Ethical management of human clinical research in the age of big data

Abstract

Objective In recent years, technology and ideology of big data has played an important role in promoting clinical science research and medical management, which has been paid more attention. And relative researches and findings were reported constantly. However, there still exists some problems on how to apply patient-related big data to clinical researches based on ethical principles. Moreover, for ethical management, it is challenging that technology and ideology of big data is introduced to human-involved clinical researches, especially for the management and protection of biological samples, clinical data, identity information and gene data. Therefore, in the present study, the ethical management methods of human-involved clinical researches in the age of big data are explored. Methods Combining work experience and think from researches, we want to make some targeted suggestions on ethical review. Results In the age of big data, following suggestions should be taken into consideration in human-involved clinical researches, which include standardizing management system of biological sample bank, establishing compulsory isolation system for identity information, improving accountability mechanism for data leakage, and defining participating qualification of gene-involved project. Conclusions The suggestions are expected to exert an enlightening and promoting role in the reformation of ethical review system in the age of big data. Key words: Big data; Human-involved clinical research; Ethical management