Guidelines and ethics committees MCQs With Answer

Introduction:

This quiz collection on Guidelines and Ethics Committees is designed specifically for M.Pharm students preparing for exams and research responsibilities. It covers national and international regulatory frameworks, ethical principles, institutional ethics committee (IEC) functions, composition and review processes, informed consent, vulnerable populations, and the investigator’s and sponsor’s responsibilities. Questions focus on practical application of guidelines such as ICH-GCP, Declaration of Helsinki, Schedule Y and national ethical policies, helping students internalize how ethics committees safeguard participant rights and scientific integrity. Use these MCQs to test knowledge, identify gaps, and strengthen understanding needed for conducting and reviewing clinical research ethically and compliantly.

Q1. Which international document primarily provides ethical principles for medical research involving human subjects and is issued by the World Medical Association?

• International Conference on Harmonisation Good Clinical Practice (ICH-GCP)
• Declaration of Helsinki
• Belmont Report
• CIOMS Guidelines

Correct Answer: Declaration of Helsinki

Q2. Which guideline is considered the global standard for Good Clinical Practice that harmonizes technical requirements for clinical trials?

• Declaration of Helsinki
• WHO Ethical Guidelines
• International Conference on Harmonisation Good Clinical Practice (ICH-GCP)
• National Drug Policy

Correct Answer: International Conference on Harmonisation Good Clinical Practice (ICH-GCP)

Q3. What is the principal responsibility of an Institutional Ethics Committee (IEC) when reviewing a clinical research proposal?

• Maximizing recruitment speed to meet sponsor timelines
• Protecting the rights, safety, and well-being of research participants
• Approving all requests for budget increases
• Publishing trial results on behalf of the investigator

Correct Answer: Protecting the rights, safety, and well-being of research participants

Q4. Which of the following is an essential element of informed consent documentation?

• Guarantee of therapeutic benefit to all participants
• Clear description of study purpose, procedures, risks, and benefits
• Assurance that personal data will be publicized
• Promise of free medical care for unrelated conditions indefinitely

Correct Answer: Clear description of study purpose, procedures, risks, and benefits

Q5. Which composition requirement is commonly recommended for an ethics committee to ensure diverse perspectives?

• Only clinicians from the same department
• Members solely from the sponsoring company
• Multidisciplinary membership including clinicians, a basic scientist, a legal expert and a lay/community member
• Only institutional administrators

Correct Answer: Multidisciplinary membership including clinicians, a basic scientist, a legal expert and a lay/community member

Q6. What type of review may an ethics committee use for studies involving minimal risk and well-established procedures?

• Full committee review only
• Expedited review
• Automatic approval without documentation
• International regulatory review

Correct Answer: Expedited review

Q7. Which document should an investigator submit to an ethics committee to demonstrate scientific rationale and design of a clinical trial?

• Participant recruitment flyers only
• Study protocol
• Investigator’s social media profile
• Financial disclosure form alone

Correct Answer: Study protocol

Q8. Which principle emphasizes treating individuals with autonomy, providing adequate information and allowing voluntary decision making?

• Beneficence
• Justice
• Respect for persons (autonomy)
• Nonmaleficence only

Correct Answer: Respect for persons (autonomy)

Q9. If a research participant is physically incapable of giving informed consent and no legally authorized representative is available, what is the ethically appropriate action?

• Enroll the participant immediately without any consent
• Delay any non‑urgent research interventions until consent can be obtained
• Proceed if the investigator believes it is for the participant’s good
• Obtain verbal agreement from any nearby person

Correct Answer: Delay any non‑urgent research interventions until consent can be obtained

Q10. What is the role of the ethics committee regarding safety monitoring during an ongoing clinical trial?

• Only review safety at initial approval and never thereafter
• Conduct continuing review and require reporting of serious adverse events
• Replace the sponsor’s responsibility for data monitoring completely
• Approve safety reports only after study completion

Correct Answer: Conduct continuing review and require reporting of serious adverse events

Q11. Under ethical guidelines, who should disclose potential conflicts of interest to the ethics committee?

• Only the sponsor
• Investigators, committee members and sponsors when relevant
• Only the institution’s finance office
• No one; conflicts are irrelevant to ethics review

Correct Answer: Investigators, committee members and sponsors when relevant

Q12. Which ethical consideration is particularly important when enrolling vulnerable populations such as children, pregnant women or cognitively impaired persons?

• Vulnerability can be ignored if the trial is low cost
• Enhanced protections and justification for inclusion with appropriate consent/assent
• Automatic exclusion from all research regardless of potential benefit
• Obtaining consent from the investigator only

Correct Answer: Enhanced protections and justification for inclusion with appropriate consent/assent

Q13. Which of the following best describes prospective ethical review?

• Approval by the ethics committee after recruitment has ended
• Review and approval by the ethics committee before participant enrollment begins
• Informal verbal permission from a single member of the committee
• Approval only required for publication

Correct Answer: Review and approval by the ethics committee before participant enrollment begins

Q14. What is an essential function of an ethics committee regarding informed consent forms?

• Editing language to ensure clarity, completeness and cultural appropriateness
• Removing all risk information to avoid participant alarm
• Replacing consent with a brief verbal note in all cases
• Approving only after data collection is complete

Correct Answer: Editing language to ensure clarity, completeness and cultural appropriateness

Q15. Which document outlines national ethical principles and standards for biomedical research involving human subjects in many countries, serving as a primary reference for local ECs?

• Institutional grant application
• National ethical guidelines or national bioethics policy (e.g., ICMR guidelines)
• Individual investigator’s lecture notes
• Marketing brochure of the investigational product

Correct Answer: National ethical guidelines or national bioethics policy (e.g., ICMR guidelines)

Q16. When is expedited review by an ethics committee generally appropriate?

• For all first‑in‑human studies regardless of risk
• For minimal risk research or minor changes to approved protocols
• For trials involving invasive experimental surgery
• For multi‑center trials requiring central approval only

Correct Answer: For minimal risk research or minor changes to approved protocols

Q17. What is the ethics committee’s responsibility if serious unanticipated harms emerge during a trial?

• Ignore new information until study completion
• Assess new information, require modifications, and consider suspension or termination if risks outweigh benefits
• Delegate all decisions to the sponsor without review
• Only inform the principal investigator and take no further action

Correct Answer: Assess new information, require modifications, and consider suspension or termination if risks outweigh benefits

Q18. Which statement best describes the difference between an ethics committee and a Data Safety Monitoring Board (DSMB)?

• They are the same body with identical functions
• IEC provides ethical oversight and approval; DSMB provides independent ongoing safety and efficacy monitoring during a trial
• DSMB handles recruitment while IEC manages budgeting
• IEC only audits finances while DSMB writes the protocol

Correct Answer: IEC provides ethical oversight and approval; DSMB provides independent ongoing safety and efficacy monitoring during a trial

Q19. What is required for multicenter trials regarding ethics committee approvals?

• Approval from a single site suffices for all sites in all jurisdictions
• Each participating site must have ethics approval from a competent EC unless central review is accepted by local regulations
• Ethics approval is unnecessary for sites outside the sponsor’s country
• Only the sponsor’s ethics committee approval is needed

Correct Answer: Each participating site must have ethics approval from a competent EC unless central review is accepted by local regulations

Q20. Which action by an investigator would constitute research misconduct in the context of ethics committee oversight?

• Reporting all adverse events promptly and accurately
• Fabricating or falsifying participant data or withholding information from the ethics committee
• Seeking prior EC approval for protocol amendments
• Providing complete and comprehensible consent information to participants

Correct Answer: Fabricating or falsifying participant data or withholding information from the ethics committee

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