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 sponsor-employed nurse conducts the informed consent discussion for a trial at an investigative site. What is the key concern with this arrangement?
Answer: The participant may feel undue pressure to enroll because the nurse represents the entity funding the trial
Sponsor employees obtaining consent may create a conflict of interest and undue influence, as participants may feel obligated to enroll to please the funding source.
What does the term 'capacity' mean in the context of informed consent?
Answer: A participant's ability to understand information, appreciate its relevance, reason about options, and communicate a choice
Capacity refers to the cognitive and communicative ability to make an informed voluntary decision, distinct from legal competence.
Under the ICH E6(R3) GCP guidelines, who is ultimately responsible for ensuring that informed consent is properly obtained?
Answer: The investigator
ICH E6(R3) places ultimate responsibility on the investigator to ensure that informed consent is obtained before any trial-related procedures are conducted.
A participant's cognitive status deteriorates during the trial and they can no longer provide ongoing consent. What is the appropriate next step?
Answer: Seek consent from a legally authorized representative and assess whether continued participation is in the participant's best interest
When a participant loses capacity, a legally authorized representative must assume the consent role, and the ethical appropriateness of continued participation must be evaluated.
Which of the following scenarios represents a breach of informed consent documentation requirements under FDA regulations?
Answer: The consent form is signed after a study-related blood draw has already been performed
Performing any study-related procedure before obtaining signed informed consent violates 21 CFR 50.20, which requires consent prior to trial participation.
A participant asks whether they can withdraw from the study at any time. Which response is most accurate according to GCP?
Answer: Participants may withdraw at any time without penalty or loss of benefits to which they are otherwise entitled
GCP and 21 CFR 50.25(a)(8) require that participants be informed they may withdraw at any time without penalty or loss of otherwise entitled benefits.
What is the purpose of including a statement about confidentiality limits in the informed consent form?
Answer: To inform participants that regulatory authorities and sponsors may inspect records, limiting absolute confidentiality
Participants must be told that while confidentiality will be maintained, records may be inspected by the FDA, sponsor, and IRB, so absolute privacy cannot be guaranteed.