CPI Ethics & Professional Standards 3 — Questions and Answers
Question 1: The principle of 'justice' in the Belmont Report specifically addresses which research concern?
- Ensuring informed consent is properly documented
- Fair distribution of research benefits and burdens across populations (Correct answer)
- Minimizing physical risk to participants
- Maintaining confidentiality of participant data
Correct 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.
Question 2: A participant with mild cognitive impairment wishes to enroll in a clinical trial. Which approach best satisfies ethical requirements?
- Exclude the participant automatically due to impaired cognition
- Assess decision-making capacity individually and involve a legally authorized representative if needed (Correct answer)
- Enroll the participant using only surrogate consent without assessing personal capacity
- Obtain verbal consent only, as written consent may be confusing
Correct 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.
Question 3: Which FDA regulation governs IRB standards and requirements for research involving human subjects?
- 21 CFR Part 50
- 21 CFR Part 56 (Correct answer)
- 21 CFR Part 312
- 45 CFR Part 46
Correct answer: 21 CFR Part 56
21 CFR Part 56 establishes FDA requirements for IRB composition, operations, and review functions.
Question 4: In a double-blind randomized controlled trial, an investigator unblinding data for personal review of outcomes before trial completion is:
- Acceptable if the investigator is also a treating physician
- Permissible when fewer than 10% of subjects remain enrolled
- A serious protocol deviation that could bias results and must be reported (Correct answer)
- Standard practice for quality assurance purposes
Correct 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.
Question 5: Which element is NOT required in a federally compliant informed consent document under 21 CFR Part 50?
- A statement that participation is voluntary
- Description of foreseeable risks and discomforts
- Guarantee that the participant will receive the experimental treatment (Correct answer)
- An explanation of the purposes of the research
Correct 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.
Question 6: A sponsor asks the PI to omit negative safety findings from the final study report. The PI's ethical obligation is to:
- Comply if the sponsor provides a scientific rationale
- Report all findings accurately, including negative results, regardless of sponsor pressure (Correct answer)
- Submit a modified report to the IRB and the complete report privately to the FDA
- Seek a third investigator's opinion before deciding
Correct 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.
Question 7: Under GCP, what must an investigator do before enrolling the first participant in a clinical trial?
- Obtain only sponsor approval
- Secure IRB/IEC approval and all required regulatory authorizations (Correct answer)
- Complete enrollment of a pilot cohort without IRB review
- Submit a post-marketing surveillance plan
Correct 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.
CPI Ethics & Professional Standards 3
The principle of 'justice' in the Belmont Report specifically addresses which research concern?