CRA Regulatory Compliance & Licensing 3 — Questions and Answers
Question 1: A foreign national researcher joins a federally funded project involving export-controlled technology. What must the research administrator assess first?
- The researcher's visa expiration date
- Whether a deemed export license is required (Correct answer)
- The researcher's publication history
- Whether the researcher holds dual citizenship
Correct answer: Whether a deemed export license is required
Sharing export-controlled technology with a foreign national in the U.S. is a 'deemed export' and may require an EAR or ITAR license.
Question 2: Under the NIH Grants Policy Statement, what is the maximum allowable indirect cost rate on training grants (T and F series)?
- The institution's negotiated F&A rate
- 8% of modified total direct costs (Correct answer)
- 26% of total direct costs
- Zero — indirect costs are not allowed
Correct answer: 8% of modified total direct costs
NIH caps indirect costs on training grants at 8% of modified total direct costs, regardless of the institution's negotiated rate.
Question 3: Which federal law established the requirement for research institutions receiving PHS funding to have written policies on research misconduct?
- The Stevenson-Wydler Technology Innovation Act
- The Public Health Service Act as amended (42 CFR Part 93) (Correct answer)
- The Federal Grant and Cooperative Agreement Act
- The National Research Act of 1974
Correct answer: The Public Health Service Act as amended (42 CFR Part 93)
42 CFR Part 93 implements PHS research misconduct regulations requiring institutions to have policies, procedures, and reporting requirements.
Question 4: What does 'assurance' refer to in the context of human subjects research compliance at a federally funded institution?
- A financial guarantee provided to grant sponsors
- A Federalwide Assurance (FWA) committing the institution to follow 45 CFR Part 46 (Correct answer)
- A certification that all researchers completed CITI training
- An IRB approval letter for a specific protocol
Correct answer: A Federalwide Assurance (FWA) committing the institution to follow 45 CFR Part 46
A Federalwide Assurance is a formal institutional commitment to OHRP to follow federal human subjects protections for all research.
Question 5: An institution discovers a significant financial conflict of interest (FCOI) on an active NIH grant mid-project. What is the required timeline for reporting to NIH?
- Within 30 days of identification
- Within 60 days of identification (Correct answer)
- At the next annual progress report
- Before the next competing renewal
Correct answer: Within 60 days of identification
Under 42 CFR Part 50 Subpart F, institutions must report identified FCOIs to NIH within 60 days and implement a management plan.
Question 6: Which of the following activities is specifically exempt from IACUC review under the Animal Welfare Act?
- Surgical procedures on rats
- Field studies of free-living wild animals that do not involve harm, deprivation, or stress (Correct answer)
- Behavioral studies involving food deprivation in mice
- Breeding studies for genetically modified mice
Correct answer: Field studies of free-living wild animals that do not involve harm, deprivation, or stress
The Animal Welfare Act exempts field studies of free-living wild animals where the research does not involve invasive procedures or captivity.
Question 7: Under Uniform Guidance 2 CFR 200, what is the threshold above which a non-Federal entity must have a single audit conducted?
- $500,000 in federal expenditures
- $750,000 in federal expenditures (Correct answer)
- $1,000,000 in federal expenditures
- $250,000 in federal expenditures
Correct answer: $750,000 in federal expenditures
2 CFR 200.501 requires a single audit for non-Federal entities that expend $750,000 or more in federal awards during a fiscal year.
CRA Regulatory Compliance & Licensing 3
A foreign national researcher joins a federally funded project involving export-controlled technology.
What must the research administrator assess first?