Study on the Minimal Risk Evaluation Criteria for Simple Interventions in Pediatric Biomedical Research
10.12026/j.issn.1001-8565.2018.02.16
- VernacularTitle:儿童生物医学研究中简单干预措施的最小风险评估标准研究
- Author:
Hongrong YANG
1
;
Yan TANG
;
Yiqun XI
Author Information
1. 上海市儿童医院/上海交通大学附属儿童医院伦理委员会
- Keywords:
Pediatric Biomedical Research;
Simple Intervention;
Minimal Risk;
Evaluation Criteria
- From:
Chinese Medical Ethics
2018;31(2):224-229
- CountryChina
- Language:Chinese
-
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.
