For the first time in 16 years, the U.S. Food and Drug Administration is issuing new guidance about getting informed consent from people who agree to become study subjects for medical drugs, medical devices and other products the agency regulates.
The FDA is taking comments—until Sept. 15—on its guidance for the sponsors of studies, clinical investigators who are responsible for ensuring studies are carried out according to plan and for protecting the welfare of test subjects, and institutional review boards who are the ethical monitors for research involving people.
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