CRA Resident Rights & Advocacy 3 — Questions and Answers
Question 1: Under HIPAA, which authorization element must be included when research involves use of protected health information (PHI)?
- An expiration date or event for the authorization (Correct answer)
- The subject's Social Security number for identification purposes
- IRB chair's personal signature on each authorization form
- The sponsor's agreement to indemnify subjects for data breaches
Correct 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.
Question 2: A research participant who is a prisoner is considered a vulnerable population primarily because of concerns about which ethical issue?
- Compromised voluntariness due to institutional coercion (Correct answer)
- Inability to understand complex research protocols
- Lack of legal standing to sign consent documents
- Automatic disqualification from minimal-risk research
Correct 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.
Question 3: Which type of IRB review is appropriate for research involving no more than minimal risk that uses educational tests or survey procedures?
- Expedited review
- Full board review
- Exempt determination (Correct answer)
- Continuing review waiver
Correct 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.
Question 4: What is the primary purpose of a Data Safety Monitoring Board (DSMB) in protecting research participants?
- To conduct interim reviews of accumulating data and recommend stopping or modifying a trial if safety concerns arise (Correct answer)
- To audit financial disclosures of principal investigators
- To verify that all participants have signed informed consent
- To approve the final statistical analysis plan after data lock
Correct 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.
Question 5: When must an investigator report an unanticipated problem involving risk to participants to the IRB?
- As soon as possible following the investigator's awareness of the problem (Correct answer)
- Only at the time of scheduled annual continuing review
- Within 90 days as required by FDA regulations
- At the conclusion of the study in the final report
Correct 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.
Question 6: Which document specifically governs protections for children as research subjects under HHS regulations?
- 45 CFR 46 Subpart D (Correct answer)
- 45 CFR 46 Subpart B
- 21 CFR Part 50 Subpart C
- ICH E6 Good Clinical Practice guideline
Correct 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.
Question 7: A subject advocate is reviewing a consent form. Which readability standard is most commonly recommended for research consent documents?
- Sixth to eighth grade reading level (Correct answer)
- College sophomore reading level
- Twelfth grade reading level
- Graduate school reading level for complex trials
Correct 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.
CRA Resident Rights & Advocacy 3
Under HIPAA, which authorization element must be included when research involves use of protected health information (PHI)?