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Ethical Principles in Research Flashcards

7 cards from real SOCRA 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 Principles in Research flashcards as text

  1. Which of the following constitutes research misconduct as defined by federal regulations?

    Answer: Fabrication, falsification, or plagiarism in proposing, performing, or reporting research

    Federal policy defines research misconduct as fabrication, falsification, or plagiarism (FFP) in research activities; honest error and differences of opinion are excluded.

  2. A clinical investigator holds equity in the company sponsoring the trial they are conducting. This situation is best described as:

    Answer: A financial conflict of interest that must be disclosed to the IRB and managed appropriately

    Financial interests in a sponsor company represent a conflict of interest that must be disclosed and managed to protect research integrity and participant safety.

  3. Under ICH E6(R2) GCP, which party bears ultimate responsibility for the conduct and integrity of a clinical trial?

    Answer: The sponsor

    Under ICH E6(R2), the sponsor bears ultimate responsibility for the trial, although they may delegate duties to a CRO.

  4. The Declaration of Helsinki states that research involving human subjects may only proceed if:

    Answer: The importance of the objective outweighs the risks and burdens to research subjects

    The Declaration of Helsinki requires that the importance of the research objective must outweigh inherent risks and burdens to participants.

  5. A site coordinator discovers that source data have been altered retrospectively without any documentation of the reason. This is an example of:

    Answer: Data falsification or a data integrity violation

    Undocumented retrospective changes to source data are a serious data integrity violation and may constitute falsification of research data.

  6. Which principle underpins the requirement that researchers must report unanticipated problems involving risks to subjects or others to the IRB?

    Answer: Beneficence and non-maleficence — protecting participants from harm

    Reporting unanticipated problems protects participants from harm, reflecting the combined principles of beneficence and non-maleficence.

  7. An investigator publishes the same study results in two separate journals without disclosing the prior publication. This practice is known as:

    Answer: Duplicate publication

    Duplicate publication involves publishing the same data or findings in more than one journal without appropriate disclosure, which is considered research misconduct.