Comment from Klote Medical Research Advisors and Hartsmith Consulting

Summary: The commenters, representing former OHRP leadership and consulting firms, support the FDA's goal of improving safety reporting quality but argue that the current guidance could increase administrative burdens. They suggest specific revisions to clarify "immediate" reporting timelines, frame investigator causality as preliminary clinical judgment, and preserve core concepts from the 2009 IRB guidance to prevent excessive reporting.