Is existing UW practice affected by the new FDA/NIH registration requirement?
From the beginning, the UW has promoted registration of trials/studies meeting the broad ICMJE definition. Therefore, the new FDA law does not expand the scope that the UW has applied for registering studies in the past, nor does the new FDA law change the UW existing practice for defining the “responsible party” for registering a trial. What has been affected by the new FDA law is the penalty for noncompliance. As explained above at “What are the penalties for failing to register?” and in the information references below, failing to register applicable trials on ClinicalTrials.gov may now include civil monetary penalties and, for federally funded trials, the withhholding or the recovery of grant funds. The ICMJE penalty for failure to register continues to be the journals’ refusal to consider publication of trial results.
