Research considered an Applicable Clinical Trial (ACT) by the FDA must include the following statement somewhere in the consent form:
“A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.”
Starting this month, IRB reviewers and the ClinicalTrials.gov Review Committee will start requesting PIs use a slightly different statement for their non-ACT studies registering with ClinicalTrials.gov. This new statement will not reference U.S. law, as only ACTs are required by law to create and maintain a record on ClinicalTrials.gov (some studies must register as a condition of their grant, for publication purposes, etc.).