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 ...
In a remarkable federal human subject research policy development, it appears that the U.S. Department of Health and Human Services (HHS) Secretary's Advisory Committee on Human Research Protections ...
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, ...
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 ...
I worked for 20 years for the HHS office that safeguarded people in research studies. DOGE gutted it
Pritchard worked in the Office for Human Research Protections for 20 years and retired as the senior adviser to the director of OHRP in 2024. Deciding whether to participate in a clinical research ...
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Services (HHS) Office for Human Research Protections (OHRP) and the US Food & Drug Administration (FDA) released a draft guidance document ...
Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Human subject means a living ...
The Purdue University Human Subject Protection Program is undergoing an internal assessment to ensure compliance with the institution's Federalwide Assurance. Researchers who have studies where IRB ...
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 ...
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 ...
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 ...
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