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Exhibit A <br /> Copy of Waiver <br /> 1'111' UN1Vt'ItS1`1'Y <br /> ol' NORT11 CAROLINA <br /> 11 4 II A 1't• I If 1 1 1, <br /> April 11, 2013 <br /> Replaces letter dated 1/3/2013 and is revised to provide a more comprehensive study description <br /> and to clarify that research is limited to decedents. <br /> To: Eugene Chung <br /> Heart And Vascular Center <br /> From: Office of Human Research Ethics <br /> Date: 4/11/2013 <br /> RE: Determination that Research or Research-Like Activity does not require IRB Approval <br /> Study#: 12-0083 <br /> Study Title: NC Sudden Unexpected Cardiac Death Registry <br /> This submission was reviewed by the Office of Human Research Ethics, which has determined <br /> that this submission does not constitute human subjects research as defined under federal <br /> regulations [45 CFR 46.102 (d or f) and 21 CFR 56.102(c)(e)(1)] and does not require IRB <br /> approval. <br /> The use or disclosure of PHI is sought solely for research on PHI of decedents. If the IRB <br /> requests it, the researcher will provide documentation to the death of the individuals. <br /> Study Description: <br /> Background <br /> Sudden unexplained death (SUD), also known as sudden cardiac arrest(SCA) and sudden <br /> cardiac death (SCD) is the most common cause of death in the United States. Estimates of SUD <br /> in the US vary widely, from 180,000 to >450,000 annually. The mechanisms of SUD are poorly <br /> understood. Large population studies point to fatal cardiac arrhythmias as the culprit. Cohort <br /> studies of SUD victims confirm this view, but generally these studies have been done on <br /> homogeneous populations, largely consisting of Caucasians in Oregon and Europe. <br /> 4 <br /> I <br />