Feasibility of a national fatal asthma registry: More evidence of IRB variation in evaluation of a standard protocol

Purpose Approximately 4500 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 examiner 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 HIPAA. The project was revived in 2004 when a standard protocol was submitted to IRBs in four different states. Results All vital statistics departments reported that they were able to identify the decedentʹs 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 Examinerʹs offices. In late 2003, investigators in Massachusetts met with their IRB Chair and made two detailed revisions of the protocol, which resulted in local IRB approval of a protocol with methods that complied with HIPAA guidelines, as interpreted by the IRB at their institution. This version was then shared with investigators in three other states. Even after extensive review and approval in Massachusetts, and close contact between investigators at each site and their local IRB, there was an average of two revisions required at the other three participating sites before approval was obtained. Based on different interpretations of HIPAA, each IRB 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.