Ethics & Professional Standards 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 Ethics & Professional Standards flashcards as text
The principle of 'justice' in the Belmont Report specifically addresses which research concern?
Answer: Fair distribution of research benefits and burdens across populations
Justice requires equitable selection of subjects so that no group bears a disproportionate share of research burdens or is excluded from benefits.
A participant with mild cognitive impairment wishes to enroll in a clinical trial. Which approach best satisfies ethical requirements?
Answer: Assess decision-making capacity individually and involve a legally authorized representative if needed
Capacity must be assessed individually; participants who retain sufficient capacity should consent themselves, with a LAR involved if capacity is insufficient.
Which FDA regulation governs IRB standards and requirements for research involving human subjects?
Answer: 21 CFR Part 56
21 CFR Part 56 establishes FDA requirements for IRB composition, operations, and review functions.
In a double-blind randomized controlled trial, an investigator unblinding data for personal review of outcomes before trial completion is:
Answer: A serious protocol deviation that could bias results and must be reported
Unauthorized unblinding compromises study integrity, introduces bias, and constitutes a protocol deviation requiring immediate reporting.
Which element is NOT required in a federally compliant informed consent document under 21 CFR Part 50?
Answer: Guarantee that the participant will receive the experimental treatment
Consent documents cannot guarantee receipt of experimental treatment; randomization and blinding mean assignment is uncertain.
A sponsor asks the PI to omit negative safety findings from the final study report. The PI's ethical obligation is to:
Answer: Report all findings accurately, including negative results, regardless of sponsor pressure
Selective reporting of results is research misconduct; investigators must ensure complete and accurate reporting of all findings.
Under GCP, what must an investigator do before enrolling the first participant in a clinical trial?
Answer: Secure IRB/IEC approval and all required regulatory authorizations
No participant may be enrolled until the IRB/IEC has granted written approval and all applicable regulatory requirements are met.