摘要
医疗器械临床试验研究者技术水平直接影响试验的效度和风险,但目前几乎所有的研究方案和知情同意书都没有指定研究者。通过对三份知情同意书内容的分析认为,"研究者信息"是受试者非常关注也有权利知晓的,为尊重受试者自主权、维护研究公正、减少伤害、维持社会和谐,涉及手术操作的有重大风险的医疗器械临床试验研究者的信息应告知受试者,对此,政策或伦理审查实践中应提出明确要求。
The technological level of medical device trials researchers directly affects the validity and risk of tri- als, but now almost all the research programs and informed consents don＇t have designate researchers. The analy- ses of the contents of three informed consents suggested that ＂researcher information＂ was that the subjects paid great attention to and had the right to know; in order to respect the subject autonomy, maintain the justice of re- search, reduce the harm and maintain social harmony, the information of researchers of medical device clinical trials with significant risk involved operation should be informed to subjects. In this regard, policy and ethical review should make clear requirements in practice.
出处
《中国医学伦理学》
2017年第12期1517-1521,共5页
Chinese Medical Ethics
基金
教育部人文社科规划基金(12YJA720003)
山西省高等学校哲学社会科学研究项目(2014319)
国家社科基金项目(14BFX161)
关键词
医疗器械临床试验
研究者信息
伦理辩护
Medical Device Clinical Trials
Researcher Information
Ethical Defense
