CRA Regulatory Compliance & Licensing 2

Question 1

Under the Bayh-Dole Act, what must a contractor do if it decides not to retain title to a federally funded invention?

Accepted Answer

Notify the federal agency and allow the government to obtain title

Answer

If a contractor elects not to retain title, it must notify the funding agency, which then has the right to obtain patent rights.

Question 2

Which federal regulation governs the export of controlled biological agents and select agents for research purposes?

Accepted Answer

Select Agent Program (42 CFR Part 73)

Answer

The Select Agent Program under 42 CFR Part 73 regulates possession, use, and transfer of biological select agents and toxins.

Question 3

A researcher wants to conduct a clinical trial at a VA medical center. Which additional regulatory requirement applies beyond standard IRB approval?

Accepted Answer

VA Research and Development Committee approval

Answer

VA regulations require VA R&D Committee approval for all research conducted at VA facilities, in addition to IRB approval.

Question 4

What is the primary purpose of the System for Award Management (SAM) registration requirement for federal grant recipients?

Accepted Answer

To establish eligibility to receive federal awards and report subaward data

Answer

SAM registration is required to receive federal awards and to comply with Federal Funding Accountability and Transparency Act (FFATA) reporting obligations.

Question 5

Under 45 CFR Part 46, which category of research with children qualifies for expedited review involving greater than minimal risk but presenting the prospect of direct benefit?

Accepted Answer

46.405

Answer

45 CFR 46.405 covers research involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects.

(CRA) Certified Research Administrator Practice Test

(CRA) Certified Research Administrator Practice Test

CRA Regulatory Compliance & Licensing 2