Clinical trials : journal of the Society for Clinical Trials
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Pragmatic trials comparing "standard of care" treatments provide comparative effectiveness data to make practice of medicine more evidence-based. With electronic health records, recruiting and conducting such trials can be relatively inexpensive. But some worry that the traditional research ethics framework poses unnecessary obstacles and is not appropriate for evaluating such clinical trials. This concern is based on the view (which we call the "Standard of Care Principle") that such research is similar to usual clinical practice and therefore does not raise significant ethical issues since everyone in the research study will receive an accepted standard of care treatment. ⋯ The Standard of Care Principle is ethically inadequate and misleading even when it is applied to the pragmatic randomized clinical trial proposed as a paradigm case for its application.
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All agree that informed consent is a process, but past research has focused content analyses on post-consent or on one conversation in the consent series. Our aim was to identify and describe the content of different types of consent conversations. ⋯ We identified and described four types of consent conversations. Our novel findings include (1) four different types of conversations with one (priming) not mentioned before and (2) a change of focus from describing the content of one phase 1 consent conversation to describing the content of different types. These in-depth descriptions provide the foundation for future research to determine whether the four types of conversations occur in sequence, thus describing the structure of the consent process and providing the basis for coaching interventions to alert physicians to the appropriate content for each type of conversation. A switch from a focus on one conversation to the types of conversations in the process may better align the consent conversations with the iterative process of shared decision making.