Rethinking Local Institutional Review Board (IRB) Review at State Health Departments: Implications for a Consolidated, Independent Public Health IRB

Several unique problems plague human research protection efforts at State Departments of Health (DOHs). First, parsing public health activities into research or practice can be vexing and likely produces variability in how individual DOHs make the determination between research and practice and in the outcomes of such decisions for the same or similar projects. A second problem is that DOH or Institutional Review Board (IRB) officials may misclassify public health practice activities as research (and vice versa), which can have costly, adverse consequences. The third problem pertains to the unique political situation that exists at DOHs. Since DOH IRBs report to and are accountable to publicly elected or appointed officials, many decisions and determinations have unknown or unforeseen political consequences that might endanger the public health employees that make them. Given (1) the paucity of research or data on the prevalence of these problem at DOHs, (2) the lack of clarity in the public health legal resources designed to help clarify crucial research determinations, and (3) the potential, adverse impact on public health, IRB review at DOHs and DOH failure to distinguish research from practice activities represent under-appreciated impediments to public health – one that an independent, centralized or regionalized IRB for public health might ameliorate. This presentation will expound in detail on these problems and suggest that while public health agencies are in the midst of reviewing the regulations for how IRBs operate, the time is also ripe to rethink local review of research by public health departments.