Informed consent competency assessment for brain-computer interface clinical research and application in psychiatric...

Area of Science:

• Neuroscience
• Psychiatry
• Bioethics

Background:

• Brain-computer interface (BCI) technology is rapidly advancing in psychiatric applications.
• Assessing informed consent competency (ICC) in psychiatric patients is critical for ethical clinical research.

Purpose of the Study:

• To analyze the assessment of ICC in psychiatric patients undergoing BCI research.
• To develop a multi-dimensional framework for evaluating ICC in BCI clinical research for psychiatric disorders.

Main Methods:

• A systematic review of 103 studies on ICC assessment in BCI research involving six types of psychiatric disorders.
• Literature search conducted across PubMed, ScienceDirect, and Web of Science with no date restrictions.

Main Results:

• Executive function impairment significantly impacts ICC; processing speed and memory deficits are noted in conditions like schizophrenia and Alzheimer's disease.
• Key ethical issues in BCI research include specificity, vulnerability, autonomy, dynamic ICC, comprehensiveness, and uncertainty.
• Fifty-eight studies detailed ICC factors, while 45 addressed ICC-related ethical issues.

Conclusions:

• A novel Five-Dimensional evaluative framework (clinical, ethical, sociocultural, legal, procedural) is proposed.
• This framework aims to enhance future ICC research in BCI clinical trials involving psychiatric populations.