Update – February 3, 2011

Informed Consent Document – New Rule

The FDA is coming up with a new rule for existing informed consent document which is as follows:

  • Informed consent documents for all clinical trials including Biologics and medical devices should include a specific statement that trial information will be entered into a databank which is clinicaltrial.org operated by NIH and NLM.

Reason behind this Final rule is

  1. To improve the transparency of clinical research to participants and patients
  2. Submission of this information is mandated by FDAAA (food and drug administration amendment act of 2007)

Henceforth after the effective date all clinical Trial protocol have to include the above statement.

  • Effective date of this rule is effective from March 7, 2011.
  • The compliance date of this final rule is March 7, 2012, for clinical trials that are initiated on or after the compliance date.
  • Compliance date of new Sec.50.25(c) will be 1 year after the effective date of this final rule for all informed consent documents and processes related to a clinical investigation that is initiated on or after the compliance date of this rule.

Any questions on this new FDA rule please email us at info@mdiconsultants.com and Ref: Informed Consent requirements.