Applies to: Agreement V3.0
The Letter of Acknowledgment (LOA) is the primary way to document a reliance arrangement for a study when institutions are not using the Reliance System or IREx. With Version 3.0 there are three templates; pick one per arrangement.
| Version | Use it when… | Download |
|---|---|---|
| Basic | You want a one-page record of who is relying on whom for which study, and nothing more. Closest to the original 2017 letter. | Basic |
| Default Implementation | The standard terms of the Agreement and the SMART IRB SOPs apply. The letter says so explicitly, and you can note default terms that are easy to forget (whether HIPAA applies, for example). | Default |
| Flexible Implementation | The institutions are exercising one or more flexible provisions — insurance waiver, HIPAA arrangements, alternative SOPs, reporting responsibilities, indemnification scope. The letter lists every option; keep the ones that apply and delete the rest. Replaces the "flexible terms addendum" many institutions used to write. | Flexible |
Features common to all three - Validation options for IRB/HRPP staff to declare the implementation approach. SMART IRB does not require a signature on an LOA; add or remove signature blocks to fit your institution's policy. - Points of Contact are linked to the Participating Institutions page rather than typed in, so they stay current.
Customizing. Institutions routinely add logos, signature blocks, eIRB numbers, grant numbers, and local contacts. Any customization is fine as long as it does not contradict the Agreement.
Storing. Regulators may ask for the LOA in an audit. Store it where IRB/HRPP staff can find it — in your eIRB system and wherever your institutional policy requires.
See also - The Implementation Checklist - Default vs. flexible implementation - Customize SMART IRB resources for your institution
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