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Research consent — MCCQE Part 1 MCQ

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ModerateEthics & ProfessionalismResearch consentMCCQE Part 1

70-year-old inpatient presents with invited into a trial by his treating physician. He worries refusal will affect his care. Which of the following is the most appropriate next step?

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Correct answer: B — Clarify voluntariness and separate clinical care from research participation

Clarify voluntariness and separate clinical care from research participation is best because research consent must be voluntary and free from undue influence. Breach confidentiality broadly without legal basis is suboptimal because disclosure must be limited to what is legally authorised or clinically necessary; Let family preference override a capable patient is suboptimal because capable patients direct their own care; Refuse to discuss the issue and document nothing is suboptimal because professional practice requires communication and clear documentation; Delay a mandatory report until certainty is absolute is suboptimal because statutory reporting thresholds are often suspicion or reasonable belief, not proof. Therapeutic misconception is common in clinical research.

Reference: TCPS 2 research ethics guidance