CRA Ethical & Legal Considerations 2 — Questions and Answers
Question 1: A researcher discovers mid-study that a participant is experiencing an unexpected serious adverse event. What is the FIRST obligation?
- Complete the scheduled data collection before reporting
- Immediately report to the IRB and sponsor and ensure participant safety (Correct answer)
- Wait until the next scheduled monitoring visit to document
- Inform only the principal investigator and take no further action
Correct 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.
Question 2: Which federal regulation specifically governs the protection of human subjects in research funded by U.S. federal agencies?
- 21 CFR Part 50
- 45 CFR Part 46 (The Common Rule) (Correct answer)
- ICH E6 GCP Guidelines
- The Belmont Report
Correct 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.
Question 3: When must a researcher obtain a Certificate of Confidentiality (CoC) for a study?
- Only when the study involves minors
- When sensitive data collection could expose participants to legal risks if disclosed (Correct answer)
- Whenever a study receives NIH funding regardless of topic
- Only when participants explicitly request one
Correct 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.
Question 4: A sponsor asks a CRA to backdate a source document to align with the protocol timeline. The CRA should:
- Comply if the discrepancy is minor and won't affect outcomes
- Refuse and report the request as a potential GCP violation (Correct answer)
- Ask the investigator to decide whether to comply
- Backdate only if the site also agrees
Correct 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.
Question 5: Which principle from the Belmont Report requires researchers to maximize benefits and minimize harms to participants?
- Respect for Persons
- Justice
- Beneficence (Correct answer)
- Nonmaleficence
Correct answer: Beneficence
Beneficence obligates researchers to actively protect participants from harm while maximizing potential benefits.
Question 6: A study site loses a laptop containing unencrypted participant data. Under HIPAA, the covered entity must notify affected individuals within:
- 30 days of discovery
- 60 days of discovery (Correct answer)
- 90 days of discovery
- 180 days of discovery
Correct 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.
Question 7: An IRB grants expedited review to a study. This means the research involves:
- No more than minimal risk and fits an approved category (Correct answer)
- Significant risk but high scientific value
- Vulnerable populations requiring extra protection
- Previously approved protocols requiring only minor changes
Correct 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.
CRA Ethical & Legal Considerations 2
A researcher discovers mid-study that a participant is experiencing an unexpected serious adverse event.
What is the FIRST obligation?