Getting the ethics right regarding research in the emergency setting: Lessons from the PolyHeme Study

Research in emergency settings (RES) has become a major public issue with urgent policy implications. Significant attention has focused recently on RES in response to the trial of PolyHeme, a synthetic blood substitute, in trauma victims in hemorrhagic shock. Unfortunately, the discussion of the PolyHeme trial in the popular and scholarly press leaves important questions unanswered. This paper articulates three important lessons from the PolyHeme trial that have significant policy implications. First, the RES regulations should be re-visited, particularly the requirement that existing treatments be unproven or unsatisfactory in order for research to be acceptable without consent. Second, further conceptual and empirical scholarship is needed to accomplish the goal of effectively involving communities. Third, a more subtle analysis is needed regarding how to balance the needs of maintaining public trust and protecting confidential trade information in the context of RES.