FDA Amends Informed Consent Regulations

By Susan J. Matthees –

Last week, FDA announced that the Agency has adopted final amended informed consent regulations.  As we noted last year, the Food and Drug Administration Amendments Act ("FDAAA") § 801(b)(3)(A) required that FDA amend the informed consent regulations set forth at 21 C.F.R. § 50.25 to include a statement to inform potential clinical trial participants that data from the trial has been or will be entered into a databank accessible to the public via www.clinicaltrials.gov.  FDA published the proposed rule implementing the FDAAA requirement in December 2009, and after considering comments, adopted the final rule, which will become effective on March 7, 2011.  However, FDA is providing a grace-period of 1 year, stating that the Agency intends to enforce the rule only for informed consent documents that are initiated on or after March 7, 2012. 

The statement that is required by amended 21 C.F.R. § 50.25 reads: “A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law.  This Website will not include information that can identify you.  At most, the Website will include a summary of the results.  You can search this Website at any time.”

Of note, FDAAA § 801(b)(3)(A) amends FDC Act § 505(i), which applies to drugs, so facially, it would appear that the new informed consent statement would only apply to drug trials.  However, FDA stated that because 21 C.F.R. Part 50 is one of the implementing regulations for FDC Act § 505(i), and 21 C.F.R. Part 50 applies to drugs and devices, FDA is applying the new informed consent language for drug and device trials.  FDA further explained that this will help maintain a uniform system for human subject protection and prevent confusion. 

Also interesting to note is that it is the investigator’s responsibility to obtain informed consent from research subjects.  21 C.F.R. § 50.20.  However, it is typically the responsibility of the sponsor of an applicable clinical trial to post the information to www.clinicaltrials.gov.