History of medical research ethics MCQs With Answer

Introduction

History of medical research ethics MCQs With Answer is designed for M.Pharm students to build a strong foundation in the evolution of ethical principles governing clinical research. This collection covers landmark events, influential documents, regulatory milestones and ethical concepts that shaped modern practices — including the Nuremberg Code, Declaration of Helsinki, Belmont Report, CIOMS guidelines and ICH-GCP. Each question emphasizes conceptual understanding, historical context and regulatory relevance critical for designing, evaluating and conducting ethically sound research. These MCQs will help students prepare for examinations and professional practice by connecting historical lessons to current ethical requirements, institutional review processes and protections for research participants.

Q1. Which document is widely regarded as the first international code formally outlining ethical principles for human experimentation?

• The Declaration of Helsinki (1964)
• The Belmont Report (1979)
• The Nuremberg Code (1947)
• CIOMS Guidelines (1993)

Correct Answer: The Nuremberg Code (1947)

Q2. The Declaration of Helsinki was developed by which organization to guide physicians conducting biomedical research?

• World Health Organization (WHO)
• World Medical Association (WMA)
• Council for International Organizations of Medical Sciences (CIOMS)
• Food and Drug Administration (FDA)

Correct Answer: World Medical Association (WMA)

Q3. Which US report established the ethical principles of Respect for Persons, Beneficence and Justice?

• The Belmont Report (1979)
• The Tuskegee Syphilis Study Report
• The Nuremberg Trials Findings
• ICH-GCP Guideline

Correct Answer: The Belmont Report (1979)

Q4. The Tuskegee Syphilis Study is most often cited as an example of violation of which ethical principle?

• Scientific validity
• Informed consent and respect for persons
• Proper statistical analysis
• Animal welfare

Correct Answer: Informed consent and respect for persons

Q5. Henry K. Beecher’s 1966 NEJM article contributed to the ethics movement by highlighting what issue?

• Economic benefits of clinical trials
• Seventy examples of unethical clinical research practices
• New laboratory techniques for drug synthesis
• The need for faster drug approval timelines

Correct Answer: Seventy examples of unethical clinical research practices

Q6. Which international guideline provides ethical guidance specifically for biomedical research in developing countries and vulnerable populations?

• Helsinki Declaration
• CIOMS Guidelines
• ICH-GCP E6
• Belmont Report

Correct Answer: CIOMS Guidelines

Q7. The ICH-GCP (E6) guideline, influential in global clinical trials, was first adopted in which decade?

• 1970s
• 1980s
• 1990s
• 2000s

Correct Answer: 1990s

Q8. Which historical event directly stimulated the creation of the Nuremberg Code?

• The Declaration of Helsinki adoption
• The World War II medical experiments and Nuremberg Trials
• The founding of the FDA
• The discovery of penicillin

Correct Answer: The World War II medical experiments and Nuremberg Trials

Q9. In the Belmont Report framework, “Beneficence” primarily requires researchers to do what?

• Ensure equal distribution of benefits among subjects
• Maximize possible benefits and minimize possible harms to participants
• Obtain permission from community leaders only
• Publish all study results regardless of quality

Correct Answer: Maximize possible benefits and minimize possible harms to participants

Q10. Which of the following best describes the principle of clinical equipoise?

• Investigators must be indifferent to study outcomes
• A genuine uncertainty within the expert medical community about which treatment is superior
• Patients must receive placebo in all control arms
• Research must always use the newest investigational therapy

Correct Answer: A genuine uncertainty within the expert medical community about which treatment is superior

Q11. Which milestone emphasized formal ethics committee review (IRB/EC) as a routine requirement for clinical research?

• The Nuremberg Code
• Declaration of Helsinki and subsequent national regulations
• Beecher’s 1966 paper
• The invention of randomized control trials

Correct Answer: Declaration of Helsinki and subsequent national regulations

Q12. Which guideline specifically harmonized technical requirements for registration of pharmaceuticals among US, Europe and Japan and includes GCP principles?

• CIOMS Guidelines
• ICH (International Conference on Harmonisation)
• Belmont Report
• World Medical Association

Correct Answer: ICH (International Conference on Harmonisation)

Q13. Which ethical principle addresses fair selection of research subjects and equitable distribution of research burdens and benefits?

• Beneficence
• Justice
• Non-maleficence
• Autonomy

Correct Answer: Justice

Q14. The evolution of informed consent emphasized in post-World War II ethics requires which of the following elements?

• Consent only from a physician
• Voluntariness, information disclosure and decision-making capacity
• Payment to participants to ensure compliance
• Waiver of consent in all therapeutic studies

Correct Answer: Voluntariness, information disclosure and decision-making capacity

Q15. Schedule Y and the 2019 New Drugs and Clinical Trials Rules in India relate to which aspect of research ethics?

• International trade tariffs on pharmaceuticals
• National regulatory requirements for conduct of clinical trials and ethical oversight
• Guidelines only for animal research
• Educational curriculum for pharmacy students

Correct Answer: National regulatory requirements for conduct of clinical trials and ethical oversight

Q16. Which scandal led to stronger rules on placebo use and vulnerable populations in human research internationally?

• Tuskegee Syphilis Study
• The polio vaccine campaign
• The discovery of insulin
• The first randomized trial of penicillin

Correct Answer: Tuskegee Syphilis Study

Q17. Retrospective analysis of historical unethical studies teaches modern researchers which key lesson?

• That ethics are optional if science is important
• How to prioritize participant welfare, transparency and independent review
• That informed consent is unnecessary for observational studies
• That only regulatory approval matters, not ethical reasoning

Correct Answer: How to prioritize participant welfare, transparency and independent review

Q18. Which revision process demonstrates that the Declaration of Helsinki is a living document responding to new ethical challenges?

• It has never been revised since 1964
• Periodic amendments by the World Medical Association responding to emerging issues
• A one-time rewrite by the FDA in 1970
• Adoption of CIOMS as a replacement

Correct Answer: Periodic amendments by the World Medical Association responding to emerging issues

Q19. The concept of “minimal risk” used in ethical review primarily helps to determine what?

• Whether a study requires complex statistical methods
• Whether expedited review or full ethics committee review is required and appropriate protections for participants
• How much the sponsor will be charged
• Which drug formulation to use

Correct Answer: Whether expedited review or full ethics committee review is required and appropriate protections for participants

Q20. Which historical document first articulated voluntary informed consent as an ethical requirement specifically in the context of experimental procedures?

• The Belmont Report
• The Nuremberg Code
• The Declaration of Helsinki
• CIOMS Guidelines

Correct Answer: The Nuremberg Code

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