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 with a psychiatric disorder has been assessed as having decision-making capacity. What is the correct approach to obtaining their consent?
Answer: Obtain consent directly from the participant since they have been assessed as having capacity
A psychiatric diagnosis does not automatically negate consent capacity; if assessed as having capacity, the participant provides their own consent.
What is the significance of the Belmont Report's principle of 'respect for persons' to the informed consent process?
Answer: It mandates that individuals be treated as autonomous agents and that those with diminished autonomy receive special protections
Respect for persons requires acknowledging individual autonomy and providing additional protections for those with diminished capacity, forming the ethical basis for informed consent.
An IRB waives the requirement for written informed consent for a minimal-risk study. Which of the following conditions must be met for this waiver?
Answer: The research could not practicably be carried out without the waiver and involves no more than minimal risk
Under 21 CFR 56.109(c) and 45 CFR 46.117(c), IRBs may waive written consent when the research involves minimal risk and cannot practicably be conducted otherwise.
A prospective participant is in an acute pain crisis when approached for consent to a pain management trial. Which concern does this raise?
Answer: Pain may impair voluntary decision-making and comprehension, raising questions about the validity of consent obtained in this state
Acute distress or pain can compromise a person's ability to make a truly voluntary and fully informed decision, so consent obtained under these conditions may be ethically questionable.
Which federal regulation specifically governs informed consent requirements for FDA-regulated clinical investigations in the United States?
Answer: 21 CFR Part 50
21 CFR Part 50 is the FDA regulation that establishes informed consent requirements for clinical investigations of FDA-regulated products.
A participant signs the consent form but later tells a nurse they did not understand what they signed. What is the most appropriate action?
Answer: Re-conduct the consent discussion to ensure comprehension, answer all questions, and have the participant re-sign if they still wish to participate
Informed consent is an ongoing process; if a participant indicates they did not understand, the consent discussion must be repeated and comprehension verified before continued participation.
What is the role of an impartial witness during the informed consent process?
Answer: To attest that the information was accurately explained and that the participant voluntarily signed the consent form
An impartial witness attests that the consent information was presented accurately and that the participant's consent was voluntary, serving as an independent verification of the process.