FDA’s informed consent guidance gets a 21st century makeover

The FDA has issued a new, final guidance on informed consent for clinical investigations – the first update since 1998. The new guidance offers recommendations for institutional review boards (IRBs), investigators and sponsors on key aspects of informed consent, significantly expanding FDA’s recommendations on several key topics, including reimbursement for research participation.

The FDA, HHS, and research and informed consent policies

In the U.S., many types of clinical research must comply with regulations intended to protect the rights of research participants. Those protections are found at 21 CFR 50 and 56 and include concepts like informed consent, appropriate clinical trial oversight by institutional review boards (IRBs), the review of investigational research protocols by the FDA, and ensuring that test articles have been appropriately vetted prior to human use.

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