Ethical committees and IRB functions MCQs With Answer

Introduction

This quiz set on Ethical Committees and Institutional Review Board (IRB) Functions is tailored for M.Pharm students preparing for exams and clinical research roles. It covers composition, responsibilities, review types, documentation, informed consent, vulnerable populations, conflict of interest, and regulatory interactions. Questions probe both conceptual understanding and practical application of IRB processes—such as expedited review, continuing review, approval conditions, and safety oversight—so you can confidently evaluate ethical aspects of clinical trials and pharmacovigilance. Use these MCQs to deepen your knowledge of how ethical oversight protects participant rights and ensures scientific integrity in clinical research.

Q1. What is the primary ethical principle that an IRB applies to ensure research subjects are not exposed to unnecessary risk?

• Justice
• Respect for persons
• Beneficence
• Autonomy

Correct Answer: Beneficence

Q2. Which of the following best describes an IRB’s role in informed consent processes?

• To draft consent forms for investigators
• To ensure consent forms are ethical, understandable, and complete
• To obtain consent directly from participants
• To replace investigator responsibility for consent documentation

Correct Answer: To ensure consent forms are ethical, understandable, and complete

Q3. Which group should typically NOT make up the majority of an IRB membership to prevent institutional bias?

• Scientists/clinicians from the institution
• Non-scientific layperson
• Legal or ethics expert
• Community representative or lay member

Correct Answer: Scientists/clinicians from the institution

Q4. What is the main purpose of expedited IRB review procedures?

• To bypass ethical review for low-risk research
• To accelerate review of research involving minimal risk and minor changes
• To allow only the chair to approve high-risk protocols
• To permit investigators to self-certify ethical compliance

Correct Answer: To accelerate review of research involving minimal risk and minor changes

Q5. Which document is essential for IRB review to assess scientific validity and participant safety?

• Investigator’s CV only
• Study protocol
• Advertising material exclusively
• Laboratory reference ranges

Correct Answer: Study protocol

Q6. During continuing review, what is a critical factor the IRB evaluates?

• Investigator’s salary
• Number of publications arising from the study
• Accumulated adverse events and risk–benefit balance
• Course schedules of student investigators

Correct Answer: Accumulated adverse events and risk–benefit balance

Q7. Which action should an IRB take if an ongoing study shows a new risk that changes the risk–benefit profile?

• Ignore until the next annual review
• Require prompt reporting to participants and consider suspension or modification
• Advise investigators to publish the finding only
• Delegate the decision to the sponsor

Correct Answer: Require prompt reporting to participants and consider suspension or modification

Q8. What is a conflict of interest in the context of IRB members?

• Having a different academic opinion from the investigator
• Personal or financial interest that could affect impartial review
• Being a clinician at the same institution
• Serving on multiple IRBs

Correct Answer: Personal or financial interest that could affect impartial review

Q9. Which population is considered vulnerable and requires special protections by the IRB?

• Healthy adult volunteers with full capacity to consent
• Prisoners, minors, pregnant women, or cognitively impaired individuals
• Research staff conducting the study
• Institutional reviewers

Correct Answer: Prisoners, minors, pregnant women, or cognitively impaired individuals

Q10. What documentation must an IRB maintain to demonstrate compliance with ethical review standards?

• Only approval letters
• Minutes of meetings, membership rosters, SOPs, protocols, consent forms and correspondence
• Only adverse event logs
• Only investigator CVs

Correct Answer: Minutes of meetings, membership rosters, SOPs, protocols, consent forms and correspondence

Q11. When may an IRB waive the requirement for written informed consent?

• Never; written consent is always required
• When the research involves no more than minimal risk and written consent is impractical or detrimental
• When the investigator is trusted by the IRB
• For all industry-sponsored studies

Correct Answer: When the research involves no more than minimal risk and written consent is impractical or detrimental

Q12. What is the IRB’s responsibility regarding safety reporting in a clinical trial?

• To file safety reports with the sponsor only
• To review serious adverse event reports and ensure appropriate action and communication
• To manage clinical care for adverse events
• To withhold SAE information from participants

Correct Answer: To review serious adverse event reports and ensure appropriate action and communication

Q13. Which factor is essential for quorum at an IRB meeting to approve research?

• Presence of only the chairperson
• Majority of members present including at least one non-scientist and one member unaffiliated with the institution
• Only scientific experts related to the protocol
• All members must be present without exception

Correct Answer: Majority of members present including at least one non-scientist and one member unaffiliated with the institution

Q14. What is the appropriate IRB action when an investigator proposes a significant amendment to a protocol after approval?

• Implement the change immediately and notify the IRB later
• Submit the amendment for IRB review and approval before implementation (unless urgent for safety)
• Allow the sponsor to approve the amendment
• Discard the amendment

Correct Answer: Submit the amendment for IRB review and approval before implementation (unless urgent for safety)

Q15. How does an IRB assess the adequacy of subject recruitment materials?

• By confirming that the materials exaggerate benefits
• By ensuring accuracy, non-coercive language, appropriate risk description, and clarity for the target population
• By limiting recruitment to internal staff
• By removing all discussion of risks

Correct Answer: By ensuring accuracy, non-coercive language, appropriate risk description, and clarity for the target population

Q16. Which international guidance is commonly used by IRBs to frame ethical review of clinical research?

• Good Manufacturing Practice (GMP)
• Declaration of Helsinki and ICH-GCP
• Pharmacopoeia monographs
• Marketing regulations for pharmaceuticals

Correct Answer: Declaration of Helsinki and ICH-GCP

Q17. What should an IRB consider when reviewing payment or compensation to research participants?

• That payment must always be high to ensure recruitment
• That compensation should not constitute undue influence and must be proportionate to time and inconvenience
• That payments should be secret
• That only the sponsor decides payment amount without IRB input

Correct Answer: That compensation should not constitute undue influence and must be proportionate to time and inconvenience

Q18. In multicenter trials, what is a common IRB arrangement to avoid duplicate reviews?

• Each site conducts a completely independent review with no communication
• Use of a central IRB reliance model or single IRB review with local site oversight
• Sponsor approval replaces all IRB reviews
• Skipping ethical review for familiar protocols

Correct Answer: Use of a central IRB reliance model or single IRB review with local site oversight

Q19. Which of the following is an IRB power to enforce compliance when serious non-compliance is identified?

• Request additional funding for the study
• Suspend or terminate IRB approval of the research
• Replace the principal investigator without review
• Publish the investigator’s personal data

Correct Answer: Suspend or terminate IRB approval of the research

Q20. What role does an IRB play in protecting data confidentiality and privacy?

• IRB drafts clinical data analysis plans
• IRB evaluates data handling procedures, anonymization, access controls and consent language for confidentiality
• IRB stores all study data centrally
• IRB prohibits any data sharing under any circumstances

Correct Answer: IRB evaluates data handling procedures, anonymization, access controls and consent language for confidentiality

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