Informed consent and other ethical and regulatory considerations in emergency research

Complex mechanisms are in place to protect research subjects and to ensure that participants are informed of the risks, benefits, and alternatives available to them prior to enrolling in a research study. However, the process for obtaining informed consent is obscured in the setting of medical emergencies, specifically when subjects are incapacitated. This makes progress in emergency, trauma, and resuscitation research challenging, disciplines in which there is an ongoing need to improve diagnostic and management strategies. There are several guidelines-such as the Declaration of Helsinki, The Common Rule, and the Final Rule-to help researchers navigate this terrain. Unfortunately, none of these regulations sufficiently defines the nuances regarding informed consent among patients in need of emergent intervention. In this chapter, we seek to shed light on the ethical and regulatory considerations surrounding research subjects in emergent medical situations, particularly with regard to the appropriate interpretation of informed consent. As the administrative landscape continues to evolve, principles concerning emergency research should be further standardized to offer sufficient protection to study subjects, while permitting research efforts to proceed without excessive regulatory burden. Throughout this process, it will be crucial for researchers to understand the ethical principles that dictate policy among this uniquely vulnerable population.

Duke Scholars

Author Daniel Philip Nussbaum Surgical Oncology