Criteria and Ethical Issues for Clinical Research of Spinal Cord Injury (review) / 中国康复理论与实践

ABSTRACT

The outcome of spinal cord injury is related to many factors, such as mechanism and severity of injury, and differences of individual. The standard of clinical trial plays a very important role in the reliability of the research. especially the inclusion and exclusion criterias, ethical issues, treatment standardization, informed consent and other issues. The effect of these factors on the clinical trial of spinal cord injury was summarized in this article. The inclusion and exclusion criterias to control the consistency should be developed based on the specific research content. Informed consent for clinical trial is also necessary, especially to the clinical trials with uncertainly benefits and risks, as well as the standardization of the operation procedures and rehabilitation treatment.