Behavioral Science & Ethics USMLE Step 1 Practice Question
A phase III randomized controlled trial is comparing a novel minimally invasive surgical technique to standard open repair for ventral hernia. The trial was designed to enroll 800 patients with interim analysis planned at 400 patients. At the interim analysis, the Data Safety Monitoring Board (DSMB) reviews preliminary safety data and finds that the novel technique has an 18% major complication rate compared to 7% for standard repair (p=0.003). The DSMB is concerned that continuing to randomize patients to the novel technique may expose them to unnecessary harm. Which of the following ethical principles most strongly justifies the DSMB's recommendation to halt enrollment in the experimental arm?
Answer choices
- AAutonomy—patients have the right to choose which surgical technique they receive without researcher influence
- BVeracity—the researchers must provide complete and truthful disclosure of all interim findings to enrolled participants
- CNon-maleficence—the duty to avoid causing harm to research subjects takes precedence over completing the trialCorrect answer
- DJustice—the experimental technique should be offered equally to all hernia repair patients regardless of socioeconomic status
- EBeneficence—the trial should continue because it may eventually benefit future patients with hernias
- FFidelity—researchers must remain loyal to the original study protocol regardless of interim safety signals
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