ELSI issues of Precision medicine - Comparison of US, South Korea, China and Mongolia focusing on informed consent and privacy

Abstract

This study aims to review current precision medicine, analyze ELSI issues and compare legal and regulatory framework of informed consent and privacy issues in countries, namely US, South Korea, China and Mongolia. This has been conducted through analysis of current situation and challenges that four countries are facing in terms of informed consent and privacy issues in precision medicine. The purpose of this study is to develop recommendation for Mongolia based on three countries experiences and pros during development of precision medicine regarding informed consent and privacy. In order to carry out this study, mainly two study methods are applied. First, the literature review was performed with academic articles and reports on precision medicine and its ELSI research including informed consent and privacy issues, and officual documents from each government website. Secondly, the comparative analysis of the legal and regulatory frameworks that relate to informed consent and privacy on prevision medicine was conducted in four countries. Through the analysis, it has clearly revealed that Mongolia need to improve regulation related to informed consent, including appropriate language and terms, evaluation questions and approval of electronic version. But in Mongolia, special contemplation should be discussed in order to develop electronic informed consent due to nomadic life, lack of infrastructure, like internet, computer in remote areas, and low computer and health literacy, especially in non-capital areas. Since Mongolia is taking first step in privacy protection in context of personal information and sensitive information including genetic and biometric, several updates and recommendation could be proposed based on described approaches and solution ways from respective countries. This includes official implementation of PIPL, development of guideline for de-identification of personal information and building capacity for human resources and technology. Moreover, experience from developed countries can help improvement but approach need to be naturalized accordance with Mongolian background. Even though Mongolian government is started to focus on biomedical researches and related issues to enhance quality of research field and open more gates to researchers, infrastructure preparedness has developed very slowly. Recommendations arise from this study, may provide some opinions in building better frameworks targeting informed consent and privacy issues in Mongolian situation. Furthermore, detailed analysis from expert’s perspective will need to be conducted for achieving successful results with improvement from international experts’ experiences and support.