ETHICAL ISSUES IN ANIMAL EXPERIMENTATIONS

ETHICAL ISSUES IN
ANIMAL
EXPERIMENTATIONS
(with emphasis on CPCSEA guidelines)
Sandeep Lahiry
Department of Pharmacology
IPGMER, Kolkata

Outline
• Introduction
• History
• Animal ethics
• Extent of Animal Use
• Rethink ‘3R’
• Regulations: World & India
• Guidelines on the Regulation of Scientific Experiments on Animals (2005)
• CPCSEA: Overview
• SOP & Functions of CPCSEA (2010)
• IAEC: Overview & Functions
• CPCSEA Guidelines for Animal Facility (2005)
• Animal Testing regulations around the world
• Conclusion
9/26/2018 Ethics in Animal Research | Lahiry | Pharmacology | IPGMER-Kolkata 2

9/26/2018
Ethics in Animal Research | Lahiry |
Pharmacology | IPGMER-Kolkata
4Poll by Canadian Council on Animal Care (2013). https://speakingofresearch.com/2014/01/page/2/. (Retrieved 10 May, 2017)

9/26/2018 Source: Animal Experiments in India. 2003 [Animal Defenders International & National Anti-Vivisection Society ] 5

9/26/2018 Source: Animal Experiments in India. 2003 [Animal Defenders International & National Anti-Vivisection Society ] 6

Animal Ethics: History
“A physiological demonstration with vivisection of a dog,”
by ÉmileÉdouard Mouchy.
“An Experiment on a Bird in an air pump”,
by Joseph Wright of Derby (detail) (1768).
Franco NH. Animal Experiments in Biomedical Research: A Historical Perspective. Animals (Basel). 2013 Mar 19;3(1):238-73. doi:
10.3390/ani3010238. Review. PubMed PMID: 26487317; PubMed Central PMCID: PMC4495509.

Animal Ethics
• Crux: ‘How animals ought to be treated’
• The subject matter includes:
Animal Rights, Animal Welfare, Animal Law, Speciesism, Animal
Cognition, Wildlife Conservation, The Moral Status of Non-human Animals,
Concept of Non Human Personhood, Human Exceptionalism, The History of
Animal Use, and Theories of Justice.*
Beauchamp, Tom L. "Introduction," in Tom L. Beauchamp and R.G. Frey. The Oxford Handbook of Animal Ethics. Oxford University Press, 2011.Schaffner,
Joan E. An Introduction to Animals and the Law. Palgrave MacMillan, 2011, p. xvii;

Trends in Animal Research
9/26/2018 10Ethics in Animal Research | Lahiry | Pharmacology | IPGMER-Kolkata
This schematic illustration (adapted with permission from an original by Professor Bert van Zupthen) attempts to
describe trends in the use of animals for scientific purposes in the Western world across time.
Franco NH. Animal Experiments in Biomedical Research: A Historical Perspective. Animals (Basel). 2013 Mar 19;3(1):238-73. doi:
10.3390/ani3010238. Review. PubMed PMID: 26487317; PubMed Central PMCID: PMC4495509.

Extent of Animal Use
The Mouse Trap. https://goo.gl/pkwJyj [ Retrieved 10 May, 2017]

Russell, W. M. S., & Burch, R. L. (1959).
The principles of humane experimental technique.
+ Reuse & Rehabilitation
Kumar HA. Effectively communicating the 5R's (replace, reduce, refine, reuse, and rehabilitate) of research ethics, biomedical waste, personalized medicines
and the rest. Journal of Natural Science, Biology and Medicine. 2012;3(1):1.

Badyal DK, Desai C. Animal use in pharmacology education and research: The changing scenario. Indian journal of pharmacology. 2014 May 1;46(3):257.
World Regulations Indian Regulations

Focus
Guidelines:
• Guidelines on the Regulation of Scientific Experiments on Animals (2007)
• CPCSEA Guidelines for Laboratory Animal Facility (2005)
Statutory provisions:
❑ 2.0 Prevention of Cruelty to Animals (PCA) Act,1960; (revised in1982)
❑ 2.0 Breeding of and Experiments on Animals (Control and Supervision) Rules,
1998; 2001; 2006
CPCSEA Standard Operating Procedures (SOP) for IAEC [2010] https://goo.gl/53vz0J

Guidelines on the Regulation of Scientific
Experiments on Animals (2007)
3.0Principles for scientific experiments on animals, relevant changes in
Rules and guidelines for specific situations evolved by the ‘Consultative’
Group accepted by CPCSEA (2004)
3.1 Ethical principles adopted by CPCSEA for use of animals in scientific experiments
3.2 CPCSEA Guidelines on specific aspects regarding the use of animals in scientific
experiments
4.0 Procedures for approval of scientific experiments on animals
Guidelines on the Regulation of Scientific Experiments on Animals [ MoEF (Animal Welfare Division) June 2007] https://goo.gl/53vz0J

3.1 (Five) Ethical principles adopted by
CPCSEA for use of animals in scientific
experiments
• Principle 1: “Experiments on animals” must be for advancement new discovery
• Principle 2: Animals on the ‘lowest phylogenetic state’ must be used
Minimum no. of animals must used to yield results with 95% CI
• Principle 3: Avoidance or minimization of pain & suffering inflicted on animals
• Principle 4: Investigator moral responsible for aftercare and/or rehabilitation after
experiments, and may be permitted to euthanize, only in following situations:
1. Incapacitated or paralyzed, and not able to perform its natural function
2. Severe recurring pain, or signs of long term extreme pain & suffering
3. Life-threatening to humans or other animals
• Principle 5: Living condition appropriate for their species

3.2 CPCSEA Guidelines on specific aspects
regarding the use of animals in scientific
experiments
3.2.1 Need to minimize pain & suffering inflicted on experimental animals
3.2.2 Proper care, handling and use of experimental animals
3.2.3 Agricultural production research
3.2.4 Powers of IAEC
3.2.5 Inspection of animal house facilities

4.0 Procedures for approval of scientific
experiments on animals
4.1 Definition of ‘experiment’ In terms of Rule 2 (e) of the Breeding of and
Experiments on Animals (Control and Supervision) Rules, 1998, as
amended:
Amendment: “Experiment” definition to include “significant gains in the well-being of the people of the country”

4.2 Experimental animals which are subject to regulation the relative sentience
of different species of animals are as follows:
Invertebrates (e.g., cockroaches) < Birds < Rodents < Canines/Felines <
Bovine/Equines < Primates (e.g., Rhesus Macaque)< more evolved Primates
(e.g., chimpanzee)
*Anything higher than invertebrates in terms of level of sentience requires regulation.
4.3 Function of CPCSEA
4.4 Functions of IAEC
IAEC is not empowered to clear research proposals that involve experiments on animals higher on the
phylogenetic state scale than rodents (e.g. rabbits, rats & rabbits). In such cases, proposals are to be
forwarded to CPCSEA*

Defined under Breeding of and Experiments on Animals (Control & Supervision) Rules, 1998
4.5 Registration of establishments (Rule 4)
4.6 Approval of animal house facilities (Rule 5)
4.7 Use of animals in experiments (Role 9(bb))
4.8 Procurement of animals (Rule 10)
4.9 Welfare of animals during use in experiments (Rule 9(cc))
4.10 Aftercare & rehabilitation of animals after use in scientific experiments (Rule 9(cc))
4.11 Situations where euthanisation of animals is permissible (Rule 9(cc))
4.12 Suspension/revocation of registration of an establishment by CPCSEA (Rule 14)

CPCSEA
*Committee for the Purpose of Control and
Supervision of Experiments on Animals
• Est. under Chapter 4 Section 15(1), PCA Act [1960]
• Fist enacted by Ministry of Agriculture [1968];
wound up in 1977
• After 13 years, recommendations from AWBI
(Animal Welfare Board of India)
• Since 8th July, 1991 - under Ministry of Environment,
Forest & Climate Change (MoEFCC);
Recent reconstitution of CPCSEA: 17th Feb, 2016
• Present Chairman (2017):
Shri Hem Pande (Add. Secretary, MoEF)
Source: CPCSEA website http://cpcsea.nic.in/Auth/index.aspx (Retrieved 10 May, 2017)

CPCSEA
*Committee for the Purpose of Control and Supervision
of Experiments on Animals
• Over 1618 facilities with IAEC are registered (2017)
• Empowered to approve research project proposals that use rats, mice, guinea-pigs or
rabbits; canines, ovines, bovines or non-human primates
• Protocol for the production of immunobiologicals from equines has been formulated and
ratified by the Supreme Court of India (2005)

Registered Non-Human Primate Testing Centres
Rhesus:
CDRI Lucknow, AIIMS, New Delhi; National
Institute of Immunology, New Delhi;PGI,
Chandigarh; National Institute of Virology, Pune;
and National Institute of Nutrition, Hyderabad.
Langurs:
Department of Zoology, University of Rajasthan
Bonnets:
Primate Research Laboratory at the Indian
Institute of Science, Bangalore; Institute for
Research in Reproduction, Bombay, and the
National Institute of Immunology, New Delhi.
National Research Council (US) Institute for Laboratory Animal Research. International Perspectives: The Future of Nonhuman Primate Resources.
Washington (DC): National Academies Press (US); 2003. Use of Nonhuman Primates in Biomedical Research in India: Current Status and Future
Prospects. Available from: https://www.ncbi.nlm.nih.gov/books/NBK221767

Functions of CPCSEA
1. Registration of establishments conducting animal experimentation or breeding of
animals for this purpose.
2. Selection and appointment of nominees in the Institutional Animal Ethics Committees
(IAEC) of registered establishments.
3. Approval of Animal House Facilities on the basis of reports of inspections conducted by
CPCSEA.
4. Permission for conducting experiments involving use of animals.
5. Recommendation for import of animals for use in experiments.
6. Action against establishments in case of violation of any legal norm/stipulation.

IAEC
COMPOSITION - Eight members
1. A biological scientist,
2. Two scientists from different biological disciplines,
3. A veterinarian involved in the care of animal,
4. Scientist in charge of animals facility of the establishment concerned,
5. A scientist from, outside the institute,
6. A non scientific socially aware member and
7. A nominee of CPCSEA
Reconstitution every 5 years (earlier 3yrs)
*Notification: F. No 25/197/2013-CPCSEA (Vol I-III), MoEFCC [19.08.2016]
Quorum: 6 members; Presence of CPCSEA nominee is a must.
Reporting to CPCSEA
– Minutes of IAEC meeting to be sent to CPCSEA within 15 days.
– Inspection report of animal house with photographs to be sent yearly
– If action is required, the facility must provide ATR within 30days.

IAEC
As per “Breeding of and Experiments on Animals (Control and Supervision) Rules, 1998”
Functions:
1. Review and approve all types of research proposals involving animal
experimentation before the start of the study.
2. Monitor the research throughout the study and after completion of study
through periodic reports and visit to animal house and laboratory where the
experiments are conducted.
3. Ensure compliance with all regulatory requirements, applicable rules,
guidelines and laws.

2.1 CPCSEA Guidelines for Laboratory Animal
facility (2005)
‘Promote humane care of animal used in biomedical
and behavioral research and testing’

facility (2005)
• Veterinary Care
• Animal Procurement (Annex. 4)
• Quarantine, Stabilization &
Separation
• Surveillance, Diagnosis,
Treatment & Control of disease
(Annex. 1 & 2)
• Animal Care & Technical
Personnel (Annex. 7)
• Personal Hygiene
• Animal experimentation
involving Hazardous agents
(Annex. 8)
• Multiple surgical procedures on
single animal
• Duration of experiments
• Physical restraint
• Location of Animal Facilities to
laboratories
• Functional areas
• Physical facilities &
Specifications
• Environment
• Animal Husbandry (Annex. 3)
• Environment

facility (2005)
• Activity
• Food, Bedding, Water
• Sanitation & cleanliness
• Waste Disposal
• Pest Control
• Emergency, Weekend & Holiday
Care
• Record keeping
• Standardized SOP
• Personnel/Training
(Annexure 7)
• Transport of laboratory animals
(Annexure 4)
• Anesthesia & Euthanasia
(Annexure 5, 6)
• Lab Animals Ethics
• Transgenic animals
• Maintenance
• Disposal
• Breeding & Genetics

facility (2005)

facility (2005)
*CPCSEA Notification: Role And Responsibilities Of Nominees Of CPCSEA p#4, Part C
*“It is strongly recommended that an over dose of Thiopentone Sodium be used for
euthanasia of all species, except under very exceptional cases.”

facility (2005)

European Union: Regulations
• Experiments on vertebrate animals in the EU are since January 1, 2013 subject
to Directive 2010/63/EU on the ‘Protection Of Animals Used For Scientific
Purposes’.
• Cosmetics Directive, 2004 amendment: Animal testing for cosmetic products
is forbidden in the EU.
• Animal testing for cosmetic ingredients is prohibited since March 2009.
• The amendment also prohibited, since 11 March 2009, to market cosmetic
products containing ingredients which have been tested on animals.
• *The amendment does not prohibit companies to use animal testing to fulfill
regulatory requirements in other countries.
Source: "Directive 86/609/EEC on the protection of Animals used for Experimental and other scientific purposes" Archived August 5, 2009, at the Wayback
Machine. European Commission, 1986. Retrieved February 8, 2007

Testing Regulation around the World
France
Requires an institutional and project license (validity: 5years) before testing
on vertebrates is carried out (Decree of October 19, 1980 )
Germany
‘Utilitarian priniciple’ (German Animal Welfare Act)
United Kingdom
Experiments to be regulated by 3 licences (Animals Scientific Procedures)
Act 1986
Licensing based on ‘Cost-benefit analysis’ approach
Mandates having institutional Animal Welfare and Ethical Review Body
(AWERB, Directive 2010/63/EU)
Source: "Directive 86/609/EEC on the protection of Animals used for Experimental and other scientific purposes" Archived August 5, 2009, at the Wayback
Machine. European Commission, 1986. Retrieved February 8, 2007

Testing Regulation around the World
US
• Animal Welfare Act of 1966 (AWA), and the Animal Welfare Regulations which is
enforced by the Animal Care division of the Animal and Plant Health Inspection
Service (APHIS) of the United States Department of Agriculture (USDA).
• Each institution to maintain an Institutional Animal Care and Use
Committee (IACUC).
Canada
• Canadian Council on Animal Care (CCAC).
• The Criminal Code of Canada Section 446 and 447 of the Criminal Code protect
animals from cruelty, abuse and neglect.
• The Health of Animals Act
• ‘The Spending Power ’
Sources:
"Archived copy" (PDF). Archived from the original (PDF)on 2013-12-19. Retrieved 2014-02-25.
"Archived copy". Archived from the original on 2012-09-02. Retrieved 2012-05-01.

Conclusion
*A large advertisement published in the 13 May 1991 edition of
The Hour (p. 9), and part of a campaign in defense of animal
Research. [sponsored by United States Surgical Corporation]

ETHICAL ISSUES IN ANIMAL EXPERIMENTATIONS

ETHICAL ISSUES IN ANIMAL EXPERIMENTATIONS

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