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Ethical & Legal Considerations Flashcards

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

Read the first 7 Ethical & Legal Considerations flashcards as text

  1. A research site in a low-income community is offered extra compensation for enrolling participants quickly. This arrangement raises primary concerns about:

    Answer: Undue inducement that may compromise voluntary participation

    Excessive financial incentives can constitute undue inducement, compromising the voluntariness of informed consent.

  2. Which document establishes the ethical framework that ICH GCP guidelines are built upon?

    Answer: The Declaration of Helsinki

    ICH GCP guidelines explicitly state they are developed in accordance with the Declaration of Helsinki's ethical principles.

  3. An investigator wants to enroll pregnant women in a study with potential direct benefit to them. Under 45 CFR Part 46 Subpart B, this is:

    Answer: Permitted provided specific conditions protecting the mother and fetus are met

    Subpart B allows pregnant women to be enrolled when conditions protecting both mother and fetus are satisfied, including assessment of risk/benefit.

  4. A CRA finds that a site enrolled a participant who did not meet an inclusion criterion. The most appropriate classification is:

    Answer: A protocol violation with potential impact on data integrity

    Enrolling an ineligible participant is a protocol violation that may compromise data integrity and require regulatory reporting.

  5. Research misconduct as defined by the U.S. Office of Research Integrity (ORI) includes all of the following EXCEPT:

    Answer: Honest errors or differences of opinion

    ORI's definition of research misconduct explicitly excludes honest errors and good-faith differences in interpreting data.

  6. A sponsor requires the CRA to collect participant names and contact information in the sponsor's database. This likely requires:

    Answer: A data use agreement and appropriate consent authorization

    Transferring identifiable health information to a sponsor requires a properly executed data use agreement and participant authorization under HIPAA.

  7. Which of the following best describes 'assent' in pediatric research?

    Answer: A child's affirmative agreement to participate when developmentally appropriate

    Assent is the affirmative agreement of a minor to participate in research, required alongside parental permission when the child is capable.