Summary Report: Workgroup on Human Subjects Protection (IRB) and Health Information Portability and Accountability Act (HIPAA), February 7, 2007: Issues Related to Developing a National Surveillance System and Registries for Amyotrophic Lateral Sclerosis (ALS) and Multiple Sclerosis (MS)

摘要

The Agency for Toxic Substances and Disease Registry (ATSDR) has had an interest in surveillance for selected neurological and autoimmune diseases because of the lack of information necessary to answer community concerns about the incidence and prevalence of these diseases. In September 2002, ATSDR held a series of expert panels to begin exploring issues related to the design and maintenance of a successful surveillance system for selected neurological and autoimmune diseases. In March of 2006, a workshop was held to specifically discuss surveillance for multiple sclerosis (MS) and amyotrophic lateral sclerosis (ALS). MS and ALS were selected as the focus of the surveillance effort because of the large number of databases and research registries that already existed for these two diseases. At this meeting, a strategy of coordinating these extant groups to create a large database was discussed. In July 2006, ATSDR continued to advance the goal of surveillance systems for MS and ALS by funding five pilot projects, three in ALS and two in MS, which would attempt to implement a surveillance system for a defined geographic area. Information gained from these pilot projects would be used to guide the national effort. The issues of human subjects protection and privacy have major implications for the success of such a strategy for a surveillance system. Therefore, it was decided to hold this workshop to discuss issues related to Human Subjects Protection (IRB) and the Health Insurance Portability and Accountability Act Privacy Rule and their implications for how the surveillance system might be structured.