Ethical and regulatory considerations in the design of traumatic brain injury clinical studies.

Research is essential for improving outcomes after traumatic brain injury (TBI). However, the ubiquity, variability, and nature of TBI create many ethical issues and accompanying regulations for research. To capture the complexity and importance of designing and conducting TBI research within the framework of key ethical principles, a few highly relevant topics are highlighted. The selected topics are: (1) research conducted in emergency settings; (2) maintaining equipoise in TBI clinical trials; (3) TBI research on vulnerable populations; and (4) ethical considerations for sharing data. The topics aim to demonstrate the dynamic and multifaceted challenges of TBI research, and also to stress the value of addressing these challenges with the key ethical principles of respect, beneficence, and justice. Much has been accomplished to ensure that TBI research meets the highest ethical standards and has fair and enforceable regulations, but important challenges remain and continued efforts are needed by all members of the TBI research community.