Infection control committee and research ethics committees MCQs With Answer

Introduction: This quiz collection on Infection Control Committees and Research Ethics Committees is designed specifically for M.Pharm students taking Hospital & Community Pharmacy (MPP 103T). It highlights core principles, committee structures, roles and responsibilities, regulatory expectations, and practical procedures that pharmacists must understand in hospital settings. Questions combine infection prevention (surveillance, standard precautions, antimicrobial stewardship, outbreak response, waste management) with ethics oversight (informed consent, protocol review, adverse event reporting, vulnerable populations, EC functioning). These MCQs will help reinforce theoretical knowledge and application-focused reasoning needed for professional practice, internal assessments, and exam preparation.

Q1. What is the primary objective of a hospital Infection Control Committee (ICC)?

• To conduct clinical research on new antimicrobials
• To develop and monitor infection prevention and control policies within the facility
• To manage hospital finances related to infection outbreaks
• To replace the hospital administration in operational decisions

Correct Answer: To develop and monitor infection prevention and control policies within the facility

Q2. Which of the following is an essential member of a Research Ethics Committee (REC)/Institutional Ethics Committee (IEC)?

• Accounting officer of the hospital
• Independent community representative or lay person
• Only clinicians from the same department conducting the research
• Pharmaceutical sales representative

Correct Answer: Independent community representative or lay person

Q3. Which activity is typically under the remit of an Infection Control Committee?

• Preparing patient discharge summaries
• Periodic surveillance of healthcare-associated infections (HAIs)
• Authorizing research grants for basic science
• Managing inventory of hospital stationery

Correct Answer: Periodic surveillance of healthcare-associated infections (HAIs)

Q4. What is the minimum requirement for quorum in many ethics committees to make a decision?

• Only the Chairperson must be present
• Majority of members including at least one non-scientific member
• All members including external regulatory inspectors
• Any two members can form a quorum

Correct Answer: Majority of members including at least one non-scientific member

Q5. Which document provides national guidance for ethical conduct of biomedical research involving human participants in India?

• Good Laboratory Practices (GLP) Manual
• Indian Council of Medical Research (ICMR) National Ethical Guidelines
• World Health Organization financial manual
• Pharmacy Council of India syllabus

Correct Answer: Indian Council of Medical Research (ICMR) National Ethical Guidelines

Q6. In infection control, what is the best immediate action after a needle-stick injury from an unknown source?

• Ignore it if the needle looked clean
• Wash the area with soap and water and report to occupational health for risk assessment
• Apply a tourniquet and wait 24 hours
• Immediately start empiric chemotherapy

Correct Answer: Wash the area with soap and water and report to occupational health for risk assessment

Q7. Which of the following is NOT typically a responsibility of an ethics committee during protocol review?

• Assessing scientific validity and risk–benefit ratio
• Ensuring informed consent processes are appropriate
• Negotiating the researchers’ salaries
• Reviewing provisions for compensation and insurance for participants

Correct Answer: Negotiating the researchers’ salaries

Q8. Which infection control strategy focuses on reducing inappropriate antimicrobial use at the institutional level?

• Universal isolation
• Antimicrobial stewardship program (ASP)
• Routine environmental culturing of all surfaces
• Daily mass screening of all staff for colonization

Correct Answer: Antimicrobial stewardship program (ASP)

Q9. Which one of the following is considered an essential element of informed consent?

• Guaranteed personal benefit from the research
• Explanation of purpose, procedures, risks, benefits and voluntary participation
• Written consent from the head of department instead of the participant
• Requirement that the participant waives the right to withdraw

Correct Answer: Explanation of purpose, procedures, risks, benefits and voluntary participation

Q10. For surveillance of healthcare-associated infections, which indicator is commonly used to monitor central line-associated bloodstream infections (CLABSI)?

• Number of central lines ordered per month
• CLABSI rate per 1,000 central line-days
• Monthly central line manufacturing defects
• Average duration of antibiotic therapy in outpatient department

Correct Answer: CLABSI rate per 1,000 central line-days

Q11. Which of the following justifies expedited review by an ethics committee?

• A Phase III randomized trial with complex interventions
• Minimal-risk procedures such as anonymous survey research
• Research involving vulnerable populations requiring full board review
• First-in-human high-risk drug studies

Correct Answer: Minimal-risk procedures such as anonymous survey research

Q12. Which practice is part of standard precautions applicable to all patient care?

• Isolating all patients in private negative pressure rooms
• Performing hand hygiene before and after patient contact
• Wearing double gloves for routine oral medication administration
• Only using masks when the patient has a confirmed respiratory infection

Correct Answer: Performing hand hygiene before and after patient contact

Q13. What should an ethics committee require regarding participant data confidentiality?

• Public posting of identifiable participant data for transparency
• Appropriate data anonymization, secure storage and limited access
• No measures are necessary if the study is academic
• Sharing identifiable data freely with sponsors without consent

Correct Answer: Appropriate data anonymization, secure storage and limited access

Q14. Which of the following best describes the function of an antibiogram developed by an ICC?

• A financial report on antibiotic procurement costs
• A summary of local antimicrobial susceptibility patterns to guide empirical therapy
• A list of antibiotics banned from hospital use without explanation
• An international comparison of antibiotic prices

Correct Answer: A summary of local antimicrobial susceptibility patterns to guide empirical therapy

Q15. When must a Research Ethics Committee be notified of a serious adverse event (SAE) related to a study intervention?

• Only at the time of final study report
• Promptly, according to national regulations and the committee’s SOPs
• After publication of the study results
• Only if the investigator deems it reportable months later

Correct Answer: Promptly, according to national regulations and the committee’s SOPs

Q16. Which waste segregation color coding is commonly used for infectious clinical waste? (Note: local rules may vary.)

• Paper waste in red bags
• Infectious clinical waste in yellow bags/bins
• Food waste in autoclave bags
• Sharps in blue cloth bags

Correct Answer: Infectious clinical waste in yellow bags/bins

Q17. What is the recommended role of the Chairperson in an ethics committee meeting?

• To unilaterally approve protocols without discussion
• To lead the meeting, ensure fair review and enforce conflict-of-interest policies
• To perform all administrative tasks including minutes preparation alone
• To recruit participants for the studies

Correct Answer: To lead the meeting, ensure fair review and enforce conflict-of-interest policies

Q18. Which of the following is an important component of outbreak investigation conducted or overseen by an ICC?

• Immediate termination of all hospital services
• Case definition, case finding, descriptive epidemiology and control measures
• Publishing preliminary names of suspected staff online
• Waiting for external regulators before taking any action

Correct Answer: Case definition, case finding, descriptive epidemiology and control measures

Q19. Under conflict-of-interest policy, how should an ethics committee handle a member who is a principal investigator on a submitted protocol?

• Allow the member to lead the discussion and voting
• Require the member to declare the conflict and abstain from discussion and voting
• Terminate the committee meeting
• Automatically disqualify the protocol without review

Correct Answer: Require the member to declare the conflict and abstain from discussion and voting

Q20. Which standard is most relevant for ethical oversight of clinical trials involving investigational drugs?

• Good Manufacturing Practice (GMP) only
• Good Clinical Practice (GCP) guidelines and applicable national regulations
• Only institutional marketing guidelines
• Hospital housekeeping protocols

Correct Answer: Good Clinical Practice (GCP) guidelines and applicable national regulations

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