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 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 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," ...

IRB: Ethics & Human Research explores issues in research with human subjects, including findings and analyses of empirical studies. Six issues are published each year, containing scholarly articles ...

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 Human Research Protection Program (HRPP) is responsible for providing administrative and regulatory support to the Drexel University Institutional Review Boards (IRB). HRPP provides guidance on ...

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 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 ...