Feasibility of a National Fatal Asthma Registry: More Evidence of IRB Variation in Evaluation of a Standard Protocol

Abstract

Purpose. Approximately 4,500 Americans die from asthma each year. Our objective was to determine the feasibility of creating a national fatal asthma registry to better understand this problem. Methods. Using a standard questionnaire, 18 state vital statistics departments and 22 medical examiners offices were contacted in 2001 to assess availability of fatal asthma data. Funding was obtained in 2002 to implement a fatal asthma registry. During 2003, the project was put on hold due to uncertainty about the impact of the Health Insurance Portability and Accountability Act (HIPAA). The project was revived in 2004 when a standard protocol was submitted to Institutional Review Boards (IRBs) in four different states. Results. All vital statistics departments reported that they were able to identify the decedent's name and demographic characteristics. Contact information for a relative or doctor was available in all states. Demographic characteristics and autopsy findings were available from 100% of the medical examiners offices. However, IRBs at the four institutions required major protocol modifications, including language and approach for contacting next of kin. Conclusion. Availability of demographic and clinical data across states is consistent. The creation of a national fatal asthma registry appears feasible, but different IRB interpretations of what is permissible preclude a standard approach across states.