Ethical principles in biomedical research MCQs With Answer

Introduction: Ethical principles in biomedical research MCQs With Answer is a focused quiz resource designed for M.Pharm students preparing for Clinical Research (MPP 104T). This collection covers core ethical frameworks such as the Belmont Report, Declaration of Helsinki, Good Clinical Practice, informed consent, confidentiality, risk–benefit assessment, vulnerable populations, Institutional Ethics Committee roles, and data safety monitoring. Each multiple-choice question probes conceptual understanding and application to real-world research scenarios, aiming to reinforce critical thinking and regulatory knowledge required in clinical trials and pharmaceutical research. Use these MCQs to evaluate readiness for exams and to deepen your grasp of ethical conduct in biomedical research.

Q1. Which principle from the Belmont Report primarily requires researchers to respect a participant’s autonomy and provide adequate information for informed consent?

• Beneficence
• Justice
• Respect for persons
• Nonmaleficence

Correct Answer: Respect for persons

Q2. Informed consent is considered valid only when which of the following elements is present?

• Compensation for participation
• Understanding and voluntary agreement
• Signature from the investigator
• Approval from the funding agency

Correct Answer: Understanding and voluntary agreement

Q3. Which principle requires maximizing potential benefits while minimizing possible harms to research participants?

• Respect for persons
• Beneficence
• Justice
• Confidentiality

Correct Answer: Beneficence

Q4. Which document specifically provides internationally accepted guidelines for physicians conducting biomedical research involving human subjects?

• Helsinki Declaration
• Belmont Report
• ICH E6 (GCP)
• Nuremberg Code

Correct Answer: Helsinki Declaration

Q5. What is the primary role of an Institutional Ethics Committee (IEC)/IRB in clinical research?

• To recruit study participants
• To approve research ensuring ethical protection of participants
• To fund clinical trials
• To market investigational products

Correct Answer: To approve research ensuring ethical protection of participants

Q6. Which of the following best describes “equipoise” in the context of clinical trials?

• Participants must be blinded to treatment
• Investigators are unbiased in financial interests
• Genuine uncertainty among the expert community about the comparative therapeutic merits of each arm
• Use of placebo in all treatment arms

Correct Answer: Genuine uncertainty among the expert community about the comparative therapeutic merits of each arm

Q7. When is use of a placebo ethically acceptable in a clinical trial?

• When effective proven therapy exists and withholding it poses no risk of serious or irreversible harm
• Always, because it ensures scientific rigor
• Only when the sponsor pays more compensation
• When participants are not told they may receive placebo

Correct Answer: When effective proven therapy exists and withholding it poses no risk of serious or irreversible harm

Q8. Which population is considered vulnerable and often requires additional protections during research?

• Healthy adults with high education
• Prisoners, children, or cognitively impaired individuals
• Investigators’ family members with full capacity
• Licensed medical professionals

Correct Answer: Prisoners, children, or cognitively impaired individuals

Q9. Which of the following is the best description of “assent” in pediatric research?

• Parental permission only, without child involvement
• A child’s affirmative agreement to participate, appropriate to age and understanding
• Formal consent required from the child regardless of age
• Investigator’s decision on behalf of the child

Correct Answer: A child’s affirmative agreement to participate, appropriate to age and understanding

Q10. Which principle addresses fair distribution of the benefits and burdens of research across different social groups?

• Respect for autonomy
• Justice
• Beneficence
• Scientific validity

Correct Answer: Justice

Q11. Under Good Clinical Practice, which action must investigators take when an unexpected serious adverse event (SAE) occurs?

• Ignore if it seems unrelated
• Report promptly to the sponsor and IEC/IRB and take appropriate measures
• Withhold information from regulators to avoid delays
• Only inform participants at study end

Correct Answer: Report promptly to the sponsor and IEC/IRB and take appropriate measures

Q12. Which concept relates to protecting personal health information of a study participant from unauthorized disclosure?

• Informed consent
• Confidentiality
• Equipoise
• Randomization

Correct Answer: Confidentiality

Q13. Conflict of interest in clinical research most commonly refers to which situation?

• Participant refusal to sign consent
• Investigator’s personal or financial interests that may compromise judgment
• Use of placebo in trials
• Long study duration

Correct Answer: Investigator’s personal or financial interests that may compromise judgment

Q14. Which regulatory requirement ensures continuous monitoring of accumulating safety data during a trial?

• Peer review of the protocol
• Data Safety Monitoring Board (DSMB) or Committee
• Sponsor’s marketing authorization
• Trial registration only

Correct Answer: Data Safety Monitoring Board (DSMB) or Committee

Q15. Which statement best reflects the ethical handling of participant compensation?

• Compensation should be so high that it constitutes undue inducement
• Compensation should reimburse expenses and time without causing undue inducement
• Compensation is unnecessary for low-risk studies
• Only investigators should decide compensation after enrolment

Correct Answer: Compensation should reimburse expenses and time without causing undue inducement

Q16. What is “ancillary care” obligation in research ethics?

• Care unrelated to trial participation that investigators may have ethical duties to provide or arrange
• Only emergency care during the trial visit
• Compensation provided after study completion
• Selling health services to participants

Correct Answer: Care unrelated to trial participation that investigators may have ethical duties to provide or arrange

Q17. Which of the following practices helps ensure voluntariness in consent for participants with low literacy?

• Using complex medical jargon to explain risks
• Using translated materials, simplified language, and teach-back methods
• Requiring a legal professional to interpret
• Skipping documentation to avoid embarrassment

Correct Answer: Using translated materials, simplified language, and teach-back methods

Q18. Which regulatory registration is often required before initiating a clinical trial involving human subjects?

• Registry on a clinical trials database such as ClinicalTrials.gov or CTRI
• Publication in a peer-reviewed journal
• Approval from the local hospital administration only
• Marketing approval from regulatory authority

Correct Answer: Registry on a clinical trials database such as ClinicalTrials.gov or CTRI

Q19. In cross-cultural research settings, which ethical consideration is most important to address?

• Ignoring local customs to maintain standard procedures
• Respecting cultural norms and obtaining community engagement while ensuring individual consent
• Replacing local ethics oversight with sponsors’ ethics policies
• Using only investigators from the sponsor country

Correct Answer: Respecting cultural norms and obtaining community engagement while ensuring individual consent

Q20. Which ethical guideline arose directly from abuses in human experimentation during World War II and emphasizes voluntary consent?

• Declaration of Helsinki
• Nuremberg Code
• Belmont Report
• ICH E6 (GCP)

Correct Answer: Nuremberg Code

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