The optional Indemnification Addendum

Applies to: Agreement V3.0 (§4.10 and Exhibit C)

What indemnification is. An agreement by one party to protect another from financial loss — typically the costs of third-party claims — arising from a shared activity. Earlier versions of the Agreement did not include an indemnification provision, so institutions that wanted one negotiated separate documents (for example, the Trial Innovation Network's Letter of Indemnification, on which the new Addendum is modeled).

What Version 3.0 offers. An optional, standardized Indemnification Addendum attached to the Agreement as Exhibit C. Institutions join it by e-signing a separate Indemnification Addendum Joinder in the Reliance System (§4.10). Institutions remain free to request, or enter into, other separate indemnification agreements instead.

Key facts

• Optional, but encouraged. Whether to join is entirely at each institution's discretion, and joining or declining does not affect eligibility to participate in the Agreement (§4.10).
• V3.0 first. Any Participating Institution in Version 3.0 can join, at the same time as the Joinder or later. Each legally separate entity signs its own Addendum Joinder.
• Scope (Exhibit C §2). Between two or more Addendum signatories, the Addendum applies to every Covered Activity they begin together after their Effective Dates, unless they agree to a narrower scope for particular activities. It does not supersede separate indemnification agreements for activities begun before an institution joined the Addendum.
• Private institutions (Exhibit C §3) are Indemnifying Parties: each agrees to hold harmless, indemnify, and defend the other signatory institutions in its Covered Activities — and their trustees, directors, Personnel, and IRB members — against Losses from third-party claims, but only to the extent the Losses are attributable to the Indemnifying Party's (or its IRB's or Personnel's) negligence, recklessness, or willful misconduct in performing its obligations, breach of the Agreement, or failure to comply with law. The Indemnifying Party controls the defense and any financial settlement, but may not agree to non-financial terms (such as an admission of liability) without the indemnified institution's consent.
• Public institutions other than federal agencies (Exhibit C §4) are Responsible Parties: each agrees to be responsible to and reimburse the other signatories for the same categories of Losses — but only to the extent its responsibility is not limited by law, regulation, or constitution. Signing does not waive any immunity, defense, or privilege the institution has (§6).
• Federal agencies may join and be indemnified, but will not indemnify others (Agreement §4.10). Where a third party is required by law to defend a federal institution, that may limit the Indemnifying Party's duty to defend, but not its duty to indemnify.
• Notice (Exhibit C §5). An institution seeking indemnification or reimbursement notifies the other party promptly in writing; late notice does not relieve the obligation except to the extent it materially prejudices the defense, and settlements made before notice are not reimbursable.
• Governing law and venue (Exhibit C §7). The law and courts of the defending institution's state govern a dispute under the Addendum, except as limited by law for public institutions; federal law governs for federal institutions. The Agreement itself has no governing-law clause.
• Conflicts. Where the Addendum or any other indemnification agreement conflicts with the Agreement, the Agreement prevails (§8.12).

Narrowing the scope. Two signatories can agree not to apply the Addendum to a specific study or body of research and document that agreement (for example, in the Implementation Checklist); they may then use a separate indemnification arrangement for that research. What they cannot do is turn the Addendum into a one-way indemnification. Institutions that want a one-way arrangement should use a separate, non-SMART IRB indemnification document, or agree that the Addendum will not apply to that study.

Leaving the Addendum. An institution may withdraw from the Addendum at any time; if it has ongoing Covered Activities it gives 60 business days' written notice to the institutions involved (§7.2.2.2). Participation in the Addendum ends automatically when participation in the Agreement ends (§7.2.2.3). Obligations for Covered Activities within the Addendum's scope survive any termination (§8.14).

How to see who has signed. The Indemnification column on the Participating Institutions page.

See also - Join the optional Indemnification Addendum - The insurance requirement - What survives termination