Who investigates if there is a problem or noncompliance in research covered under the SMART IRB Agreement?

Both the Reviewing IRB and the Relying Institution have authority to conduct an investigation or audit of any allegation or matter relating to a research study for which review is ceded under the Agreement. Such investigations may be conducted separately or jointly. The Reviewing IRB also has the authority to request the Relying Institution to conduct such investigation. Regardless of whether it is the Reviewing IRB or the Relying Institution that conducts an investigation, the other party is required to reasonably cooperate with the investigation, and the investigating party is required to report its findings of fact to the other. No party is required to share information that is protected by attorney-client privilege or other applicable legal privileges.

The Relying Institution must comply with any corrective actions required by the Reviewing IRB, but may also adopt its own additional corrective actions.