INTENSIVE COURSE ON BASIC STATISTICS AND RESEARCH METHODOLOGY (PPSP) [ANIMAL ETHICS] USM Health Campus July Dr.

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1 INTENSIVE COURSE ON BASIC STATISTICS AND RESEARCH METHODOLOGY (PPSP) [ANIMAL ETHICS] USM Health Campus July 2017 Dr. Saidi Jaafar

2 The Governance of USM

3 Research Council Research University Council [Majlis Penyelidikan Universiti MPU] DASAR DAN ETIKA PENYELIDIKAN UNIVERSITI SAINS MALAYSIA 3.1 ETIKA PENYELIDIKAN Semua penyelidikan yang dijalankan oleh ahli akademik dan pelajar termasuk projek penyelidikan yang dijadikan sebagai sebahagian daripada program pengajaran hendaklah pada tahap etika yang tinggi berpandukan Kod Etika Manusia dan/atau Kod Etika Haiwan dan Kod Amalan Terbaik Penyelidikan Universiti.

4 The R&I of USM

5 The Ethical Office

6 The Source of Governance for Ethics The University must establish policies on the use of animal subjects to promote their humane care and use in research and instruction and to ensure institutional compliance with all applicable national laws and regulations and University policies governing the use of animals.

7 Animal Welfare Animal Welfare Act - Establishment of Animal Welfare Board: To monitor the work of associations and organizations for the purpose of preventing trauma, pain or suffering to the animals. - Practice of ethical animal research & testing: For the ethical care and use of animals for research 1. Australia: Animal Welfare Act, SA 1985; ACT 1992; WA 2002 [The Australian Code for the Care and Use of Animals for Scientific Purposes (the Australian Code) was established on the initiative of scientists in 1969] 2. Singapore: Animals and Birds Act (Chapter 7), Animals and Birds (Care and Use of Animals for Scientific Purposes) Rules, Thailand: Animal Cruelty Prevention and Animal Welfare Provision Act, Malaysia: Animal Welfare Act, 2015

8 Permission to Use Animals in Research, Teaching or Breeding Animal Welfare Act: Law or guideline that permit and control the use of animals for scientific experimentation. They vary greatly around the world but most governments aim to control the number of times individual animals may be used; the overall numbers used; and the degree of pain that may be inflicted without anesthetic.

9 Purpose of IACUC 1. To ensure that all care & use of animals is conducted in compliance with the Guidelines on the Care and Use of Animals for Scientific Purposes 2. To apply a set of principles, outlined in the Guidelines, that governs the ethical conduct of people whose work involves use of animals for scientific purposes 3. To ensure that the use of animals is justified, provides for the welfare of those animals & incorporates the principles of Replacement, Reduction & Refinement (3Rs)

10 How to get an IACUC approval Get the correct application form, fill out the form completely & correctly

11 The flowchart of IACUC approval APPROVED RESEARCH PROPOSAL APPROVED WITHOUT CHANGES Written IACUC approval issued Research begin GETTING & FILLING IACUC FORM SUBMISSION OF IACUC FORM - IACUC SECRETARIATE APPLICATION REVIEW PROCESS - CHAIRPERSON - allocate expert to review the proposal REVIEWER gives comments/suggestions IACUC MEETING (DEFENSE SESSION) * Reviewer will decide whether the investigators have to defend their proposal or not. * If there are clarifications needed, IACUC will invite INVESTIGATOR to defend the proposal. If there is no queries, the proposal will be discussed without the presence of the investigator AMENDMENTS REQUIRED Proposal revised as per suggestions by IACUC Resubmission to IACUC secretariate Changes ascertained by the Chairperson / Reviewer Written IACUC approval issued Research begin

12 The fundamental concepts or issues in making ethical decisions on individual projects involving the use of animal A set of principals that need to be followed in allowing animal research (the good arising out of experimentation does outweigh harm to the animal) 1. Concept of 3Rs 2. Ethical implications 3. Right animal model & experimental design

13 1. Concept of 3Rs Replacement: Alternative methods can be used that do not involve experiments on animals Reduction: The number of animals used for each test will be minimised Refinement: Animal distress (pain, discomfort) is minimised before, during and after the test

14 2. Ethical Implications of a Research Project Ethical Principal of animal experimentation: Show proper respect and care for animals when using them in research. Do not conduct unnecessary or poorly designed animal experiments Ethical Implication of animal experimentation: Any actions that could have ethical or morally conflicting consequences

15 Classifications of an animal study based on ethical implications: 1. Sacrifice the animal for the preparation of the whole animal, embryo or tissue specimen. 2. Carry out certain procedures under anaesthesia and the animal will be sacrificed without regaining consciousness. 3. Carry out intervention which causes major or prolonged stress (major surgery and prolonged restraint) 4. Carry out intervention which causes minimal stress of short duration. 5. Carry out behavioural study including pain assessment study 6. Infective or biohazard experimentation 7. Genetic modification of animals 8. Toxicity study 9. Production of antibody 10.Blood vessel cannulation 11.Breeding project

16 3. Selecting appropriate animal models and experimental designs The most brilliant design, the most elegant procedures, the purest reagents, along with investigator talent, public money, and animal life are all wasted if the choice of animal is incorrect Bernard E. Rollin Prof. Rollin is an American philosopher, currently professor of philosophy, animal sciences, and biomedical sciences at Colorado State University Appropriate animal model/experimental design: - Species, breed and strain with the closest homology to humans must be chosen. - Because new animal models are continually being identified and characterized: need to get latest information The Institute for Laboratory Animal Research (

17 Some other important questions 1. Do I need to go through a specific animal handling training? 2. Who should I see to discuss my animal experimentation plan? 3. Where and when should I order the animal? 4. Where can I house the animal and conduct my experiment?

18 Application Form

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