Introduction and significance of Helsinki MCQs With Answer

Introduction and significance of Helsinki MCQs With Answer

The Declaration of Helsinki is a foundational document guiding ethical conduct in medical research involving human participants. For M.Pharm students, understanding its principles is essential for designing, conducting, and evaluating clinical studies responsibly. This blog-style MCQ set focuses on core Helsinki concepts: informed consent, risk–benefit assessment, vulnerable populations, placebo use, post-trial access, ethics committee review, and transparency of results. Each question is crafted to deepen comprehension, link ethics to practical trial scenarios, and prepare students for real-world regulatory and institutional requirements. These MCQs, with explanations implied by options and answers, reinforce ethical judgment needed in clinical pharmacology and pharmaceutical research.

Q1. What is the primary purpose of the Declaration of Helsinki?

• To regulate pharmaceutical pricing internationally
• To provide ethical principles for medical research involving human subjects
• To establish clinical trial statistical methods
• To define manufacturing standards for drugs

Correct Answer: To provide ethical principles for medical research involving human subjects

Q2. Which organization originally adopted the Declaration of Helsinki?

• World Health Organization (WHO)
• International Council for Harmonisation (ICH)
• World Medical Association (WMA)
• United Nations (UN)

Correct Answer: World Medical Association (WMA)

Q3. In which year was the Declaration of Helsinki first adopted?

• 1948
• 1964
• 1975
• 1996

Correct Answer: 1964

Q4. Which core ethical principle emphasized by the Declaration of Helsinki underpins the requirement for informed consent?

• Justice
• Autonomy (respect for persons)
• Non-maleficence only
• Scientific validity

Correct Answer: Autonomy (respect for persons)

Q5. According to the Declaration, who must review and approve research protocols before human studies begin?

• Investigational site sponsor
• National regulatory authority only
• Independent ethics committee / institutional review board
• Pharmaceutical company legal department

Correct Answer: Independent ethics committee / institutional review board

Q6. How does the Declaration of Helsinki address research involving individuals incapable of giving informed consent?

• Such individuals are categorically excluded from all research
• They may be included only with proxy consent and additional protections, and ideally when research benefits them
• Consent may be assumed by the investigator if in the patient’s best interest
• No special provisions; standard consent applies

Correct Answer: They may be included only with proxy consent and additional protections, and ideally when research benefits them

Q7. Under what condition does the Declaration permit the use of placebo in a controlled trial?

• Placebo is always prohibited in clinical trials
• When no proven effective intervention exists or when withholding proven intervention does not expose subjects to serious harm
• Placebo can be used whenever it simplifies trial design
• Only in healthy volunteer studies and never in patients

Correct Answer: When no proven effective intervention exists or when withholding proven intervention does not expose subjects to serious harm

Q8. What does the Declaration state regarding post-trial access for participants who benefit from an intervention?

• There is no obligation to provide post-trial access
• Participants who benefit should have access to the proven intervention after the trial ends
• Post-trial access is the responsibility of national governments only
• Participants must purchase the intervention at market price after the trial

Correct Answer: Participants who benefit should have access to the proven intervention after the trial ends

Q9. Which statement best describes the Declaration’s guidance on research involving vulnerable groups?

• Vulnerable populations should be excluded to avoid exploitation
• They may be involved only if the research is responsive to their health needs and additional safeguards are provided
• Vulnerability is not recognized as a consideration in the Declaration
• They can be enrolled without consent if it facilitates recruitment

Correct Answer: They may be involved only if the research is responsive to their health needs and additional safeguards are provided

Q10. What does the Declaration require concerning conflicts of interest for researchers?

• Conflicts of interest should be concealed to protect intellectual property
• They must be disclosed to relevant bodies and managed to avoid undue influence
• Only financial conflicts need disclosure; non-financial are irrelevant
• Conflicts are the sole responsibility of the sponsor

Correct Answer: They must be disclosed to relevant bodies and managed to avoid undue influence

Q11. How should risks and benefits be considered according to the Declaration of Helsinki?

• Risks can be ignored if scientific knowledge is valuable
• Risks must be minimized and justified by potential benefits; net benefit should be favorable
• Only benefits to society matter, not to the participant
• Benefits to researchers are considered sufficient justification

Correct Answer: Risks must be minimized and justified by potential benefits; net benefit should be favorable

Q12. For non-therapeutic research with no direct benefit to the participant, what condition does the Declaration emphasize?

• Such research is prohibited regardless of risk
• It may be permissible only if risks are minimal and there is important knowledge to be gained
• The same risk thresholds as therapeutic research apply
• Consent is unnecessary for non-therapeutic research

Correct Answer: It may be permissible only if risks are minimal and there is important knowledge to be gained

Q13. What obligation regarding registration and publication of research findings is stated in the Declaration?

• There is no obligation to publish negative or inconclusive results
• Researchers should register clinical trials and make results publicly available, including negative findings
• Only trials with positive outcomes must be registered
• Publication is optional and left to investigator discretion

Correct Answer: Researchers should register clinical trials and make results publicly available, including negative findings

Q14. Which of the following best reflects the Declaration’s view on placebo-controlled trials when an effective treatment exists?

• Placebo can be used regardless of alternative treatments
• Placebo is acceptable only if compelling methodological reasons require it and participants are not subject to serious harm
• Placebo must always be used to ensure blinding
• Placebo use is mandated by the Declaration in comparative studies

Correct Answer: Placebo is acceptable only if compelling methodological reasons require it and participants are not subject to serious harm

Q15. In emergency situations where obtaining prior informed consent is impossible, what does the Declaration permit?

• Proceed without any oversight or later disclosure
• Enrollment without prior consent may be permitted if approved by ethics committee and consent is sought as soon as possible
• Such research is strictly forbidden under all circumstances
• Consent can be assumed from the treating physician

Correct Answer: Enrollment without prior consent may be permitted if approved by ethics committee and consent is sought as soon as possible

Q16. How does the Declaration of Helsinki address participant privacy and data confidentiality?

• Privacy is secondary to scientific goals and can be compromised
• Researchers must protect privacy and handle personal data confidentially, using anonymization when appropriate
• Confidentiality applies only to publication stage
• Data can be shared freely among sponsors without restrictions

Correct Answer: Researchers must protect privacy and handle personal data confidentially, using anonymization when appropriate

Q17. What is the role of an independent ethics committee during the conduct of a study, per the Declaration?

• To design the study protocol and sponsor the trial
• To provide continuous oversight, approve amendments, and monitor participant safety
• To market the investigational product after approval
• To act as legal counsel for the investigator

Correct Answer: To provide continuous oversight, approve amendments, and monitor participant safety

Q18. According to the Declaration, who is responsible for arranging compensation and treatment for research-related injury?

• Only the investigator is responsible
• The sponsor and investigator should ensure arrangements are in place to provide compensation and treatment
• Participants must secure personal insurance themselves
• National governments exclusively handle compensation

Correct Answer: The sponsor and investigator should ensure arrangements are in place to provide compensation and treatment

Q19. How does the Declaration distinguish therapeutic from non-therapeutic research?

• Therapeutic research aims to provide direct benefit to the participant; non-therapeutic may not offer direct benefit but seeks generalizable knowledge
• Non-therapeutic research always involves higher risk
• There is no distinction; all research is therapeutic by default
• Therapeutic research requires no ethical review

Correct Answer: Therapeutic research aims to provide direct benefit to the participant; non-therapeutic may not offer direct benefit but seeks generalizable knowledge

Q20. Which of the following statements is NOT consistent with the Declaration of Helsinki?

• Investigators must obtain informed consent from participants or their legal representatives
• All clinical trials must be registered and results published, including negative findings
• Placebo use is always prohibited regardless of context
• Research involving vulnerable populations requires additional safeguards

Correct Answer: Placebo use is always prohibited regardless of context

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