本文選題：研究者發(fā)起的臨床研究 + 生物醫(yī)學(xué)研究　； 參考：《中國(guó)新藥雜志》2017年22期

【摘要】：研究者發(fā)起的臨床研究在監(jiān)督管理的操作層面存在不足,目前大多數(shù)機(jī)構(gòu)由倫理委員會(huì)進(jìn)行審批、評(píng)估風(fēng)險(xiǎn)從而保護(hù)受試者。受試者在參加臨床研究時(shí)會(huì)受到來(lái)自身體生理傷害、心理精神危害、隱私侵犯與個(gè)人信息資料泄露以及經(jīng)濟(jì)侵犯的風(fēng)險(xiǎn),風(fēng)險(xiǎn)存在不大于最小風(fēng)險(xiǎn)、低風(fēng)險(xiǎn)、中度風(fēng)險(xiǎn)和高風(fēng)險(xiǎn)4個(gè)等級(jí)。倫理委員會(huì)在審查時(shí)應(yīng)基于風(fēng)險(xiǎn)進(jìn)行評(píng)估,考慮研究?jī)?nèi)容和研究操作所帶來(lái)的風(fēng)險(xiǎn),從研究人員資質(zhì)、受試人群的選擇、前期研究基礎(chǔ)、干預(yù)因素及應(yīng)急搶救預(yù)案等方面綜合評(píng)估。本文從超說(shuō)明書(shū)用藥研究、特殊人群的臨床研究、醫(yī)療新技術(shù)臨床應(yīng)用和不大于最小風(fēng)險(xiǎn)的臨床研究4個(gè)方面淺析倫理委員會(huì)如何對(duì)研究者發(fā)起的臨床研究進(jìn)行基于風(fēng)險(xiǎn)的倫理審查。
[Abstract]:The clinical research initiated by the researchers is inadequate in the operational level of supervision and management. At present, most institutions are approved by the ethics committee to assess the risks and protect the subjects. The subjects were exposed to the risks of physical and psychological harm, privacy invasion and personal information leakage, and economic aggression when they participated in clinical studies. The risk was not greater than the minimum risk and the low risk. Moderate risk and high risk 4 grades. The ethics committee should make an assessment based on the risk, consider the risk of the research content and the research operation, from the qualification of the researcher, the selection of the subjects, the basis of the previous research, Comprehensive evaluation of intervention factors and emergency rescue plan. In this paper, the study of drug use in the supermanual, the clinical study of special population, Clinical application of new medical technology and clinical research with no greater than minimum risk: an analysis of how the Ethics Committee conducts a risk-based ethical review of clinical research initiated by researchers.
【作者單位】： 中國(guó)人民解放軍總醫(yī)院藥物臨床研究中心;
【分類(lèi)號(hào)】：R95

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