Key Takeaways
- FDA Commissioner Robert Califf said informed consent discussions should include a discussion of the risk of not joining the trial.
- During a Patient Engagement Advisory Committee meeting, Califf also said consent forms are long and legalistic, but still have information gaps.
- He encouraged more research of digital and other tools that could enhance the informed consent process.
Informed consent discussions should incorporate information about the risks of not joining the trial and relying on the standard of care, FDA Commissioner Robert Califf suggested during a 30 October...
“We don’t have enough discussions about the risks of routine clinical care when the right intervention is not known,” Califf said. “Discussing uncertainty in clinical practice is unsettling and difficult....
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