Informed consent process MCQs With Answer

Informed Consent Process MCQs With Answer (Regulatory Affairs, MPH 104T)

The informed consent process is the ethical and regulatory cornerstone of clinical research. For M. Pharm students specializing in Regulatory Affairs, mastering its components—from participant information, comprehension assessment, documentation, and ongoing consent to region-specific requirements—is essential. This quiz focuses on practical and regulatory nuances aligned with ICH-GCP, Declaration of Helsinki, and national regulations such as India’s NDCTR 2019. You will encounter questions on audiovisual recording, consent in vulnerable populations, assent and LAR roles, e-consent validation, waiver/alteration criteria, compensation for trial-related injury, re-consent triggers, and documentation standards. Use these MCQs to test not only your factual recall but also your ability to apply regulatory principles to real-world clinical trial scenarios.

Q1. Which statement best reflects the ethical core of informed consent in clinical trials?

• It is a one-time signature confirming participation
• It is a continuous, dialog-based process ensuring voluntary, informed decision-making
• It is a legal obligation performed only by the sponsor’s representative
• It is a recruitment tactic to maximize enrollment

Correct Answer: It is a continuous, dialog-based process ensuring voluntary, informed decision-making

Q2. Under ICH-GCP E6(R2), which of the following must always be included in the Participant Information Sheet/ICF?

• A statement that randomization will guarantee better outcomes
• A description of foreseeable risks or inconveniences to the subject
• Specific names of all site staff
• A promise of financial benefit to every participant

Correct Answer: A description of foreseeable risks or inconveniences to the subject

Q3. In India under the NDCTR 2019, which is generally required regarding informed consent documentation in clinical trials?

• Only verbal consent with no recording
• Audio-visual recording of the informed consent process along with written consent
• Electronic consent without IRB approval
• Consent by the sponsor on behalf of the participant

Correct Answer: Audio-visual recording of the informed consent process along with written consent

Q4. Which situation most clearly requires re-consent during an ongoing trial?

• Changing the clinic’s waiting room layout
• New safety data emerge that may affect participants’ willingness to continue
• Replacing a site receptionist
• Routine monitoring visit scheduling

Correct Answer: New safety data emerge that may affect participants’ willingness to continue

Q5. What is the role of an impartial witness during the informed consent process?

• To persuade the subject to join the trial
• To sign for the subject as the legal representative
• To attend the entire consent discussion for an illiterate subject and attest that information was accurately explained and understood
• To replace the investigator in explaining the protocol

Correct Answer: To attend the entire consent discussion for an illiterate subject and attest that information was accurately explained and understood

Q6. Which of the following best mitigates therapeutic misconception during consent?

• Stating that the investigational product is proven superior
• Clarifying the difference between research and individualized medical care, including the use of randomization and placebo where applicable
• Avoiding mention of placebo to preserve blinding
• Promising personal medical benefit

Correct Answer: Clarifying the difference between research and individualized medical care, including the use of randomization and placebo where applicable

Q7. Which element is essential for consent to be considered voluntary?

• Offering large financial inducements
• Assuring that refusal or withdrawal will not affect standard care or entitlements
• Requiring employer approval for participation
• Restricting time for questions

Correct Answer: Assuring that refusal or withdrawal will not affect standard care or entitlements

Q8. Which of the following is an appropriate comprehension check during consent?

• Asking the subject to repeat key risks and procedures in their own words
• Providing a glossary of terms only
• Having the subject sign immediately after reading
• Quizzing the subject on sponsor financial reports

Correct Answer: Asking the subject to repeat key risks and procedures in their own words

Q9. In pediatric trials, which approach aligns with good ethical and regulatory practice?

• Rely solely on parental permission; never involve the child
• Obtain parental permission and, when developmentally appropriate, the child’s assent
• Accept assent in place of parental permission
• Enroll minors without any consent in minimal risk studies

Correct Answer: Obtain parental permission and, when developmentally appropriate, the child’s assent

Q10. Which content is mandatory to include in the ICF regarding injury?

• A statement that the sponsor has no responsibility for injuries
• A clear explanation of medical management and compensation for trial-related injury as per applicable regulations
• Only a phone number for emergency contact
• A waiver signed by subjects releasing liability

Correct Answer: A clear explanation of medical management and compensation for trial-related injury as per applicable regulations

Q11. When is a waiver or alteration of informed consent ethically and regulatorily justifiable?

• To accelerate recruitment in high-enrolling sites
• When the research involves no more than minimal risk and consent is impracticable, without adversely affecting subjects’ rights and welfare, and approved by the IEC/IRB
• For all retrospective chart reviews regardless of identifiers
• Whenever the sponsor requests it

Correct Answer: When the research involves no more than minimal risk and consent is impracticable, without adversely affecting subjects’ rights and welfare, and approved by the IEC/IRB

Q12. Which is the best practice for language in consent documents?

• Use technical jargon to avoid oversimplification
• Write at an understandable reading level in the participant’s local language and avoid unexplained jargon
• Translate only the title page
• Provide English consent to all participants globally

Correct Answer: Write at an understandable reading level in the participant’s local language and avoid unexplained jargon

Q13. Regarding eConsent in clinical trials, which statement is most accurate?

• eConsent does not require IEC/IRB review if content is identical to paper
• eConsent systems must ensure identity verification, version control, audit trails, and provide a copy to the participant
• eConsent eliminates the need for training staff
• eConsent allows removal of the impartial witness for illiterate subjects

Correct Answer: eConsent systems must ensure identity verification, version control, audit trails, and provide a copy to the participant

Q14. Which action is most appropriate when a participant turns 18 during a long-term study started in childhood?

• Continue under parental permission without change
• Obtain the participant’s informed consent at the earliest opportunity
• Withdraw the participant automatically
• Revert to assent only

Correct Answer: Obtain the participant’s informed consent at the earliest opportunity

Q15. What is the correct approach to translations of consent documents?

• Use machine translation without review
• Perform forward translation, independent back-translation, and IEC/IRB approval to ensure conceptual equivalence
• Translate only risk sections
• Allow site staff to explain in local language without written translation

Correct Answer: Perform forward translation, independent back-translation, and IEC/IRB approval to ensure conceptual equivalence

Q16. Under ICH-GCP, how long should essential documents (including consent forms) typically be retained?

• Until the last subject’s last visit
• For a minimum of 2 years after the last marketing approval in any ICH region and until there are no pending applications, or longer if required by local law
• Only during the study conduct
• For 6 months after database lock

Correct Answer: For a minimum of 2 years after the last marketing approval in any ICH region and until there are no pending applications, or longer if required by local law

Q17. Which is the most appropriate timing for obtaining informed consent?

• After performing screening procedures that are solely for research
• Before any study-specific procedures are initiated, allowing adequate time for questions
• Immediately before drug administration without discussion
• Only after randomization

Correct Answer: Before any study-specific procedures are initiated, allowing adequate time for questions

Q18. Which statement best describes the role of the Legally Acceptable Representative (LAR)?

• A person appointed by the sponsor to speed up enrollment
• An independent individual authorized under applicable law to consent on behalf of a participant lacking capacity
• A family friend witnessing the signature
• The hospital’s administrative officer by default

Correct Answer: An independent individual authorized under applicable law to consent on behalf of a participant lacking capacity

Q19. What should the ICF state regarding costs and payments to participants?

• Participants will pay all trial-related costs
• Details of reimbursement for expenses, any compensation for time/inconvenience, and any costs covered by the sponsor/investigator
• No information is necessary to avoid undue influence
• Only the per-visit payment amount without context

Correct Answer: Details of reimbursement for expenses, any compensation for time/inconvenience, and any costs covered by the sponsor/investigator

Q20. For future use of biological samples beyond the current study, which approach aligns with good regulatory practice?

• Store and use samples indefinitely without consent
• Obtain explicit consent for future use, including scope, storage duration, and data protection measures, or de-identify per regulations if consent is not feasible and approved by IEC/IRB
• Assume consent if the participant did not object verbally
• Rely solely on sponsor’s internal policies

Correct Answer: Obtain explicit consent for future use, including scope, storage duration, and data protection measures, or de-identify per regulations if consent is not feasible and approved by IEC/IRB

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