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Clinical Trials – New Requirements for Informed Consent

The FDA published a rule on January 4, 2011, governing language that is required to appear unedited in informed consents that are used in “applicable clinical trials”. This new language relates to informing patients that de-identified data collected from the trial they enroll in will appear on the Federal Clinical Trials website (http://clinicaltrials.gov/).

  • The effective date of the requirement is March 7, 2011.
  • Enforcement is not slated to begin until March 7, 2012.
  • The requirements relate to a specific statement in the Informed consent that the patient signs upon enrollment that the clinical trial.
  • “Re-consenting” patients already enrolled is not required for investigations initiated before the March 7, 2012 date.
  • More information about the specifics related to the entire ruling can be found at 21 CFR Part 50 (http://origin.www.gpo.gov/fdsys/pkg/FR-2011-01-04/pdf/2010-33193.pdf).

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