The footnote states that federal agencies are not required to maintain liability coverage for their activities under the SMART IRB Agreement. NIH, for example, follows, among other processes, federal statutory requirements for determinations of liability coverage and thus cannot assure that all people affiliated with NIH and conducting research involving human subjects under the NIH Federalwide Assurance (FWA) will be included under NIH’s federal liability coverage.
Articles in this section
- Are local, state, or federal agencies subject to the insurance provision in the SMART IRB Agreement?
- Guidance Regarding Scope of Review Provision of the Trial Innovation Network (TIN) Letter of Indemnification (LOI)
- Does the SMART IRB Agreement contain any "representations and warranties" by the parties or, disclaimers of representations and warranties?
- Why doesn’t the SMART IRB Agreement require Participating Institutions to carry specific types or amounts of insurance coverage?
- Can NIH provide additional detail specifying which people affiliated with NIH are (or are not) covered under NIH’s federal liability coverage?
- How does the addition of the footnote in SMART IRB Agreeemnt v2.0, Section 4.10, Insurance, affect the Agreement’s insurance provision?
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