Republic of Korea |
National Bioethics Review Committee |
Bioethics and Safety Acts (2016) |
IRB review and approval: required. |
Consent: required, may be waived in specific cases, with discretionary power of the IRB committee. |
United States |
Department of Health and Human Services |
Common rule |
Consent: If personal information is secured, can be used without further consent. |
US FDA |
Human subjects regulations |
IRB review and approval: exempted, if personal information is secured and the tissue was not collected for research purpose. |
HIPAA |
Privacy Rule, Security Rule |
SACHRP |
SACHRP Guideline |
Japan |
Ministry of Health, Labour and Welfare |
Pharmaceutical Affairs Act and the Act on the Safety of Regenerative Medicine |
No specific regulations on archived tissue research. |
No consent needed after tissue has been acquired (diagnostic/treatment purpose). |
Singapore |
Medical Council |
Human Biomedical Research Act (2015) |
Consent and IRB review may or may not be required for residual/archived tissue (case by case). |
Bioethics Advisory Committee |
Ethical Guidelines for Human Biomedical Research (2010) |
United Kingdom |
The Human Tissue Authority |
Human Tissue Act (2004) |
Consent is not required. |
IRB approval and review: not required, if personal information is unidentifiable or anonymized. |
Australia |
National Health and Medical Research Council |
National Statement on Ethical Conduct in Human Research (2015) |
Consent waiver is possible. |
IRB approval and review: required. |
Privacy Act (2001) |
Residual tissues considered as abandoned. |