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Ethical Considerations & Compliance Flashcards

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

Read the first 7 Ethical Considerations & Compliance flashcards as text
  1. A researcher conducting an online survey fails to include a privacy policy or data security statement. Which ethical principle is MOST directly violated?

    Answer: Respect for Persons and autonomy

    Failing to disclose how data will be protected undermines participants' ability to make an informed, autonomous decision about participation.

  2. A study team member suspects the PI is falsifying source documents. According to responsible conduct of research standards, the team member should:

    Answer: Report the concern through the institution's research integrity officer or hotline

    Research misconduct concerns must be reported to the institutional research integrity officer or through official whistleblower channels.

  3. Under HIPAA, which of the following qualifies as a 'Limited Data Set' that may be shared without individual authorization?

    Answer: Data that retains dates and geographic subdivisions below state level but removes direct identifiers

    A Limited Data Set removes most direct identifiers but may retain dates and geographic information larger than a city block, and requires a Data Use Agreement.

  4. Which scenario BEST illustrates the ethical problem of undue inducement in research recruitment?

    Answer: Offering $5,000 to terminally ill patients to join a high-risk Phase I trial

    Undue inducement occurs when compensation is so large it impairs a potential participant's ability to weigh the risks objectively.

  5. A researcher collects race and ethnicity data without a scientific justification in the study protocol. This raises concerns about:

    Answer: Scientifically unjustified collection that could stigmatize groups

    Collecting sensitive demographic data without clear scientific justification risks stigmatization and fails to meet the ethical standard of minimizing unnecessary risk.

  6. Which of the following is a key requirement of Good Clinical Practice (GCP) as outlined in ICH E6?

    Answer: All trial information should be recorded and reported accurately to allow verification

    ICH E6 GCP requires that all clinical trial information be accurately recorded, handled, and stored to allow for verification, audit, and inspection.

  7. A researcher uses a validated survey instrument from a published study without citing the original authors. This is an example of:

    Answer: Plagiarism

    Using another researcher's instrument without attribution constitutes plagiarism, a form of research misconduct under federal policy.