UC Comment Letters

This comment letter responds to SMART IRB's proposed revisions to their Reliance Agreement 3.0. UC asks SMART IRB to preserve continuity for existing studies under prior reliance-agreement versions, clarify confusing withdrawal/reporting language, and allow flexibility for non-federally regulated research through agreed-upon commensurate protections rather than defaulting rigidly to SMART IRB SOPs or the Common Rule. UC also raises several deal-breaker legal and operational concerns, including overly broad liability and indemnification language, burdensome or unclear QA/QI and reporting obligations, lack of flexibility for DOE-managed labs, and governing-law/venue provisions that could complicate participation.