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
Which scenario would most clearly require convening a full IRB board review rather than expedited review?
Answer: A Phase III trial of an investigational cancer chemotherapy
Phase III chemotherapy trials involve more than minimal risk and must receive full board review by the IRB.
The concept of 'therapeutic misconception' in clinical research refers to:
Answer: Participants mistakenly believing that research procedures are designed primarily for their personal benefit
Therapeutic misconception occurs when participants conflate clinical care with research, undermining truly informed consent.
A CPI conducting a multi-site trial receives pressure from the coordinating center to accelerate enrollment beyond what is safely manageable at the site. The appropriate response is to:
Answer: Refuse to exceed safe enrollment capacity and communicate site limitations to the coordinating center
Investigator obligations to participant safety supersede sponsor enrollment pressures, and site limitations must be communicated honestly.
Which of the following best describes the researcher's obligation under the 'respect for persons' principle when enrolling prisoners?
Answer: Enrollment requires additional safeguards because incarceration may compromise voluntariness
Prisoners are a protected class because coercive institutional settings threaten voluntariness, requiring enhanced IRB scrutiny per 45 CFR 46 Subpart C.
What is the primary purpose of a Data Safety Monitoring Board (DSMB) in a clinical trial?
Answer: To monitor accumulating data and protect participant safety, recommending early stopping if needed
A DSMB conducts interim analyses of unblinded data to identify safety signals or clear efficacy, with authority to recommend stopping or modifying a trial.
An investigator receives a gift from a pharmaceutical company valued at $500 for speaking at a company-sponsored dinner. What is the most appropriate ethical action?
Answer: Disclose it to the institution and IRB per conflict-of-interest policies
Financial relationships with sponsors, however small, must be disclosed per institutional conflict-of-interest policies to maintain research integrity.
Under ICH E6(R2), which of the following is the investigator's responsibility regarding delegation of trial-related duties?
Answer: Investigators must maintain a delegation log listing qualified personnel and their assigned responsibilities
ICH E6(R2) requires investigators to maintain a delegation log documenting which qualified staff members have been assigned specific trial tasks.