CRA Regulatory Compliance & Licensing 3

Question 1

A foreign national researcher joins a federally funded project involving export-controlled technology. What must the research administrator assess first?

Accepted Answer

Whether a deemed export license is required

Answer

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)?

Accepted Answer

8% of modified total direct costs

Answer

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?

Accepted Answer

The Public Health Service Act as amended (42 CFR Part 93)

Answer

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?

Accepted Answer

A Federalwide Assurance (FWA) committing the institution to follow 45 CFR Part 46

Answer

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?

Accepted Answer

Within 60 days of identification

Answer

Under 42 CFR Part 50 Subpart F, institutions must report identified FCOIs to NIH within 60 days and implement a management plan.

(CRA) Certified Research Administrator Practice Test

(CRA) Certified Research Administrator Practice Test

CRA Regulatory Compliance & Licensing 3