How will any outstanding concerns/requirements and/or local context issues be addressed?

A Relying Institution is required to identify, interpret and communicate to the Reviewing IRB the requirements of any applicable state or local laws, regulations, institutional policies, standards, or other local factors, including local ancillary reviews and restrictions on use and disclosure of PHI, and federal laws and regulations other than human subjects protection regulations that are relevant to a research study for which review is being ceded under the Agreement. The Reviewing IRB is not expected to identify or interpret such requirements on its own. The Reviewing IRB is required to consider and apply any local requirements communicated to it by the Relying Institution in connection with its review of the research study. Because the Relying Institution is in the best position to identify and interpret applicable local requirements, this responsibility remains with the Relying Institution. Relying institutions are encouraged to develop appropriate procedures to ensure applicable local requirements are communicated by individuals knowledgeable about those requirements.

When written informed consent is required for a research study, the Reviewing IRB will provide informed consent documents for use by the Relying Institution/Site Investigator. The Relying Institution may customize site-specific language within the documents, e.g., the availability of treatment and compensation for research-related injury, payment/reimbursement of costs incurred by subjects for participation, and Site Investigator contact information. To the extent the Relying Institution requires specific consent language to ensure compliance with any applicable state, local or federal (other than human subjects protection) laws or regulations, it should provide that language to the Reviewing IRB.