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 ...
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 ...
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 US Food and Drug Administration (FDA) on Tuesday issued two proposed rules aimed at harmonizing certain sections of the agency’s regulations on human subject protections and Institutional Review ...
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 ...
President Shapiro is heading an effort to rethink the way human-subject experiments are regulated. As chair of the National Bioethics Advisory Committee — commissioned by President Clinton in 1995 — ...
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 ...
With an eye to reducing confusion between the revised Common Rule from the Department of Health and Human Services (HHS) and the US Food and Drug Administration’s (FDA) regulations, FDA on Friday ...
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