JAMA : the journal of the American Medical Association
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With the increase in trials assessing comparative effectiveness of approved products and alternative care strategies, guidance is needed to ensure ethical oversight is fit for purpose for the risks, burdens, and constraints on choice this research presents. ⋯ Ethical oversight of clinical research must be fit for purpose-with greater oversight for studies with greater risks, uncertainties, and impacts on meaningful patient decisions-and more streamlined oversight for other types of research.