CDU IRB Announcement - February 28, 2012

FDA Final Rule: Disclosure of Clinical Trials Registration in the Informed Consent as a New Element

Under the FDA Amendments Act of 2007 (FDAAA), the FDA has amended its current informed consent regulations in 21CFR50.25 as of March 7, 2011 (http://edocket.access.gpo.gov/2011/2010-33193.htm).

The amendment requires that the informed consent documents and processes, of applicable clinical investigation, disclose that the data will be added to the clinical trial registry databank.  The final rule is expected to promote transparency and increase the awareness of clinical trials, inform the participants where to view trial progress, and increase accountability of investigators. 

If you are planning to submit an IRB application for clinical investigation, please add the following 4 statements under Privacy and Confidentiality in the Consent Form (F-114) to comply with the FDA Final Rule.  The compliance date is March 7, 2012

“A description of this clinical trial will be available on http://www.clinicaltrials.gov, as required by U.S. Law.  This Web site will not include information that can identify you.  At most, the Web site will include a summary of the results.  You can search this Web site at any time.”

Here are some things to keep in mind.

  1. There is no need to re-consent if clinical investigation was started before the compliance date (March 7, 2012).
  2. Pure observational studies will not require registration
  3. If the IRB waives the requirement for a signed written consent form and requires “the investigator to provide subjects with a written statement regarding the research”, the four additional statements must be included in the information sheet.

 

If you have any question, please e-mail irb@cdrewu.edu with ClinicalTrials.gov as subject header or call 323-563-4966.