Facilitating Efficient and Ethical Trials at the Intersection of Research and Clinical Care.

The editorial discusses the challenges faced by investigators conducting research within clinical care settings, particularly in navigating institutional review board (IRB) approval processes. The authors propose a normative framework to align ethical oversight with the level of risk and burden posed by research activities, advocating for a more proportionate approach to consent requirements. They argue that current regulatory interpretations have led to confusion and propose adjustments to facilitate efficient and ethical trials at the intersection of research and clinical care. The authors emphasize the need for regulatory clarity to support ethical goals and encourage IRBs to focus on the unique risks of research activities rather than conflating them with standard care risks. [Extracted from the article]