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Research Ethics & Compliance Flashcards

7 cards from real CPI practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

Read the first 7 Research Ethics & Compliance flashcards as text

  1. Which federal office has authority to debar an investigator from receiving federal research funding due to research misconduct?

    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.

  2. A Certificate of Confidentiality (CoC) protects identifiable research data from being disclosed in which of the following situations?

    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.

  3. In the context of conflict of interest, what must a researcher disclose to the institution according to federal PHS regulations?

    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.

  4. A PI enrolls a participant who does not meet all inclusion criteria without prior IRB approval. This constitutes a:

    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.

  5. What is the key difference between 'research misconduct' and a 'questionable research practice' (QRP)?

    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.

  6. According to GCP guidelines, how long must investigators retain essential clinical trial documents after trial completion?

    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.

  7. A study team member is pressured by a sponsor's representative to alter adverse event severity ratings. The appropriate response is to:

    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.