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 ...

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, ...

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 ...

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.

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 ...

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 ...

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

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Services (HHS) Office for Human Research Protections (OHRP) and the US Food & Drug Administration (FDA) released a draft guidance document ...

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 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 ...