Research studies in critically ill populations pose many unique regulatory and ethical challenges that have implications for study design and execution. The life-threatening nature of conditions being studied and the urgency of rapid treatment initiation can make it difficult to obtain informed consent for patient enrollment. High illness severity may also affect judgments of equipoise, which can create hesitancy in critical care clinicians to enroll patients into clinical trials where an intervention may be randomized. These type of factors can decrease study feasibility, introduce selection bias, and reduce the generalizability of study findings. The complexity of these issues increases in the setting of multi-center studies, where local practice and regulatory requirements at each institution involved must be incorporated into research protocols. In addition, most institutions are involved in quality improvement initiatives, which often involve data collection and the implementation of new practices or interventions, and it can be unclear whether such projects should be considered research studies and what level of oversight is required.

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