The proposed federal guidelines are currently open for feedback are calling for greater transparency with informed consent and CER, which might stifle innovation, according to some advocacy groups.
A patient plagued with difficult-to-control asthma is at the end of his rope until his doctor suggests joining a clinical trial. He's no longer just a patient but also a research subject, and he'll be testing one existing treatment approach while others stay on a different therapy. These kinds of studies are the bedrock of medical science—they ensure that medicines and procedures are safe and effective. Before agreeing, he needs to know what he's getting himself into—the potential benefits and harms, known as "informed consent."
The federal government has regulated informed consent for decades. But some advocacy organizations are warning that proposed federal guidelinesÂ—which could be finalized in the upcoming year—could have a chilling effect on innovation, while fundamentally altering which studies get done.
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