Introduction: This quiz collection on IRB/IEC composition and responsibilities is tailored for M.Pharm students preparing for advanced coursework and examinations in Clinical Research & Regulatory Requirements. It focuses on the structure, membership criteria, decision-making authority, ethical review processes and practical responsibilities of Institutional Review Boards (IRBs) / Institutional Ethics Committees (IECs). Questions emphasize regulatory principles (including national and international guidance), quorum and independence, conflict-of-interest management, review of protocols and informed consent, safety reporting and continuing oversight. Use these questions to test comprehension, reinforce critical concepts required for ethical trial conduct, and prepare for professional roles involving ethics review or clinical trial oversight.
Q1. What is the primary purpose of an IRB/IEC?
- To monitor the financial aspects of clinical trials
- To train investigators in clinical trial methodology
- To protect the rights, safety and well-being of research participants and ensure ethical and regulatory compliance
- To market investigational products to physicians
Correct Answer: To protect the rights, safety and well-being of research participants and ensure ethical and regulatory compliance
Q2. According to common national and international guidelines, what is the minimum recommended number of members for an IEC in India?
- 3 members
- 5 members
- 7 members
- 10 members
Correct Answer: 7 members
Q3. Which statement best describes the recommended background of the IEC Chairperson in institutional committees?
- The Chairperson must be the head of the research department conducting trials
- The Chairperson should be an external or independent person, not routinely involved in the institution’s research governance
- The Chairperson must be the principal investigator in the majority of trials
- The Chairperson must be a junior faculty member to encourage learning
Correct Answer: The Chairperson should be an external or independent person, not routinely involved in the institution’s research governance
Q4. What is the role of a lay member or community representative on an IEC?
- To provide specialized statistical review
- To represent non-scientific, community perspectives and safeguard participant interests
- To approve budgets and sponsor payments
- To replace the legal expert when absent
Correct Answer: To represent non-scientific, community perspectives and safeguard participant interests
Q5. Which professional is typically designated as the ‘basic medical scientist’ on an IEC?
- Clinical psychologist
- Pharmacologist or another basic sciences specialist
- Hospital administrator
- Clinical trial monitor
Correct Answer: Pharmacologist or another basic sciences specialist
Q6. Why is it important to include a legal expert on an IEC?
- To provide clinical trial monitoring services
- To advise on legal and regulatory obligations, consent validity, and participant rights
- To recruit participants for studies
- To perform laboratory quality control
Correct Answer: To advise on legal and regulatory obligations, consent validity, and participant rights
Q7. What is the primary administrative role of the IEC Member Secretary?
- To fund the research projects under review
- To handle day-to-day administration, prepare agendas, maintain records and communicate decisions
- To act as the principal investigator for all trials
- To provide independent clinical assessment of every protocol
Correct Answer: To handle day-to-day administration, prepare agendas, maintain records and communicate decisions
Q8. Which of the following is a typical quorum requirement for an IEC meeting?
- At least 2 members including the chairperson
- At least 3 basic scientists only
- At least 5 members including at least one non-scientific member and one lay/community representative
- No fixed quorum; decisions can be made by email without members
Correct Answer: At least 5 members including at least one non-scientific member and one lay/community representative
Q9. How should an IEC manage a declared conflict of interest by one of its members for a specific protocol?
- Allow the member to participate but not vote
- Require the member to leave the room and abstain from discussion and decision for that protocol
- Ignore the conflict and proceed as usual
- Allow the member to be the primary reviewer to ensure transparency
Correct Answer: Require the member to leave the room and abstain from discussion and decision for that protocol
Q10. During protocol review, which assessment is central to the IEC’s ethical determination?
- Commercial viability of the investigational product
- Risk–benefit ratio for participants and adequacy of safeguards including informed consent
- Investigator’s preferred statistical method
- Publication plan for the trial results
Correct Answer: Risk–benefit ratio for participants and adequacy of safeguards including informed consent
Q11. What is the recommended frequency for IEC continuing review of an ongoing clinical trial?
- Once every five years
- At least annually, or more frequently depending on risk
- No continuing review after initial approval
- Only when the sponsor requests it
Correct Answer: At least annually, or more frequently depending on risk
Q12. How should an IEC handle proposed amendments to an approved protocol?
- Allow immediate implementation without review
- Require prior review and approval by the IEC except for urgent safety measures
- Delegate approval to the sponsor without oversight
- Only record the amendment after study completion
Correct Answer: Require prior review and approval by the IEC except for urgent safety measures
Q13. Who is primarily responsible for promptly notifying the IEC about serious adverse events (SAEs) occurring during a clinical trial?
- The sponsor only
- The investigator (and sponsor as required) must report SAEs to the IEC
- The journal editor publishing the trial
- The study monitor exclusively
Correct Answer: The investigator (and sponsor as required) must report SAEs to the IEC
Q14. Which documents are essential elements of IEC records and must be maintained?
- Only the final approval letter
- Membership list, SOPs, meeting minutes, protocol review forms and decision letters
- Only financial invoices for research studies
- Only copies of informed consent forms without other documentation
Correct Answer: Membership list, SOPs, meeting minutes, protocol review forms and decision letters
Q15. What specific aspect of the informed consent process is the IEC expected to evaluate?
- Whether consent will be obtained in the sponsor’s preferred font
- Comprehensibility, voluntariness, completeness of information and suitability of language for the participant population
- Whether the consent form supports marketing activities
- Only the length of the consent form, not its content
Correct Answer: Comprehensibility, voluntariness, completeness of information and suitability of language for the participant population
Q16. Why must an IEC include at least one member who is independent or not affiliated with the institution?
- To facilitate faster approvals
- To provide an unbiased perspective and reduce institutional conflicts of interest
- To serve as an alternate secretary
- To perform laboratory assessments
Correct Answer: To provide an unbiased perspective and reduce institutional conflicts of interest
Q17. Which principle underlies the need for diverse IEC composition, including gender balance and multidisciplinary representation?
- To comply with budgetary constraints
- To ensure comprehensive ethical, scientific and social perspectives are considered in review
- To reduce the time taken for meetings
- To limit the number of dissenting opinions
Correct Answer: To ensure comprehensive ethical, scientific and social perspectives are considered in review
Q18. What actions can an IEC take if a trial is found to have serious ethical or safety concerns during oversight?
- Require minor edits only and continue without restrictions
- Approve without changes because the investigator is experienced
- Suspend or terminate approval, require protocol amendments, or impose corrective measures
- Delegate all decisions to the sponsor
Correct Answer: Suspend or terminate approval, require protocol amendments, or impose corrective measures
Q19. Under which circumstances is an expedited review by an IEC typically appropriate?
- For first-in-human, high-risk interventional trials
- For administrative changes or studies involving minimal risk and minor amendments
- When the study has significant ethical controversies
- For multicenter trials requiring full board oversight always
Correct Answer: For administrative changes or studies involving minimal risk and minor amendments
Q20. What training is generally expected of IEC members to perform effective ethical review?
- No training is required; experience alone suffices
- Training in research ethics, applicable regulations (e.g., GCP and national guidelines), conflict-of-interest management and review procedures
- Only sponsor-specific protocol training
- Training only in statistical methods
Correct Answer: Training in research ethics, applicable regulations (e.g., GCP and national guidelines), conflict-of-interest management and review procedures
