Declaration of Helsinki: history MCQs With Answer

Declaration of Helsinki: history MCQs With Answer

The Declaration of Helsinki is a foundational document in biomedical research ethics, drafted by the World Medical Association in 1964 and revised several times since. For M.Pharm students, understanding its history, key revisions, and core principles (such as informed consent, protection of vulnerable groups, ethical review, and the relationship to the Nuremberg Code and modern regulations) is essential for designing and conducting clinical research responsibly. This blog presents focused multiple-choice questions that test both factual knowledge of the Declaration’s evolution and practical implications for contemporary pharmaceutical research and ethics committees.

Q1. In which year and city was the Declaration of Helsinki originally adopted?

• 1964, Helsinki
• 1947, Nuremberg
• 1975, Tokyo
• 2000, Edinburgh

Correct Answer: 1964, Helsinki

Q2. Which organization drafted and adopted the Declaration of Helsinki?

• World Health Organization (WHO)
• World Medical Association (WMA)
• Council for International Organizations of Medical Sciences (CIOMS)
• International Council for Harmonisation (ICH)

Correct Answer: World Medical Association (WMA)

Q3. Which earlier ethical document had a major influence on the creation of the Declaration of Helsinki?

• Belmont Report
• Nuremberg Code
• ICMJE Recommendations
• Good Clinical Practice (GCP) Guideline

Correct Answer: Nuremberg Code

Q4. Which of the following topics was emphasized more strongly in later revisions of the Declaration (1990s–2000s)?

• Requirement for informed consent
• Prohibition of all placebo use
• Registration of clinical trials and disclosure of results
• Exclusion of vulnerable populations from research

Correct Answer: Registration of clinical trials and disclosure of results

Q5. How often has the Declaration of Helsinki been officially revised since its original adoption up to 2013?

• Twice
• Four times
• Seven times
• More than ten times

Correct Answer: Seven times

Q6. Which revision year is commonly cited as the most recent major update to the Declaration of Helsinki?

• 1996
• 2008
• 2013
• 2018

Correct Answer: 2013

Q7. One core principle introduced by the Declaration is that clinical research must be based on which of the following?

• Commercial interests of sponsors
• Best available scientific knowledge and preclinical evidence
• Physician convenience
• Historical practice without scientific review

Correct Answer: Best available scientific knowledge and preclinical evidence

Q8. The Declaration distinguishes between therapeutic and non-therapeutic research. What ethical implication does this distinction carry?

• Non-therapeutic research never requires informed consent
• Therapeutic research may ethically justify higher risk if direct benefit exists
• All research must be classified as therapeutic
• Non-therapeutic research is always unethical

Correct Answer: Therapeutic research may ethically justify higher risk if direct benefit exists

Q9. Which requirement regarding review of research protocols is explicitly stated in the Declaration of Helsinki?

• Only principal investigators need to approve protocols
• Independent ethics committee review is required before research begins
• Sponsor approval is sufficient without ethics review
• Review may occur after completion of the study

Correct Answer: Independent ethics committee review is required before research begins

Q10. What does the Declaration say about the use of placebo when effective treatments exist?

• Placebo is always acceptable for scientific reasons
• Placebo use is permissible only when no proven effective intervention exists or compelling methodological reasons justify it and patients will not face additional risk
• Placebo must never be used under any circumstances
• Placebo can be used if the trial is sponsored by a non-profit organization

Correct Answer: Placebo use is permissible only when no proven effective intervention exists or compelling methodological reasons justify it and patients will not face additional risk

Q11. Which group is specifically emphasized for special protection under the Declaration of Helsinki?

• Healthy adult volunteers only
• Vulnerable populations such as children, pregnant women, prisoners, and those with diminished autonomy
• Only professional researchers
• Commercial stakeholders

Correct Answer: Vulnerable populations such as children, pregnant women, prisoners, and those with diminished autonomy

Q12. How does the Declaration address post-trial access to beneficial interventions?

• It states there is no obligation to provide post-trial access
• It recommends considering arrangements to provide patients access to proven beneficial interventions after the trial
• It mandates lifelong free access for all participants
• It requires post-trial access only for placebo recipients

Correct Answer: It recommends considering arrangements to provide patients access to proven beneficial interventions after the trial

Q13. Which statement best describes the Declaration’s influence on international guidelines like ICH-GCP?

• The Declaration replaced ICH-GCP
• The Declaration contributed ethical principles that helped shape ICH-GCP and other regulatory guidance
• The Declaration is unrelated to ICH-GCP
• ICH-GCP is the sole source of ethical standards and supersedes the Declaration

Correct Answer: The Declaration contributed ethical principles that helped shape ICH-GCP and other regulatory guidance

Q14. Which revision introduced stronger language on trial registration and disclosure of results?

• 1964 original text
• 1975 revision
• 2008 revision
• 2013 revision

Correct Answer: 2008 revision

Q15. What ethical principle is central to the informed consent requirements of the Declaration?

• Beneficence without autonomy
• Respect for persons and their autonomous decision-making
• Justice only for researchers
• Mandatory enrollment to speed scientific progress

Correct Answer: Respect for persons and their autonomous decision-making

Q16. Which of the following is true about surrogate decision-makers according to the Declaration?

• Surrogate consent is never acceptable
• Surrogate decision-makers may consent when subjects lack capacity, but researchers must seek assent from the subject where possible and protect their interests
• Surrogates can always override a subject’s expressed wishes
• Only family members can serve as surrogates, regardless of context

Correct Answer: Surrogate decision-makers may consent when subjects lack capacity, but researchers must seek assent from the subject where possible and protect their interests

Q17. Historically, which scandal/concern helped motivate stronger ethical oversight leading to the Declaration?

• Development of antibiotics
• Nazi medical experiments and the Nuremberg trials
• Discovery of DNA structure
• Advances in anesthesia techniques

Correct Answer: Nazi medical experiments and the Nuremberg trials

Q18. The Declaration’s position on compensation and treatment for research-related injury recommends:

• There is no responsibility for compensation
• Appropriate provisions should be made for compensation and treatment for subjects harmed as a result of participation
• Compensation should be decided by the sponsor after study end
• Only non-monetary apologies are necessary

Correct Answer: Appropriate provisions should be made for compensation and treatment for subjects harmed as a result of participation

Q19. Which concept introduced by later revisions aims to prevent exploitation of research subjects in low-resource settings?

• Requirement that all trials be industry-funded
• Provision that benefits of research should be made reasonably available to the population where research is conducted
• Mandatory exclusion of local ethics committees
• Allowing lower standards in low-resource settings

Correct Answer: Provision that benefits of research should be made reasonably available to the population where research is conducted

Q20. For M.Pharm students designing clinical studies, which practical implication of the Declaration is most relevant?

• Study designs should ignore ethical review to save time
• Ensure protocol approval by an independent ethics committee, obtain informed consent, minimize risks, and plan for post-trial responsibilities
• Use placebos whenever scientifically convenient regardless of available care
• Prioritize sponsor timelines over participant welfare

Correct Answer: Ensure protocol approval by an independent ethics committee, obtain informed consent, minimize risks, and plan for post-trial responsibilities

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