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Effective January 1, 2003, California law requires local IRBs to review research using State of California-produced death data files containing personal identifying information (i.e., state issued death certificates and indices). This new law is more restrictive than federal human research protection regulations, which govern use of living humans or identifiable data about living humans. In short, the state now requires IRBs to protect identifiable information from state death data files as carefully as information about living persons. UCSD researchers wishing, for research purposes, to obtain state death data files containing personal identifying information are now required to submit an application for IRB review. Because state death records do not fall under the federal exemption from IRB approval for research on publicly available existing data (as these records are no longer publicly available), such studies may require expedited review under 45 CFR 46.110. In order for an IRB to permit such a study, the state requires that the researcher must have a "valid scientific interest." The full text of the relevant sections of the law is available here in PDF format. In most cases, research involving decedent records will be biomedical in nature, and the project should be submitted for review using the Biomedical Project application. For assistance in understanding and complying with this law, call HRPPat
858-455-5050 or send e-mail to hrpp@ucsd.edu
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