FDA Updates Informed Consent Regulations to Require Statement on Government Databank Disclosure
This post was written by Paul Sheives.
The Food and Drug Administration (FDA) has issued a final rule that will require that informed consent documents associated with clinical trials include a specific statement regarding entry of the clinical trial information into the government databank, www.clinicaltrials,gov. Under the current regulations, certain clinical trials must submit information to this databank. All such clinical trials initiated after March 7, 2012 must include a specific statement informing the public regarding the entry of the trial results into the databank.
