Medicine
A patient is invited to participate in a clinical trial for a new drug.
She is worried that she might be placed in the placebo group. The doctor reassures her by saying, Don't worry, we'll continue the standard management. Which ethical principle is most relevant to this situation?
Explanation
Core Concept: Non-maleficence is the ethical principle of 'do no harm.' In clinical trials, it dictates that patients in the control group must not be deprived of established, effective standard-of-care treatments simply to test a new intervention.
Clinical Presentation: N/A (Ethics/Research).
Diagnosis: N/A.
Management:
- Acute: Reassure the patient that her safety and standard care will not be compromised by trial participation.
- Long-term/Definitive: Ensure the trial design uses 'add-on' therapy or active-comparator designs rather than placebo-only arms when standard effective treatments exist, thereby adhering to the Declaration of Helsinki and the principle of non-maleficence.