涉及人的生命科学和医学研究伦理审查委托合同指引

Guidelines for Ethical Review Entrustment Contract of Life Science and Medical Research Involving Humans

通过伦理审查,是涉及人的生命科学和医学研究开展的必要条件和前提条件。目前部分医疗卫生机构没有伦理审查能力或者审查能力不足。伦理审查能力的欠缺和不足,成为制约涉及人的生命科学和医学研究开展的瓶颈。《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》《关于加强科技伦理治理的意见》等文件提出,机构可以书面委托有能力的机构伦理审查委员会或者区域伦理审查委员会开展伦理审查。委托审查为需要开展涉及人的生命科学和医学研究但是未设立伦理(审查)委员会或者伦理(审查)委员会无法胜任审查的机构,提供了可行的解决途径。开展委托审查需要委托人和受托人正式达成委托。《涉及人的生命科学和医学研究伦理审查办法》规定医疗卫生机构及其伦理审查委员会未接受正式委托为其他机构出具伦理审查意见的,将由县级以上地方卫生健康主管部门对有关机构和人员依法给予行政处罚和处分。签署委托审查合同,实施合法合规的委托审查,才能更有效地保护受托人和委托人的权益,保护研究参与者。

The passing of ethical review is a necessary conditions and prerequisite for the development of life science and medical research involving humans.At present,some medical and health institutions have no or insufficient ethical review capabilities.The lack of ethical review ability has become a bottleneck restricting the development of life science and medical research involving humans.According to documents such as Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Pharmaceutical and Medical Devices,Opinions on Strengthening the Ethical Governance of Science and Technology,institutions can entrust competent institutional ethics review committees or regional ethics review committees in writing to conduct ethical review.Entrustment ethical review provides a viable solution for institutions that need to carry out life science and medical research involving humans but do not have an ethics(review)committee or the ethics(review)committee is not competent to review.To conduct the entrustment ethical review,the entrustment between the principal and the trustee is required.According to The Measures for Ethical Review of Life Sciences and Medical Research Involving Humans,if medical and health institutions and their ethical review committees do not accept the formal entrustment to provide the ethical review opinions for other institutions,the local health authorities at or above the county level will impose administrative penalties and sanctions on the relevant institutions and personnel in accordance with the law.Signing the entrustment ethical review contract,implementing legal compliance entrusted ethical review to protect the rights and interests of the trustee and the principal,and protect the research participants.