Shared decision making honors patient autonomy and improves patient comprehension and therefore should be a part of every clinical decision a patient makes. Use of shared decision making in research informed consent conversations is more complicated due to diverse and potentially divergent investigator and patient interests, along with the presence of clinical equipoise. This article clarifies these different interests and discusses ways in which shared decision making can be applied in research. Provided there is transparency about competing interests, patient-centered and values-focused communication approaches embodied in shared decision making can support the ethical recruitment of patients for clinical research.
CaseDr T is a rheumatologist and principal investigator in several clinical trials on biologic agents. One of her patients, Mr X, has rheumatoid arthritis that has not responded well to standard treatment. Dr T approaches Mr X about enrolling in a phase II trial, the purpose of which is to evaluate the efficacy, safety, and dose specifications of a new monoclonal antibody. Dr T explains the trial's design to Mr X, emphasizing the possibility that he would not receive the antibody if he is randomized to the placebo arm of the study. Dr T also explains that, if he does receive the antibody, Mr X could experience negative side effects and complications. Mr X agrees to participate in the trial.About 2 weeks into the trial, during a follow-up visit, Dr T asks Mr X about his responses to the experimental agent. Mr X says, "Thank you, Dr T, for letting me try this treatment." Dr T explains that the antibody is neither a treatment nor (even anywhere near being) an approved clinical intervention. Dr T reminds Mr X of the trial's goals. Mr X responds, "I'm so lucky I have a doctor like you who can use research to help patients in ways other doctors can't. This new medicine is great." Dr T wonders how to respond.
The case which I here present was in the per¬ son of Mrs. K. G., aet. 50, a healthy, well-nour¬ ished woman, who was seen first on the 7th of May, 1889. There was a large growth on the anterior portion of the left eye, involving the entire front of the ball.
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