The insurance requirement

Applies to: Agreement V3.0

The Agreement (§4.9) sets a basic expectation that Participating Institutions carry liability coverage for their and their Personnel's research, Covered Activities, and obligations under the Agreement — including coverage of the IRB and its members when acting as a Reviewing IRB. It does not specify policy types or minimum amounts, because institutions insure research risk differently depending on their size, structure, and legal status.

What Version 3.0 changed

• Self-funded coverage counts. An institution may rely on self-insurance or a self-funded liability program instead of, or in addition to, commercial insurance.
• Public institutions are exempt. Participating Institutions that are local, state, or federal government entities are not required to maintain insurance coverage for their activities under the Agreement.

Checking a partner's coverage. Before agreeing to a Covered Activity, any Participating Institution may ask another that is subject to §4.9 for a certificate or equivalent documentation of its coverage (including sponsor-provided coverage), and may decline to participate if it does not consider the coverage adequate.

Waiving the requirement. Institutions may mutually agree to waive the insurance requirement for a particular study — a flexible implementation documented in the Implementation Checklist or the Flexible LOA.

Federal institutions. Federal agencies are covered by federal statutes such as the Federal Tort Claims Act rather than by insurance. NIH has said it cannot provide case-by-case detail about which NIH-affiliated individuals would be covered in a hypothetical event; institutions with questions should consult their own counsel. The Department of Justice's FTCA overview is a starting point.

See also - The optional Indemnification Addendum - Default vs. flexible implementation