MCQ Quiz: Human Subjects Research Ethics

All clinical research involving human participants is built upon a strict ethical framework designed to protect their rights and welfare. For pharmacists, who are both critical consumers of and sometimes participants in research, understanding these principles is a core professional obligation. As covered in courses like Principles of Evidence-Based Practice and Pharmacy Law and Ethics, a deep knowledge of research ethics is non-negotiable. This quiz will test you on the foundational principles of the Belmont Report, the process of informed consent, and the critical role of the Institutional Review Board (IRB).

1. The Belmont Report established three fundamental ethical principles for human subjects research. They are:

• a. Honesty, Integrity, and Compassion
• b. Efficacy, Safety, and Quality
• c. Respect for Persons, Beneficence, and Justice
• d. Planning, Doing, and Studying

Answer: c. Respect for Persons, Beneficence, and Justice

2. The principle of “Respect for Persons” is primarily operationalized in research through which process?

• a. Statistical analysis
• b. Publication in a peer-reviewed journal
• c. Informed consent
• d. Data security

Answer: c. Informed consent

3. The ethical principle of “Beneficence” requires that a research study:

• a. Must guarantee a positive outcome for all participants.
• b. Is designed to maximize possible benefits while minimizing possible harms.
• c. Is conducted only in healthy volunteers.
• d. Is funded by the government.

Answer: b. Is designed to maximize possible benefits while minimizing possible harms.

4. What is the primary role of an Institutional Review Board (IRB)?

• a. To secure funding for a research study.
• b. To review and approve research involving human subjects to protect their rights and welfare.
• c. To analyze the data from a completed study.
• d. To publish the results of a study.

Answer: b. To review and approve research involving human subjects to protect their rights and welfare.

5. A researcher must obtain IRB approval:

• a. At any time before publishing the study results.
• b. After enrolling the first few participants.
• c. Before initiating any research activities involving human subjects.
• d. Only if the research involves an investigational new drug.

Answer: c. Before initiating any research activities involving human subjects.

6. The “Principles of Pharmacy Law and Ethics” course provides the foundational framework for understanding research ethics.

• a. True
• b. False

Answer: a. True

7. Which of the following is NOT a required element of informed consent?

• a. A description of the study procedures.
• b. A discussion of potential risks and benefits.
• c. A statement that participation is voluntary.
• d. A guarantee that the participant will personally benefit from the study.

Answer: d. A guarantee that the participant will personally benefit from the study.

8. The ethical principle of “Justice” in research requires:

• a. That all participants receive the active treatment, not a placebo.
• b. That the selection of research subjects is fair and the burdens and benefits of research are distributed equitably.
• c. That all research is funded by the government to ensure fairness.
• d. That only one demographic group is enrolled in a study to ensure consistency.

Answer: b. That the selection of research subjects is fair and the burdens and benefits of research are distributed equitably.

9. The infamous “Tuskegee Syphilis Study” was a major ethical violation primarily because:

• a. The study was too short.
• b. Researchers withheld a known effective treatment (penicillin) from participants.
• c. The participants were not compensated enough.
• d. The results were not published.

Answer: b. Researchers withheld a known effective treatment (penicillin) from participants.

10. “Informed consent” is best described as:

• a. A one-time event of signing a form.
• b. An ongoing process of communication between the researcher and the participant.
• c. A legal document that protects the researcher from all liability.
• d. A form that is only required for high-risk studies.

Answer: b. An ongoing process of communication between the researcher and the participant.

11. The course “Principles of Evidence-Based Practice” covers the ethical conduct of clinical trials.

• a. True
• b. False

Answer: a. True

12. Which of the following would be considered a “vulnerable population” in research, requiring additional protections?

• a. Pharmacists
• b. Physicians
• c. Prisoners
• d. Healthy adults

Answer: c. Prisoners

13. A researcher tells a potential subject that they will lose access to their regular medical care if they do not enroll in the study. This is an example of:

• a. Coercion
• b. Beneficence
• c. Justice
• d. Proper informed consent

Answer: a. Coercion

14. A key responsibility of an IRB is to ensure that:

• a. The research question is interesting.
• b. The risks to subjects are minimized and are reasonable in relation to the anticipated benefits.
• c. The study is guaranteed to be published.
• d. The study’s budget is appropriate.

Answer: b. The risks to subjects are minimized and are reasonable in relation to the anticipated benefits.

15. A pharmacist can serve as a member of an Institutional Review Board.

• a. True
• b. False

Answer: a. True

16. The Nuremberg Code, one of the earliest codes of research ethics, was developed in response to:

• a. The Tuskegee Syphilis Study.
• b. The development of the first polio vaccine.
• c. Medical experiments conducted by the Nazis during World War II.
• d. The discovery of DNA.

Answer: c. Medical experiments conducted by the Nazis during World War II.

17. The “How New Drugs are Developed” module would inherently involve the application of human subjects research ethics.

• a. True
• b. False

Answer: a. True

18. What does “voluntariness” in informed consent mean?

• a. The subject must volunteer for every part of the study.
• b. The subject’s decision to participate is free from coercion or undue influence.
• c. The researcher volunteers their time for the study.
• d. The study drug is provided free of charge.

Answer: b. The subject’s decision to participate is free from coercion or undue influence.

19. A study involving only the analysis of de-identified, pre-existing data may be considered what by an IRB?

• a. A high-risk study requiring full board review.
• b. Exempt from IRB review.
• c. A study that does not require informed consent.
• d. Both b and c.

Answer: d. Both b and c.

20. The “Experimental Studies” module, which covers RCTs, is part of the EBP course.

• a. True
• b. False

Answer: a. True

21. A placebo control is used in a clinical trial. The ethical principle of ____ requires that the use of a placebo is justified and patients are not denied a known, effective therapy for a serious condition.

• a. Justice
• b. Respect for Persons
• c. Beneficence/Non-maleficence
• d. Autonomy

Answer: c. Beneficence/Non-maleficence

22. An IRB must be composed of:

• a. Only scientists and physicians.
• b. Only lawyers and ethicists.
• c. At least five members with varying backgrounds, including at least one scientist and one non-scientist.
• d. Only members from within the institution conducting the research.

Answer: c. At least five members with varying backgrounds, including at least one scientist and one non-scientist.

23. “Equitable subject selection” is a key component of which Belmont principle?

• a. Respect for Persons
• b. Beneficence
• c. Justice
• d. It is not part of the Belmont principles.

Answer: c. Justice

24. An active learning session on EBP is part of which course?

• a. PHA5244 Principles of Evidence-Based Practice
• b. PHA5163L Professional Skills Lab 3
• c. PHA5781 Patient Care I
• d. PHA5787C Patient Care 5

Answer: a. PHA5244 Principles of Evidence-Based Practice

25. A pharmacist reviewing a patient’s profile notes they are enrolled in a clinical trial. A key role for the pharmacist is to:

• a. Convince the patient to drop out of the trial.
• b. Continue to provide standard pharmaceutical care, including screening for drug interactions with the investigational agent.
• c. Ignore the patient’s participation in the trial.
• d. Report the patient to the FDA.

Answer: b. Continue to provide standard pharmaceutical care, including screening for drug interactions with the investigational agent.

26. A study that involves deception of subjects is:

• a. Always considered ethical.
• b. Never considered ethical.
• c. Only considered ethical if it is scientifically necessary and the IRB approves a plan for debriefing subjects afterward.
• d. Allowed as long as the subjects are paid.

Answer: c. Only considered ethical if it is scientifically necessary and the IRB approves a plan for debriefing subjects afterward.

27. The principle of “minimizing risk” in a research study might involve:

• a. Using the most invasive procedures possible.
• b. Collecting only the data that is essential to answer the research question.
• c. Extending the study for as long as possible.
• d. Enrolling the sickest patients available.

Answer: b. Collecting only the data that is essential to answer the research question.

28. An active learning session on study design is part of the EBP curriculum.

• a. True
• b. False

Answer: a. True

29. The Declaration of Helsinki is a statement of ethical principles for medical research involving human subjects, developed by the:

• a. Food and Drug Administration (FDA)
• b. World Medical Association (WMA)
• c. National Institutes of Health (NIH)
• d. American Medical Association (AMA)

Answer: b. World Medical Association (WMA)

30. The “Common Rule” is:

• a. A set of U.S. federal regulations governing human subjects research.
• b. A guideline for writing research papers.
• c. A rule for statistical analysis.
• d. An international treaty.

Answer: a. A set of U.S. federal regulations governing human subjects research.

31. A patient’s right to withdraw from a research study at any time without penalty is a key component of:

• a. Beneficence
• b. Justice
• c. Voluntariness and Respect for Persons
• d. The study budget

Answer: c. Voluntariness and Respect for Persons

32. A pharmacist working in an institutional setting may be asked to be part of the IRB.

• a. True
• b. False

Answer: a. True

33. What is the primary ethical concern with conducting research in developing countries?

• a. The research is too expensive.
• b. The potential for exploitation of vulnerable populations.
• c. The results are not generalizable.
• d. The language barrier is too difficult.

Answer: b. The potential for exploitation of vulnerable populations.

34. Confidentiality of research data is an important aspect of which ethical principle?

• a. Justice
• b. Beneficence
• c. Respect for Persons
• d. All of the above

Answer: c. Respect for Persons

35. An Investigational New Drug (IND) application, which is reviewed by the FDA, contains:

• a. Pre-clinical data.
• b. The protocol for the proposed human clinical trials.
• c. Information about the drug’s manufacturing.
• d. All of the above.

Answer: d. All of the above.

36. A Phase 1 clinical trial typically enrolls:

• a. A large group of patients with the disease.
• b. A small group of healthy volunteers.
• c. A small group of patients with the disease.
• d. Children and pregnant women.

Answer: b. A small group of healthy volunteers.

37. The ethical justification for a randomized controlled trial is “clinical equipoise,” which means:

• a. The researcher knows that the new treatment is superior.
• b. The researcher knows that the placebo is superior.
• c. There is genuine uncertainty among experts about which treatment is better.
• d. The trial has an equal number of men and women.

Answer: c. There is genuine uncertainty among experts about which treatment is better.

38. The lecture on the drug approval process is part of the Medicinal Chemistry and Pharmacology course.

• a. True
• b. False

Answer: a. True

39. Data and Safety Monitoring Boards (DSMBs) are independent committees that:

• a. Review data as a clinical trial progresses to ensure the safety of participants.
• b. Help to recruit patients for a trial.
• c. Secure funding for a trial.
• d. Publish the results of a trial.

Answer: a. Review data as a clinical trial progresses to ensure the safety of participants.

40. An active learning session covering EBP is part of which course?

• a. PHA5244 Principles of Evidence-Based Practice
• b. PHA5163L Professional Skills Lab 3
• c. PHA5781 Patient Care I
• d. PHA5787C Patient Care 5

Answer: a. PHA5244 Principles of Evidence-Based Practice

41. The ethical principle of Justice would be violated if a study:

• a. Enrolls a diverse group of participants.
• b. Enrolls only poor or minority patients for a risky study while the benefits are likely to accrue to a wealthier population.
• c. Provides fair compensation for participation.
• d. Has a clear inclusion and exclusion criteria.

Answer: b. Enrolls only poor or minority patients for a risky study while the benefits are likely to accrue to a wealthier population.

42. The informed consent document must be written in language that is understandable to the participant.

• a. True
• b. False

Answer: a. True

43. A pharmacist’s role includes ensuring that a patient understands their treatment options, which is a core tenet of:

• a. Paternalism
• b. Informed consent and patient autonomy
• c. The business of pharmacy
• d. A dispensing-only model

Answer: b. Informed consent and patient autonomy

44. If significant new risk information is discovered during a study, the researchers must:

• a. Keep it a secret to avoid participants dropping out.
• b. Inform the IRB and all current participants.
• c. Stop the study immediately.
• d. Only inform new participants.

Answer: b. Inform the IRB and all current participants.

45. Which of the following is NOT a vulnerable population requiring special protection in research?

• a. Children
• b. Prisoners
• c. Cognitively impaired individuals
• d. Competent, adult pharmacists

Answer: d. Competent, adult pharmacists

46. The three elements of informed consent are information, comprehension, and:

• a. Compensation
• b. Voluntariness
• c. Publication
• d. Blinding

Answer: b. Voluntariness

47. A “conflict of interest” in research exists if:

• a. The researcher has a financial stake in the outcome of the study.
• b. The researcher disagrees with their colleagues.
• c. The study results are negative.
• d. The study is difficult to conduct.

Answer: a. The researcher has a financial stake in the outcome of the study.

48. An active learning session on research ethics is part of which course module?

• a. Module 4: Experimental Studies
• b. Module 1: Formulating a Clinical Question
• c. Module 6: Summarizing the Evidence
• d. Module 3: Applying Biostatistics

Answer: a. Module 4: Experimental Studies

49. The overall framework for human subjects research ethics is designed to:

• a. Make research impossible to conduct.
• b. Protect the rights, safety, and well-being of research participants above all other interests.
• c. Ensure that all new drugs are approved quickly.
• d. Benefit the researcher primarily.

Answer: b. Protect the rights, safety, and well-being of research participants above all other interests.

50. The ultimate reason for a pharmacist to understand research ethics is to:

• a. Be able to conduct and critically evaluate research in a manner that upholds the highest professional and ethical standards.
• b. Be able to serve on an IRB.
• c. Pass the Law and Ethics course.
• d. Avoid all involvement in research.

Answer: a. Be able to conduct and critically evaluate research in a manner that upholds the highest professional and ethical standards.