National ethical guidelines: ICMR and Schedule Y overview MCQs With Answer

Introduction:
The following MCQ set is designed for M.Pharm students preparing for advanced topics in clinical research and pharmacovigilance, focusing on National ethical guidelines (ICMR) and Schedule Y (Drugs & Cosmetics Rules) in India. Questions cover core ethical principles, ethics committee composition and responsibilities, informed consent, vulnerable populations, sponsor and investigator duties, trial phases, trial registration, data safety monitoring and post-marketing obligations. The items emphasize practical regulatory requirements and everyday decision-making in clinical trials, helping students consolidate knowledge required for conduct, oversight and compliance. Answers are provided to facilitate self-assessment and quick concept reinforcement for academic exams and regulatory practice.

Q1. What is the primary purpose of the ICMR National Ethical Guidelines for Biomedical and Health Research involving Human Participants?

• To provide a legal code punishable by law
• To provide a technical manual for laboratory procedures
• To provide an ethical framework and operational guidance for the conduct of biomedical and health research involving human participants
• To regulate pharmaceutical pricing

Correct Answer: To provide an ethical framework and operational guidance for the conduct of biomedical and health research involving human participants

Q2. Which year saw the publication of the most widely referenced version of the ICMR National Ethical Guidelines currently used in India?

• 2000
• 2006
• 2017
• 2021

Correct Answer: 2017

Q3. Schedule Y is a part of which regulatory framework in India?

• The Indian Penal Code
• The Drugs and Cosmetics Rules
• The National Health Policy
• The Medical Council of India regulations

Correct Answer: The Drugs and Cosmetics Rules

Q4. According to ICMR guidance, which characteristic best describes the required composition of an institutional Ethics Committee (EC)?

• Only clinicians from the host institute
• A multidisciplinary committee including scientific members and non-scientific/lay representation
• Only legal experts and administrators
• A single-member committee headed by the principal investigator

Correct Answer: A multidisciplinary committee including scientific members and non-scientific/lay representation

Q5. Which of the following is NOT a fundamental element of valid informed consent as emphasized by ICMR?

• Provision of adequate information about risks and benefits
• Voluntariness without undue influence
• Payment of participants as the primary reason to enroll
• Documentation of comprehension and consent

Correct Answer: Payment of participants as the primary reason to enroll

Q6. Which groups are typically classified as vulnerable populations in ICMR ethical guidance?

• Healthy adult volunteers with full capacity
• Clinical investigators and sponsors
• Children, pregnant women, persons with mental disability and economically or socially disadvantaged groups
• Regulatory inspectors and auditors

Correct Answer: Children, pregnant women, persons with mental disability and economically or socially disadvantaged groups

Q7. Under Indian regulations and ethical guidance, who holds primary responsibility for providing compensation for trial-related injury or death?

• The trial participant
• The Ethics Committee
• The institutional hospital only
• The sponsor of the clinical trial

Correct Answer: The sponsor of the clinical trial

Q8. In the context of Schedule Y, Phase I clinical trials are most often conducted in which population?

• Large patient populations across multiple centers
• Healthy adult volunteers (except certain cytotoxic agents where patients are used)
• Only pediatric patients
• Post-marketing consumers

Correct Answer: Healthy adult volunteers (except certain cytotoxic agents where patients are used)

Q9. When must a clinical trial be registered in the Clinical Trials Registry – India (CTRI)?

• After the first participant completes the study
• Only for Phase IV trials
• Before recruitment of the first participant
• Only when the manuscript is submitted for publication

Correct Answer: Before recruitment of the first participant

Q10. Under ethical guidance, the use of a placebo in a clinical trial is considered acceptable when:

• There is a proven effective standard therapy and it is withheld from participants
• There is no proven effective intervention or there are compelling methodological reasons and no additional risk of serious harm
• It makes recruitment faster irrespective of risk
• The sponsor prefers lower cost interventions

Correct Answer: There is no proven effective intervention or there are compelling methodological reasons and no additional risk of serious harm

Q11. A Data Safety Monitoring Board (DSMB) is particularly recommended for which type of trials?

• Small, single-center, low-risk observational studies
• Large multicenter trials or trials with substantial safety concerns or mortality endpoints
• In vitro laboratory experiments
• Non-clinical animal studies

Correct Answer: Large multicenter trials or trials with substantial safety concerns or mortality endpoints

Q12. Which of the following is an essential responsibility of the principal investigator as per Schedule Y and ICMR guidance?

• Obtaining valid informed consent and ensuring accurate trial conduct and SAE reporting
• Setting national health policy
• Approving drug marketing authorizations
• Managing sponsor finances

Correct Answer: Obtaining valid informed consent and ensuring accurate trial conduct and SAE reporting

Q13. Before initiating a new drug clinical trial in India as governed by Schedule Y, the sponsor must obtain permission from which authority?

• Local municipal corporation
• Central Drugs Standard Control Organization (CDSCO) or designated licensing authority
• International pharmaceutical associations
• World Health Organization

Correct Answer: Central Drugs Standard Control Organization (CDSCO) or designated licensing authority

Q14. According to ICMR guidelines, informed consent documents should be prepared in:

• Only in English regardless of participant background
• Technical legal language to prevent disputes
• Languages understandable to the prospective participants or their legally authorized representatives
• Only in the investigator’s preferred dialect

Correct Answer: Languages understandable to the prospective participants or their legally authorized representatives

Q15. Phase I oncology trials differ from most Phase I trials because they are usually conducted in:

• Healthy volunteers without disease
• Patients with the target cancer disease due to expected toxicity and lack of therapeutic equipoise in healthy subjects
• Only elderly subjects over 75 years
• Only in pediatric volunteers

Correct Answer: Patients with the target cancer disease due to expected toxicity and lack of therapeutic equipoise in healthy subjects

Q16. Post-marketing studies that monitor safety and effectiveness after approval are classified under Schedule Y as which phase?

• Phase I
• Phase II
• Phase III
• Phase IV

Correct Answer: Phase IV

Q17. How frequently should an Ethics Committee review ongoing approved research protocols as a minimum practice?

• Only once at initial approval
• At least annually or more frequently depending on risk
• Every five years
• Only when an adverse event occurs

Correct Answer: At least annually or more frequently depending on risk

Q18. Good Clinical Practice (GCP) principles are primarily intended to protect:

• The commercial interests of the sponsor only
• The rights, safety and well-being of trial participants and to ensure reliability of clinical trial data
• The reputation of the investigator only
• The confidentiality of the regulatory authority

Correct Answer: The rights, safety and well-being of trial participants and to ensure reliability of clinical trial data

Q19. Data confidentiality in clinical research requires which of the following actions?

• Sharing participant identifiers freely for transparency
• Storing participant data with appropriate safeguards and sharing only de-identified information unless consented otherwise
• Publishing full participant contact lists
• Using participant data for unrelated commercial marketing without consent

Correct Answer: Storing participant data with appropriate safeguards and sharing only de-identified information unless consented otherwise

Q20. Which document is the primary, authoritative guidance on ethical conduct for biomedical research involving human participants in India?

• Schedule X of the Drugs and Cosmetics Rules
• ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants
• The Indian Evidence Act
• Clinical trial protocols from overseas sponsors only

Correct Answer: ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants

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