Study on the Minimal Risk Evaluation Criteria for Simple Interventions in Pediatric Biomedical Research / 中国医学伦理学

ABSTRACT

Objective:To collect the simple interventions in pediatric biomedical research and analyze the risk condition, to establish the minimal risk evaluation criteria, thus to provide the scientific method for the ethical re-view of pediatric biomedical research. Methods:The expert consultation was carried out on the minimal risk evalu-ation of the simple interventions for pediatric biomedical research, and 25 experts from 11 medical institutions car-rying out children' s clinical research were selected to conduct 2 rounds of expert consultation. Results:25 valid questionnaires were collected, and the positive coefficient of the respondents was 100％. The judgment and famili-arity or degree of attention on the related problems was 0 . 764 . The minimal risk evaluation criteria of 25 simple in-terventions in 4 dimensions were determined. Conclusion: We determine the minimal risk evaluation criteria for simple interventions in pediatric biomedical research using the Delphi method, and the research results were relia-ble and could provide a reference for the ethical review of pediatric biomedical research.