Informed Consent Process Flashcards
7 cards from real CTA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Informed Consent Process flashcards as text
A participant who is illiterate wants to enroll in a clinical trial. Which approach is acceptable for obtaining informed consent?
Answer: Have the participant sign an X and have a witness sign attesting to the verbal consent process
For illiterate participants, an impartial witness must be present during the entire consent process and sign the form along with the participant's mark.
What is the primary purpose of the 'cooling-off' period sometimes allowed between consent and enrollment?
Answer: To give participants time to reconsider their decision and consult with others before committing
A cooling-off period gives participants adequate time to reflect on their decision and discuss participation with family or advisors without pressure.
Under 21 CFR Part 50, which of the following constitutes a required element of informed consent?
Answer: A description of any reasonably foreseeable risks or discomforts
21 CFR 50.25(a)(2) requires disclosure of reasonably foreseeable risks or discomforts as a basic element of informed consent.
A participant signs the consent form but then asks the study coordinator not to tell their spouse about their participation. How should the coordinator respond?
Answer: Inform the participant that while their records are confidential, their personal health disclosures are their own choice
Confidentiality of study records is maintained by the research team; what participants share personally is their own decision.
When must reconsent be obtained from a study participant?
Answer: When a protocol amendment adds new risks or substantially changes the nature of participation
Reconsent is required when amendments introduce new information that could affect a participant's willingness to continue, such as new risks or significant procedural changes.
Which statement best describes 'assent' in the context of pediatric clinical trials?
Answer: Assent is the minor's affirmative agreement to participate, obtained in addition to parental permission
Assent is the child's affirmative agreement to participate and is obtained in addition to, not instead of, parental or guardian permission.
A participant enrolled in a blinded study asks the investigator to reveal their treatment assignment. What is the most appropriate response?
Answer: Explain that unblinding is only done for medical necessity or at study end, per protocol procedures
Unblinding during a trial is generally reserved for medical emergencies or as defined by the protocol, and investigators should explain this to participants.