ETHICAL ASPECTS OF EXPERIMENTAL RESEARCH. Dr. Sandhya Kamat. Associate Professor,

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1 ETHICAL ASPECTS OF EXPERIMENTAL RESEARCH Dr. Sandhya Kamat Associate Professor, Dept. of Pharmacology & Therapeutics, Seth G.S. Medical College & K.E.M. Hospital.

2 Animals used for the pursuit of science Alcmaeon (500 B.C.) Aristotle ( BC ) dissected animals to study their anatomy Galen ( AD ) demonstrations on live pigs - now known as vivisection.

3 William Harvey (1628)- animal experiments to study heart function and movement of blood. Rene Descartes - I think therefore I am ( ) Francis Bacon - Observation is the basis of all scientific knowledge

4 Cartesian + Baconian approaches Attitudes of scientists towards use of animals in research

5 Milestones in Animal Welfare First Legislation forbidding cruelty to animals passed in the Court of Massachusetts First anti-cruelty law was passed in England and SPCA in England and USA The British Association for the Advancement of Science published guidelines for animal experimentation American Antivivisection society came into existence

6 Milestones - Indian scenario Act preventing cruelty to animals implemented Later replaced by THE PREVENTION OF CRUELTY TO ANIMALS ACT, Committee for the Purpose of Control and Supervision of Experiments on Animals CPCSEA - monitors animal research

7 Animals: a key to medical research Provide new measures for the health and welfare of humans Solutions to many questions only because of animal research Use of monkeys in polio research. Anti-hypertensives due to research on cats. Successful kidney/organ transplants due to research in dogs and rodents.

8 Current Uses of Laboratory animals Biomedical Research Regulatory Requirements Quality Control Measures Training Demonstrations

9 Should Laboratory animals be used for Research? He who sees both sides of the question sees absolutely nothing at all - Oscar Wilde

10 Using animals for biomedical research evokes strong emotions 3 viewpoints are observed The scientist s viewpoint The philosopher s viewpoint The animal activist s viewpoint

11 The Scientist s Viewpoint Animals are not the only biosystem in use. If not animals then experiments in humans under uncontrolled conditions. Animal research vital to medical progress. In vitro alternatives provide supplementary information and work only as adjuncts. Certain life processes cannot be investigated without involving whole animal systems.

12 The Philosopher s Viewpoint 2 schools of thought? Cost of animal research benefited mankind to justify moral trespass. Human life has a value higher than other lives. The philosopher helps to bridge the gap between the scientists and animal activists.

13 The Animal Activist s Viewpoint Animals are exposed to too much suffering. Better alternatives than animal research. Superior human life does not confer the right to exploit inferior order s life.

14 The three differing viewpoints appear valid and reasonable when seen separately. Is a reconcilation possible? Yes! If a common goal of a common good has to be achieved.

15 Steps Towards Using Fewer Animals The 3 R s and Biomedical Research In 1926, Charles Humes, founded "UFAW (Universities Federation for Animal Welfare) to change the attitude of people to animals. In 1959, he commissioned William Russell and Rex Burch, to write, The Principles Of Humane Experimental Technique

16 Steps Towards Using Fewer Animals The Principles Of Humane Experimental Technique Scientific excellence and humane use of laboratory animals are inextricably linked Concept of "Three R s " R eduction R efinement R eplacement

17 Steps Towards Using Fewer Animals Reduction More data from a given number of animals Minimum necessary animals Collaborating with colleagues Refinement Methods to minimise pain/suffering Laparoscopy, alteration in frequency and volume of dose Enhancement of animal well-being

18 Steps Towards Using Fewer Animals Replacement Methods that use organisms with limited sentience, microorganisms,invertebrates Improved information exchange Mathematics and computer models

19 15th December 1998 The Ministry for Social Justice and Empowerment C PCSEA Registration of animal establishments Ethics Committee Guidelines for laboratory animal facility Power to suspend or revoke registration

20 Animal Ethics Committee Members Senior biological scientist Scientist in charge of the animal house Veterinary Doctor 2 scientists from biological disciplines Scientist from outside the institute

21 Animal Ethics Committee Project proposal Study rationale Number of animals Methodology - details of procedures Species ( Procurement & transportation) Trained personnel and veterinary care Anaesthesia Euthanasia

22 Animal Ethics Committee Review of project Is the animal study justified? Is replacement, reduction or refinement possible? Is pain or suffering involved? Will survival surgery be done? How will euthanasia be carried out? Where will the animals be housed? What food will be given? How will dead animals be disposed of?

23 Controlling Pain? Environmental / behavioural strategies taken to relieve pain & distress Decreasing noise Familiar environment Separation Gentle handling

24 Will survival surgery be carried out?

25 Surgery in animals Surgery major survival minor survival non-survival Major survival surgery body cavity exposed or impairment of physiological functions e.g. laparotomy, joint replacement Carried out under anaesthesia

26 Surgery in animals Minor survival surgery no exposure of body cavity and little or no physical impairment e.g. wound suturing; peripheral-vessel cannulation Administration of analgesics

27 Surgery in animals Non-survival surgery Animal euthanatized before recovery from anaesthesia. Not necessary to follow aseptic techniques

28 Anaesthesia /Analgesia If survival surgery is to be carried out which anaesthetics and analgesics will be used? Sodium pentobarbital used commonly. i.v. in larger animals (rabbit, dog, monkeys) i.p. in rodents (rat,mouse,hamster).

29 Anaesthesia/ Analgesia Use of anaesthetic or analgesic is based upon species and the age of the animal the type and degree of pain the effects of particular agents on specific organ systems length of the operative procedure the safety of an agent for an animal

30 EUTHANASIA Act of killing animals by inducing rapid unconsciousness and death without pain or distress. At the end of the study procedure Relieve severe pain or distress Barbiturates & inhalant anaesthetics are preferable to physical methods

31 Painless + Rapid EUTHANASIA Procedure Reliable and non-reversible Should cause minimum psychological stress Carried out in a separate room as animals recognise sound and smell Skilled personnel Trained Personnel should confirm death.