Regulatory Compliance and Ethics Flashcards
7 cards from real CRA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Regulatory Compliance and Ethics flashcards as text
A university discovers that a PI has been charging personal travel expenses to a federal grant for two years. Under 2 CFR Part 200.405, this is an example of:
Answer: An unallowable cost that must be removed and may trigger audit findings
Personal expenses are explicitly unallowable under 2 CFR Part 200.405 and the cost principles; they must be removed from the federal award and repaid.
The term 'engaged in research' under OHRP guidance means an institution is engaged when its employees or agents:
Answer: Obtain data specifically for the research from living individuals through intervention or interaction
OHRP defines engagement as occurring when an institution's employees or agents obtain data through intervention or interaction with subjects, or obtain identifiable private information for research purposes.
In a multi-site clinical trial, Site B relies on Site A's IRB as the IRB of record. If the study is suspended at Site A due to safety concerns, what must Site B do?
Answer: Immediately suspend enrollment and await guidance from the reviewing IRB
When the IRB of record suspends a study, all relying sites must follow the same suspension because they operate under that IRB's authority.
A researcher wants to use a Limited Dataset (as defined under HIPAA) for research without obtaining individual authorization. What is required?
Answer: A Data Use Agreement and IRB waiver of authorization or exempt determination
A Limited Dataset still contains some indirect identifiers, so HIPAA requires a Data Use Agreement, and the researcher must also address IRB requirements for human subjects research.
Under OMB Circular A-133 (now superseded by 2 CFR Part 200 Subpart F), the threshold for a single audit has been updated to:
Answer: $750,000 in federal expenditures per fiscal year
The 2 CFR Part 200 Subpart F raises the single audit threshold to $750,000 in federal expenditures per fiscal year, up from the former $500,000 under A-133.
Which of the following actions by a research administrator would constitute a conflict of interest requiring disclosure?
Answer: Approving a subcontract to a company in which the administrator holds $6,000 in stock
Holding a financial interest in a company receiving institutional funds creates a direct conflict of interest that must be disclosed and managed.
The 'three Rs' framework in animal research (Replacement, Reduction, Refinement) is required to be considered by the IACUC under which federal law?
Answer: Both the PHS Policy and the Animal Welfare Act independently require consideration of the three Rs
Both the PHS Policy (for PHS-funded research) and the Animal Welfare Act regulations (for regulated species) require IACUC consideration of alternatives, minimizing animal numbers, and refining procedures.