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 researcher discovers mid-study that a participant is experiencing an unexpected serious adverse event. What is the FIRST obligation?
Answer: Immediately report to the IRB and sponsor and ensure participant safety
Serious adverse events must be reported immediately to protect participant safety and comply with federal regulations.
Which federal regulation specifically governs the protection of human subjects in research funded by U.S. federal agencies?
Answer: 45 CFR Part 46 (The Common Rule)
45 CFR Part 46, known as the Common Rule, is the primary federal regulation protecting human research subjects.
When must a researcher obtain a Certificate of Confidentiality (CoC) for a study?
Answer: When sensitive data collection could expose participants to legal risks if disclosed
A CoC protects researchers from being compelled to disclose identifiable sensitive research information in legal proceedings.
A sponsor asks a CRA to backdate a source document to align with the protocol timeline. The CRA should:
Answer: Refuse and report the request as a potential GCP violation
Backdating documents constitutes data fraud; CRAs must refuse and escalate such requests per GCP guidelines.
Which principle from the Belmont Report requires researchers to maximize benefits and minimize harms to participants?
Answer: Beneficence
Beneficence obligates researchers to actively protect participants from harm while maximizing potential benefits.
A study site loses a laptop containing unencrypted participant data. Under HIPAA, the covered entity must notify affected individuals within:
Answer: 60 days of discovery
The HIPAA Breach Notification Rule requires notification to affected individuals no later than 60 days after discovery of a breach.
An IRB grants expedited review to a study. This means the research involves:
Answer: No more than minimal risk and fits an approved category
Expedited review applies to research involving no more than minimal risk that falls within specific federally approved categories.