Institutional ethics/IRB composition and functions MCQs With Answer

Welcome to this focused MCQ collection on Institutional Ethics Committees (IRBs) tailored for M.Pharm students preparing for Clinical Research (MPP 104T). This set covers composition, roles, review procedures, documentation, conflict of interest, expedited review, SAE reporting, informed consent oversight, and monitoring responsibilities. Each question targets applied knowledge—regulatory principles, ethical reasoning and operational practices—to help you master concepts required for exams and practical ethics committee interactions. Answers are provided to reinforce learning and prompt deeper study. Use these questions for self-assessment, group discussion, or rapid revision before viva voce and university assessments. They emphasize real-world scenarios, critical appraisal of protocols and regulatory compliance. Read each question carefully and refer to national guidelines and institutional SOPs for detailed rules.

Q1. What is the primary reason for ensuring diverse professional and non‑professional membership on an Institutional Ethics Committee?

• To speed up administrative paperwork for trials
• To ensure a wide range of perspectives are present to protect participant rights and welfare
• To meet sponsor demands for expertise
• To increase the number of reviews an EC can perform simultaneously

Correct Answer: To ensure a wide range of perspectives are present to protect participant rights and welfare

Q2. International guidance commonly recommends a minimum number of IRB/EC members to ensure balanced review. What is that commonly cited minimum?

• At least three members from the same specialty
• At least five members with varying backgrounds
• At least ten members including all department heads
• No minimum; any number is acceptable

Correct Answer: At least five members with varying backgrounds

Q3. Which element is essential for an IRB quorum to make an ethical and valid decision on a protocol?

• All members must be scientific investigators
• Presence of both scientific and non‑scientific members, including at least one member not affiliated with the institution
• Only external members should be present
• Quorum requires only the chairperson and one member

Correct Answer: Presence of both scientific and non‑scientific members, including at least one member not affiliated with the institution

Q4. Which of the following best describes the primary function of an Institutional Ethics Committee/IRB?

• To maximize recruitment rates for clinical trials
• To review scientific validity only and leave ethics to the sponsor
• To protect the rights, safety and well‑being of research participants through independent review
• To provide funding and logistical support for trials

Correct Answer: To protect the rights, safety and well‑being of research participants through independent review

Q5. Which type of research activity is typically eligible for expedited IRB review?

• First‑in‑human trials of a novel drug
• Studies involving invasive surgical procedures
• Minimal risk procedures and minor amendments to approved protocols within listed expedited categories
• Research involving vulnerable populations with more than minimal risk

Correct Answer: Minimal risk procedures and minor amendments to approved protocols within listed expedited categories

Q6. A full board (convened) review is generally required when a study involves which of the following?

• Anonymous questionnaires about non‑sensitive topics
• Only archival, de‑identified biological samples with no identifiers
• Greater‑than‑minimal risk interventions or participation of vulnerable populations
• Routine staff training evaluations with consent waived

Correct Answer: Greater‑than‑minimal risk interventions or participation of vulnerable populations

Q7. How should an IRB handle a member who has a direct financial interest in a protocol under review?

• Allow the member to participate fully to benefit from their expertise
• Require the member to declare the interest and recuse themselves from deliberation and voting on that protocol
• Ignore the interest if the member claims no time to review
• Ask the member to vote but not to speak during discussion

Correct Answer: Require the member to declare the interest and recuse themselves from deliberation and voting on that protocol

Q8. For a life‑threatening serious adverse event (SAE) that is unexpected and possibly related to study intervention, what is the expected reporting practice to the ethics committee?

• Report only in the annual continuing review
• Report promptly to the sponsor and notify the ethics committee immediately or within the short timeframe required by applicable regulations (for example, within 24 hours for life‑threatening events)
• Wait for the final study report to report the SAE
• No reporting is needed if the investigator documents it in site records

Correct Answer: Report promptly to the sponsor and notify the ethics committee immediately or within the short timeframe required by applicable regulations (for example, within 24 hours for life‑threatening events)

Q9. Which responsibility regarding informed consent documents belongs to the IRB?

• Drafting the consent form language instead of the investigator in all cases
• Reviewing and approving the content, ensuring clarity, completeness, and appropriateness for the target population
• Collecting signed consent forms from participants on behalf of the sponsor
• Providing medical care described in the consent form

Correct Answer: Reviewing and approving the content, ensuring clarity, completeness, and appropriateness for the target population

Q10. How frequently should an IRB conduct continuing review of approved studies under typical regulations?

• Only once at initial approval with no further review
• At least annually, or more frequently if required by the level of risk or by regulation
• Every five years regardless of study status
• Continuing review is required monthly for all studies

Correct Answer: At least annually, or more frequently if required by the level of risk or by regulation

Q11. Why are Standard Operating Procedures (SOPs) essential for an Institutional Ethics Committee?

• They allow the EC to waive ethical review when convenient
• They provide standardized, transparent processes to ensure consistent, compliant and defensible ethical review and decision‑making
• They are optional and rarely used in accredited ECs
• They replace the need for member training

Correct Answer: They provide standardized, transparent processes to ensure consistent, compliant and defensible ethical review and decision‑making

Q12. Regarding participant privacy and data confidentiality, what is the IRB’s main duty?

• To design the database architecture for the study
• To ensure that adequate measures for data protection and confidentiality are described and implemented in the protocol and consent documents
• To store all primary data centrally at the IRB office
• To provide individual participants with raw data about other participants

Correct Answer: To ensure that adequate measures for data protection and confidentiality are described and implemented in the protocol and consent documents

Q13. Who is most appropriate to serve as the IRB chairperson?

• The principal investigator of the majority of active trials at the institution
• A member ideally independent of day‑to‑day research operations, with knowledge of ethics and leadership skills
• A sponsor representative who funds most studies
• Any junior staff member to encourage rapid meeting scheduling

Correct Answer: A member ideally independent of day‑to‑day research operations, with knowledge of ethics and leadership skills

Q14. Which of the following best describes the regulatory basis for an expedited review procedure?

• Expedited review can be used for any clinical trial at the discretion of the investigator
• Expedited review applies only to non‑human subject research
• Expedited review is limited to specific categories of minimal risk research outlined in regulations and for minor changes to approved protocols
• Expedited review eliminates the need for record‑keeping

Correct Answer: Expedited review is limited to specific categories of minimal risk research outlined in regulations and for minor changes to approved protocols

Q15. What is the appropriate approach to retention of IRB records and essential trial documents?

• Destroy all records immediately after final participant leaves
• Retain documents according to sponsor, institutional and regulatory requirements, typically for several years after study completion
• Keep only the minutes and discard all correspondence
• Transfer records to the sponsor and keep no institutional copies

Correct Answer: Retain documents according to sponsor, institutional and regulatory requirements, typically for several years after study completion

Q16. An IRB may withhold approval of a protocol primarily because of which of the following ethical concerns?

• The protocol has too much statistical power
• Potential risks outweigh the anticipated benefits and safeguards are inadequate
• The investigator is from a competing institution
• The protocol requests free medication for participants

Correct Answer: Potential risks outweigh the anticipated benefits and safeguards are inadequate

Q17. Which activity is within the responsibilities of an IRB after initial approval of a study?

• Performing all clinical monitoring visits instead of sponsors or monitors
• Requesting periodic progress reports, reviewing SAEs and amendments, and overseeing participant safety through continuing review
• Acting as the primary data analysis center
• Recruiting subjects for the study to ensure enrollment

Correct Answer: Requesting periodic progress reports, reviewing SAEs and amendments, and overseeing participant safety through continuing review

Q18. When can an investigator implement an amendment to a protocol without prior IRB approval?

• Whenever the investigator believes the change is beneficial
• Only when the amendment is intended solely to eliminate immediate hazards to participants, with subsequent prompt IRB notification
• If the sponsor approves it orally
• If the amendment reduces study costs

Correct Answer: Only when the amendment is intended solely to eliminate immediate hazards to participants, with subsequent prompt IRB notification

Q19. What is the first action an IRB member should take upon recognizing a potential conflict of interest?

• Hide the interest to avoid delays
• Immediately disclose the conflict to the committee and follow procedures for recusal if required
• Continue to lead the discussion to manage bias personally
• Delegate the review to a junior member without disclosure

Correct Answer: Immediately disclose the conflict to the committee and follow procedures for recusal if required

Q20. Which items are essential to include in IRB meeting minutes to meet regulatory and accreditation expectations?

• Only the list of protocols reviewed, no details of decisions
• Attendance, summary of deliberations, votes and decisions, basis for decisions, and any minority opinions
• Only the chair’s personal opinions without recording votes
• Financial details of investigators unrelated to decisions

Correct Answer: Attendance, summary of deliberations, votes and decisions, basis for decisions, and any minority opinions

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