The Online Human Subjects Determination (OHSD) Form has been reinstated and updated to include additional questions related to FDA-regulated activities and research funding. These updates are intended to help ensure that the information needed to make an appropriate human subject research determination is captured during submission.
As a reminder, the OHSD Form should only be used to request a determination regarding whether a proposed project requires IRB review/oversight. It should not be used as a substitute for consultation or for general questions about IRB requirements.