CPI Research Ethics & Compliance 2 — Questions and Answers
Question 1: A researcher discovers mid-study that a participant is experiencing an unanticipated serious adverse event. What is the FIRST required action?
- Complete the study visit before reporting
- Report immediately to the IRB and sponsor per protocol (Correct answer)
- Wait to see if the event resolves on its own
- Notify the participant's personal physician only
Correct answer: Report immediately to the IRB and sponsor per protocol
Unanticipated problems involving risks to participants must be reported promptly to the IRB and sponsor as required by federal regulations.
Question 2: Under 45 CFR 46, which of the following research populations requires additional protections beyond the Basic Policy?
- Graduate student volunteers
- Prisoners as research subjects (Correct answer)
- Healthy adult employees
- Retired military veterans
Correct answer: Prisoners as research subjects
Subpart C of 45 CFR 46 provides additional federal protections specifically for prisoners involved in research.
Question 3: What does the principle of 'justice' in the Belmont Report primarily require researchers to do?
- Maximize benefits to individual participants
- Distribute research burdens and benefits fairly across society (Correct answer)
- Obtain written informed consent from all participants
- Minimize psychological risks during procedures
Correct answer: Distribute research burdens and benefits fairly across society
Justice requires equitable selection of subjects so that vulnerable populations are not exploited and benefits are distributed fairly.
Question 4: A PI wants to conduct a telephone survey on dietary habits with no sensitive questions. Which IRB review category most likely applies?
- Full board review
- Expedited review
- Exempt review (Correct answer)
- Emergency use authorization
Correct answer: Exempt review
Survey research involving no sensitive topics and no identifiable data typically qualifies for exempt status under 45 CFR 46.104(d).
Question 5: What is the primary purpose of a Data Safety Monitoring Board (DSMB) in a clinical trial?
- To approve the study budget
- To independently monitor accumulating data and safeguard participant safety (Correct answer)
- To recruit participants for the study
- To audit the sponsor's financial disclosures
Correct answer: To independently monitor accumulating data and safeguard participant safety
A DSMB independently reviews interim data to protect participant safety and ensure the trial's continued validity.
Question 6: A researcher retains identified data beyond the approved retention period without IRB authorization. This is an example of:
- Acceptable protocol deviation
- Non-compliance with IRB requirements (Correct answer)
- Standard data management practice
- Exempt research modification
Correct answer: Non-compliance with IRB requirements
Retaining data beyond the approved period without authorization constitutes non-compliance with IRB-approved protocol terms.
Question 7: When a minor reaches the age of majority during a longitudinal study, what must the PI obtain?
- Parental re-consent for the new adult participant
- Full informed consent from the now-adult participant (Correct answer)
- IRB waiver to continue without any new consent
- Sponsor approval to reclassify the participant
Correct answer: Full informed consent from the now-adult participant
Once a minor becomes an adult, the study must obtain the participant's own independent informed consent to continue their involvement.
CPI Research Ethics & Compliance 2
A researcher discovers mid-study that a participant is experiencing an unanticipated serious adverse event.
What is the FIRST required action?