基于组学技术临床检验大数据研究的伦理问题  

Ethical issues in the study of clinical laboratory data based on omics techniques

作　　者：贾效伟[1] 宋艳双[2] 陆祖宏[3] 

机构地区：[1]北京大学口腔医院科研处,100086 [2]北京大学医学部科研处 [3]北京大学工学院健康系统工程研究所

出　　处：《中华医学科研管理杂志》2016年第1期11-13,共3页Chinese Journal of Medical Science Research Management

基　　金：国家自然科学基金资助重点项目（91546203）

摘　　要：随着基因组测序成本的大幅度下降，高通量测序技术开始应用于临床医学检验领域，并在复杂疾病的临床诊断和治疗中将发挥越来越重要的作用。基于组学技术的临床检验数据系统记载了患者的诊疗信息，成为当前大健康产业重要的独立医疗研究资源。但是，由于这些数据包含患者的身份信息，在开展医疗健康大数据研究的同时，存在患者知情同意权保护、患者隐私保护、数据安全管理等一系列伦理问题。本文基于这些问题，提出可对临床检验数据进行标准化提取，建立临床检验大数据知识库，供教学培训使用，以提高医疗资源的利用率。另外可在临床检测采集样本过程中实施书面化知情同意，告知病人该数据在提供其诊疗后，可能再应用于相关的科学研究。With dramatic decline of genome sequencing cost, high--throughput sequencing technologies have been applied in clinical laboratory field, and play an increasingly important role in clinical diagnosis and treatment in complex diseases. Based on omics techniques, clinical laboratory data recording patient＇s diagnosis information has become the important independent medical research resources of the major health industry. Because these data include the patient＇s identity information, there are a series of ethical issues to be solved, such as protection of patients＇ informed consent right, patient privacy protection, information security protection, when carrying out the medical health big data research. Based on these problems, it proposed clinical laboratory data should be standard extraction, establishment of clinical laboratory data base for teaching, training, in order to improve the utilization of medical resources. Moreover, it is best to implement the written informed consent during the process of sample collection, informing the patient the data collected in diagnosis and treatment process may be used in related research in future.

关 键 词：组学技术 临床检验数据 数据标准化 知情同意 伦理审查 

分 类 号：R18-39[医药卫生—流行病学]