Ethics committee and IRB operations MCQs With Answer

Ethics committee and IRB operations MCQs With Answer are designed to help M. Pharm students master core regulatory concepts underpinning ethical clinical research oversight. This quiz covers Institutional Ethics Committees (IECs) in India and Institutional Review Boards (IRBs) globally, including their composition, quorum, SOPs, reporting timelines, informed consent nuances, and decision-making authority. You will also encounter practical scenarios around serious adverse event (SAE) reporting, expedited review, continuing review, documentation requirements, and oversight of vulnerable populations. Questions integrate ICMR National Ethical Guidelines (2017), ICH-GCP E6(R2), U.S. Common Rule (45 CFR 46/21 CFR 56), and Indian NDCTR 2019 expectations. Use this set to consolidate exam readiness and build regulatory confidence for real-world clinical trial governance.

Q1. What is the primary purpose of an Ethics Committee/IRB in clinical research?

• To enhance recruitment rates and shorten study timelines
• To protect the rights, safety, and well-being of human participants
• To negotiate site budgets and contracts with sponsors
• To guarantee regulatory approval of investigational products

Correct Answer: To protect the rights, safety, and well-being of human participants

Q2. As per ICMR National Ethical Guidelines (2017), an Institutional Ethics Committee (IEC) should have a minimum of how many members?

• 5 members
• 7 members
• 3 members
• 9 members

Correct Answer: 7 members

Q3. For IEC meetings in India, which statement best reflects quorum requirements per ICMR?

• At least 3 members including the Chairperson and Member Secretary
• A simple majority of members, regardless of expertise mix
• Minimum 5 members present, including a clinician, basic medical scientist, legal expert, social scientist/NGO/philosopher/ethicist/theologian, and a lay person
• Only scientific members are needed if the study is high risk

Correct Answer: Minimum 5 members present, including a clinician, basic medical scientist, legal expert, social scientist/NGO/philosopher/ethicist/theologian, and a lay person

Q4. Under U.S. Common Rule (45 CFR 46), which composition requirement is mandatory for an IRB?

• Only clinicians with advanced degrees
• At least one member unaffiliated with the institution and at least one non-scientist
• All members must be from the same department
• Only scientists with prior IRB experience

Correct Answer: At least one member unaffiliated with the institution and at least one non-scientist

Q5. How should an IEC/IRB handle a member’s conflict of interest (COI) with a protocol under review?

• Allow discussion and voting but record the COI in minutes
• Exclude the member from voting but include them in quorum
• Require the member to leave during discussion and voting; they do not count toward quorum
• Permit the member to vote if they disclose the COI verbally

Correct Answer: Require the member to leave during discussion and voting; they do not count toward quorum

Q6. Which statement about IRB/IEC authority is correct?

• Institutional officials can override IRB disapproval if the sponsor requests
• IRB/IEC can approve, require modifications, or disapprove research; disapproval cannot be overridden by institutional officials
• Only national regulators can suspend studies for safety reasons
• IRB/IEC can only advise; final decisions rest with the investigator

Correct Answer: IRB/IEC can approve, require modifications, or disapprove research; disapproval cannot be overridden by institutional officials

Q7. Which item must IRB/IEC minutes include to meet good documentation practices?

• Only a summary of the presentation by the PI
• Attendance, actions taken, vote counts (for/against/abstaining), controverted issues and their resolution
• Names of absent members only
• Budgetary discussions with the sponsor

Correct Answer: Attendance, actions taken, vote counts (for/against/abstaining), controverted issues and their resolution

Q8. Which situation is most appropriate for expedited IRB/IEC review?

• First-in-human study of a novel gene therapy vector
• Major protocol amendment increasing risk exposure
• Minor changes to an already approved protocol involving no greater than minimal risk
• Open-label extension introducing a new unapproved drug

Correct Answer: Minor changes to an already approved protocol involving no greater than minimal risk

Q9. Which type of activity is most likely eligible for exemption from IRB review under the Common Rule?

• Prospective clinical trial of a marketed drug for a new indication
• Secondary analysis of publicly available, fully de-identified health datasets
• Interventional device feasibility study
• Phase I bioavailability study

Correct Answer: Secondary analysis of publicly available, fully de-identified health datasets

Q10. Which set describes the standard IRB/IEC criteria for approval of research?

• Scientific novelty, market potential, and sponsor reputation
• Risks minimized and reasonable, equitable subject selection, informed consent, adequate monitoring, privacy/confidentiality protections, safeguards for vulnerable groups
• Investigator seniority and publication record
• Institutional revenue and site throughput

Correct Answer: Risks minimized and reasonable, equitable subject selection, informed consent, adequate monitoring, privacy/confidentiality protections, safeguards for vulnerable groups

Q11. What is the usual frequency of continuing review for more-than-minimal risk studies?

• At least annually, or more frequently as determined by the IRB/IEC based on risk
• Every five years regardless of risk
• Only when the sponsor requests it
• Not required once initial approval is granted

Correct Answer: At least annually, or more frequently as determined by the IRB/IEC based on risk

Q12. In India, what is the investigator’s standard timeline for reporting a Serious Adverse Event (SAE) during a clinical trial?

• Notify sponsor within 72 hours; no need to inform EC
• Report to sponsor, EC, and CDSCO within 24 hours; submit a detailed analysis within 14 calendar days
• Report to DCGI only within 7 days
• Include in annual safety report only

Correct Answer: Report to sponsor, EC, and CDSCO within 24 hours; submit a detailed analysis within 14 calendar days

Q13. Which statement about informed consent documentation in Indian clinical trials is correct under NDCTR 2019?

• Audio-video recording of informed consent is not permitted
• Audio-video recording of the informed consent process is required; for vulnerable subjects, an impartial witness is additionally required
• Only written consent without any recording is acceptable
• AV recording is required only for oncology trials

Correct Answer: Audio-video recording of the informed consent process is required; for vulnerable subjects, an impartial witness is additionally required

Q14. When is the presence of an impartial witness mandatory during the consent process?

• For all outpatient participants
• Whenever the participant is illiterate or the subject is considered vulnerable
• Only when the participant is a minor
• Only for Phase IV studies

Correct Answer: Whenever the participant is illiterate or the subject is considered vulnerable

Q15. In India, ethics committees reviewing biomedical and health research (not regulated as clinical trials of drugs/devices) must be registered with which body?

• World Health Organization (WHO)
• U.S. Food and Drug Administration (FDA)
• Department of Health Research’s National Ethics Committee Registry for Biomedical and Health Research (NECRBHR)
• European Medicines Agency (EMA)

Correct Answer: Department of Health Research’s National Ethics Committee Registry for Biomedical and Health Research (NECRBHR)

Q16. Which set of documents is core to IRB/IEC initial review and approval under ICH-GCP?

• Protocol, Investigator’s Brochure/Device information, informed consent forms and process, recruitment materials, subject compensation, safety monitoring plan
• Site rental agreement and cafeteria policy
• Press releases and media kits only
• Only the abstract and investigator CV

Correct Answer: Protocol, Investigator’s Brochure/Device information, informed consent forms and process, recruitment materials, subject compensation, safety monitoring plan

Q17. For higher-risk, blinded, multicenter trials, which safety oversight approach is most appropriate?

• Rely on investigator self-reporting only
• Constitute an independent Data Safety Monitoring Board (DSMB) with predefined stopping rules
• Only annual safety summaries
• Safety monitoring is unnecessary if consent is obtained

Correct Answer: Constitute an independent Data Safety Monitoring Board (DSMB) with predefined stopping rules

Q18. Which statement best describes the role of Independent Ethics Committees (IECs) in India under NDCTR 2019?

• They may review any clinical trial at any site without restrictions
• They are permitted to review bioavailability/bioequivalence (BA/BE) studies; clinical trials are ordinarily reviewed by the site’s Institutional Ethics Committee
• They only review animal studies
• They approve marketing authorizations

Correct Answer: They are permitted to review bioavailability/bioequivalence (BA/BE) studies; clinical trials are ordinarily reviewed by the site’s Institutional Ethics Committee

Q19. What is the minimum recommended retention period for IRB/IEC records and study documents under ICH-GCP, unless a longer period is required by local law?

• 6 months after study start
• 1 year after first subject enrolled
• 3 years after study completion/termination
• Indefinitely without archiving

Correct Answer: 3 years after study completion/termination

Q20. Which statement about participant recruitment materials is correct?

• They are marketing tools and do not need IRB/IEC review
• They must be reviewed and approved by the IRB/IEC before use to ensure they are not coercive or misleading
• Only television advertisements require review
• Review is needed only if compensation is offered

Correct Answer: They must be reviewed and approved by the IRB/IEC before use to ensure they are not coercive or misleading

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