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 ...
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 EPA has adopted the Common Rule under 40 CFR 26 Subpart A §26.101-124: Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA. Order 1000.17A, Policy and ...
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Services (HHS) Office for Human Research Protections (OHRP) and the US Food & Drug Administration (FDA) released a draft guidance document ...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 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 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 ...
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