On January 18th, the US Department of Health and Human Services (HHS) and 15 other federal departments and agencies issued a final rule to revise the federal Policy for the Protection of Human Subjects. The Policy for the Protection of Human subjects, aka the Common...
According to Zachary Brennan of RAPS, The U.S. Department of Health and Human Services Inspector General will be investigating FDA on post-marketing requirements, supply chain exchanges, hospital medical device oversight, and three additional programs on food and...
Single IRB – A Guide to the Common Rule sIRB Mandate
The sIRB requirement is active. Is your study affected?