECRETARY’S ANIMAL CARE AND ETHICS COMMITTEE

(SECRETARY’S ACEC)

APPLICATION FOR AN ANIMAL RESEARCH AUTHORITY

1.Name and designation of Principal Investigator:

Under the NSW Animal Research Act 1985 a Corporation must be accredited. For information on accreditation Email [email protected]

2.Address for correspondence:

Telephone:(Work)

(Mobile)

E-mail:

3.Have you previously held an Animal Research Authority with the Secretary’s Animal Care and Ethics Committee?

If not, please supply with your application, referee reports from two independent referees that support your expertise in the procedures you wish to perform.

Have you previously held an Animal Research Authority with any other Animal Ethics Committee other than the Secretary’s Animal Care and Ethics Committee?

If yes, which Animal Ethics Committee(s) and what was the period of time that this approval was granted?

4.Type of proposed research (please use simple English):

Title of proposed research proposal:

Location of proposed research:

Please attach a copy of the completed Animal Research Protocol application (Protocol 4-14).

5.Has an Animal Research Authority or an Animal Suppliers Licence previously been held by any personnel participating in the proposed project and been cancelled?

Have any personnel participating in the proposed project been convicted in the last 3 years of an offence under:

a) Animal Research Act 1985 or Regulations?YES/NO

b) Prevention of Cruelty to Animals Act 1979 or Regulations? YES/NO

c) National Parks and Wildlife Act 1974 or Regulations? YES/NO

d) Exhibited Animals Protection Act 1986 or Regulations? YES/NO

e) Non-Indigenous Animals Act 1987 or Regulations? YES/NO

f) Any equivalent Commonwealth, other State or Territory Statute or Regulations? YES/NO

If you answered YES to any of the above, please provide details of the offence and any penalty imposed.

6.Personnel

List the names, qualifications, training and relevant experience of all personnel who will be participating in the animal components of the proposed project.

a) Principal Investigator

Name:

· Relevant qualifications:

· Relevant training/experience:

b)Associate Investigator(s)

Name(s):

· Relevant qualifications:

· Relevant training/experience:

c)Other people participating:

7.Application fee

Credit Card payment for $100 is enclosed (form attached to application)

For alternative methods of payment please Email: [email protected]

Fees for Authorities and Accreditations to allow research to be undertaken on animals under the Animal Research Act 1985 have been approved as exempt from GST. Division 81.

8.Signature:Date:

Name (in print):

Receipt of your application will be acknowledged. Thank you.

THE SECRETARY’S ANIMAL CARE AND ETHICS COMMITTEE

(SECRETARY’S ACEC)

ANIMAL RESEARCH PROJECT APPLICATION (PROTOCOL) (General)

Section 1: Administration

1.Title of project:

2.Name and designation of Principal Investigator:

3.Location of research

4.1Institution (if applicable)

4.2Relationship between Principal Investigator and the institution (e.g. employee, collaborative research, etc):

5.Proposed date of commencement:

6.Proposed date of completion:

7Is the project being supported by an external organisation?

7.1has an application been lodged for external support?

if the answer to either 7 or 7.1 is YES, state the name of the organisation and

date of application and whether the application has to date been successful:

7.2If a funding application is not successful, will the project still go ahead?

8.Please indicate whether this application is for:

8.1a new project?

8.2a project which has (previously or simultaneously) been submitted to this or another ethics committee?

8.3a significantly revised current protocol?

If this is not a new project, please provide reasons for re-submission or simultaneous submission and include the name of the ACEC(s).

If significantly revised, please quote the approval number and species and number of animals used to date

9.Does the project involve recombinant DNA technology or infectious, toxic, radioactive or carcinogenic agents that may be harmful to other animals or persons?

If the answer is Yes:

9.1Will adequate precautions be taken in accordance with statutory requirements and have relevant personnel been informed?

9.2Has the appropriate authority or licence been obtained?

10. Does the project involve native, imported or protected species?

If the answer is Yes,

10.1Have the relevant licences been obtained from the National Parks and Wildlife Service or other authorities?

Permit issued by:

Permit number:

Section 2: Justification For Animal Use

Aim of the Project in Lay Terms

The Code of Practice states that “Animal experiments may only be performed when the scientific merit justifies the use of animals”.

Your answer is crucial for the assessment of scientific or educational merit and the necessity for animal use. Use lay terms - terms that will be understood by a person without a scientific background.

11. Describe the aims of the project in lay terms. Comment on the significance of the research which you believe justifies the use of animals.

Specify what you hope to achieve.

12. If the project repeats previously reported experiments, give the reasons for the experiments to be repeated.

Reasons for Animal Use

13. Why is it necessary to use animals in this experiment?

14. What alternatives to animals have been considered and why is it not possible to use these?

15. What species of animal will be used? Give the scientific and common name (and strain, age, sex and weight if applicable).

16. Why has this species (and strain, age, sex and weight if applicable) of animal been chosen?

Numbers of animals

17. How many animals will be required?

18. Explain, on the basis of experimental design, why this number of animals will be required.

Section 3: Ethical Considerations

A. Assessment of the Impact on Animal Wellbeing

Sequence of Events

19. Give details (sequentially) of what will happen to the animal(s) from the time you obtain them until the time the project is completed.

A flow chart or sequence of events table may assist in making this information clear.

Impact

20. Identify all factors and procedures that may have an impact on an animal's wellbeing in this activity. This may include handling, housing etc, as well as specific experimental procedures.

(Refer to the CHECKLIST to ensure all details have been considered.)

21. Describe each factor or procedure and detail how any adverse impacts will be minimised.

Details should include treatment substances, dose rates, routes of administration; surgical and related procedures including anaesthetic, analgesic and tranquillising agents and methods of monitoring their adequacy, if applicable. Refer to the CHECKLIST to ensure that all details have been considered.

Animal Monitoring

22. Who will monitor the animals? Include names, qualifications and experience with the species being used.

22.1During weekdays?

22.2At night (if applicable)?

22.3During weekends and holidays?

23. How will animals be monitored while the procedures are carried out? Include details of frequency and methods used.

24. How will animals be monitored for the duration of the project? (Include frequency and details of methods used.)

25. Who will be responsible for the management of emergencies and how will you ensure that the nominee(s) can be contacted?

Animal Housing and Management

26. Where will the animals be housed?

27. Describe the type of housing to be provided.

28. What will be the maximum and minimum number of animals per cage/pen?

28.1State dimensions of proposed cage/pen.

29. Where will procedures be performed?

30. What will animals be fed, and how often will they be fed?

Source

31. Where will you get the animals from?

Duration

32. What will be the maximum time an individual animal is held?

Re-use

33. Does this project involve the use of any animals that have been the subject of previous research?

If the answer is YES,

33.1what has previously been done to these animals? Include project name(s) and identification number(s).

Fate of Animals

34. What will happen to the animals at the completion of the project?

35. Will factors affecting the animals determine the endpoint of the project (eg tumour size, maximum weight loss)?

If the answer is YES, give details.

If the answer is NO, what will be the end point?

36. How will you euthanase the animals if there is an emergency or if euthanasia is an end point?

36.1How will this be done?

36.2Where will euthanasia be carried out?

36.3Who will do it, and what is their experience in the technique to be used?

36.4Could animal tissue be shared with other investigators?

Section 4: Declaration Of Responsibilities

Declaration by the Principal and Associate Investigators

I certify that the use of animals in this project will conform with NSW legislation and the principles of the NH&MRC Australian Code for the Care and Use of Animals for Scientific Purposes. I accept responsibility for the conduct of all procedures detailed in this application and for the supervision of all personnel delegated to perform any such procedures.

I confirm that all personnel have read this application and have agreed to comply with the procedures described and any conditions imposed by the Secretary’s Animal Care and Ethics Committee.

Principal Investigator Signature:Date:

Associate Investigator(s) Name:Date:

(Signature)

PRIVACY NOTICE AND CONSENT FORM

In order to comply with the Privacy and Personal Information Act 1998, the Secretary’s Animal Care and Ethics Committee requires all applicants for Animal Research Authorities to complete the following form.

Privacy NoticeThe information provided by the applicant whose name appears below, is being collected for the purpose of an application for an animal research authority under the Animal Research Act 1985. It will be used by NSW Department of Planning, Industry & Environment (DPIE) for administration of the Act and will not be provided to other agencies. The information has been provided because it is required by law and will be stored securely within the Chief Scientist Branch, NSW Department of Primary Industries (DPI).

You may access or amend your personal information by contacting the Secretary’s Animal Care and Ethics Committee Email: [email protected] , or by writing to the Secretary’s Animal Care @ Ethics Committee, NSW Department of Primary Industries (DPI), Locked Bag 21, Orange, NSW 2800.

Consent FormThe Privacy and Personal Information Protection Act 1998 obliges NSW Department of Planning, Industry & Environment (DPIE) to make you aware of the purposes for which we might use the contact details you supply to us. In order to comply with the requirements of the Act, we are obliged to ask you to indicate whether or not you wish to have your name and address included on a mailing list for the purpose of distributing information to authority holders regarding the Secretary’s Animal Care and Ethics Committee. The mailing list will remain in use until you allow your authority to lapse and you may amend, or remove, your contact details from the mailing list at any time by contacting the Secretary’s Animal Care and Ethics Committee Email: [email protected] , or by writing to the Secretary’s Animal Care & Ethics Committee, NSW Department of Primary Industries, Locked Bag 21, Orange NSW 2800..

Please indicate your preference with an X

[ ]Yes, include my personal contact details on the Secretary’s Animal Care and Ethics Committee mailing list.

[ ]No, do not include my personal contact details on the Secretary’s Animal Care and Ethics Committee mailing list.

Name…………………………………………………………………………..

Address…………………………………………………………………………..

…………………………………………………………………………..

Signature ....................................................………… Date:……………..……

NON-INVOICED PAYMENTS

CREDIT CARD DETAILS

Name of Principal Investigator:__________________________________________

VISA/ MASTERCARD/ (please circle one)

Please be advised that effective 1st January 2013, the following merchant surcharge will occur on credit card transactions: 0.4% for Mastercard and Visa.

CARD HOLDERS NAME:________________________________________________

CUSTOMER TELEPHONE NO. ( ) ______________________________________

CARD NUMBER (16 numbers) _________ ________ ________ __________

SECURITY NUMBER (3 numbers) (back of card – may be in italics) ___________

EXPIRY DATE (month/year) __________ / __________

AMOUNT TO BE PAID: $_________________

REASON FOR PAYMENT:_______________________________________________

FOR OFFICE USE ONLY:

_____________________________________________________________________

GL ACCOUNT:___________________________________

WBS: ___________________________________

TAX CODE: ___________________________________

CUSTOMER NUMBER:__________________________________________________

DATE:_____________________________

Should you require any assistance or need further information please do not hesitate to contact Colleen Henry on [email protected]

Secretary’s ACEC Application Form GENERAL

November 20201

CHECKLIST

· What is happening to the animals?

· What will be the effects?

· How will the effects be minimised.

Anaesthesia

Fasting

Induction (drug, dose, route)

Maintenance (drug, dose, route)

Methods of monitoring anaesthesia and recovery

Additional support during anaesthesia and recovery

(eg heat, intravenous fluids)

Location of induction and recovery areas

Behaviour modification

Stimulus (type, duration, frequency)

Blood/body fluid collection

Volume

Route

Frequency

Anaesthesia or analgesia

Restraint

Animal monitoring (methods, frequency)

Diet/water modifications

Type

Amount

Effects

Measurement of intake

Animal monitoring

Drug treatments

Substance

Volume

Route

Frequency/total number per animal

Local and systemic effects

Anaesthesia or analgesia

Possible side effects

Restraint

Euthanasia

Method

Location (where procedure will be performed)

Expertise of personnel

Genetic manipulation

Methods

Potential effects

Housing

Location

Isolation

Group housing (stocking rates, sexes)

Shelter

Bedding

Hiding areas

Environmental enrichment

Duration held

Conditioning period

In-vitro studies

Source of animals

Duration held

Euthanasia

Surgery

Anaesthesia

Location of pre-operative preparation area

Pre-operative preparation

Surgical procedure (site, technique)

Sterile technique (instruments, drapes, surgeon)

Location of and housing in post-operative recovery area

Post-operative management

Post-operative monitoring (methods, frequency, duration)

Use of analgesics (type, dose, route, frequency, means of determining necessity for use)

Expertise

Transport

Type

Duration

Confinement

Numbers of animals

Air-conditioning

Toxicology

Substance

Volume

Route

Frequency of treatments / total number per animal

Local and systemic effects

Anaesthesia or analgesia

Restraint

Animal monitoring (methods, frequency)

Endpoint/duration

Tumour/neoplasia induction

Method

Site

Endpoint

Animal monitoring (methods, frequency)

Teaching

Source of animals

Housing

Duration held

Method of disposal

Wildlife studies

Location

Methods

Capture methods

Handling/restraint

Housing

Monitoring

Release

Effects on population