The Institutional Review Board is a local review board, established by the Western Michigan University Board of Trustees in accord with federal regulations, to interpret and apply federal regulations, ...

The death of a young man, Jesse Gelsinger, in a 1999 gene therapy experiment has focused attention on the challenges of research with human subjects. This issue had been simmering just below the ...

Your article "Monitoring Human Subjects and Clinical Trials" 1 reports on the findings of the Health and Human Services Inspector General concerning institutional review boards and determines that ...

The Department of Justice (DoJ), which includes the National Institute of Justice (NIJ) and the Federal Bureau of Prisons and other agencies, complies with the Common Rule as codified at 28 CFR 46.

On March 1, 2024, the US Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the US Food & Drug Administration (FDA) released a draft guidance document ...

The Smith College Institutional Review Board (IRB) upholds the principles of respect, beneficence and justice, with established guidelines to ensure that human research participants are treated with ...

On March 1, 2024, the US Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the US Food & Drug Administration (FDA) unveiled a preliminary guidance document ...

Pregnant women, children, and other vulnerable populations may be entered into Department of Veterans Affairs (VA) research if Veterans Health Administration (VHA) requirements are met as described in ...

Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Human subject means a living ...

Hi. I’m Art Caplan. I'm at the Division of Medical Ethics at the NYU Grossman School of Medicine. Many of you may not give much thought to what sort of protections are given to people who want to ...

Late last year, the U.S. Food and Drug Administration (FDA) quietly introduced a regulation that may be one of the most important shifts in how non-profit and for-profit U.S. institutions, both at ...

The IRB reviews research involving human subjects if one or more of the following apply: The research is sponsored by WMU, regardless of the location of the project. The research is conducted by, or ...