The Food and Drug Administration (FDA) recently issued a proposed rule that would extensively modify and modernize its current regulations governing the protection of human subjects and Institutional ...

The federal government recently made extensive revisions to the Federal Regulations that govern all human subjects research, otherwise known as the Common Rule. Many of these revisions took effect on ...

With an eye to reducing confusion between the revised Common Rule from the Department of Health and Human Services (HHS) and the US Food and Drug Administration’s (FDA) regulations, FDA on Friday ...

The US Food and Drug Administration (FDA) on Tuesday issued two proposed rules aimed at harmonizing certain sections of the agency’s regulations on human subject protections and Institutional Review ...

The Revised Common Rule requires all clinical trials to post an unsigned consent form on a publicly available website. The Revised Common Rule is in effect for studies approved on or after January 21, ...

The Federal Policy for the Protection of Human Subjects or the “Common Rule” outlines specific regulations for human subjects research. The Common Rule is heavily based on the "The Belmont Report," ...

As part of its broader efforts to improve the informed consent process for prospective study participants, the U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections ...