Criteria and Ethical Issues for Clinical Research of Spinal Cord Injury (review)
10.3969/j.issn.1006-9771.2016.02.007
- VernacularTitle:脊髓损伤临床研究的纳入标准和伦理问题
- Author:
Yuming WANG
;
Huiming GONG
;
Yonggang WU
;
Ke MA
;
Jianjun LI
- Publication Type:Journal Article
- Keywords:
spinal cord injury;
clinical trial;
inclusion criteria;
ethics;
review
- From:
Chinese Journal of Rehabilitation Theory and Practice
2016;22(2):156-159
- CountryChina
- Language:Chinese
-
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.