What laws and regulations must the Reviewing IRB consider?

What laws and regulations must the Reviewing IRB consider in reviewing a study under the SMART IRB Agreement? Who is responsible for determining that a study is compliant with all applicable laws and regulations?

The Agreement requires a Reviewing IRB to perform its review in accordance with federal human subjects protection regulations. These include the Common Rule, the FDA human subjects regulations, and any human subjects regulations of federal agencies that do not follow the Common Rule (as applicable to the study). The Agreement also requires the Reviewing IRB to make certain determinations under the federal HIPAA privacy regulations, unless the Reviewing IRB communicates to the Relying Institution that it will not make these determinations.

 The Agreement also requires a Reviewing IRB to take into account any local requirements communicated to it by the Relying Institution in connection with the study. These local requirements may include applicable state and local laws and regulations; institutional policies, standards or other local factors (including local ancillary reviews and restrictions on use and disclosure of PHI); and applicable federal laws and regulations other than human subjects protection regulations that may affect the study. An example of potentially applicable federal laws and regulations other than human subjects protection regulations is 42 CFR Part 2, regarding the confidentiality of certain substance abuse treatment records. If a study involves use/disclosure of such records, the Relying Institution would be expected to communicate any requirements applicable to its site under these regulations to the Reviewing IRB.

 As a result of this allocation of tasks, the Reviewing IRB is responsible to assure that its review and the study comply with federal human subjects protection regulations. Although as part of that review it is required to consider and apply those local requirements communicated to it by the Relying Institution, the Reviewing IRB is not responsible for identifying the local requirements (including federal requirements other than the human subjects protection regulations) or for interpreting the local requirements. The Reviewing IRB depends on the Relying Institution to identify and interpret the local requirements and ultimately to determine whether the research reviewed by the Reviewing IRB meets the local requirements.