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
An investigator wants to use a short-form consent document. What additional step is required beyond the participant signing the short form?
Answer: A summary of the full consent discussion must be provided to the participant and signed by a witness
When using a short-form consent document, a written summary of what is presented orally must be given to the participant, and a witness must sign both the short form and the summary.
A CTA notices that the IRB-approved consent form version used at the site is six months out of date. What is the most appropriate immediate action?
Answer: Notify the investigator immediately so that the current IRB-approved version can be implemented and affected participants can be reconsented
Using an outdated consent form is a protocol deviation; the site must switch to the current IRB-approved version immediately and reconsent participants if required.
Which of the following best describes 'therapeutic misconception' in clinical trial research?
Answer: A participant's mistaken belief that all trial procedures are tailored to their individual medical benefit rather than to generate generalizable knowledge
Therapeutic misconception occurs when participants confuse the purpose of research with individualized medical treatment, compromising the voluntariness of consent.
A participant enrolled in a long-term study moves to another state. They call the site and verbally revoke their consent over the phone. How should the site document this?
Answer: Document the withdrawal in the source records, note the date and method, and send a written confirmation to the participant
Withdrawal of consent can be communicated verbally; the site must document it thoroughly in source records and may send written confirmation to the participant.
Which element is classified as an 'additional' rather than 'basic' element of informed consent under 21 CFR 50.25?
Answer: A statement that significant new findings will be disclosed to participants
Under 21 CFR 50.25(b), disclosing significant new findings that may affect willingness to continue is an additional element, not a required basic element.
When obtaining consent from a non-English speaking participant, which approach is compliant with FDA requirements?
Answer: Use an IRB-approved translated consent form in the participant's language, with a qualified interpreter if needed
The FDA requires that consent information be presented in language understandable to the participant; IRB-approved translations or the short-form process with a qualified interpreter are acceptable approaches.
A participant experiences a serious adverse event (SAE) mid-trial that is identified as a new risk. How does this affect the informed consent process?
Answer: The IRB must be notified and may require a consent form amendment; currently enrolled participants may need to be reconsented
New safety information that may affect participant willingness must be reported to the IRB, which may require a consent amendment and reconsent of enrolled participants.