Working procedures of Ethics Committees MCQs With Answer

Introduction

Ethics Committees play a critical role in safeguarding participant rights and ensuring ethical conduct of clinical research. This MCQ set on Working Procedures of Ethics Committees is designed for B. Pharm students to deepen understanding of protocol review, informed consent, risk–benefit assessment, continuing review, adverse event reporting, confidentiality, conflict of interest, SOPs, and regulatory guidelines (GCP, ICMR, CDSCO). Questions focus on committee composition, expedited and full-board review, documentation, approval processes, monitoring, and responsibilities of investigators and reviewers. Clear knowledge of these procedures helps future pharmacists contribute to ethical clinical trials and pharmacovigilance. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary responsibility of an Ethics Committee (EC) reviewing clinical research?

• Maximizing study enrollment
• Protecting rights, safety and well‑being of research participants
• Approving budgets and funding
• Promoting a specific sponsor’s drug

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

Q2. Which element is essential in the composition of a properly functioning Ethics Committee?

• Only senior clinicians from the same department
• Multidisciplinary membership including at least one lay person and legal/ethical expertise
• All members must be employees of the sponsoring company
• Only pharmacologists and statisticians

Correct Answer: Multidisciplinary membership including at least one lay person and legal/ethical expertise

Q3. What is a key purpose of Standard Operating Procedures (SOPs) for an Ethics Committee?

• To allow ad hoc and inconsistent decision‑making
• To define consistent processes for review, documentation, reporting and monitoring
• To replace national regulatory guidelines
• To determine investigators’ salaries

Correct Answer: To define consistent processes for review, documentation, reporting and monitoring

Q4. Which type of review is appropriate for minimal‑risk research that poses little to no harm to participants?

• Full board review only
• Expedited review
• No review at all
• Automatic approval by the sponsor

Correct Answer: Expedited review

Q5. What must an Ethics Committee assess regarding informed consent documents?

• That documents use complex technical terms to impress reviewers
• Comprehensibility, completeness of information, voluntariness and appropriate language for participants
• That consent forms include only the title of the study
• That the investigator’s CV is included instead

Correct Answer: Comprehensibility, completeness of information, voluntariness and appropriate language for participants

Q6. Which activity is part of continuing review by an Ethics Committee?

• Reviewing new safety data, protocol deviations and renewal of approval
• Negotiating sponsor payments to investigators
• Designing the study intervention
• Recruiting participants for the trial

Correct Answer: Reviewing new safety data, protocol deviations and renewal of approval

Q7. When evaluating risk–benefit ratio, what should the Ethics Committee focus on?

• Only the potential benefits to the sponsor
• Whether anticipated benefits to participants and society justify the foreseeable risks
• That risks are ignored if recruitment is slow
• Ensuring risks exceed benefits to test robustness

Correct Answer: Whether anticipated benefits to participants and society justify the foreseeable risks

Q8. What action should the EC take when a member has a conflict of interest in a review?

• Allow the member to lead the discussion
• Require recusal from discussion and decision on that protocol
• Increase the member’s voting weight
• Ignore the conflict since expertise is important

Correct Answer: Require recusal from discussion and decision on that protocol

Q9. Which document is essential for EC records after a meeting?

• Signed minutes detailing decisions, votes, rationale and any conditions
• Only the attendance sheet and no minutes
• Only a private email summary
• Financial invoices without scientific justification

Correct Answer: Signed minutes detailing decisions, votes, rationale and any conditions

Q10. What is the role of an independent lay member on an Ethics Committee?

• To provide scientific statistical analysis
• To represent community values and bring a non‑scientific perspective on participant welfare
• To recruit patients for the trial
• To adjudicate investigator disputes

Correct Answer: To represent community values and bring a non‑scientific perspective on participant welfare

Q11. Which element is NOT typically assessed by an EC during protocol review?

• Scientific validity and methodological soundness
• Informed consent process and participant selection
• Investigator’s personal investments unrelated to the study
• Risk mitigation and data confidentiality measures

Correct Answer: Investigator’s personal investments unrelated to the study

Q12. What justifies waiving informed consent in certain research?

• The study involves high risk to participants
• When research involves minimal risk, impossibility of obtaining consent, and there is strong justification and EC approval
• When the sponsor requests faster enrollment
• Whenever investigators prefer not to inform participants

Correct Answer: When research involves minimal risk, impossibility of obtaining consent, and there is strong justification and EC approval

Q13. Which is a primary responsibility of investigators in relation to the Ethics Committee?

• To submit accurate protocols, report SAEs, and comply with EC conditions
• To change study procedures without informing the EC
• To prioritize sponsor interests over participant safety
• To avoid reporting protocol deviations

Correct Answer: To submit accurate protocols, report SAEs, and comply with EC conditions

Q14. How should an EC handle multi‑center trials regarding approvals?

• A single site approval automatically covers all sites
• Each participating site normally requires local EC review unless a national framework allows central review
• Only the sponsor needs to approve other sites
• EC approval is not necessary for multi‑center trials

Correct Answer: Each participating site normally requires local EC review unless a national framework allows central review

Q15. What is an appropriate EC response to unanticipated serious adverse events (SAEs)?

• Ignore them if enrollment is high
• Require prompt reporting, rapid review, and consideration of modifications to protect participants
• Delay review until study completion
• Delegate review to the sponsor only

Correct Answer: Require prompt reporting, rapid review, and consideration of modifications to protect participants

Q16. Which factor increases vulnerability of a research participant and requires special EC consideration?

• Ability to provide fully informed, voluntary consent
• Age, cognitive impairment, economic dependency or institutionalization
• High educational attainment
• Being a licensed healthcare professional

Correct Answer: Age, cognitive impairment, economic dependency or institutionalization

Q17. Which is part of EC oversight after study approval?

• Continuous monitoring of safety data, site visits, and reviewing annual reports
• Designing the investigational product
• Handling investigator payroll
• Deciding market price of the drug

Correct Answer: Continuous monitoring of safety data, site visits, and reviewing annual reports

Q18. What should ECs verify about data confidentiality in a protocol?

• That identifiable participant data are minimized, securely stored and access is restricted
• That all participant data are publicly posted immediately
• That personal data are distributed to the sponsor’s marketing team
• That passwords are shared among all study staff without restriction

Correct Answer: That identifiable participant data are minimized, securely stored and access is restricted

Q19. How should an EC handle protocol deviations discovered during a monitoring visit?

• Document deviations, assess impact on participant safety and data integrity, and require corrective action
• Conceal them from regulatory authorities
• Ignore minor deviations regardless of safety impact
• Terminate the EC immediately

Correct Answer: Document deviations, assess impact on participant safety and data integrity, and require corrective action

Q20. What role does an Ethics Committee play in compensation for research‑related injury?

• ECs set institutional salaries only
• ECs review the compensation plan and ensure fair provisions for participants harmed by the research
• ECs decide patent rights for inventions
• ECs approve commercial advertising of the study

Correct Answer: ECs review the compensation plan and ensure fair provisions for participants harmed by the research

Q21. What is the significance of a Data Safety Monitoring Board (DSMB) in clinical trials relative to the EC?

• The DSMB replaces the EC
• The DSMB provides independent safety monitoring and may recommend changes, complementing EC oversight
• The DSMB handles EC administrative duties
• The DSMB enrolls participants

Correct Answer: The DSMB provides independent safety monitoring and may recommend changes, complementing EC oversight

Q22. Which aspect of participant information is crucial for ethical recruitment?

• Withholding alternative treatments to encourage enrolment
• Transparent disclosure of purpose, procedures, risks, benefits and voluntary nature of participation
• Using coercive payment schemes
• Misrepresenting study benefits

Correct Answer: Transparent disclosure of purpose, procedures, risks, benefits and voluntary nature of participation

Q23. How should an EC treat research that involves vulnerable groups such as children?

• Children can be enrolled without parental permission
• Require additional safeguards, assent where appropriate, and justification for inclusion
• Exclude all vulnerable populations categorically
• Allow enrollment only if sponsors insist

Correct Answer: Require additional safeguards, assent where appropriate, and justification for inclusion

Q24. What is the importance of SOPs for documentation retention by an EC?

• They determine how long minutes, approvals and correspondence must be archived for audit and accountability
• They allow random disposal of records
• They permit keeping only verbal records
• They prohibit sharing documents with auditors

Correct Answer: They determine how long minutes, approvals and correspondence must be archived for audit and accountability

Q25. Which review outcome may an Ethics Committee issue for a submitted protocol?

• Approval, conditional approval, modification required, or rejection
• Immediate publication in a journal
• Automatic transfer to another study
• Unilateral investigator appointment

Correct Answer: Approval, conditional approval, modification required, or rejection

Q26. What should an EC consider when reviewing investigator qualifications?

• Relevant training, experience, previous research conduct and ability to protect participant safety
• Only investigator’s social media presence
• Whether the investigator can recruit the most participants regardless of qualifications
• Investigator’s unrelated business interests

Correct Answer: Relevant training, experience, previous research conduct and ability to protect participant safety

Q27. How should ECs address ancillary care obligations during review?

• Ignore ancillary care and focus only on trial procedures
• Assess whether the protocol defines responsibilities for managing incidental clinical needs that arise during participation
• Require investigators to provide lifetime care without justification
• Delegate all clinical obligations to participants’ families

Correct Answer: Assess whether the protocol defines responsibilities for managing incidental clinical needs that arise during participation

Q28. Which guideline(s) typically inform Ethics Committee procedures and decisions?

• Good Clinical Practice (GCP), national ethical guidelines (e.g., ICMR), and relevant regulatory requirements
• Only advertising standards
• Company internal memos exclusively
• Random internet blogs

Correct Answer: Good Clinical Practice (GCP), national ethical guidelines (e.g., ICMR), and relevant regulatory requirements

Q29. Why is fair subject selection an ethical concern for an EC?

• Because it ensures recruitment biases, exploitation or unjust exclusion are avoided and benefits and burdens are equitably distributed
• Because it increases study costs
• Because it reduces the number of eligible participants unnecessarily
• Because fairness is not relevant to scientific validity

Correct Answer: Because it ensures recruitment biases, exploitation or unjust exclusion are avoided and benefits and burdens are equitably distributed

Q30. Which records should investigators provide to an Ethics Committee upon request during monitoring?

• Source documents, consent forms, SAE reports, protocol deviations and complete regulatory files
• Only a one‑line summary with no supporting data
• Personal financial records unrelated to the study
• Only promotional material

Correct Answer: Source documents, consent forms, SAE reports, protocol deviations and complete regulatory files

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