CPI Research Ethics & Compliance 3 — Questions and Answers
Question 1: Which federal office has authority to debar an investigator from receiving federal research funding due to research misconduct?
- The Office for Human Research Protections (OHRP)
- The Office of Research Integrity (ORI) (Correct answer)
- The Food and Drug Administration (FDA)
- The National Institutes of Health (NIH)
Correct answer: The Office of Research Integrity (ORI)
The Office of Research Integrity (ORI) oversees misconduct in PHS-funded research and can recommend administrative actions including debarment.
Question 2: A Certificate of Confidentiality (CoC) protects identifiable research data from being disclosed in which of the following situations?
- FDA inspection of clinical trial records
- Civil or criminal legal proceedings (Correct answer)
- NIH progress report submissions
- Sponsor audits of trial data
Correct answer: Civil or criminal legal proceedings
A CoC protects researchers from being compelled to disclose identifiable information in legal proceedings such as court orders or subpoenas.
Question 3: In the context of conflict of interest, what must a researcher disclose to the institution according to federal PHS regulations?
- All publications from the past five years
- Significant financial interests related to their institutional responsibilities (Correct answer)
- Personal relationships with IRB members
- Travel expenses paid by professional societies
Correct answer: Significant financial interests related to their institutional responsibilities
PHS regulations require disclosure of significant financial interests (SFIs) that could reasonably appear to affect the design, conduct, or reporting of research.
Question 4: A PI enrolls a participant who does not meet all inclusion criteria without prior IRB approval. This constitutes a:
- Minor protocol deviation requiring no report
- Protocol violation that must be reported to the IRB (Correct answer)
- Acceptable clinical judgment exception
- Exempt modification under 45 CFR 46
Correct answer: Protocol violation that must be reported to the IRB
Enrolling an ineligible participant is a protocol violation—not merely a deviation—and must be reported to the IRB because it affects participant safety.
Question 5: What is the key difference between 'research misconduct' and a 'questionable research practice' (QRP)?
- Research misconduct involves only data fabrication; QRP involves only plagiarism
- Research misconduct meets the federal definition of FFP; QRPs are unethical but fall short of that definition (Correct answer)
- QRPs are prosecuted federally; research misconduct is handled institutionally
- There is no meaningful distinction between the two
Correct answer: Research misconduct meets the federal definition of FFP; QRPs are unethical but fall short of that definition
Research misconduct is formally defined as fabrication, falsification, or plagiarism (FFP); QRPs are ethically problematic practices that do not meet the legal FFP threshold.
Question 6: According to GCP guidelines, how long must investigators retain essential clinical trial documents after trial completion?
- At least 2 years after the last approval decision
- At least 2 years after the last enrollment date
- As specified by applicable regulations, sponsor requirements, or 2 years post-approval, whichever is longest (Correct answer)
- Indefinitely with no minimum specified
Correct answer: As specified by applicable regulations, sponsor requirements, or 2 years post-approval, whichever is longest
ICH E6 GCP requires essential documents to be retained for at least 2 years after the last marketing approval, or longer per sponsor/regulatory requirements.
Question 7: A study team member is pressured by a sponsor's representative to alter adverse event severity ratings. The appropriate response is to:
- Make the changes to maintain the sponsor relationship
- Refuse and report the pressure to the PI and IRB or ethics committee (Correct answer)
- Consult only the department chair before deciding
- Alter the data temporarily and restore it after the audit
Correct answer: Refuse and report the pressure to the PI and IRB or ethics committee
Altering data under sponsor pressure constitutes research misconduct; the team member must refuse and report the coercion through proper channels.
CPI Research Ethics & Compliance 3
Which federal office has authority to debar an investigator from receiving federal research funding due to research misconduct?