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
Under the Export Administration Regulations (EAR), what is the 'fundamental research exclusion' as it applies to universities?
Answer: Basic and applied research where results are intended for publication and freely shared is excluded
The fundamental research exclusion applies to basic and applied research at accredited institutions where results are ordinarily published and shared broadly, with no publication restrictions imposed by sponsors.
A graduate student notices that her PI has been fabricating data points in a dataset submitted to a journal. Under institutional policy, what is the MOST appropriate first step?
Answer: Report the concern through the institution's research integrity reporting mechanism
Most institutions have designated research integrity officers or anonymous reporting mechanisms, which provide the appropriate and protected channel for reporting suspected misconduct.
Which of the following best describes a 'covered account' under the Red Flags Rule as it might apply to a research institution offering deferred payment plans?
Answer: An account that allows multiple payments or transactions, subject to a foreseeable risk of identity theft
The Red Flags Rule defines a covered account as one permitting multiple payments with a foreseeable risk of identity theft, which can apply to certain institutional billing accounts.
An IRB is reviewing a study that involves recruiting prisoners as research subjects. Under 45 CFR Part 46 Subpart C, which of the following is a required finding?
Answer: The research presents no more than minimal risk or offers direct benefit to subjects
Subpart C requires the IRB to find that the research involves no more than minimal risk, or that it offers direct benefit to the individual prisoner subject, among other required findings.
A Cost Accounting Standard (CAS) 502 violation would occur when an institution:
Answer: Applies cost accounting practices inconsistently across similar costs
CAS 502 requires consistent application of cost accounting practices across similar types of costs; inconsistency between sponsored and non-sponsored activities constitutes a violation.
Under 2 CFR Part 200 (Uniform Guidance), the period of performance for a federal award ends on the award's end date. What happens to unobligated balances at that point?
Answer: They must be returned to the federal agency unless a no-cost extension is approved
Unobligated balances at the end of the period of performance must be returned unless a no-cost extension has been approved by the awarding agency.
Which ethical principle primarily justifies the requirement that research involving potential therapeutic benefit must offer a favorable risk-benefit ratio?
Answer: Beneficence
The Belmont principle of Beneficence obligates researchers to maximize possible benefits and minimize possible harms, including assessing the overall risk-benefit ratio.