Dr. Rosamond Rhodes: “FDA Issues Reformed Consent Guidance”
The FDA recently issued an updated guidance document on obtaining informed consent for clinical trials, but little has changed that would affect enrollment, according to one expert.
The FDA recently issued an updated guidance document on obtaining informed consent for clinical trials, but little has changed that would affect enrollment, according to one expert. "It was never a requirement at all that people be informed what happened, so this is a big change and a very positive change," said Rosamond Rhodes, PhD, Director of Bioethics Education, Professor of Medical Education, Icahn School of Medicine at Mount Sinai. Learn more
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