Table 2.
ELSI practices and regulations for human genomic research in East Asia
| Regulations a | Responsible agencies | Challenges for research collaboration and public participation | |
|---|---|---|---|
| China |
Interim Measures for the Administration of Human Genetic Resources (1998) [30] |
Ministry of Science and Technology; Ministry of Health |
Public concerns about the misuse of genetic information |
| |
|
|
Public distrust of authorities |
| |
Regulations on Ethics Review of Biomedical Research Involving Human Subjects (2007) [31] |
Ministry of Health |
|
| Indonesia |
National Guideline on Research Ethics: Genetic Research (2008) |
National Committee on Research Ethics |
Protection of rights and privacy of indigenous populations |
| |
National Regulation on Material Transfer Agreement (2009) |
Ministry of Health |
Need for more integrated approach on genome research |
| |
|
|
Low public awareness on genetic information and related ELSI issues |
| Japan |
Ethical Guidelines for Human Genome/Gene Analysis Research (2001) |
Ministry of Education, Culture, Sports, Science and Technology; Ministry of Health, Labour and Welfare; Ministry of Economy, Industry and Trade |
Public concerns about privacy protection in relation to genetic information |
| |
Protection of Personal Information Act (2003) |
Consumer Affairs Agency |
|
| Singapore |
Guidelines for IRBs (2004) |
Bioethics Advisory Committee/Ministry of Health |
Public concerns about potential discrimination, inequitable access and conflicts of interest |
| |
Guidelines on Genetic Testing and Research (2005) |
Bioethics Advisory Committee/Ministry of Health |
|
| |
National Registries of Disease Act (2007) |
National Registry of Diseases Office (NRDO) |
|
| |
Guidelines on Use of Personal Information in Biomedical Research (2007) |
Bioethics Advisory Committee/Ministry of Health |
|
| |
Personal Data Protection Act (2012) |
Data Protection Commission |
|
| South Korea |
Bioethics and Biosafety Act (2005) |
National Bioethics Committee |
Low public awareness of genomic medicine |
| |
Personal Information Protection Act (2012) |
Ministry of Public Administration and Security |
|
| |
Guidelines for Protecting Genomic Information in Medical Institutions (2012) |
Ministry of Public Administration and Security; Ministry of Health and Welfare |
|
| |
Guidelines for Protecting Genomic Information (2013) |
National Project for Personalized Genomic Medicine 21 (PGM21) [32] |
|
| Taiwan |
Guidelines for Collection and Use of Human Specimens for Research (2002) |
Ministry of Health and Welfare |
Insufficient public communication and trust |
| |
|
|
Strict legal regulations due to privacy concerns from human right groups |
| |
Regulations on Human Trials (2009) |
Ministry of Health and Welfare |
|
| |
Personal Information Protection Act (2010) |
Ministry of Justice |
|
| |
Human Biobank Management Act (2010) [33] |
Ministry of Health and Welfare |
|
| Human Subjects Research Act (2011) | Ministry of Health and Welfare |
aYear of establishment of regulation, or enactment of law, is shown in parentheses.