Informed consent process and ethical considerations MCQs With Answer

Informed consent is a cornerstone of ethical clinical practice and research, especially for B. Pharm students who will counsel patients and contribute to trials. This introduction reviews the informed consent process, essential ethical considerations, and practical elements such as capacity assessment, voluntariness, clear consent forms, documentation, and confidentiality. Emphasizing principles like patient autonomy, beneficence, non-maleficence, and justice, it also covers protections for vulnerable populations, surrogate decision-making, and regulatory frameworks (ICH-GCP, national laws). Understanding risks, benefits, disclosure standards, and withdrawal rights is critical for pharmacists involved in drug development and patient care. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary ethical principle underlying the informed consent process?

• Beneficence
• Patient autonomy
• Confidentiality
• Non-maleficence

Correct Answer: Patient autonomy

Q2. Which element is essential to determine a person’s capacity to give informed consent?

• Ability to pay for treatment
• Ability to understand relevant information
• Presence of a family member
• Professional status of the clinician

Correct Answer: Ability to understand relevant information

Q3. Voluntariness in consent primarily means:

• Consent obtained after intensive persuasion
• Decision free from coercion or undue influence
• Consent documented by any staff member
• Consent given only by legal authorities

Correct Answer: Decision free from coercion or undue influence

Q4. Which document typically contains details of purpose, procedures, risks, benefits, and alternatives?

• Investigator brochure
• Case report form
• Consent form
• Protocol synopsis

Correct Answer: Consent form

Q5. When is assent required in pediatric research?

• For all children regardless of age
• Never; only parental consent is needed
• When the child is capable of providing meaningful agreement
• Only when the study has no risk

Correct Answer: When the child is capable of providing meaningful agreement

Q6. Which regulatory guideline is widely used for good clinical practice related to informed consent?

• ISO 9001
• ICH-GCP
• HACCP
• GLP only

Correct Answer: ICH-GCP

Q7. In an emergency with no time to obtain consent, what is an accepted approach for research in many jurisdictions?

• Immediate enrollment under deferred consent or waiver provisions
• Refusal to treat until consent obtained
• Enrollment only if family consents beforehand
• Postpone all interventions

Correct Answer: Immediate enrollment under deferred consent or waiver provisions

Q8. Which of the following is a valid reason to re-consent a participant?

• Minor clerical error in the investigator’s name
• Significant protocol change affecting risk/benefit
• Completion of data entry
• Change of hospital phone number

Correct Answer: Significant protocol change affecting risk/benefit

Q9. Who approves the consent form and overall ethics of a clinical study?

• Principal investigator alone
• Institutional Review Board/Independent Ethics Committee (IRB/IEC)
• Sponsor’s marketing team
• Pharmacy department head

Correct Answer: Institutional Review Board/Independent Ethics Committee (IRB/IEC)

Q10. Therapeutic misconception refers to:

• Belief that clinical research ensures individualized therapeutic benefit
• Mistaking a placebo for active drug
• Confusing adverse events with expected side effects
• Assuming research has no risks

Correct Answer: Belief that clinical research ensures individualized therapeutic benefit

Q11. Which party is primarily responsible for ensuring informed consent is properly obtained?

• Sponsor’s legal department
• Clinical investigator
• Regulatory authority
• Data manager

Correct Answer: Clinical investigator

Q12. Confidentiality in informed consent covers:

• Only the medication given
• Protection of identifiable participant data and privacy
• Only lab test results
• Only financial information

Correct Answer: Protection of identifiable participant data and privacy

Q13. Which element must be explained to participants regarding their right to withdraw?

• Withdrawal means legal penalties
• Withdrawal can be immediate and without affecting standard care
• Withdrawal obliges payment of fees
• Withdrawal requires court approval

Correct Answer: Withdrawal can be immediate and without affecting standard care

Q14. For illiterate participants, an ethically acceptable consent method includes:

• Signing a blank form
• Oral explanation in presence of an impartial witness and thumbprint
• Relying solely on family consent
• Using the investigator’s signature only

Correct Answer: Oral explanation in presence of an impartial witness and thumbprint

Q15. Which situation is a permissible exception to obtaining explicit informed consent?

• Any routine clinical visit
• Minimal-risk public health surveillance with waiver approved by IRB
• High-risk experimental surgery
• Non-clinical staff collecting identifiable data for marketing

Correct Answer: Minimal-risk public health surveillance with waiver approved by IRB

Q16. What is the role of a legally authorized representative (LAR) in consent?

• Provide consent on behalf of an incapable subject according to law
• Always act as co-investigator
• Only provide assent for research
• Serve as a witness only

Correct Answer: Provide consent on behalf of an incapable subject according to law

Q17. Which phrase best describes “adequate disclosure” in consent?

• Providing every published study on the topic
• Presenting clear information about procedures, risks, benefits, and alternatives
• Only stating the possible benefits
• Giving scientific articles to read

Correct Answer: Presenting clear information about procedures, risks, benefits, and alternatives

Q18. What must be included in consent when genetic data or biobanking is involved?

• No information is needed
• Clear explanation of storage, future use, and data sharing policies
• Only the storage temperature
• Only the institution’s logo

Correct Answer: Clear explanation of storage, future use, and data sharing policies

Q19. How should language barriers be addressed during the consent process?

• Use a family member as translator without documentation
• Provide translation using qualified interpreter and translated consent form
• Proceed in English regardless
• Skip consent entirely

Correct Answer: Provide translation using qualified interpreter and translated consent form

Q20. Which is a sign that a participant may not have understood consent information?

• Asking clarifying questions
• Inability to restate key study aspects or risks
• Signing promptly after explanation
• Requesting a copy of the form

Correct Answer: Inability to restate key study aspects or risks

Q21. What is an appropriate approach if a participant shows decisional impairment due to severe mental illness?

• Force participation for perceived benefit
• Assess capacity formally and involve LAR if necessary
• Ignore capacity concerns and proceed
• Exclude them without consideration

Correct Answer: Assess capacity formally and involve LAR if necessary

Q22. Which describes “ongoing consent” in clinical research?

• Consent is a single one-time signature only
• Reinforcing information, checking understanding, and updating consent as study evolves
• Consent is only for data collection
• Only the sponsor maintains contact

Correct Answer: Reinforcing information, checking understanding, and updating consent as study evolves

Q23. In placebo-controlled trials, consent must explicitly address:

• That placebos are never used
• The possibility of receiving placebo and implications for benefit
• Only the active drug’s benefits
• The investigator’s salary

Correct Answer: The possibility of receiving placebo and implications for benefit

Q24. Privacy safeguards for electronic consent (e-consent) should include:

• Public Wi-Fi transmission only
• Secure authentication, encryption, and audit trails
• No record keeping
• Use of personal social media for sharing

Correct Answer: Secure authentication, encryption, and audit trails

Q25. How should compensation for research-related injury be described in consent?

• Not mentioned to avoid liability
• Clear information on available treatment and compensation policies
• Only verbal assurance
• Stated as indefinite and unspecified

Correct Answer: Clear information on available treatment and compensation policies

Q26. Which action indicates undue influence during recruitment?

• Providing balanced information about risks
• Offering excessive payments that impair voluntary choice
• Allowing time to consider participation
• Explaining alternatives to participation

Correct Answer: Offering excessive payments that impair voluntary choice

Q27. What must be documented when consent is obtained by telephone in decentralized trials?

• Nothing needs documenting
• Transcript or recorded confirmation and witness/verification per regulations
• Only investigator’s memory
• Only an email to the sponsor

Correct Answer: Transcript or recorded confirmation and witness/verification per regulations

Q28. Which is a key difference between assent and consent?

• Assent is legally binding; consent is not
• Assent is agreement from a minor who cannot legally consent; consent is legal authorization
• Assent requires IRB approval; consent does not
• There is no difference

Correct Answer: Assent is agreement from a minor who cannot legally consent; consent is legal authorization

Q29. When should potential conflicts of interest be disclosed in the consent process?

• Only if participant asks
• At the time of consent so participants can make informed decisions
• Never disclosed to avoid bias
• Only in the final report

Correct Answer: At the time of consent so participants can make informed decisions

Q30. Which practice strengthens ethical validity of consent in low-literacy populations?

• Using complex legal terminology
• Using plain language, teach-back method, and culturally appropriate materials
• Providing consent only in written English
• Relying on technical brochures

Correct Answer: Using plain language, teach-back method, and culturally appropriate materials

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