Guidance on Engagement of Institutions in HHS-Funded Human Subjects Research
The HHS Office for Human Research Protections has released its “Guidance on Engagement of Institutions in Human Subjects Research.” The guidance document describes whether certain scenarios would result in an institution being considered engaged in a human subjects research project, and addresses institutional review boards' review considerations for cooperative research in which multiple institutions are engaged in the same non-exempt human subjects research project. The guidance is intended primarily for IRBs, research administrators and other relevant institutional officials, investigators, and funding agencies that may be responsible for the conduct, review and oversight of human subject research that is conducted or supported by the U.S. Department of Health and Human Services.
