Working together when there is a dispute or breach

Applies to: Agreement V3.0

Version 3.0 asks institutions to solve problems together before anyone reaches for withdrawal or termination. When a Participating Institution has concerns about another's potential noncompliance with, or breach of, the Agreement — whether prompted by a §4.6.1 notification or otherwise — it may raise them at any time, including through discussion between the Institutional Officials; other options include consulting the relevant regulatory agency or engaging a neutral third party. Nothing in this section limits an institution's right to enforce the Agreement, but the parties agree to work together in good faith to resolve concerns when possible (§4.6.2). Every institution must also work diligently to correct its own noncompliance with applicable law and with its Agreement obligations (§§4.2, 4.3).

Where concerns cannot be resolved, a Reviewing IRB may withdraw from a study for significant cause with 60 business days' notice (§2.5.2.2), and only a Participating Institution itself — never another institution — can end its participation in the Agreement (§7.2.1).

See also - Ending a reliance arrangement for a study - Terminating your institution's participation