CRA Regulatory Compliance and Ethics 2

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?

Accepted Answer

Research involving only benign behavioral interventions with no identifiable data

Answer

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?

Accepted Answer

Ownership and commercialization of inventions arising from federal funding

Answer

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:

Accepted Answer

Research misconduct under the category of falsification

Answer

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?

Accepted Answer

Office of Research Integrity (ORI)

Answer

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?

Accepted Answer

$5,000 in aggregate over the prior 12 months

Answer

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.

(CRA) Certified Research Administrator Practice Test

(CRA) Certified Research Administrator Practice Test

CRA Regulatory Compliance and Ethics 2