Resident Rights & Advocacy Flashcards
7 cards from real CRA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Resident Rights & Advocacy flashcards as text
Under the Common Rule (45 CFR 46), which condition must be met for an IRB to waive the requirement for written informed consent documentation?
Answer: The research involves no more than minimal risk and the waiver will not adversely affect subjects' rights
45 CFR 46.117(c) allows IRBs to waive written consent documentation when the research presents no more than minimal risk and the waiver won't adversely affect participants' rights and welfare.
A subject in a longitudinal study withdraws consent mid-study. Which action by the research team is ethically required?
Answer: Continue using previously collected data but collect no new data from that subject
Withdrawal of consent means no new data collection; previously collected data may generally be retained unless the consent form specified otherwise.
Which federal principle requires that research subjects be selected equitably so that burdens and benefits are distributed fairly across populations?
Answer: Justice
The Belmont Report's principle of Justice requires fair distribution of research burdens and benefits, preventing exploitation of vulnerable or convenient populations.
An advocate notices that a consent form for a drug trial omits information about alternative treatments. Which Belmont element is violated?
Answer: Disclosure of relevant alternatives
Informed consent requires disclosure of appropriate alternative procedures or treatments that might be advantageous to the subject.
What does the concept of 'therapeutic misconception' mean in the context of research subject protections?
Answer: Subjects mistakenly believe research procedures are designed for their individual benefit rather than to generate generalizable knowledge
Therapeutic misconception occurs when subjects fail to distinguish research from individualized clinical care, undermining true informed consent.
Which mechanism allows a legally authorized representative (LAR) to provide permission for a cognitively impaired adult to participate in research?
Answer: Surrogate consent based on substituted judgment or best interests standard
An LAR may provide surrogate consent using substituted judgment (what the subject would have wanted) or best interests when the subject cannot consent independently.
A participant advocate discovers that subjects are being pressured by their physicians to enroll in a study. Which ethical principle is most directly compromised?
Answer: Voluntariness
Voluntariness requires that participation be free from coercion or undue influence, including influence from treating physicians who hold authority over patients.