CPI Ethics & Professional Standards 2

Question 1

When a research participant withdraws consent mid-trial, what is the investigator's primary obligation?

Accepted Answer

Stop participation immediately and retain only already-collected data per protocol

Answer

Withdrawal must be honored immediately, but data already lawfully collected may be retained as specified in the IRB-approved protocol.

Question 2

Which ethical principle primarily guides the requirement that research risks must be minimized and justified by anticipated benefits?

Accepted Answer

Beneficence

Answer

Beneficence obligates investigators to maximize benefits and minimize harms, requiring a favorable risk-benefit ratio.

Question 3

An investigator discovers a serious, unexpected adverse event. Under FDA regulations, the sponsor must report it to the FDA within:

Accepted Answer

7 calendar days if fatal or life-threatening; 15 calendar days for others

Answer

FDA 21 CFR 312.32 requires 7-calendar-day reporting for fatal/life-threatening unexpected SAEs and 15-calendar-day reporting for other unexpected serious adverse events.

Question 4

Which document outlines the globally accepted ethical principles for conducting research involving human subjects that emerged from the Nuremberg trials?

Accepted Answer

Nuremberg Code

Answer

The Nuremberg Code (1947) established foundational ethical principles for human experimentation, including voluntary consent, after Nazi war crimes.

Question 5

A CPI learns that a colleague has fabricated patient data in a clinical trial. What is the most appropriate immediate action?

Accepted Answer

Report the misconduct to the IRB, sponsor, and relevant institutional authorities

Answer

Research misconduct must be reported to protect participants and the integrity of science; self-correction by the offending party is insufficient.

(CPI) Certified Physician Investigator Practice Test

(CPI) Certified Physician Investigator Practice Test

CPI Ethics & Professional Standards 2