研究者发起的临床研究生物样本委托检测合同审查思考和建议  

Considerations and recommendations through the review of agreement for the delegations of biological sample testing in investigators initiated trial

作　　者：曹烨[1] 张斅琳 杨海燕 苏钿欢 杨秋意 何莲珠[1] 关光俊 CAO Ye;ZHANG Xiao-lin;YANG Hai-yan;SU Tian-huan;YANG Qiu-yi;HE Lian-zhu;GUAN Guang-jun(Cancer Center,Sun Yat-sen University,Guangzhou 510060,China;Hospital of Stomatology,Sun Yat-sen University,Guangzhou 510055,China;Renji Hospital,School of Medicine,Shanghai Jiao Tong University,Shanghai 200120,China;Guangzhou Eighth People's Hospital,Guangzhou Medical University,Guangzhou 510030,China)

机构地区：[1]中山大学肿瘤防治中心,广州510060 [2]中山大学附属口腔医院,广州510055 [3]上海交通大学医学院附属仁济医院,上海200120 [4]广州医科大学附属市八医院,广州510030

出　　处：《中国新药杂志》2022年第19期1914-1921,共8页Chinese Journal of New Drugs

摘　　要：随着生物医学、精准治疗的高速发展,研究者发起的临床研究(investigator initiated trial,IIT)生物样本委托检测合同日益增多,成为约定委托检测服务各方的重要契约文件。本文通过对国内2家医院2017年1月—2022年12月期间受理的50份IIT样本检测合同进行回顾分析,总结归纳IIT样本检测合同的一般特征及审查常见问题。50份合同以中文文本为主,检测机构以企业为主,项目类型以前瞻性队列研究、前瞻性单臂研究和回顾性队列研究为主,委托服务类别以进行样本检测和后续数据分析为主。常见问题表现为:92%的合同文本基本信息不规范,26%的合同未提及委托方权责,34%的合同未提及受托方权责,80%的合同未明确项目是否涉及外资单位,72%的合同完全未提及样本是否涉及人类遗传资源管理,剩余样本的处理方式、样本信息和检测数据的处理方式约定不明确,检测费用和支付方式的描述不详细,成果交付的细节未提及,知识产权和保密条款不清晰,违约责任和争议解决方式缺失。本文分别从样本检测合同的基本信息、双方权责、人类遗传资源管理要求、剩余样本的处理、样本信息和检测产生的数据处理、检测费用、成果交付、知识产权和保密、违约责任和争议方式等方面提出了思考和建议。With the rapid development in the biotechnology and precise medication,a rising demand emerges in the areas of biological samples testing of investigator initiated trials(IIT).The related service request for such testing become an important part in the service agreement with all parties involved.This article systematically reviews and analyzes 50 agreements of IITs involving biological sample testing from two hospitals from January 2017 to December 2022,the general characteristics and common problems in which are summarized.The 50 contracts are mainly written in the language of Chinese.The delegated testing institutions are mainly commercial laboratories.The testing biological samples are mainly from the prospective cohort studies and single-arm studies.The service scope mainly covers both sample testing and the subsequent data analysis.The identified common problems of these service agreements are as follows:92%of them did not provide well-defined essential components;26%did not claim the rights and responsibilities of involving parties;34%did not mention the rights and responsibilities of the delegated laboratories;80%did not specify whether the service involved the foreign invested entities;72%did not mention whether the samples were categorized as human genetic resources management;the management of the remained samples,sample information and testing results were unclear;the testing fees and payment methods were not described in detail,as well as the distribution and publication of results;The intellectual property rights and confidentiality clauses are unclear;the liability for breach of contract and dispute resolution methods are missing.Based on the findings in this review,our considerations and recommendations were further provided on the essential agreement components,the rights and responsibilities of involving parties,the management of human genetic resources,the management of remained samples,the data handling procedure of sample data,testing fees,distribution of analysis outcome,intellectual property

关 键 词：研究者发起的临床研究 生物样本 委托检测 合同 

分 类 号：R969.4[医药卫生—药理学]