The Food and Drug Administration ("FDA") expands informed consent exceptions with a final rule permitting institutional review board ("IRB") waiver or alteration of elements for certain FDA-regulated ...

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," ...

The Common Rule describes the basic DHHS policy for the protection of human research participants and is incorporated into University policy for: IRB review types and processes; criteria for IRB ...

The Department of Health and Human Services (DHHS) was the first federal agency to codify regulations governing human research protection. The Code of Federal Regulations at 45 CFR 46 describes the ...

The UAB Institutional Review Board for Human Use (IRB) is a committee established under federal regulations for the protection of human subjects in research (45 CFR 46). Its purpose is to help protect ...

Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or Obtains, uses, studies, analyzes, or ...