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
A researcher wants to re-contact subjects from a completed study to recruit them into a new study. What is the primary ethical concern?
Answer: The original consent may not have authorized future contact for new research
If the original consent form did not address re-contact for future studies, researchers must seek IRB guidance before reaching out to former participants.
Which practice best exemplifies the principle of 'assent' in pediatric research?
Answer: Explaining the study to a child in age-appropriate language and seeking their affirmative agreement to participate
Assent requires that children be given developmentally appropriate information about the study and have their agreement solicited, separate from parental permission.
A subject enrolled in a nutrition study discovers they were assigned to the control arm and did not receive the supplement they hoped for. They express disappointment but do not withdraw. Which ethical obligation must the researcher fulfill?
Answer: Ensure the subject understands they may withdraw at any time without penalty
Researchers must continuously affirm participants' right to withdraw without penalty or loss of benefits to which they are entitled.
Under 45 CFR 46 Subpart B, which condition must be met to conduct research involving pregnant women that presents greater than minimal risk?
Answer: The research must hold out the prospect of direct benefit to the woman or fetus, or the risk must be minimized
Subpart B requires that research with pregnant women presenting greater than minimal risk must offer prospect of direct benefit or meet stringent risk minimization standards.
What is the main distinction between a Certificate of Confidentiality and a confidentiality pledge in a consent form?
Answer: A Certificate of Confidentiality is a federal protection that shields research data from compelled disclosure in legal proceedings
Certificates of Confidentiality, authorized under 42 USC 241(d), provide legally enforceable protection against compelled disclosure of identifiable research data.
A community member objects that a clinical trial being conducted in their neighborhood excludes local residents from the study's benefit-sharing plan. Which ethical principle supports their concern?
Answer: Justice, because the community bearing research risks should also share in research benefits
Justice requires that communities bearing the burdens of hosting research should have fair access to resulting benefits, a principle emphasized in community-based research ethics.
Which scenario best illustrates 'undue inducement' that could compromise voluntary informed consent?
Answer: Offering low-income subjects a payment so large relative to their income that it overrides their judgment about acceptable risk
Undue inducement occurs when payment is so disproportionately large that it impairs rational decision-making about risks, particularly for economically vulnerable populations.