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Question preview · USMLE Step 2 CK

A researcher is enrolling adults into a medication trial. One candidate with delirium cannot explain the study purpose, risks or alternatives and has no advance research directive. The investigator proposes accepting the patient's signature because the patient can physically hold a pen. Which Belmont principle is most directly threatened?

  1. A. Justice, because the study does not enroll equal numbers from every age group
  2. B. Beneficence, because all investigational drugs must offer direct benefit
  3. C. Fidelity, because the researcher did not promise clinical improvement
  4. D. Veracity, because the protocol has not yet produced results
  5. E. Respect for persons, because diminished autonomy requires protection and valid authorization

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