Getting the Ethics Right Regarding Research in the Emergency Setting: Lessons from the PolyHeme Study

Abstract

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.

Community attitudes towards emergency research and exception from informed consent

“…The public trust is required for in acceptance of all research; with EFIC studies, it is especially important. Public confidence in the research enterprise can be strengthened with thoughtful approaches to community engagement ( 17,18). …”

Patients' perceptions of research in emergency settings: A study of survivors of sudden cardiac death

“…Many stated that individual interests should not be compromised, but most acknowledged that research involves risks that might not otherwise exist, reflecting a tension at the heart of research ethics. Determining what constitutes reasonable risk in emergency settings is a project with serious policy implications (Dickert & Sugarman, 2007). Estimating risk and benefit are technical tasks best done by the medical community, but determining the reasonableness of risk-benefit tradeoffs is a value judgment that should consider the views of people likely to be enrolled (Brody, 1995; Karlawish, 1996).…”

Part 3: Ethics

“…95,96 This has proven to be a challenge for research involving patients in cardiac arrest because research interventions must frequently be implemented at a time when it is impossible to obtain consent. 97,98 After much public discussion and in recognition of the value of this type of human research, the United States government, through the Food and Drug Administration and the National Institutes of Health, adopted regulations that allow an exception for the need to obtain informed consent in certain limited circumstances. 99 These exceptions to informed consent for research enrollment apply only if the following conditions are met:…”