What if an amendment (change of protocol) could be affected by the state law or other local institutional requirements from a Relying Institution?
If the SMART IRB Standard Operating Procedures (SOPs) are used, the Points of Contact (POCs) at Relying Institutions must authorize amendment submissions that appear to affect any local or state law, “local consideration” or "other consideration" issues that a Relying Institution noted as part of its original agreement to cede review. If a study team is not sure whether an amendment is affected by state law or other local institutional requirements, they can consult with their institution’s POC. If the Reviewing IRB is unsure whether an amendment is affected by state law or other local institutional requirements, they can consult with the POC from the Relying Institution.
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