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 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 ...

For ADULTS and CHILDREN, a waiver or alteration of the requirements for obtaining informed consent can occur under any of the following three provisions set forth by HHS: 1. Research in general: an ...

Obtaining informed consent is more than getting a signature on a form. Informed consent is one of the primary ethical considerations underlying research with human subjects. ALL human subject research ...

When is IRB Approval Required? If your project involves "research" and "human subjects" as defined by 45 CFR 46, you must submit an application to the Case Western Reserve University Institutional ...