临床试验的伦理审查:服刑人员、劳教人员

Ethic review in clinical research: persons who are serving a sentence or receiving reeducation through labour

本文所谓的“服刑人员”是指监狱服刑人员,“劳教人员”是指劳动教养管理所的收容人员,简称“服刑劳教人员”。涉及这一特殊群体临床研究的伦理审查要求包括:伦理委员会的组成应该包括具有相应背景和经验的服刑劳教人员代表;研究是针对服刑劳教人员所患的疾病,并且如果不选择服刑劳教人员为受试者,研究不能同样好地进行;最小风险应该参照“健康人群”进行判断;知情同意应充分尊重其自主选择权;试验结束后治疗安排;以及公平招募,保护隐私,合理补偿等。

Persons who are serving a sentence refer to those who are serving a sentence in a prison, Persons who are receiving reeducation through labour refer to those who are receiving reeducation through labour in an institution, for short, both are called persons who are serving a sentence or receiving reeducation through labour. Ethical justification for research involving this special group are as follow： specific IRB should include someone who has appropriate background and experience to serve in that capacity; the research might not equally well be carried out with subjects other than persons who are serving a sentence or receiving reeducation through labour; definition of minimal risk shouldn＇ t be compared with the risks normally encountered by this special group, but rather that of healthy persons; free choice in informed consent should be ensured; arrange treatment for research subjects after research terminated; fairly distribute research burdens; maintain confidentiality of research data and privacy; reasonable payment need to be considered, etc.