CPI Ethics & Professional Standards 3

Question 1

The principle of 'justice' in the Belmont Report specifically addresses which research concern?

Accepted Answer

Fair distribution of research benefits and burdens across populations

Answer

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?

Accepted Answer

Assess decision-making capacity individually and involve a legally authorized representative if needed

Answer

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?

Accepted Answer

21 CFR Part 56

Answer

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:

Accepted Answer

A serious protocol deviation that could bias results and must be reported

Answer

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?

Accepted Answer

Guarantee that the participant will receive the experimental treatment

Answer

Consent documents cannot guarantee receipt of experimental treatment; randomization and blinding mean assignment is uncertain.

(CPI) Certified Physician Investigator Practice Test

(CPI) Certified Physician Investigator Practice Test

CPI Ethics & Professional Standards 3