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Changes Ahead for FDA’s Informed Consent Requirements

FDA regulations dictating informed consent requirements for drug and medical device clinical trials are set to change on March 7, 2012.

The FDA’s amendment will require that informed consent documents and processes include a statement that clinical trial information will be entered into the National Institutes of Health/National Library of Medicine’s clinical trial registry databank, www.clinicaltrials.gov. Mandated by the Food and Drug Administration Amendments Act of 2007, the new requirement is intended to boost transparency of clinical research in the US for participants and patients. The compliance date of March 7, 2012 applies to clinical trials begun on or after that date. (There is no retroactive compliance requirement for clinical trials initiated prior to that date.)

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