Ethical & Legal Considerations Flashcards
7 cards from real CRA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Ethical & Legal Considerations flashcards as text
A participant in a longitudinal study becomes legally incapacitated after enrolling. What happens to their continued participation?
Answer: A legally authorized representative may provide consent to continue
When a participant loses decision-making capacity, a legally authorized representative (LAR) must provide surrogate consent for continued participation.
Which scenario constitutes a conflict of interest that a researcher must disclose?
Answer: Having a financial interest in the sponsor company funding the study
A direct financial interest in the sponsoring company creates a conflict of interest that must be disclosed to the IRB and institution.
The principle of 'justice' in the Belmont Report primarily addresses:
Answer: Fair distribution of research benefits and burdens across populations
Justice requires that the selection of research subjects be fair and that no group bears a disproportionate burden of research risks.
A CRA reviewing source documents finds that a laboratory value was changed without an explanation or audit trail. This is an example of:
Answer: Data falsification, a form of research misconduct
Altering data without documentation or justification constitutes data falsification, a serious form of research misconduct.
Under 21 CFR Part 50, which of the following is NOT a required element of informed consent?
Answer: The name of the IRB chairperson
The eight basic elements of informed consent do not include identifying the IRB chairperson by name.
A participant asks to withdraw from a study but wants to keep their data in the analysis. The researcher should:
Answer: Honor the request since consent allows data retention if desired
Participants may withdraw from further participation while allowing already-collected data to remain in the analysis, and researchers should honor this preference.
Which FDA regulation governs financial disclosure requirements for clinical investigators?
Answer: 21 CFR Part 54
21 CFR Part 54 requires sponsors to certify or disclose financial interests of clinical investigators to the FDA.