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Human Subjects Division (HSD)

Regulatory Updates

FDA: Informed Consent Elements - Final Rule

Jan 10, 2011 at 1:14pm

The Food and Drug Administration (FDA) is amending the current informed consent regulations to require that informed consent documents and processes for applicable drug (including biological products) and device clinical trials include a specific statement that clinical trial information will be entered into a databank.  The databank referred to in this final rule is the clinical trial registry databank maintained by the National Institutes of Health/National Library of Medicine (NIH/NLM) which was created by statute. The submission of clinical trial information to this databank also is required by statute.  This amendment to the informed consent regulations is required by the Food and Drug Administration Amendments Act of 2007 (FDAAA) and is designed to promote transparency of clinical research to participants and patients.


Effective date: This rule is effective March 7, 2011.

Compliance date: The compliance date of this final rule is March 7, 2012, for clinical trials that are initiated on or after the compliance date.

See the Federal Register here: http://edocket.access.gpo.gov/2011/pdf/2010-33193.pdf