2. Animal Ethics
Term used to describe human-animal relationships and how
animals ought to be managed and treated. It includes,
• Animal rights
• Animal welfare
• Animal law
• Animal cognition
• Wildlife conservation
• Moral status of nonhuman animals
3. 5 Freedoms of Animal Welfare
• Freedom from hunger or thirst by ready access to fresh water and a
diet to maintain full health and vigour
• Freedom from discomfort by providing an appropriate environment
including shelter and a comfortable resting area
• Freedom from pain, injury or disease by prevention or rapid
diagnosis and treatment
• Freedom to express (most) normal behaviour by providing
sufficient space, proper facilities and company of the animal's own
kind
• Freedom from fear and distress by ensuring conditions and
treatment which avoid mental suffering
4. Prevention of Cruelty to Animals
Act 1960
• Individuals conducting experiments must be qualified, and the
experiments are performed under their full responsibility
• Experiments to be performed with due care and humanity, as
far as possible, experiments involving operations are performed
under the influence of some anaesthetic
• During course of experiments performed under the influence
of anaesthetics, if an animal becomes so injured that recovery
would involve serious suffering, it will be euthanised while
still anaesthetised.
5. Prevention of Cruelty to Animals
Act 1960
• Experiments on animals are avoided wherever it is
possible to do so, if other teaching devices such as
books, models, films and the like may equally suffice
• Experiments on larger animals are avoided when it is
possible to achieve the same results by experiments upon
small laboratory animals, such as guinea-pigs, rabbits,
frogs and rats
• Experiments are not performed merely for the purpose
of acquiring manual skill
6. Prevention of Cruelty to Animals
Act 1960
• Animals intended for the performance of experiments are
properly looked after both before and after experiments
• Suitable records are maintained with respect to
experiments performed on animals.
7. CPCSEA & IAEC
• Currently in India, experimentation on animals is covered
under the provisions of Prevention of Cruelty to
Animals Act, (PCA Act) 1960 and the Rules under the
amended Act of 1998 and 2001.
• Implemented through Committee for the Purpose of
Control & Supervision of Experiments on Animals
(CPCSEA), established in 1964 under Section 15(1) of the
PCA Act under the Ministry of Environment Forest &
Climate Change
8. CPCSEA & IAEC
• Institutional Animal Ethics Committees (IAECs)
constituted in registered laboratories under CPCSEA
• Currently, there are 86 medical universities, 80 pharmacy
colleges, 35 veterinary universities and 464 institutions
that use animals for biomedical/regulatory research
9. Institutional Animals Ethics Committee
As defined in “Breeding of and Experiments on Animals
(Control and Supervision) Rules, 1998”:
Institutional Animals Ethics Committee means a body
comprising of a group of persons recognized and
registered by the CPCSEA, performed in an
establishment which is constituted and operated in
accordance with procedures specified for the purpose
by the Committee.
10. Objective of IAEC
To contribute to the effective functioning of the Institutional
Animal Ethics Committee (IAEC) so that a standard and
consistent ethical review procedure for animal research is
practised for all proposals dealt by the Committee as
prescribed by the CPCSEA under PCA Act 1960 and
Breeding and Experimentation Rules 1998.
11. Functions of IAEC
• 8 member IAEC that includes a nominee of the
CPCSEA is constituted in every registered institute as a
necessary prerequisite
• All research project proposals using small animals, such
as rats, mice, rabbits or guinea-pigs, have to be approved
by the IAEC before initiation
• Every member of the IAEC has the right to
question/disapprove of a project; unapproved
proposals are referred to a subcommittee of experts for
scrutiny and possible approval
12. Functions of IAEC
• IAEC cannot approve research projects on large
animals, such as dogs, cats, nonhuman primates, cattle,
goats, sheep, and so forth, and can only recommend the
same to the sub-committee of the CPCSEA, which, alone,
has the power to approve projects on higher vertebrates
• Monitoring research throughout the study and after
completion of study through periodic reports and visit
animal house and laboratory where the experiments are
conducted.
13. Functions of IAEC
• The committee has to ensure compliance with all
regulatory requirements, applicable rules, guidelines and
laws
• IAEC accords quality and consistency in review of
research proposals and to prevent infliction of
unnecessary pain & sufferings before, during and after
experiments on animals, to follow the CPCSEA
guidelines.
14. Composition of IAEC
Institutional Animals Ethics committee shall include eight
members as follows.
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
15. Composition of IAEC
5. A scientist from outside the institute
6. A non scientific socially aware member
7. A nominee of CPCSEA
The Chairperson of the Committee and Member Secretary
would be nominated by the Institution from among the eight
members. Members against Serial number 1-4 will be
nominated by the institute and approved by CPCSEA where
as members 5,6 and 7 will be nominated by CPCSEA
16. IAEC Requirements
• Duration of appointment is for a period of 5 years
• Committee is required to be reconstituted at the time of
renewal of registration, and at least half of the members
will be replaced
• A member can be replaced in the event of death or long-
term non-availability or for any action not commensurate
with the responsibilities laid down in the guidelines
deemed unfit for a member
17. IAEC Requirements
• A member can tender resignation from the committee
with proper reasons to do so
• All members should maintain absolute confidentiality of
all discussions during the meeting and sign a
confidentiality form.
• Conflict of interest should be declared by members of the
IAEC.
18. Quorum Requirements
• Minimum of 6 members required to compose a quorum
• Decisions will be made only in meetings where quorum is
complete.
• All decisions should be taken in meetings and not by
circulation of project proposals.
• Presence of CPCSEA nominee is a must
• Socially aware member’s presence is compulsory in cases
referred to CPCSEA and at least in one meeting in a
calendar year
19. Conduct of Business
• IAEC meeting will be conducted once in 3 months
• The copies of the proposals will be sent to the members 2
weeks prior to the meeting
• The Chairperson will conduct all meetings of the IAEC. If
he/she is not available an alternate Chairperson will be
elected from the members by the members present, who will
conduct the meeting
20. Conduct of Business
• The Member Secretary is responsible for organizing the
meetings, maintaining the records and communicating
with all concerned
• Approval letters will be issued no later than 15 days of the
meeting
• Revised and resubmitted proposals approval will be issued
no later than 7 days of re submission
21. Participation by Investigators /
Experts
• IAEC may call upon subject experts who may provide
special review of selected research protocols, if need be.
• They are required to give their specialized views but do
not take part in the decision making process which will be
made by the members of the IAEC
22. Review Procedure
• Need of the proposed research work based on existing
information available
• Type and the reason for the animal chosen
• Number of animals required
• Detailed procedure involved - grouping of animals,
handling, feeding, blood withdrawal, anaesthetics used and
their dose, route of administration of the investigational
agents, the dose, duration and monitoring of animals and
how the samples will be used
23. Review Procedure
• The safety data available for the investigational agent
• Post study plan - rehabilitation / euthanasia
• Details of euthanasia
• Method of disposal of carcass
• Decisions will be taken by consensus after discussions.
Negative view points should be recorded in the minutes.
In case consensus is not reached, the case should be
referred to CPCSEA
24. Decision-making
• Decisions will be made only in meetings where quorum is
complete
• Only members can make the decision. The experts /
investigators / invitees will only offer their opinions.
• Decision may be to approve, reject or revise the
proposals. Specific suggestions for modifications and
reasons for rejection should be given.
25. Decision-making
• A member should withdraw from the meeting during the
decision procedure concerning an application where a
conflict of interest arises and this should be indicated to
the chairperson prior to the review of the application and
recorded in the minutes
• Modified proposals may be reviewed by an expedited
review through identified members.
26. Communicating the Decision
• Decision will be communicated by the Member Secretary
in writing
• Suggestions for modifications, if any, should be sent by
IAEC
• Reasons for rejection should be informed to the
researchers.
27. Reporting to CPCSEA
• IAEC is required to send a copy of minutes of IAEC
meeting to CPCSEA within 15 days
• Inspection report of animal house with photographs by
IAEC members is required to be sent once in a calendar
year
• Fees Payable to CPCSEA: Registration fee of Rs. 10,000/-
and renewal fee of Rs. 2,500/-
28. Record keeping by IAEC
All following documents must be stored for a period of five
years
• Curriculum Vitae (CV) of all members
• Copy of all study protocols with enclosed documents,
progress reports
• Minutes of all meetings duly signed by the Chairperson
and the members
29. Record keeping by IAEC
• Copy of all existing relevant national and international
guidelines on animal ethics and laws along with
amendments
• Copy of all correspondence with members, researchers
and other regulatory bodies
• Record of Breeding of animals, supply etc, if breeding of
animals is undertaken
• Record of import of animals with species, source,
quantity, usage etc.
31. Dissection Monitoring Committee
(DMC)
• All institutes of Higher Education require Dissection
Monitoring Committee (DMC) to ensure strict
compliance of instructions, relating to the use of animals
for research purposes only.
• Prohibits dissection by students or teachers for teaching
purposes in UG and PG programs
• Promotes use of digital alternatives, models, charts etc for
educational purposes
32. Dissection Monitoring Committee
(DMC)
• Convener and Chairperson: Head of concerned
department
• Members: 2 senior faculty members of concerned
department, 1 faculty member of a related department,
same institute, 1/ 2 faculty members of concerned
department from nearby institute
33. Dissection Monitoring Committee
(DMC)
• Tenure: 2 years
• Quorum for the meeting shall be 3/6, where atleast 1
member from the neighboring institute must be present
• DMC shall meet atleast once each semester/half year and
approve or review alternative experimentation of animals
for lab exercises
34. Functions of DMC
• Ensure that animals permitted for use are procured from
ethical sources, and not removed from the wild
• Ensure stress-free transportation to lab
• Proper care and anesthetization of live animals, if used
• Ensure that the institute maintains appropriate records of
procurement of animals, their transport, number of
animals used, use of anesthesia/euthanasia etc.
• Reduction in number of animals for dissection &
experimentation
