CPI Ethics & Professional Standards 2 — Questions and Answers
Question 1: When a research participant withdraws consent mid-trial, what is the investigator's primary obligation?
- Continue data collection until the current study phase ends
- Stop participation immediately and retain only already-collected data per protocol (Correct answer)
- Destroy all previously collected data at once
- Require a 30-day cooling-off period before honoring the withdrawal
Correct answer: Stop participation immediately and retain only already-collected data per protocol
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?
- Respect for Persons
- Justice
- Beneficence (Correct answer)
- Veracity
Correct answer: Beneficence
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:
- 7 calendar days if fatal or life-threatening; 15 calendar days for others (Correct answer)
- 24 hours for all serious adverse events regardless of severity
- 30 calendar days for all unexpected serious adverse events
- 15 calendar days only if the event results in hospitalization
Correct answer: 7 calendar days if fatal or life-threatening; 15 calendar days for others
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?
- Declaration of Helsinki
- Belmont Report
- Nuremberg Code (Correct answer)
- Common Rule (45 CFR 46)
Correct answer: Nuremberg Code
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?
- Confront the colleague privately and give them time to self-correct
- Report the misconduct to the IRB, sponsor, and relevant institutional authorities (Correct answer)
- Ignore it if the overall study data appear valid
- Withdraw from the trial without informing anyone to avoid conflict
Correct answer: Report the misconduct to the IRB, sponsor, and relevant institutional authorities
Research misconduct must be reported to protect participants and the integrity of science; self-correction by the offending party is insufficient.
Question 6: Under ICH E6(R2) GCP, the investigator's primary responsibility regarding protocol deviations is to:
- Document all deviations and notify the IRB/ethics committee and sponsor as required (Correct answer)
- Correct the deviation quietly without documentation to avoid regulatory scrutiny
- Obtain post-hoc approval from only the sponsor, not the IRB
- Halt the entire study pending a full regulatory audit
Correct answer: Document all deviations and notify the IRB/ethics committee and sponsor as required
ICH E6(R2) requires investigators to document protocol deviations promptly and report them per sponsor and IRB requirements.
Question 7: Which scenario best illustrates a conflict of interest for a physician investigator?
- Being the principal investigator for a drug manufactured by a company in which the PI holds significant equity (Correct answer)
- Having a co-investigator who is a former colleague
- Conducting research at an academic medical center
- Publishing results in a peer-reviewed journal with an open-access fee
Correct answer: Being the principal investigator for a drug manufactured by a company in which the PI holds significant equity
Financial interests in a sponsor company can bias study conduct or reporting, constituting a conflict of interest that must be disclosed.
CPI Ethics & Professional Standards 2
When a research participant withdraws consent mid-trial, what is the investigator's primary obligation?