CPCSEA guidelines for animal experiments MCQs With Answer

CPCSEA guidelines for animal experiments MCQs With Answer

This blog offers a focused set of multiple-choice questions on CPCSEA (Committee for the Purpose of Control and Supervision of Experiments on Animals) guidelines tailored for M.Pharm students studying pharmacological and toxicological screening methods. It emphasizes core regulatory principles used in India: ethical review, the 3Rs (Replacement, Reduction, Refinement), Institutional Animal Ethics Committee (IAEC) roles, housing and care standards, anesthesia and analgesia, humane endpoints, documentation, and compliance requirements for animal facilities. These MCQs are designed to strengthen understanding of practical and regulatory expectations, aid exam preparation, and reinforce best practices for planning and conducting ethically approved animal experiments.

Q1. Which body is primarily responsible for regulating and monitoring animal experimentation practices in India?

• Indian Council of Medical Research (ICMR)
• Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA)
• Pharmacy Council of India (PCI)
• Drug Controller General of India (DCGI)

Correct Answer: Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA)

Q2. What is the mandatory institutional committee required by CPCSEA to review and approve animal experiment protocols?

• Institutional Review Board (IRB)
• Institutional Animal Ethics Committee (IAEC)
• Central Ethics Committee (CEC)
• Animal Welfare Board of India (AWBI)

Correct Answer: Institutional Animal Ethics Committee (IAEC)

Q3. Which of the following best describes the ‘3Rs’ principle emphasized by CPCSEA?

• Reduce, Rehabilitate, Recycle
• Refine, Reduce, Replace
• Respond, Report, Record
• Review, Regulate, Reimburse

Correct Answer: Refine, Reduce, Replace

Q4. Which member is required to be part of the IAEC to provide independent perspective according to CPCSEA guidelines?

• Head of the institution only
• External nominee or lay person
• Pharmacy student representative
• Only internal investigators

Correct Answer: External nominee or lay person

Q5. Under CPCSEA, what must be obtained before starting experiments involving live animals?

• Pharmacy Council registration
• IAEC approval of the study protocol
• Food safety certificate
• Publication acceptance letter

Correct Answer: IAEC approval of the study protocol

Q6. Which of the following is a primary ethical consideration in CPCSEA guidelines when designing studies?

• Maximizing animal numbers to ensure variability
• Using animals without anesthesia to save time
• Minimizing pain and distress through appropriate analgesia and humane endpoints
• Keeping animals in isolation without enrichment

Correct Answer: Minimizing pain and distress through appropriate analgesia and humane endpoints

Q7. According to CPCSEA, which document should outline detailed procedures, housing, and care as SOPs for an animal facility?

• Standard Operating Procedures (SOPs)
• Trial master file (TMF)
• Drug master file (DMF)
• Manufacturing batch record

Correct Answer: Standard Operating Procedures (SOPs)

Q8. Which action is considered a refinement under the 3Rs in CPCSEA guidance?

• Increasing group sizes irrespective of statistical need
• Using less painful routes of administration and improved analgesia
• Replacing animal studies with computational predictions only when available
• Importing wild-caught animals instead of bred ones

Correct Answer: Using less painful routes of administration and improved analgesia

Q9. Which of the following is the recommended approach for euthanasia under CPCSEA principles?

• Methods approved, humane, and performed by trained personnel
• Any rapid method chosen by the investigator without training
• Only pharmacological overdose without regard to species-specific standards
• Leaving animals untreated until natural death

Correct Answer: Methods approved, humane, and performed by trained personnel

Q10. What is the role of CPCSEA regarding registration of institutions conducting animal experiments?

• No role; institutions self-certify
• It registers and periodically inspects animal houses and institutions
• It accredits personnel but not institutions
• It only provides training materials and no oversight

Correct Answer: It registers and periodically inspects animal houses and institutions

Q11. Which of the following must IAEC consider when approving a pharmacological experiment involving animals?

• Scientific merit, ethical justification, and animal welfare measures
• Only the cost of the study
• Whether the investigator has published previously
• Public popularity of the research topic

Correct Answer: Scientific merit, ethical justification, and animal welfare measures

Q12. Under CPCSEA rules, how should adverse events or unexpected animal deaths during a study be handled?

• Ignored unless they affect the final result
• Reported promptly to IAEC with investigation and corrective actions
• Only recorded at the end of the study
• Concealed to avoid regulatory scrutiny

Correct Answer: Reported promptly to IAEC with investigation and corrective actions

Q13. What is the CPCSEA recommendation regarding use of anesthesia and analgesia in painful procedures?

• Use of anesthesia and analgesia whenever procedures may cause pain or distress
• Never use analgesia as it interferes with study endpoints
• Only use local remedies without systemic drugs
• Delay anesthesia until animal shows overt signs of pain

Correct Answer: Use of anesthesia and analgesia whenever procedures may cause pain or distress

Q14. Who is responsible for ensuring that personnel handling animals are trained according to CPCSEA?

• The IAEC alone
• The institutional management and principal investigator together
• Individual animal handlers only
• No one; on-the-job learning is acceptable

Correct Answer: The institutional management and principal investigator together

Q15. Which of the following is true about record keeping as per CPCSEA guidelines?

• Records of animals, procedures, and outcomes must be maintained and available for inspection
• Only final study results are required to be archived
• No records are needed if the study is short
• Records should be destroyed immediately after publication

Correct Answer: Records of animals, procedures, and outcomes must be maintained and available for inspection

Q16. For experiments involving genetically modified animals, CPCSEA expects:

• Additional review for welfare implications and containment measures
• No additional review beyond normal studies
• Automatic approval if the modification is published elsewhere
• Transfer of responsibility to foreign regulators

Correct Answer: Additional review for welfare implications and containment measures

Q17. Which housing consideration is emphasized by CPCSEA to promote animal well‑being?

• Providing species-appropriate environment, socialization, and enrichment
• Keeping animals in minimal space to reduce costs
• Housing all species together to save space
• Using only wired cages without bedding for all species

Correct Answer: Providing species-appropriate environment, socialization, and enrichment

Q18. What is the recommended approach when a non-animal alternative is available for a specific experiment?

• Prefer the non-animal alternative in line with Replacement
• Ignore alternatives if animals are already available
• Use both animals and alternatives to compare results
• Proceed only with animals to maintain tradition

Correct Answer: Prefer the non-animal alternative in line with Replacement

Q19. How often should IAEC review ongoing projects or at least conduct progress reviews according to good CPCSEA practice?

• Never after initial approval
• Periodically, as defined in their SOPs, and when significant changes occur
• Only at the end of the study
• Only when an external audit requests it

Correct Answer: Periodically, as defined in their SOPs, and when significant changes occur

Q20. Which statement best reflects CPCSEA’s stance on publication of animal study data?

• Data should be reported transparently, including animal welfare considerations and methods
• Animal welfare details are optional and can be omitted
• Only positive results should be published to save resources
• Methodological details must be kept confidential

Correct Answer: Data should be reported transparently, including animal welfare considerations and methods

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