CRA Regulatory Compliance and Ethics 3 — Questions and Answers
Question 1: Under the Export Administration Regulations (EAR), what is the 'fundamental research exclusion' as it applies to universities?
- All federally funded research is automatically excluded from export controls
- Basic and applied research where results are intended for publication and freely shared is excluded (Correct answer)
- Research conducted on campus by U.S. citizens only is excluded
- Research not involving controlled technology or foreign nationals is excluded
Correct 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.
Question 2: 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?
- Contact the journal editor directly to retract the paper
- Confront the PI privately and demand correction before taking further action
- Report the concern through the institution's research integrity reporting mechanism (Correct answer)
- Notify the funding agency's program officer immediately
Correct 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.
Question 3: 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?
- Any account held by a federally funded principal investigator
- An account that allows multiple payments or transactions, subject to a foreseeable risk of identity theft (Correct answer)
- A restricted fund account managed by the sponsored programs office
- Any account associated with a foreign national researcher
Correct 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.
Question 4: 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?
- The research offers only minimal risk with no prospect of direct benefit
- The research presents no more than minimal risk or offers direct benefit to subjects (Correct answer)
- A majority of the IRB members must themselves be prisoners or prisoner advocates
- All research involving prisoners requires Secretarial approval regardless of risk level
Correct 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.
Question 5: A Cost Accounting Standard (CAS) 502 violation would occur when an institution:
- Fails to disclose its cost accounting practices in a written document
- Applies cost accounting practices inconsistently across similar costs (Correct answer)
- Charges direct costs that are also allocated as indirect costs
- Exceeds the negotiated indirect cost rate on a federal award
Correct 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.
Question 6: 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?
- They automatically carry over to the next budget period
- They must be returned to the federal agency unless a no-cost extension is approved (Correct answer)
- They may be used for up to 90 days post-award for closeout costs
- They transfer to the institution's indirect cost recovery account
Correct 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.
Question 7: Which ethical principle primarily justifies the requirement that research involving potential therapeutic benefit must offer a favorable risk-benefit ratio?
- Respect for Persons
- Beneficence (Correct answer)
- Justice
- Autonomy
Correct answer: Beneficence
The Belmont principle of Beneficence obligates researchers to maximize possible benefits and minimize possible harms, including assessing the overall risk-benefit ratio.
CRA Regulatory Compliance and Ethics 3
Under the Export Administration Regulations (EAR), what is the 'fundamental research exclusion' as it applies to universities?