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 ...

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 ...

SUMMARY: The departments and agencies listed in this document propose revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was ...

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 ...

Visit NAP.edu/10766 to get more information about this book, to buy it in print, or to download it as a free PDF. AAPP (American Academy of Pharmaceutical Physicians). 2001. Written comments to the ...

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.

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

This chapter presents a brief summary of the federal regulations governing the protection of human subjects in research, with particular attention to how the concepts of the regulations fit with the ...