A Scoping Review on Bioethics Challenges of Conducting Clinical Research in Patients with Traumatic Brain Injury:...

Area of Science:

• Emergency Medicine
• Neuroscience Research
• Bioethics

Background:

• Research in emergency departments and critical care is vital for evidence-based patient management.
• Traumatic Brain Injury (TBI) research requires adherence to ethical and legal standards for informed consent.
• High-pressure environments present unique challenges to research conduct and participant consent.

Purpose of the Study:

• To map existing literature on obstacles in TBI research, focusing on informed consent and regulatory issues.
• To identify gaps in current bioethical guidelines for TBI research.
• To clarify ethical considerations for conducting research with TBI patients.

Main Methods:

• A Scoping review was performed using Google Scholar and Medline.
• The review covered literature from inception to 2025.
• Focus was on challenges in clinical and translational TBI research, particularly informed consent and regulatory impediments.

Main Results:

• TBI patients or surrogates may lack capacity for informed consent within critical timeframes.
• Regulatory restrictions on consent are often ambiguous and criticized.
• Alternative consent methods (proxy, deferred, exceptions, waivers) are underutilized or prone to abuse, despite being ethically sound.

Conclusions:

• Clarification and modification of regulatory restrictions, including the Common Rule, are needed.
• Innovative solutions are required to balance ethical obligations with research barriers.
• Streamlining regulations can facilitate ethical TBI research while protecting participants.