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Research Ethics & Compliance Flashcards

7 cards from real CPI practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

Read the first 7 Research Ethics & Compliance flashcards as text

  1. A researcher discovers mid-study that a participant is experiencing an unanticipated serious adverse event. What is the FIRST required action?

    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.

  2. Under 45 CFR 46, which of the following research populations requires additional protections beyond the Basic Policy?

    Answer: Prisoners as research subjects

    Subpart C of 45 CFR 46 provides additional federal protections specifically for prisoners involved in research.

  3. What does the principle of 'justice' in the Belmont Report primarily require researchers to do?

    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.

  4. A PI wants to conduct a telephone survey on dietary habits with no sensitive questions. Which IRB review category most likely applies?

    Answer: Exempt review

    Survey research involving no sensitive topics and no identifiable data typically qualifies for exempt status under 45 CFR 46.104(d).

  5. What is the primary purpose of a Data Safety Monitoring Board (DSMB) in a clinical trial?

    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.

  6. A researcher retains identified data beyond the approved retention period without IRB authorization. This is an example of:

    Answer: Non-compliance with IRB requirements

    Retaining data beyond the approved period without authorization constitutes non-compliance with IRB-approved protocol terms.

  7. When a minor reaches the age of majority during a longitudinal study, what must the PI obtain?

    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.