A new guidance document by the Food and Drug Administration explains the agency’s thinking on a new regulation (21 CFR 50.25 (c)) requiring that informed consent documents include a specific statement about the availability of clinical trial information on ClinicalTrials.gov.

The statement must be included verbatim in the informed consent documents of applicable clinical trials initiated on or after March 7, 2012. ASCO submitted comments on the draft regulation and is pleased that FDA simplified the mandatory statement to make it more understandable to trial participations, consistent with ASCO’s recommendations.