The new requirement of including the statement has not altered the IRB approval process.
However, IRBs cannot modify or delete the exact statement regarding
www.ClinicalTrials.gov as stated in 21 CFR § 50.25(c). Investigators, sponsors, and
IRBs are not restricted from providing additional explanation, if determined to be needed.
It is essential, however, that the required common statement consistently be included in
all informed consent documents and processes if the trial is an applicable clinical trial.