In recognition of the widespread disruptions the COVID-19 crisis is posing to planned and ongoing clinical trials at sites throughout the United States (and global clinical sites), the Food and Drug Administration (FDA)...more
Federally-funded clinical trials conducted at multiple sites will move to a single Institutional Review Board (IRB) review scheme under a new National Institutes of Health (NIH) Policy. The NIH has finalized its policy to...more
The U.S. Department of Health and Human Services (“HHS”) and fifteen other Federal Departments and Agencies have announced a proposal to update the Federal Policy for the Protection of Human Subjects known as the “Common...more
9/9/2015
/ Clinical Trials ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Exemptions ,
Human Rights ,
Informed Consent ,
IRB ,
Medical Research ,
NPRM ,
Proposed Regulation ,
Scientific Research ,
The Common Rule ,
Transparency