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, 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 Review Committee will start requesting PIs use a slightly different statement for their non-ACT studies registering with This new statement will not reference U.S. law, as only ACTs are required by law to create and maintain a record on (some studies must register as a condition of their grant, for publication purposes, etc.).