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 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 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 ...
Do the new regulations for institutional review boards permit universities to develop a self-exemption tool for investigators conducting low-risk research in the social sciences and humanities? We ...
The University IRB adheres to the regulatory requirements for research which involves a prisoner as outlined in 45 CFR 46 Subpart C. Federal regulations consider prisoners to be a vulnerable ...
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