Affiliates, FWAs, and who has to join

Applies to: Agreement V3.0

Each legally separate institution joins on its own — including a legally separate affiliate that is covered under another institution's Assurance (§1.4.4). An affiliated hospital, health system, or campus that is its own legal entity must register in the Reliance System and execute its own Joinder Agreement, whether or not it holds its own FWA. A Joinder covers one Participating Institution only; there is no way to join "through" a parent or partner institution. The same rule applies to the Indemnification Addendum Joinder.

Parts of the same legal entity are covered by that entity's Joinder. Departments, schools, and campuses that are not legally separate from your institution participate under your Joinder. Your Point of Contact should tell SMART IRB (help@smartirb.org) when the components covered by your Assurance change, so the Reliance System reflects who is included.

Use the affiliate decision tree to work through your structure.

Can one person act for more than one institution? Yes, on both counts, if the institutions grant that authority:

• The same person can register and serve as Point of Contact for several institutions.
• The same Institutional Official can sign the Joinder Agreements for two institutions with separate Assurances — common in university–hospital affiliations. Each institution decides whom it authorizes.

If you serve several institutions, ask help@smartirb.org to associate your Reliance System account with each of them.

See also - What are the eligibility criteria? - Join SMART IRB (step by step)