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33 Ethical Review of Clinical Research During an Emergency Response

  • Jerome F. Pierson

摘要

This chapter focuses on the ethical review of clinical research implemented in an emergency response carried out in partnership between two countries. This material could also apply to other research partnerships; the roadmap it provides for investigators and planners in an emergency research response, along with the ethical considerations described, also apply to planning and oversight in non-emergency research. Whether part of an emergency response or not, research must be fully compliant with applicable guidelines for human participant protections. It must also be scientifically sound to be ethical; putting people at risk (however minimal) without a reasonable prospect of health benefits cannot be justified. Diverting scarce clinical research capacity to substandard trials during an emergency is also arguably unethical. Establishing good ethical review for clinical research during an epidemic, especially in low-resource areas, is daunting. However, researchers should never lose sight of their goal: ethically and scientifically sound research that leads to better medical care for people suffering from disease.