ClinicalTrials.gov patient consent issues
This article was originally published in The Gray Sheet
Executive Summary
Clinical research stakeholders say a Dec. 29 proposed rule, requiring study sponsors to inform trial participants that information from the study may be submitted to the National Institutes of Health's ClinicalTrials.gov database, should be rewritten to make the required informed consent language more readable. Commenters, including Kaiser Permanente, Johns Hopkins School of Medicine and the Association of Clinical Research Organizations, say the proposed language is far too technical. Several recommend giving sponsors leeway to craft their own ClinicalTrials.gov patient consent language (1"The Gray Sheet" Jan. 4, 2010)