The SMART IRB Agreement requires a Relying Institution to ensure that its Research Personnel are informed of and required to comply with the Relying Institution’s obligations under the Agreement regarding coordination, communication, compliance, and reporting. The Agreement also requires the Relying Institution to require its Research Personnel to comply with the Reviewing IRB’s requirements and determinations. How does a Relying Institution implement these requirements?
The Agreement does not dictate how Relying Institutions implement these requirements. Relying Institutions must determine for themselves how they can best ensure that their investigators and other Research Personnel are informed of the institution’s obligations when relying on an external IRB and how they will enforce these obligations internally. For example, some institutions may adopt policies and procedures for reliance arrangements, or may send written notification to investigators/personnel of specific requirements, or may require investigators/personnel to sign an acknowledgement or agreement as to specific responsibilities when they submit a protocol for ceded review.