CRA Regulatory Compliance & Licensing 2 — Questions and Answers
Question 1: Under the Bayh-Dole Act, what must a contractor do if it decides not to retain title to a federally funded invention?
- Destroy all records related to the invention
- Notify the federal agency and allow the government to obtain title (Correct answer)
- License the invention exclusively to a domestic entity
- Publish the invention details within 60 days
Correct answer: Notify the federal agency and allow the government to obtain title
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?
- ITAR (International Traffic in Arms Regulations)
- EAR (Export Administration Regulations)
- Select Agent Program (42 CFR Part 73) (Correct answer)
- HIPAA Privacy Rule
Correct answer: Select Agent Program (42 CFR Part 73)
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?
- FDA pre-investigational new drug application
- VA Research and Development Committee approval (Correct answer)
- NIH Special Emphasis Panel review
- State medical board certification
Correct answer: VA Research and Development Committee approval
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?
- To verify institutional tax-exempt status
- To establish eligibility to receive federal awards and report subaward data (Correct answer)
- To register intellectual property with the federal government
- To certify compliance with the Davis-Bacon Act
Correct answer: To establish eligibility to receive federal awards and report subaward data
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?
- 46.404
- 46.405 (Correct answer)
- 46.406
- 46.407
Correct answer: 46.405
45 CFR 46.405 covers research involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects.
Question 6: A university receives a federal grant for research on a dual-use research of concern (DURC) pathogen. What additional oversight is required?
- OSHA Biosafety Committee approval only
- Institutional Review Entity (IRE) review and an Institutional Biosafety Committee assessment (Correct answer)
- FDA Investigational New Drug exemption
- DOD Special Access Program clearance
Correct answer: Institutional Review Entity (IRE) review and an Institutional Biosafety Committee assessment
DURC policy requires institutions to establish an Institutional Review Entity and conduct biosafety risk assessments for covered research.
Question 7: Which provision of the Federal Acquisition Regulation (FAR) requires contractors to disclose and manage organizational conflicts of interest?
- FAR 52.203-13
- FAR 9.5 (Correct answer)
- FAR 31.201-2
- FAR 52.215-2
Correct answer: FAR 9.5
FAR Subpart 9.5 addresses organizational conflicts of interest and requires agencies to identify, evaluate, and mitigate such conflicts.
CRA Regulatory Compliance & Licensing 2
Under the Bayh-Dole Act, what must a contractor do if it decides not to retain title to a federally funded invention?