Index Entries

The Code of Laws of the United States of America
Office of the Law Revision Counsel of the United States House of Representatives

From Chapter 9 of the Food, Drug and Cosmetic Act. 

“(ii) Appropriate conditions designed to ensure that individuals to whom the product is administered are informed … (III) of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.”

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bioethics,emergency use authorization (EUA),human rights,informed consent,US law