NIH is not able to provide additional detail, due to the complexity of federal law and policy, and the unknown facts of a hypothetical event, that would determine coverage for any specific case. An example of a federal statute governing liability coverage is the Federal Tort Claims Act (FTCA), 28 U.S.C. §§1346(b), 2401(b), 2671-80 et seq. You should speak to your institution’s legal counsel if you have additional questions or interest regarding the FTCA. This Department of Justice website may be helpful as an introductory resource: https://www.justice.gov/civil/federal-tort-claims-act-litigation-section.
Articles in this section
- Background on SMART IRB Agreement v2.0
- Background: Why are the revisions to the SMART IRB Agreement reflected in SMART IRB Agreement v2.0 necessary?
- Background: How will SMART IRB Agreement v2.0 allow NIH to collaborate with extramural organizations?
- Admninistrative Issues: If my institution has already joined SMART IRB Agreement v1.0, can my institution continue to use that Version 1.0?
- Administrative Issues: My institution is not serving as a Reviewing IRB for the NIH nor is it ceding IRB review to the NIH Intramural Research Program IRB. Does my institution need to sign SMART IRB Agreement v2.0?
- Administrative Issues: If my institution serves as a Reviewing IRB for the NIH engaged and for other institutions engaged in the Research, would all of the institutions engaged in that Research need to sign SMART IRB Agreement v2.0?
- Administrative Issues: Does my institution need to re-execute a Joinder Agreement to sign Version 2.0 of the SMART IRB Agreement?
- Administrative Issues: Re-execution of a Joinder Agreement to sign Agreement v2.0 & satisfaction of Section 1.2, HRPP Quality
- Administrative Issues: Does my institution need to document which version of the SMART IRB Agreement covers each of our reliance arrangements in effect?
- Reporting: How will reporting of noncompliance and unanticipated problems be handled by NIH?