Informed consent process: structure and content MCQs With Answer

Introduction: This quiz set focuses on the informed consent process—its structure and essential content—as applicable to clinical trials and pharmacovigilance. Designed for M.Pharm students, the questions emphasize regulatory expectations (ICH-GCP, local regulations), the ethical principles of disclosure, comprehension, voluntariness and documentation, and practicalities for drug trials (investigational product details, randomization, placebo use). Topics include consent for vulnerable populations, assent, witness requirements, e-consent, re-consent, compensation for research-related injury, and procedures for emergency or waived consent. These MCQs will deepen understanding of how to design, review, and implement clear, compliant informed consent processes in clinical research.

Q1. What best describes the informed consent process in clinical research?

• A one-time signing of a document before the first dose
• A continuous process of information exchange culminating in voluntary agreement
• An administrative requirement handled solely by the sponsor
• A purely legal formality to be archived

Correct Answer: A continuous process of information exchange culminating in voluntary agreement

Q2. Which set lists the essential elements of informed consent as required by ICH-GCP?

• Investigator credentials, site address, sponsor name
• Disclosure of information, comprehension, voluntariness, capacity, and documentation
• Only risks and benefits
• Payment details and insurance policy number

Correct Answer: Disclosure of information, comprehension, voluntariness, capacity, and documentation

Q3. Who is primarily responsible for obtaining informed consent from a study participant?

• The sponsor’s legal representative alone
• The principal investigator or a qualified member of the study team delegated by the investigator
• The Ethics Committee chair during screening
• Any hospital nurse on duty

Correct Answer: The principal investigator or a qualified member of the study team delegated by the investigator

Q4. When is re-consent from participants typically required?

• Only when a participant requests it
• When new safety information or protocol changes affect participant’s willingness
• Every month irrespective of changes
• Never—initial consent is sufficient for whole study

Correct Answer: When new safety information or protocol changes affect participant’s willingness

Q5. What is the correct approach to document consent for an illiterate subject?

• Do not enroll illiterate subjects
• Use a thumb impression or mark in the presence of an impartial witness who signs
• Only record verbal assent without witness
• The investigator signs on behalf of the subject

Correct Answer: Use a thumb impression or mark in the presence of an impartial witness who signs

Q6. Under what condition may informed consent be deferred or waived in emergency research?

• If the subject has read the ICF previously in any study
• If the subject is incapacitated and delay would risk life or health and regulations permit waiver or deferred consent
• Always, if the investigator decides it’s urgent
• Only if the sponsor requests it

Correct Answer: If the subject is incapacitated and delay would risk life or health and regulations permit waiver or deferred consent

Q7. Who is normally responsible for providing compensation for trial-related injury in most regulatory frameworks?

• The participant’s family
• The investigator personally
• The study sponsor
• The Ethics Committee

Correct Answer: The study sponsor

Q8. Which information is essential in the informed consent for a randomized, placebo-controlled drug trial?

• Only the expected benefit of the test drug
• The description of investigational product, intended dose, route, randomization and placebo use
• Sponsor’s profit projections
• Investigator’s academic publications

Correct Answer: The description of investigational product, intended dose, route, randomization and placebo use

Q9. What is the primary role of an Ethics Committee (IEC/IRB) regarding informed consent forms?

• To translate the ICF into multiple languages without review
• To review and approve the informed consent form and ensure subject protection
• To sign the ICF instead of the participant
• To manage compensation payments directly

Correct Answer: To review and approve the informed consent form and ensure subject protection

Q10. Which statement best describes acceptable use of electronic informed consent (eIC)?

• eIC can replace ethics review
• eIC is allowed if it ensures comprehension, identity verification, and an audit trail
• eIC requires no documentation of signature
• eIC is not permissible under any circumstance

Correct Answer: eIC is allowed if it ensures comprehension, identity verification, and an audit trail

Q11. For pediatric studies, who must provide consent and assent?

• The minor alone signs consent
• Parent or legal guardian signs consent; minor provides assent when capable
• The Ethics Committee signs on behalf of parents
• No consent is required for minors

Correct Answer: Parent or legal guardian signs consent; minor provides assent when capable

Q12. What is “therapeutic misconception” in the informed consent context?

• The belief that all research is high risk
• Participant mistakenly believes trial aims to provide personalised medical care rather than research
• A regulatory term for therapeutic trials only
• When investigators withhold treatment intentionally

Correct Answer: Participant mistakenly believes trial aims to provide personalised medical care rather than research

Q13. Which contact information should always be included in the informed consent form?

• Investigator contact, study coordinator, and Ethics Committee contact for queries and injury
• Only the sponsor’s marketing hotline
• The investigator’s home telephone number exclusively
• No contacts are necessary to maintain confidentiality

Correct Answer: Investigator contact, study coordinator, and Ethics Committee contact for queries and injury

Q14. Which statement about data privacy and future use of samples must be included in a modern ICF?

• Data will be sold to third parties with no restrictions
• Information about confidentiality, data storage, and future use of samples must be disclosed
• Samples will be stored forever without any description
• Privacy is not a concern in clinical trials

Correct Answer: Information about confidentiality, data storage, and future use of samples must be disclosed

Q15. Which method is most effective to confirm participant comprehension during consent?

• Rely solely on a long technical document
• Use plain language and teach-back or questionnaires to confirm understanding
• Assume understanding if the subject nods
• Only provide consent in legal jargon

Correct Answer: Use plain language and teach-back or questionnaires to confirm understanding

Q16. When should the informed consent document be signed and dated?

• After completing all study procedures
• Before any study-specific procedures are performed
• Only at the end of the trial during close-out
• Whenever the sponsor requests documentation

Correct Answer: Before any study-specific procedures are performed

Q17. What is required regarding version control of the informed consent form?

• ICFs may be used without dates or version identifiers
• ICF must have a version number and date and be approved by the Ethics Committee before use
• The investigator can modify ICF at will during recruitment
• Version control is only needed for the protocol, not the ICF

Correct Answer: ICF must have a version number and date and be approved by the Ethics Committee before use

Q18. When is an impartial witness required to sign the informed consent?

• For every literate participant
• An impartial witness signs when subject is unable to read or when required by local law
• Only when the investigator is absent
• Only for phase IV studies

Correct Answer: An impartial witness signs when subject is unable to read or when required by local law

Q19. Under what conditions can an Ethics Committee waive the requirement for informed consent?

• When the research poses more than minimal risk
• When research poses minimal risk and obtaining consent is impracticable and rights/welfare are not adversely affected
• Whenever the investigator prefers faster recruitment
• For all interventional drug studies

Correct Answer: When research poses minimal risk and obtaining consent is impracticable and rights/welfare are not adversely affected

Q20. What does the ethical principle of voluntariness require in the informed consent process?

• Subjects must be paid large sums to ensure participation
• Decision must be free of coercion or undue influence and participants may withdraw at any time
• Once consented, participants cannot withdraw
• The investigator decides whether the subject should continue

Correct Answer: Decision must be free of coercion or undue influence and participants may withdraw at any time

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