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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. When must a researcher submit a continuing review application to the IRB?

    Answer: At intervals appropriate to the degree of risk, but at least annually

    The Common Rule requires continuing review at intervals determined by risk level, with a minimum frequency of once per year.

  2. A qualitative researcher is studying domestic violence survivors. Which recruitment strategy raises the greatest ethical concern?

    Answer: Recruiting through social media posts in closed survivor support groups

    Recruiting from closed support groups can breach the confidentiality of members and may expose them to undue risk of identification.

  3. What does the concept of 'assent' refer to in pediatric research ethics?

    Answer: A child's affirmative agreement to participate, separate from parental permission

    Assent is the child's own agreement to participate, which is ethically required alongside parental permission for capable minors.

  4. Which action by a researcher constitutes 'data fabrication' under federal research misconduct policy?

    Answer: Making up data points that were never actually collected

    Fabrication is the making up of data or results and recording or reporting them, as defined by 42 CFR Part 93.

  5. An IRB determines a study qualifies for expedited review. What does this mean?

    Answer: The study poses no more than minimal risk and fits a specific regulatory category

    Expedited review allows a designated IRB member to review minimal-risk research that falls within one of nine federally defined categories.

  6. A researcher alters numerical results to make the study's findings appear more statistically significant. This constitutes:

    Answer: Data falsification

    Altering or manipulating research data to change results is data falsification, a form of research misconduct under federal policy.

  7. Which principle ensures that research participants are treated as autonomous agents capable of making their own decisions?

    Answer: Respect for Persons

    Respect for Persons in the Belmont Report requires acknowledging individual autonomy and protecting those with diminished autonomy.