Institutional Review Board (IRB) and Ethics Committee structure MCQs With Answer

Institutional Review Board (IRB) and Ethics Committee structure MCQs With Answer

The Institutional Review Board (IRB) and Ethics Committee structure is vital for B. Pharm students to understand clinical research governance, protocol review, informed consent, Good Clinical Practice (GCP) and regulatory compliance. This introduction explains committee composition, roles of chairperson, scientific and lay members, quorum, continuing review, safety monitoring, conflict of interest management, documentation and SAE reporting. Familiarity with ethical frameworks such as the Declaration of Helsinki, national regulations and standard operating procedures (SOPs) helps ensure patient safety, data integrity and investigator accountability. These core concepts prepare pharmacy graduates for research involvement and regulatory interactions. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary function of an Institutional Review Board (IRB) or Ethics Committee?

• Approve all research regardless of ethical issues
• Protect the rights, safety and welfare of research participants
• Conduct the research on behalf of investigators
• Provide funding for clinical studies

Correct Answer: Protect the rights, safety and welfare of research participants

Q2. According to common regulatory standards, what is a minimum requirement for IRB membership size?

• At least two members
• At least five members
• At least ten members
• Exactly three members

Correct Answer: At least five members

Q3. Which member is essential on an IRB to provide scientific expertise in biomedical research?

• Basic medical scientist
• Administrative clerk
• Pharmaceutical salesperson
• IT technician

Correct Answer: Basic medical scientist

Q4. What are the standard categories of ethical review an IRB uses?

• Informal, formal and emergency review
• Full board, expedited and exempt review
• Scientific, clinical and financial review
• Internal, external and outsourced review

Correct Answer: Full board, expedited and exempt review

Q5. Expedited review is most appropriate for which type of research?

• High-risk interventional drug trials
• First-in-human gene therapy studies
• Minimal risk research fitting defined regulatory categories
• All research involving vulnerable populations

Correct Answer: Minimal risk research fitting defined regulatory categories

Q6. What does “quorum” mean in the context of an IRB meeting?

• The number of protocol pages required for submission
• The minimum number of IRB members present to make decisions
• The total members registered with the regulatory authority
• The required number of external consultants

Correct Answer: The minimum number of IRB members present to make decisions

Q7. Which documents are essential for initial IRB submission for a clinical study?

• Study protocol, informed consent form, investigator brochure and investigator CV
• Only a short summary and trial budget
• Patient medical records without consent
• Marketing materials and sales projections

Correct Answer: Study protocol, informed consent form, investigator brochure and investigator CV

Q8. What is the purpose of continuing review by an IRB?

• To approve unrelated new trials
• To monitor ongoing study progress, safety and compliance periodically
• To determine study budget allocations
• To recruit new investigators

Correct Answer: To monitor ongoing study progress, safety and compliance periodically

Q9. How should an IRB member handle a conflict of interest for a protocol under review?

• Vote normally but do not disclose the conflict
• Participate in all deliberations to influence outcomes
• Recuse from review and voting and disclose the conflict
• Approve the protocol to avoid delays

Correct Answer: Recuse from review and voting and disclose the conflict

Q10. What is the IRB’s role regarding serious adverse events (SAEs) occurring during a trial?

• Ignore SAEs unless media reports them
• Review SAEs and unanticipated problems and recommend actions to protect participants
• Conduct the clinical management of SAE patients
• Provide financial compensation directly

Correct Answer: Review SAEs and unanticipated problems and recommend actions to protect participants

Q11. Which statement best distinguishes a Data Safety Monitoring Board (DSMB) from an IRB?

• A DSMB conducts regulatory inspections while IRB manages budgets
• A DSMB monitors ongoing safety and efficacy data; IRB provides ethical review and oversight
• A DSMB recruits participants and IRB analyzes data
• There is no difference; both perform identical functions

Correct Answer: A DSMB monitors ongoing safety and efficacy data; IRB provides ethical review and oversight

Q12. For research involving minors, what additional ethical requirement is commonly necessary?

• Only child assent with no parental involvement
• Parental permission and, when appropriate, child assent
• No consent needed due to low literacy
• Assent from community leaders instead of parents

Correct Answer: Parental permission and, when appropriate, child assent

Q13. Which element is essential in a valid informed consent?

• Compulsion of participation by authority
• Voluntariness, explanation of risks and benefits, alternatives and confidentiality
• Omission of foreseeable risks to speed recruitment
• Advertising claims of guaranteed benefit

Correct Answer: Voluntariness, explanation of risks and benefits, alternatives and confidentiality

Q14. Which research example is most likely to be eligible for exemption from full IRB review?

• First-in-human chemotherapy dose-escalation study
• Interventional device implanted surgically
• Secondary analysis of de-identified existing datasets
• Randomized placebo-controlled vaccine trial

Correct Answer: Secondary analysis of de-identified existing datasets

Q15. What official records must an IRB maintain to demonstrate compliance?

• Only annual financial statements
• Meeting minutes, membership records, protocol files and approval letters
• Investigator’s private notes and unrelated email chains
• Only advertising materials used for recruitment

Correct Answer: Meeting minutes, membership records, protocol files and approval letters

Q16. In India, which authority is responsible for ethics committee registration of clinical trial ECs?

• World Health Organization (WHO)
• Central Drugs Standard Control Organization (CDSCO)
• Local municipal corporation
• Pharmaceutical company association

Correct Answer: Central Drugs Standard Control Organization (CDSCO)

Q17. Which type of study typically requires full board IRB review?

• Anonymous survey about non-sensitive opinions
• Low-risk observational study with de-identified data
• Interventional clinical trial with greater than minimal risk
• Classroom educational assessment within normal curriculum

Correct Answer: Interventional clinical trial with greater than minimal risk

Q18. Which ethical principle is primarily associated with respect for persons?

• Justice
• Beneficence
• Autonomy
• Nonmaleficence

Correct Answer: Autonomy

Q19. Why are Standard Operating Procedures (SOPs) important for an Ethics Committee?

• They are optional suggestions with no compliance value
• They provide consistent processes for review, documentation and regulatory compliance
• They replace the need for meeting minutes
• They only describe how to recruit participants

Correct Answer: They provide consistent processes for review, documentation and regulatory compliance

Q20. What information is typically included in an IRB approval letter?

• Conditions of approval, required changes and validity period
• Only the financial audit report
• Investigator’s personal medical history
• Vendor contacts for trial supplies

Correct Answer: Conditions of approval, required changes and validity period

Q21. When should investigators report protocol deviations to the IRB?

• Never; deviations are ignored
• As specified in SOPs and whenever deviations affect participant safety or data integrity
• Only at the end of the study in the final report
• Only if requested by participants

Correct Answer: As specified in SOPs and whenever deviations affect participant safety or data integrity

Q22. Which member type ensures community perspective is represented on an Ethics Committee?

• Legal counsel from the sponsor
• Lay person or community representative
• Only internal hospital administrators
• Study monitor employed by the investigator

Correct Answer: Lay person or community representative

Q23. How should compensation for research-related injury be addressed?

• Not mentioned in consent to avoid liability
• Described in the informed consent and managed according to regulations and EC decisions
• Decided informally by the research nurse
• Only provided if the sponsor volunteers later

Correct Answer: Described in the informed consent and managed according to regulations and EC decisions

Q24. What is a primary responsibility of the Ethics Committee chairperson?

• To personally investigate all study participants
• To preside over meetings and ensure ethical review follows SOPs
• To prepare all investigators’ manuscripts
• To manage the study’s finances

Correct Answer: To preside over meetings and ensure ethical review follows SOPs

Q25. Which practice best protects participant privacy in research data handling?

• Publishing full identifiers in open journals
• Using coding, de-identification and secure storage with restricted access
• Sharing raw data with all study staff without controls
• Keeping paper files unlocked in public areas

Correct Answer: Using coding, de-identification and secure storage with restricted access

Q26. How can multi-centric trials streamline ethical review across sites?

• By using site-specific reviews only with no coordination
• By relying on a central or single ethics committee review when permitted by regulation and site agreements
• By avoiding ethical review altogether
• By rotating review tasks daily among sites

Correct Answer: By relying on a central or single ethics committee review when permitted by regulation and site agreements

Q27. Which situation would most likely lead an Ethics Committee to suspend a study?

• Minor administrative error in a consent form with no safety impact
• Serious safety concerns or major non-compliance affecting participant welfare
• Positive efficacy results reported early
• Investigator changes employment without notification

Correct Answer: Serious safety concerns or major non-compliance affecting participant welfare

Q28. What information should IRB meeting minutes record to support decisions?

• Only the meeting date and the menu served
• Attendance, votes, key discussion points, conditions and rationale for decisions
• Confidential medical records of participants
• Personal opinions of each non-attending member

Correct Answer: Attendance, votes, key discussion points, conditions and rationale for decisions

Q29. How are retrospective chart reviews generally treated by an IRB?

• Always require full board review regardless of risk
• May qualify for exemption or expedited review if data are de-identified and risks are minimal
• Never require any documentation or approval
• Require participant re-consent in all cases

Correct Answer: May qualify for exemption or expedited review if data are de-identified and risks are minimal

Q30. Besides protocol review, how can an Ethics Committee support ethical research conduct?

• Providing training and guidance on research ethics, informed consent and regulatory compliance
• Directly managing clinical trial finances
• Recruiting participants for all studies
• Replacing investigator responsibilities for data collection

Correct Answer: Providing training and guidance on research ethics, informed consent and regulatory compliance

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