CRA Regulatory Compliance and Ethics 2 — Questions and Answers
Question 1: Under 45 CFR Part 46, which category of research qualifies for exemption from full IRB review when involving educational tests, surveys, or interviews with adults?
- Research where disclosure could place subjects at risk of criminal liability
- Research involving only benign behavioral interventions with no identifiable data (Correct answer)
- Research collecting identifiable private information about sensitive topics
- Research involving deception without debriefing procedures
Correct answer: Research involving only benign behavioral interventions with no identifiable data
Exemption Category 3 covers benign behavioral interventions with no reasonably anticipated risks, where data is not identifiable or disclosure would not harm subjects.
Question 2: The Bayh-Dole Act of 1980 primarily governs which aspect of federally funded research?
- Human subjects protections in clinical trials
- Export controls on dual-use research findings
- Ownership and commercialization of inventions arising from federal funding (Correct answer)
- Financial conflict of interest disclosure requirements
Correct answer: Ownership and commercialization of inventions arising from federal funding
Bayh-Dole allows universities and small businesses to retain title to inventions made with federal funding and encourages commercialization through technology transfer.
Question 3: A researcher submits a progress report to NIH that omits a significant adverse event that occurred during the study period. This is best characterized as:
- An administrative oversight requiring a corrective action plan
- Research misconduct under the category of falsification (Correct answer)
- A protocol deviation subject to IRB notification only
- A minor compliance issue handled by departmental review
Correct answer: Research misconduct under the category of falsification
Omitting a significant adverse event from a required federal report constitutes falsification of research records, which is a form of research misconduct under federal policy.
Question 4: Which federal office is responsible for investigating allegations of research misconduct in PHS-funded research?
- Office for Human Research Protections (OHRP)
- Office of Research Integrity (ORI) (Correct answer)
- Office of Inspector General (OIG)
- National Science Foundation Office of Inspector General
Correct answer: Office of Research Integrity (ORI)
The Office of Research Integrity (ORI) oversees and monitors research misconduct investigations at institutions receiving PHS funding.
Question 5: An institution's FCOI policy must require investigators to disclose significant financial interests that could be affected by PHS-funded research. What is the threshold dollar amount triggering disclosure?
- $1,000 in aggregate over the prior 12 months
- $5,000 in aggregate over the prior 12 months (Correct answer)
- $10,000 in aggregate over the prior 12 months
- $25,000 in aggregate over the prior 12 months
Correct answer: $5,000 in aggregate over the prior 12 months
Under 42 CFR Part 50 and 45 CFR Part 94, investigators must disclose significant financial interests exceeding $5,000 in aggregate over the prior 12 months.
Question 6: When a sponsor-investigator holds an IND, who bears primary regulatory responsibility for the conduct of the clinical investigation?
- The IRB that approved the study protocol
- The institution's research compliance office
- The sponsor-investigator themselves (Correct answer)
- The FDA division overseeing the application
Correct answer: The sponsor-investigator themselves
A sponsor-investigator combines both sponsor and investigator responsibilities under 21 CFR Parts 312 and 50, making them solely responsible for regulatory compliance.
Question 7: The principle of 'respect for persons' in the Belmont Report requires researchers to:
- Minimize risks and maximize potential benefits to subjects
- Treat all subjects equally regardless of vulnerability
- Acknowledge the autonomy of individuals and protect those with diminished autonomy (Correct answer)
- Distribute research benefits and burdens fairly across populations
Correct answer: Acknowledge the autonomy of individuals and protect those with diminished autonomy
Respect for persons encompasses both recognizing individual autonomy and providing additional protections for persons with diminished autonomy, such as children or cognitively impaired adults.
CRA Regulatory Compliance and Ethics 2
Under 45 CFR Part 46, which category of research qualifies for exemption from full IRB review when involving educational tests, surveys, or interviews with adults?