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 HIPAA, which authorization element must be included when research involves use of protected health information (PHI)?
Answer: An expiration date or event for the authorization
HIPAA requires that a valid research authorization include an expiration date or event, among other required elements, to limit the scope of PHI use.
A research participant who is a prisoner is considered a vulnerable population primarily because of concerns about which ethical issue?
Answer: Compromised voluntariness due to institutional coercion
Prisoners are protected under 45 CFR 46 Subpart C because incarceration can compromise voluntary participation through institutional pressures and perceived incentives.
Which type of IRB review is appropriate for research involving no more than minimal risk that uses educational tests or survey procedures?
Answer: Exempt determination
Category 2 of the exempt categories covers research involving educational tests, surveys, or interviews that present no more than minimal risk under certain conditions.
What is the primary purpose of a Data Safety Monitoring Board (DSMB) in protecting research participants?
Answer: To conduct interim reviews of accumulating data and recommend stopping or modifying a trial if safety concerns arise
A DSMB protects participants by independently monitoring accumulating safety and efficacy data and recommending early stopping or protocol changes when warranted.
When must an investigator report an unanticipated problem involving risk to participants to the IRB?
Answer: As soon as possible following the investigator's awareness of the problem
Unanticipated problems must be promptly reported to the IRB to allow timely protective action for current and future participants.
Which document specifically governs protections for children as research subjects under HHS regulations?
Answer: 45 CFR 46 Subpart D
45 CFR 46 Subpart D provides additional protections for children involved as subjects in HHS-conducted or -supported research.
A subject advocate is reviewing a consent form. Which readability standard is most commonly recommended for research consent documents?
Answer: Sixth to eighth grade reading level
Regulatory guidance and best practice recommend writing consent documents at a sixth to eighth grade reading level to maximize participant comprehension.