NEW TIP SHEETS
Tips for Implementing "Check the Box" Removal Options
Use this tip sheet to guide institutional decision-making and policy updates related to the removal of the “check the box” option under the revised Common Rule framework. Institutions should evaluate the operational, legal, ethical, and compliance implications of applying different oversight standards to federally and non-federally funded human subjects research and ensure appropriate policies, training, and documentation systems are in place.
FDA ClinicalTrials.gov Reporting
Use this tip sheet to update your institutional policy based on the latest FDA news release (April 13, 2026) and long-standing U.S. Food and Drug Administration (“FDA”) requirements (FDAAA 801, at 42 USC 282(j) reminding medical product companies and researchers of their legal requirement to submit results to ClinicalTrials.gov.