A Scoping Review on Bioethics Challenges of Conducting Clinical Research in Patients with Traumatic Brain Injury: Revisiting the Informed Consent Process

Background: Conducting research in emergency departments and critical care units is crucial for improving patient management through evidence-based practices. Healthcare professionals and researchers in the field of traumatic brain injury (TBI) have a moral and legal obligation to inform patients before conducting any diagnostic test or therapy as part of a clinical study. However, challenges and barriers to conducting research in these high-pressure environments must be acknowledged. Shall the pathway to obtain informed consent in TBI-related research be revisited? We sought to map literature, identify gaps, and clarify the bioethics that should be followed in TBI-related research. Methods: A Scoping review was conducted to identify the obstacles and challenges investigators encounter in clinical and translational TBI research, with a specific emphasis on informed consent and regulatory impediments that often serve as bottlenecks or rate-limiting steps for participant enrollment and overall study success. This review used google scholar and Midline from inception to 2025. Results: Patients with TBI or their surrogates may be unable to provide informed consent within limited therapeutic windows. Despite international regulations and national laws, restrictions on obtaining consent are often criticized as ambiguous in certain situations. Furthermore, the fast-paced, emotionally charged atmosphere in emergency settings poses a risk of delaying crucial research interventions. There are accepted alternatives to informed consent, such as proxy consent, deferred consent, exceptions from consent, and waivers of consent, which are ethically and socially acceptable and compliant with regulations. However, these alternatives are underutilized or may be abused in some cases. Conclusions: This review calls for clarifying and modifying arbitrary regulatory restrictions on research and streamlining the Common Rule. Scientists should also share their innovative solutions to strike a balance between ethical considerations and the minimization of research barriers.