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This SOP discusses rules governing investigator self-experimentation and experimentation on family members of investigators.
This procedure establishes the process to manage New Safety Information. This procedure begins when OHRE receives New Safety Information (regardless of whether the information is reportable). This procedure ends when the New Safety Information has been resolved administratively or the Principal Investigator (PI), Institutional Official, and if applicable, Federal Regulatory Agencies have been notified of final determinations made by the convened IRB.
Regulations require an organization to have written procedures for ensuring prompt reporting of changes in research activity; unanticipated problems involving risk to subjects or others; and any instances of serious or continuing non-compliance to the IRB, organizational officials, and applicable federal agencies.
The standards and procedures described in this document provide guidance in documentation to all researchers and animal handlers performing duties that would normally be performed by Division of Comparative Medicine (DCM) Husbandry staff (i.e. feed, water, cage change).
This Policy seeks to preserve the benefits of life sciences Dual Use Research of Concern (DURC) at the University while minimizing the risk that the knowledge, information, products, or technologies generated from such research could create the potential negative consequences identified in the Federal DURC Policy.