The University of Minnesota’s efforts to protect human subjects in research doesn’t consistently reflect best practices, a report released to the public Friday from an external review committee found.
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 ...
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 ...
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Will AI make research on humans… less human?
This became the foundation for the federal policy for human subjects protection, known as the Common Rule, which regulates IRBs. It’s not 1979 anymore. And now AI is changing the way people conduct ...
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 ...
Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or Obtains, uses, studies, analyzes, or ...
Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Human subject means a living ...
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