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
A participant in a pain management trial tells the investigator they want to join because they are desperate and have no other treatment options. This situation raises concern primarily about:
Answer: Voluntariness of consent due to therapeutic desperation
Therapeutic desperation can compromise the voluntariness required for valid informed consent, as participants may feel coerced by lack of alternatives.
Which action by a CPI constitutes research fraud under federal regulations?
Answer: Intentionally falsifying source documents to match case report forms
Falsifying source documents is research fraud, violating FDA regulations, GCP, and professional ethical standards.
When an investigational drug shows unexpectedly strong efficacy during an interim analysis, stopping the trial early is governed by:
Answer: Pre-specified stopping rules established in the statistical analysis plan
Pre-specified stopping rules in the statistical analysis plan ensure that early stopping decisions are based on rigorous, unbiased criteria.
Which of the following populations requires a legally authorized representative (LAR) for informed consent in research?
Answer: Adults who have been adjudicated as lacking decision-making capacity
Adults lacking legal decision-making capacity require consent from a legally authorized representative per applicable state law and federal regulations.
A Phase I oncology trial discloses a 1-in-10 risk of severe neutropenia. A potential participant, who is an oncologist, signs consent after review. Under ethical standards, this consent is:
Answer: Valid if the participant demonstrated understanding and signed voluntarily
Consent is valid when the participant is competent, adequately informed, and signs voluntarily, regardless of their professional background.
The Tuskegee Syphilis Study's primary ethical failure was:
Answer: Deliberately withholding effective treatment from infected participants without their knowledge
After penicillin became the standard of care, investigators continued withholding treatment to observe disease progression, violating beneficence and respect for persons.
Which of the following best describes the investigator's responsibility when new safety information emerges that could affect a participant's willingness to continue?
Answer: Promptly re-consent participants by providing updated information about the new risks
When material new safety information arises during a trial, investigators must promptly re-consent participants to allow informed decisions about continued participation.